People Always, Patients Sometimes

On this episode of People Always, Patients Sometimes we welcome Michelle Shogren back to the podcast. Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. We recently spoke to Michelle Shogren, a familiar face in the clinical trials industry, most recently at Bayer Pharmaceuticals. She recently left Bayer to form her own consulting firm called Innovate In What You Do! Michelle is parlaying her 25 years of experience fostering teams and developing an innovation mindset into her consultancy. Michelle and our host, Janet Kennedy, have a lively conversation about innovation, which I know you'll enjoy on this episode of People Always, Patients Sometimes.

 

Janet Kennedy: (00:47)

Hi, I'm Janet Kennedy and I'm a member of the Spencer Health Solutions team. It's always a pleasure to talk to Michelle Shogren on People Always, Patients Sometimes. We spoke to Michelle recently on an episode about innovation in clinical trials and the pharmaceutical industry. Today, we're gonna be talking about Michelle's new company Innovate In What You Do! Welcome back to the podcast, Michelle.

 

Michelle Shogren: (01:11)

Hi, Janet. Thanks for having me back again.

 

Janet Kennedy: (01:13)

I am so excited about your new company, but for those folks who might have jumped into this episode and hadn't heard the previous one, do you mind setting the stage a little bit and telling us a little bit about your background?

 

Michelle Shogren: (01:25)

Sure, happy to do that. So I've been in the clinical trial space now for about 25 years in different roles of patient caregiver study coordinator, site, director, marketing director on that side of the fence. Then I jumped over into the CRO world as a monitor and on to pharma to be a monitor, country lead monitor, study lead monitor, and eventually working in process excellence, and then starting an innovation function. The innovation function I created in 2015 with a team of six people who were working on something called fostering innovation. And we were trying to prove innovation made sense in R&D other than coming up with just the molecule. We were able to successfully launch that and grow it over the seven year period to a point where they said, "You know what, you're doing so much now, and it's so impactful for clinical development and operations; let's move you up to strategy portfolio and operations, and you can support all of pharma R&D," which included 11 functions now, instead of just one. So obviously we were doing something right along the way, and now I've had a chance to leave Bayer and focus on some family and some health needs. And I decided what a better time to start my own company to try to help even more people and stay close to the patients.

 

Janet Kennedy: (02:44)

All right. So I guess we're gonna start with a challenge. It's very comfortable, sometimes working for a very big organization with a lot of structure and benefits and support, and you've gone 180 degrees and you are now a self-employed entrepreneur. I understand that through work in innovation, you have to think like an entrepreneur in a big company. Do you think that that's laid the groundwork for your decision to start your company?

 

Michelle Shogren: (03:12)

I think it definitely made it easier for me. It's also something that I've been considering and thinking about for a few years and had planned as a later in life activity anyways. So when the catalyst of change came, I thought, "You know what? We can just go ahead and advance it and make it faster." But you're right. It's a little scary

 

Janet Kennedy: (03:31)

Well, there are a lot of folks out there to support you. That's the one thing that I would share with you; I did come from an entrepreneurial background, was very involved in startup weekends and innovation programs. And it is the most collegial group I have ever run into. Everybody wants you to succeed and they're all there to support. So I think even though you are pretty fresh on the entrepreneurial track, you will find that the network is there to support you. So there's a little bit of encouragement for you going forward.

 

Michelle Shogren: (04:03)

Thanks, Janet. I needed that today.

 

Janet Kennedy: (04:06)

Well, tell me about the company itself, Innovate In What You Do! Why call it that and what is it all about?

 

Michelle Shogren: (04:13)

Well, you know, it's actually, it was a phrase that our corporate innovation had thrown out one time in a presentation and had used it a couple different times. And I said, "You know what? I love this phrase because of the fact, it doesn't ask you to do innovation." It says, "You know what? You can innovate in the things that you do on a regular basis." And that is my philosophy going forward. Why innovate in some other space? You wanna innovate in what you do. And it was all around the fact that how can we be better at our day to day activities, and how can we make a difference for people out there? I have a near and dear passion of patients. So of course, if I can use these powers for good of helping patients in particular, that would be great, but I really just have a purpose within me to help others. And I think innovating what you do can do that.

 

Janet Kennedy: (05:04)

Now. I sense that this is not a quick decision that you made and that this is something you actually have experience doing. So tell me how the actual services that you would consider providing in your new business relate to the work that you did at Bayer.

 

Michelle Shogren: (05:21)

So I have been consulting in some form or fashion for years and years and years, usually just pro bono, trying to help people out and give them encouragement or some direction when they were misguided. Either startup companies, tech companies, different solution providers would come to us and I would say, "Hey, what do you think about this or that," in order to help them figure out, how do they fit into this world of pharma? How do they communicate better? And how do they think about their users at all the steps of the way? A lot of times when we think end users, we think patients, but there's study teams, there's sites. There's so many different pieces that all have to come together to make it work. So one portion of in innovating, what you do is around innovation consulting and trying to help those same people going forward.

 

Michelle Shogren: (06:06)

So maybe it's a pharma company trying to create an innovation function like I did, or maybe it is somebody who has an innovation function and they're struggling with taking those ideas that they have, and actually getting them to incubate and moving them on to implementation. But it could also be other sectors in the same environment or ecosystem that we sit in. So other solution providers, tech companies, startup companies, things of that nature, but it can also be innovating in your leadership style because that's another big piece that people need help with. And that goes back into innovating what you do.

 

Janet Kennedy: (06:42)

All right. So let's go break this down a little bit and I'm gonna get myself some free consulting here. So here's our scenario A - it is a company that really never had anybody with a title of innovation; they were just a traditional company doing the traditional things, but they recognized that maybe their process was a little stale or that they were doing business as usual so much that business was maybe even declining or productivity was declining. That's a pretty big task to come in as an outsider and try to shift that. So how would you go about it?

 

Michelle Shogren: (07:15)

It depends on what their main problem or what they think their problem is. Sometimes they don't even know. And that's where we have the first stage of Innovate In What You Do! So I call it my 'two eyes wide' approach. Cause if you look at the abbreviation for Innovate In What You Do!, it's I.I. - two eyes - and then W Y D - which also sounds like wide. So with this approach, we always have to make sure we know the problem itself and there's different innovation techniques that we can do to ensure that we are thinking about this all the way around. And we really do understand what the problem is. If they have that figured out, then we look to see, okay, well, what are your ideas that you have to fix it? Sometimes they have ideas and they just don't know what to do with it. And I can help them with that other times, they're like, you know what?

 

Michelle Shogren: (08:00)

We just know the problem. And we've been kind of trying to come up with ideas for a long time and not have a much success. So in those cases, I can help with innovation workshops, design sprints, things like that, using my knowledge of seven different innovation methods, as well as facilitation methods that allow them to focus on the content and not how to get to a solution or a resolution. If they have the ideas and they need to figure out how do I incubate them for success? A lot of people approach things like regular projects, just typical project management. This doesn't work for innovation. You actually need to know how to do innovation project management, which is an advanced form of project management. It allows you to do iterations and pivots where a standard project management doesn't even know what to do in those situations.

 

Michelle Shogren: (08:46)

And it also has a huge focus on the user. And how do you bring their voice in early? And how are you testing along the way to make sure you're on the right path and set up for success and building champions within the people that you're gonna have to end up selling this to later on. And if they have an idea of how to do that, and they've gone through everything, but now they're struggling to actually implement it. They've proven in a proof of concept. It makes sense. It totally has the benefits that are there and it's doable, but they're just failing at how to get that implemented either at their company, or maybe they're trying to sell something to another company. That's another piece that we can help as well to try to figure out, okay, why is this a problem? What do you need for a good pitch? Do you have all the data that's necessary? Are you prepared for the questions they're gonna ask? And then what are the tips and tricks that I can share from all the years of experience of being able to be proactive instead of reactive in this environment.

 

Janet Kennedy: (09:43)

So let's go back to the companies that maybe accept the idea that they need to be innovating or they're attempting innovation, but it really isn't getting off the launchpad. A lot of the problem is most employees feel like I'm already busy. Now I'm already overwhelmed. I can't get my regular work done. And now I need to go into a workshop and we're gonna brainstorm some stuff, but I'm gonna go back to my regular job after that. How do you get people on board and then how do you make them or encourage accountability once you've finished a workshop?

 

Michelle Shogren: (10:15)

Great question Janet. Many times when we find the situation, I can simply ask them, "Oh, well, how long have you been working on this topic?" And most of the time, it's not a brand new topic. It's something they've been struggling with. And they say, "Oh, we've been working on this for months already." I'm like, "Oh, okay. Well, how many ideas did you come up with in those meetings over the last couple of months?" "Oh, well we had a few, but you know, um, nothing really seemed to land well," is usually what they say. And I said, "Oh, well, can you show me the list of ideas?" "Oh, well, we don't really document them. We just talk about them." And that's big problem. Number one is that they've obviously spent a lot of time on it. And if I could have a workshop with them for two to three hours, bring all the right people together, ensure that the process was followed.

 

Michelle Shogren: (11:03)

I provide the time constraints that are necessary to keep from overthinking or chasing rabbits down holes we don't need to do. And I ensure there's documentation of all of the ideas and the concepts that come out of it. Now I've given to them what they've tried to do for the last three to six months, possibly in two to three hours. And if you add an extra hour onto that, I can give you your next step session, where we talk about jobs to be done. What are the first next steps? Because sometimes people think, "Oh gosh, there's so much to be done." And they look at the end, result, that's out there and they get overwhelmed, kind of like me in housework. So this way I can say, "Hey, what's just the first next step to get this moving in the right direction. Who's gonna be responsible for it? And when do you think it's realistic to get this step done?" And I'll help them map that through in order to be able to ensure life after the workshop actually yields results. And you can bolt on a consulting subscription to it afterwards to help make sure they're driving in that direction and see how they're going along the way and where do they need help. And sometimes you just need someone to push you. You just need that meeting on the calendar to make sure stuff's getting done.

 

Janet Kennedy: (12:09)

Even if it is the day before the meeting.

 

Michelle Shogren: (12:12)

Exactly. And many times it is, but Hey, at least it got done.

 

Janet Kennedy: (12:16)

So innovation also sounds hugely expensive. When you talk to companies, are you telling them that there's no reason meeting if you haven't set aside some budget to support the ideas that will come out of this?

 

Michelle Shogren: (12:30)

No, actually I don't because you know, back in my previous life, when I was right out of school and going into college, I sold Kirby vacuum cleaners, and these were vacuum cleaners that cost about $1,400 to purchase. And I was selling them in rural south Texas, where people made that in the entire month of work. And I found a way to be the top salesperson, even though budget constraints were definitely an issue because if there's enough value there, if there's enough shown benefits, if you do your job well enough in researching and testing things, to have data driven decisions, they'll find a way to find the money.

 

Janet Kennedy: (13:07)

Oh, that's an excellent point. So I'm now picturing you going to door selling vacuums, and I love this idea in my head. And that brings me to my next question is: a great percentage of your experience has been in pharmaceutical industries, but everybody needs to innovate. So do you feel like the processes that you've set up, the programs that you're going to be offering, that they are applicable to any industry?

 

Michelle Shogren: (13:32)

Absolutely. I think that the innovation piece of it provides the framework to be able to be applied to any place. And I've actually helped my friends in different industries innovate in what they do just as a friend. So I've helped a day spa figure out how do they retain their people that are working there, their employees, after they get trained, because they were all jumping ship. I've had a funeral home that was trying to figure out how do they have advertising in a situation like that that was quite difficult. So you can, you can apply it in any kind of area. One of the things though that I think sets me apart is the fact that I do have all the experience in all the different roles along the life cycle of a clinical trial. And that's one reason why I'm predominantly positioning myself within this area still, cause that's really where my passion lies. However, my daughter Ren, who is 26, she has come on as a creative director for my company and she has different backgrounds. She has actually worked for bayer as well for a year, as well as other medical companies. And she's also done some really interesting, crazy things with auto dealerships and marketing companies and emergency response companies. So she's seen a lot of other things and she's gonna be able and available to help in some other sectors as well, doing some of the similar things.

 

Janet Kennedy: (14:58)

Well, that was going to be my next question, which is, there is no way you could do this on your own, so how are you building out your community? Do you see this aside from your very talented daughter, do you see this as something that is trainable and replicable so that you could have additional folks leading a workshop for instance?

 

Michelle Shogren: (15:18)

Absolutely. And I already have some people that have reached out to me and were interested in helping and coming to work for me, which is really exciting. I need to have the amount of work first for me to bring them on, but I have several that have experience with innovation, possibly even with me in the past, so that I know their skill sets and their capabilities. Because whenever you do a workshop, especially you need to have two people it's so much better. And I also wanna bring in some diversity and mix because I really believe we need diversity and inclusion in order to have impactful innovation. So that's another big piece. So I'm looking for people that could support also in different places around the world going forward, but I can't get too far ahead of myself. Let's see if this even takes off the ground first.

 

Janet Kennedy: (16:04)

All right. Then one last question, and it's obviously self-serving because I believe the more podcasts the better, but I see on your website, you're thinking about launching a podcast. So what's your plan for that?

 

Michelle Shogren: (16:17)

My thought was I could interview different thought leaders about some of the things that they did as far as innovation, but we could also have some podcasts of talking about what you can do in these situations where it's more of an interview situation. And we talk through what different tools could you do, some easy things you can apply in your day to day work and you can just listen to it and have it to take away with you. Some simple understanding the problem exercises or possibly innovating in under an hour, what you could do with your teams in a regular meeting, some of these key pieces to help them learn and grow and take away some valuable educational information.

 

Janet Kennedy: (16:56)

Oh, I think that's incredibly exciting. Well, I wish you so much luck and success with your new company. I know we'll be talking to you and working with you going forward, but I guess break a leg and I hope it goes very, very well for you.

 

Michelle Shogren: (17:11)

Thank you so much, Janet. I really appreciate you having me here today.

 

Janet Kennedy: (17:14)

You've been listening to the People Always, Patients Sometimes podcast, today with our guest Michelle Shogren of Innovate In What You Do!

Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. We are proud of the amazing work that pharmacies do to support patient health and wellbeing. The need for innovation in the clinical trial ecosystem has challenged traditional pharmacies to rethink their strategy since they are the ones with the greatest access to a diverse and underserved population. On this episode of People Always, Patients Sometimes, we hear from a member of the clinical trials team at Walgreens that recently announced a corporate launch into providing clinical trial services at neighborhood store locations. Adam Sampson, head of clinical delivery operations for Walgreens is one of the team members tasked with managing the plan at clinical trial services to brick and mortar locations by the end of the year. I hope you enjoy this conversation on People Always, Patients Sometimes.

 

Janet Kennedy: (00:53)

Hi, I'm Janet Kennedy and a member of the Spencer Health Solutions team. I'm looking forward to speaking with today's podcast guest, Adam Samson on People Always, Patients Sometimes. Adam is the Head of Clinical Delivery Operations for Walgreens, and he has a really big project in front of him. Welcome to the podcast, Adam!

 

Adam Samson: (01:12)

Thanks so much, Janet. I really appreciate you having me on the show.

 

Janet Kennedy: (01:15)

Well, you know, we've heard a little bit about you from my CEO, Tom Rhoads, but I'd really like to figure out how you got where you are today, especially from your startup background. So do you mind giving us a little bit of a catch up with your career and how you ended up where you are today?

 

Adam Samson: (01:31)

Yeah, I'd be glad to. So I started my career in clinical trials as many people do, you know the cliches - to say that we kind of fell into the industry. I was a registered dietician out of undergrad and very quickly found my way into interacting directly with patients as part of clinical trials and worked as a clinical research coordinator for a few years and transitioned from there about 10 years ago into the more business side of our industry. So I worked at a couple mid-size CROs, took a very standard path. I was a regional monitor, worked in project management in line management. And then about seven years ago, my wife and I moved out here to North Carolina and I worked at Duke Clinical Research Institute for a few years. While at Duke, I did a lot of work in government funded trials in the pediatric space and completed a master's degree through George Washington in clinical trials.

 

Adam Samson: (02:28)

And then I moved to a large pharma company and was conducting global, late phase studies. And then the pandemic hit, like many of us, I was, scrambling to keep my study going. You know, it's a hundred sites in eight countries. And how do we, possibly kind of keep operations, running lots of challenges. It was an eye opening experience around how in this industry, we really are under utilizing technology. That's no surprise to anyone we've gotten a bit better, but especially at that time, the start of the pandemic, getting even things like e-consent and other things approved was very challenging. So I decided to kind of take a leap of faith and join a very small time startup that was in the decentralized clinical trial space and had a great software product, but wanted to really build out their services and operations.

 

Adam Samson: (03:22)

I joined the team when there were about 15 people and was with the team until series B and about 130 people. It was a really exciting couple years and enjoyed working in that space of how do we bring trials into patients homes and give them additional options to participate in trials? The one thing that remains a pervasive challenge when we're trying to do decentralized trials is that technology of course, is not enough. Sometimes patients there's a lack of trust. If things come through via email or they see them on the internet, not everybody wants somebody in their home. Sometimes people want to, go to a trusted healthcare provider, that's local to them. So when I saw this opportunity open up at Walgreens recently, where Walgreens was getting into the clinical trials business kind of light bulb went off, I'd been watching what's happening just overall in the retail pharmacy space.

 

Adam Samson: (04:16)

And, I saw this as just an incredible opportunity to be able to take what I had learned across my career and kind of running trials in the traditional site based model, as well as, more recently working in the decentralized trials model and saying, "What if, we can take the best of both?" And we've got the technology and Walgreens has 9,000 approximately stores in the US. So 78% of the, the us population is within five miles of the Walgreens. What if we can take and plug clinical trials into that, right? There's the existing trust within the Walgreens brand and with the pharmacists that these patients are seeing every day. And we can really build a model on a really strong foundation that Walgreens has started to build in the healthcare space. So I joined the team as Head of Clinical Delivery Operations, as you said. And my role here is really to operationalize our stores, our physical footprint. How do we make sure that we have the right people process and technologies to be able to start seeing clinical trial patients within some of Walgreen's locations?

 

Janet Kennedy: (05:26)

All right. So let's go back a little bit to joining Walgreens in clinical trials. This is very new for them and you are in a very new group at Walgreens, are you not?

 

Adam Samson: (05:37)

Absolutely. Yeah, you're correct. So about seven months ago, actually I might even take a step farther back than that and say spring of last year, we had our new - no longer new, I guess - CEO, Roz Brewer, joined. And Roz, very quickly - I believe it was by, by fall of last year - announced that we were moving into the healthcare space with the offering of Walgreen's Health. As part of that vision that she had, right? Overall moving to a more interoperable health type framework to ensure for our patients, our main constituents here at Walgreens, that we were not decoupling them from their healthcare providers, but really helping to bridge that care continuum. Part of that offering, they realized clinical trials could be part of this, right? So about seven months ago, my boss, Ramita Tandon, our Chief Clinical Trials Officer, joined the team, joined Walgreens Health, and she began to lay the framework for what this clinical trial business would look like. What services we might offer to begin with, what are the key roles that we needed leadership to get going?

 

Adam Samson: (06:50)

And then Ramita, a couple months ago started bringing on other folks like myself. So I've been with Walgreens - I believe this is the end of week six for me - we've had some folks on a couple weeks longer, or a couple weeks less than me, but we're coming from different backgrounds. We have folks on the product side, we have folks who are really accustomed on digital optimization and how do we engage with patients in a meaningful way, making sure that we leverage our footprint to engage with folks in diverse communities. so really exciting to be part of this new and growing team.

 

Janet Kennedy: (07:29)

I am both thrilled and awestruck for a huge company like that to make such a big move is amazing. And I keep thinking, you're trying to move a tank when the industry needs to be on motorcycles. That might be a horrible analogy, but it's a huge company you said over what, 7,000 locations within five miles of individuals. So how do you do that? Are you cherry picking certain markets or certain states where you already have some of those type of services in play or is this literally you're starting from a blackboard and you're just starting from the very beginning.

 

Adam Samson: (08:09)

Yeah, it's a really good question. And honestly kind of going back to when I first saw the opportunity open up here for a position with Walgreens, my first thought similar to years I think was how could this possibly happen as a company so big, right? how could you possibly get something this big done, and after a call with Ramita, it was quite clear to me that Walgreens was very much invested in this, but also that they had the leadership team Ramita included to really make this happen. I've been blown away since I've joined at not just our small core group that is starting, but outside of that, in the Walgreens ecosystem, just a lot of excitement around Walgreen's health and clinical trials in particular. So obviously we're part of this larger company, but we are somewhat entrepreneurs, right?

 

Adam Samson: (08:54)

We are being given the opportunity to start something new within a very large business and allowing some flexibility around how we might be able to make sure that we can do that in a way that is both effective and compliant, but also nimble. Now 9,000 stores - obviously we're not gonna try and open them all at once and, and activate them as clinical trial sites. The biggest thing on my mind right now is I'm traveling to a number of different locations. We have other folks on our team who are as well meeting with stores, understanding capabilities. We have identified already a number of stores that really are the ideal kind of first step, if you will, to be clinical trial sites. So we have a few investments, key investments that we've made, and some companies that I'll talk about that will really support that.

 

Adam Samson: (09:47)

And also, I will say that Walgreens has, we've started building out what we call health corners. So this has already been happening for a year. Plus health corners are a place where there are a small physical footprint within a Walgreen store. That's staffed with a registered nurse or a registered pharmacist. They have private health rooms and they have places to interact with technology. And it's a place where our patients can go and they can have deep discussions that can help them with chronic care. They can have blood pressure drawn, maybe they could have, blood taken, these type of things to help with chronic disease management and others questions that might come up. Our idea first is to leverage these existing capabilities, as you can probably draw the connection there, right? We've already got nurses, we've got a private health space.

 

Adam Samson: (10:39)

So we're gonna use that and make sure that we put trained clinical research professionals in place to support these activities within these spaces and support them with centralized staff as well. Now we don't wanna stop there. we don't wanna be limited. Now we are somewhere in the range of 200 health corners. I believe by the end of the year, we don't wanna only focus there. As I mentioned, we have some, some other key partners. One is village me medical or village MD. So village MD is actually a primary care offering in a community based setting. And these will be co-located with Walgreen. So this is actually 3,200 square feet of a Walgreen store that will be dedicated to primary care staffed with physicians and other clinicians. So this is another great opportunity for us to be able to leverage the existing Walgreens Health enterprise, to be able to plug clinical trials in make sure that we're doing it in compliant way, but utilizing the existing infrastructure.

 

Adam Samson: (11:38)

There are some other exciting partnerships we have with Shields Health and specialty pharmacy, as well as CareCentrix in post-acute and, and home care. But as far as the physical space and building that out, that's where my focus is right now. How do we activate existing health corners and Village MD, but also looking at our our physical footprint that's out there that has private health rooms because of the immunizations. We administered approximately 63 million COVID vaccines. These spaces are already being used for healthcare purposes. How can we staff those stores and make sure that they are compliant to do certain clinical trial procedures, lots to think about long winded answer there, but really, really kind of cool work to start conceptualizing.

 

Janet Kennedy: (12:27)

I've spent a little bit of time in the shopping center industry. So I feel like I've got a grasp of retail space issues and questions. And let me ask you this. A lot of the Walgreens, I would imagine in more rural or suburban areas have lots of space, but not necessarily in downtown Atlanta or downtown Raleigh or downtown New York city, are you gonna be able to find the space you need in those urban populations, which also are in areas that wouldn't be dealing with underserved populations?

 

Adam Samson: (12:58)

Yeah. And I'm glad you mentioned that too, because this is as we've been very public about in our announcement, one of our biggest focuses right now is making sure that as we are opening up these type of health corners for healthcare purposes, but also our clinical trial purposes. So more than 50% of Walgreens stores are in socially vulnerable areas. And right now there is a huge push in industry and for very good reason to increase, diversity and inclusion within clinical trials, as we're looking at potential locations of where do we start doing this? We're not making it easy on ourselves. We're not, yeah. Let's, to your point, right, go to just the stores with the highest volume or anything. We're very much focused on going into places where there is not as much access to clinical trials or healthcare overall, and areas that are in communities that are overall just underserved. We have already started having these discussions with the the regional managers to identify those stores where, to your point there's only so much retail space or pharmacy space, and this is another thing that we're bringing into stores.

 

Janet Kennedy: (14:08)

Well, you know, I'm wondering about how you're finding out what the needs are. Have you been in communication with some of the larger pharmaceutical companies in a, a, what if scenario, you know, if this were available, what kind of things could we bring to the table? What would you need to get from us? Obviously, patient records are a big part of what you have and also from the geographic location. I mean, so often now clinical trials are done where the principal investigators are. And a lot of the principal investigators are in larger city centers where there are medical centers and universities. How do you balance those needs with what do you actually have to have for the space to conduct a clinical trial?

 

Adam Samson: (14:51)

Great question. And so, yeah, when it comes down to it and what I've spent a lot of the past two years prior to coming to Walgreens doing is trying to figure out how can we leverage some of these new models, right? So how can we leverage, not necessarily even fully decentralized hybrid type models. And we're looking at that with Walgreens too, right? How can we potentially have something at something like a Village MD where there's primary care and physicians and have kind of a hub and spoke model potentially right. Where we would have a PI within a certain region that might be conducting activities within a larger clinical type site, but then have within perhaps a 40 or 50 mile radius, we have X number of Walgreens locations and patients are able to go there for perhaps some of the follow up, right? They can meet with coordinators and have their blood drawn. They can have assessments done, and then if need be, they could come into the to the larger, location for certain procedures throughout the course of that trial. So looking at it in a very broad way and saying, we need to make sure that there's that PI oversight. How can we enable that though over a bit of a larger distance through centralized administrative support, as well as really best in class technology,

 

Janet Kennedy: (16:07)

As I think about a Walgreen's on every street corner, what about the idea of the local Walgreen staff actually going to the patient to their home? Is that something you've discussed?

 

Adam Samson: (16:18)

So we are absolutely looking at also as an option, not just in store, but also bringing this at home, in a doctor's office via mobile app. So we will be in addition to the existing Walgreen staff, which we very well are looking at opportunities for folks to be upskilled into clinical trials. We will be partnering with folks like, those that we have potentially over at CareCentrix and others that are accustomed to working within patients homes so that we can offer that as a service as well, where we could if it's permitted by the protocol, be able to, rather than have patients come all the way into a larger clinic or even to have to drive 10 minutes down the road to a Walgreens that we could potentially go out for certain things like blood draws and other things, and be able to see patients in their home, especially for those type of conditions patients might have where it makes access to clinical trials has decreased because of decreased mobility.

 

Janet Kennedy: (17:16)

Now, the patient is obviously an important part of what we're talking about because that's one of the reasons that clinical trials do struggle that it isn't wrapped around what the patient needs, what the patient expects and how to support them best. Have patients been involved in these kinds of conversations, has Walgreen committed to any kind of patient advocacy committee group or focus group or anything of that sort?

 

Adam Samson: (17:41)

Yeah, I mean, it's very early days, I will say, right. So we did launch just last month, but I am thrilled that we have on board, some folks like Kendal Whitlock who comes with just vast experience in this area, right? Working with patient groups and ensuring that we get that type of representative voice within our research program. we're also talking some other organizations right now that I can't share publicly just yet. but really positioning ourselves very early on. Like I said, we're only a month or so in since our launch to make sure that we are not assuming what our constituents and what our patients want, but making sure that we're hearing directly from people within the communities. Another thing just to kind of bridge off of that is we're looking at not just how do we inform Walgreen's patients and customers about clinical trials that, that might qualify for them, but also how do we kind of help the industry and our patients with this grassroots basic general clinical research, understanding and education, because as you well know, the barriers in a lot of these communities to clinical trials is either a lack of understanding or a lack of trust.

 

Adam Samson: (18:56)

And if we just go in and, and start advertising clinical trials and every single Walgreens, I don't think that that's really gonna solve the problem. So we wanna be able to do some of that foundational clinical trial education through our pharmacist, through, through other staff to really start to build those connections with patients and hear from them so that that can help us inform our strategy.

 

Janet Kennedy: (19:21)

Well, that's really exciting because aside from the two things you already mentioned, just awareness that a patient could be eligible for a clinical trial is a real challenge. So I think the opportunity that you have to make folks aware that it's happening on my street corner is a lot different than, you know, what a lot of patients experience. And certainly if there is at all, a silver lining to the pandemic is that I believe people became aware that clinical trials are an essential part of forwarding health and forwarding the learning about drugs and new ways to deal with illnesses and diseases. So hopefully people have also understood that it is a process that while doesn't happen overnight, we were able to escalate that during the pandemic, but that it's essential that we have patients a part of the process.

 

Adam Samson: (20:16)

Absolutely. Yeah. And this idea of trying to assume what patients might want or to kind of do those checkbox activities of like, oh, well, we talked to a patient. I think, as an industry we're, we're moving past that. We're understanding that this is more than that, that we really need to engage in a meaningful way and that it's not a one and done kind thing. And I've been really glad to see that Walgreens very much is taking that approach to everything. And across the Walgreens health platform we have 160 million approximately lives that we service through Walgreens. And the trust that we have with those customers and those patients is something that is really first and foremost to Walgreen. So as we look at things like supporting, recruitment, as part of clinical trials, looking at insights gained through real world evidence, we have a really robust foundation around regulatory and privacy to make sure that we're not in any way violating that trust. And we're giving our patients, our customer the opportunity to opt in and opt out of these type of things. So that it's again seen as something that we can engage with them on, in a way that works for them, get their feedback. But if they're not interested also be able to not push the issue beyond the point where it should.

 

Janet Kennedy: (21:44)

Absolutely. I think that should be the tenant of any healthcare organization patient first and what are they going to be comfortable with? Well, I'm really excited that I was able to capture you so early and fresh in your experience with Walgreens and at the very beginning of your more public announcements related to getting involved in clinical trials. And I'm not gonna put you on the spot per se, or hold you to this, but what does it really mean? What's it gonna take to get you up and running? And, and when will the first clinical trials be supported at a local Walgreens

 

Adam Samson: (22:19)

We're shooting for this year, right. We, we want this to take months, not years to get off the ground. There's already, as I mentioned, been some groundwork done even before this initial team has started, there's been some really great work done by folks here at Walgreens to make sure that we're gonna be able to roll this thing out in a very compliant way. And now we got the folks on board that are needed to really start executing. And we're not starting from zero as well because we have as I mentioned, some physical locations that are very well staffed and set up to be able to support clinical trials. So we don't wanna rush, we do wanna walk before we run, but we anticipate that this year we will enroll patients within, a small number of clinical trials and start to get the wheels moving on this and then learn and, and build over time to be able to offer an increasing number of services and to be able to, service protocols of increasing complexity. So yeah, I would say, and expect by the end of the year to hear that we've had our first patient in store and certainly even before then, that we're, supporting recruitment in different ways as well.

 

Janet Kennedy: (23:27)

Oh, that is very exciting. Well, I look forward to not only catching up with you in six months, or a year and finding out how things rolled out, but also speaking to other members of your team, hearing maybe a little bit more about how real world data and real world evidence will be incorporated into the programs; how patient engagement is going. So let's continue the conversation and thank you very much for being a part of People Always, Patients Sometimes.

 

Adam Samson: (23:54)

Absolutely. Thanks so much, Janet for the opportunity. I look forward to reconnecting, and thanks so much everybody who listens.

Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. Today we have the first of two interviews with Michelle Shogren. Michelle is a familiar face on conference stages as a 25 year veteran of the clinical trials industry. Most recently as Senior Director of Business Excellence and Innovation for Pharma R&D at Bayer Pharmaceuticals. She recently left Bayer to form her own consulting firm, but more on that in a later episode. For now, I know you enjoy this discussion on innovation in the pharma industry with Michelle Shogren and Janet Kennedy, on this episode of People Always, Patients Sometimes.

 

Janet Kennedy: (00:40)

Hi, I'm Janet Kennedy and I'm a member of the Spencer Health Solutions team. It is such a pleasure to have Michelle Shogren as our guest on People Always, Patients Sometimes. We've known Michelle for a few years and have followed her leadership posts on social media even longer. Welcome to the podcast, Michelle!

 

Michelle Shogren: (00:58)

Thank you so much, Janet, for having me. I'm really excited to be here today.

 

Janet Kennedy: (01:02)

You know, you've heard a little bit about Michelle from our CEO, Tom Rhoads, but I'd really like to dig in and learn a lot more about you and your background. So can you kinda gimme the short version of how you got where you are today?

 

Michelle Shogren: (01:16)

I think like many of us, I kind of fell into clinical research. I started out as a nurse and someone upstairs was doing clinical trials and got to go to cool places for investigator meetings. And I said, I wanna do that too. And I convinced the doctor that maybe this was also a good way to show our patients. We were forward thinking and we were looking at additional options and have another revenue stream to come into the office. And we kicked it off from there fast forward, 25 years later. And here we sit today, having had a chance to be a patient in trials, a caregiver for my family, as well as be on the site side of things as a site director and marketing director, as well as a study coordinator. And then on the CRO and pharma side, as a monitor and someone leading the studies at different levels, as well as having an opportunity to start an innovation function at Bayer.

 

Janet Kennedy: (02:07)

Well, that really was a short introduction and I have like 10 questions just from hearing that. You know, it's interesting - you really have walked the walk. So it isn't just an esoteric type of job description; you have participated in and are living the life that many of our patients and our colleagues just talk about.

 

Michelle Shogren: (02:31)

Yeah. I actually have personally experienced the value that can come from clinical trials as someone, as an individual who needed help and have offered this kind of help to my friends and family by helping them search for trials and finding ones that might meet their needs because it's an often missed opportunity for patients out there.

 

Janet Kennedy: (02:53)

So when you joined a pharmaceutical company, was it a big shock? Was it very different from what you were expecting or did it feel like a natural evolution?

 

Michelle Shogren: (03:03)

I think one of the most surprising things for me was I had always heard that big pharma was only after your money and they couldn't trust them. And when I came to pharma and I started meeting all the people who are in research and development, I found that so many had stories like me, so many were connected to someone who had some condition and they were trying to find hope for them. And so many were dedicating their lives to really make people better or bring new opportunities there. And I was blown away by the size of the hearts from these people.

 

Janet Kennedy: (03:33)

But from a size perspective, many pharmaceutical companies, and certainly say top 20, are huge organizations. So somehow I have a hard time getting the word 'innovation' and big, giant, slow moving tank of a company in the same place at the same time.

 

Michelle Shogren: (03:53)

Absolutely. So when we started the innovation function at Bayer, it was funny because at the time back in, I guess it was 2015, we were doing an initiative called fostering innovation cause nobody thought we needed innovation in R&D other than finding the new molecules themselves, which is very innovative - I give it that, but there's so much more involved. And we had to do an eight month long research project to find out exactly, does this make sense or not? And then we had to pitch it and say, Hey, we really think this does make sense. And we can make a big difference for Bayer for our patients out there who need it and for the rest of the world, by having this. And it was a little bit of a tough sell. They're like, "Oh, I don't know. You know, we're really regulated here. I don't know how much we can do that's different." But we convinced them to do it. And it was a little struggle to get it going. And the culture change around. It was also hard. People were used to doing everything the same way for such a long time, but it was amazing to see the changes.

 

Janet Kennedy: (04:50)

So when you joined the innovation group and I'm looking here for officially your role there, so you moved from business process manager, process excellence, to head of innovation. That seems a very dramatic switch.

 

Michelle Shogren: (05:06)

Yeah. So I guess my whole career, I was always innovating in what I did anyways. I was always finding things that I said, there's gotta be a better way and then posing solutions and in process excellence, a lot of that is part of what they were doing. They were looking for. How do you bring the excellence into our ways of working? So once we did this initiative, which I was a team member with six people, we needed to have a head for this new function that we had created and I applied and was lucky enough to get that role. And so that's where I made the jump, but it felt very natural for me, especially having been part of innovation for so long in different ways.

 

Janet Kennedy: (05:45)

So I'm interested in the definition of innovation from a pharmaceutical company's perspective. I'm feeling like early on innovation was all in the lab, but now it's really every department ought to be thinking about how they can innovate.

 

Michelle Shogren: (06:01)

Yeah Janet, you're exactly right. It was always about bringing those new molecules to life or new products on a shelf. And people missed the opportunity to innovate in how they do things and their ways to gain efficiencies, to decrease time to market, to improve their business models of their own working groups, even. So this shift that we had, a mindset of, how do you apply innovation to your day to day activities was really monumental going forward. And we had a corporate innovation function that was starting at the same time as our innovation function, which formed an umbrella of services, which was absolutely wonderful. I don't think we would've been able to really get off the ground as easily as we did without having that group there. But it became very evident that we could do a lot here. And especially when we started really focusing more on our users and their involvement earlier on in our processes, that was a big change that came about with bringing in innovation.

 

Janet Kennedy: (07:02)

Well, I definitely wanna talk about patients in a little bit, but let's stay focused for just a second on this idea of innovation. Now we know that telehealth has been around for over 20 years, and in some cases, people are thinking like digital health just grew up in the last two years or the last three years. But when you think about the kind of things you were recommending innovating way back when in the dark ages of 10 years ago, what kind of things were you actually focusing on?

 

Michelle Shogren: (07:31)

I remember one of the first things that we were really bringing in at the time was eConsent and we had looked out into the industry and we saw this coming and there was a lot of pushback for it and not really a sure belief that it made sense or how could we even be sure that the actual patient was the one consenting and is this really adding value or just complexity? So that was one of the early on ones. And then now we have it as optional tool for all of our studies. So a lot has changed since then. And we were able to show that, just like children learn differently - some of them need to have something that is written, others wanna hear it, others have to interact with it to really understand things - especially our informed consents needed to have the same type of opportunity for our patients.

 

Janet Kennedy: (08:19)

Oh, that's fascinating. So then things really start to take off in the startup health space, which doesn't necessarily mean that they were funded by or driven by pharma, but it's all happening outside. So how did you go about as a company evaluating some of these new, very green ideas?

 

Michelle Shogren: (08:40)

That's a funny thing. So while technology involves so quickly in leaps and bounds, unfortunately, big pharma companies move much slower. We're used to having several years to get a drug to market. And these tech companies are launching new products left and right. So for us just to stay up on top of what's out there and what's being offered and being able to see how does this even fit into our regulated environment? What are the risks associated? Where are the real benefits at was a daunting task? And I think most pharma companies also felt that when you add in our archaic procurement type of process, which worked well for many, many years, for many different reasons, all of a sudden it didn't work well for this new style of work, this technology business situation, we would vet companies based on how long they've been around and you know, their financial ability to stay afloat. When you think about needing the data from these tech companies for many, many years later, you're sometimes just hoping and praying they stay afloat to the end of your study. How are you gonna be sure that they're gonna have the audit trails and the data that's necessary to go to the health authorities if we get an inspection many years later. So a lot of things had to change. A lot of mindsets had to change in order to be able to bring some of these things in

 

Janet Kennedy: (09:58)

Well now, with those needs for oversight, the FDA plays a little bit of a role here. Have you felt like they have partnered well with digital health in order to enable pharmaceutical companies to actually use this digital tool?

 

Michelle Shogren: (10:13)

They've done a lot of different things. They have offered some kind of measures that are trying to have a call to action, to have more things electronic. They have also enabled things like the 21st century cures act to be able to present data in different ways that we could capture in different ways, but they fall short of telling us how to do things and what exactly do they want and what is really acceptable, which is the part that makes it very difficult for the pharma companies. If you're spending millions and millions of dollars to run a study, the risk that you go to present it then to those health authorities and they throw it out simply because the way you captured data with one of these tech companies or you interacted on a medication adherence tool or something else like that, that could be very detrimental.

 

Michelle Shogren: (11:02)

And it would mean that maybe we can't do more studies because we've wasted, now the money on this. So the pharma companies are asking for the regulators, "Hey, throw us a bone, let us know what do we need to have for you." So we make sure we're spending our money in the right ways and we are heading in the right direction. But then you have the health authorities and they say, Hey, we wanna see change here. We wanna support this, but this is not our area of expertise either, so you need to come with proposals. You need to show us things and make recommendations to us and talk through your ideas and we'll be happy to talk about them. And there's a bit of a mis match around well, whose job is it to really make these decisions at this point?

 

Janet Kennedy: (11:44)

Well, I'm also curious about people within a large pharmaceutical organization - and I'm not necessarily speaking specifically about Bayer. You have been on, on the stage at multiple national conferences and trade shows and addressing with your colleagues, some of these issues. So I know you can also speak to the industry at large, but when I think about all the different players in a clinical trial from patient to the lab team, I can see that a lot of folks are traveling at different speeds. And that obviously a patient perspective is I want it now, I want it yesterday, to the general, just idea generation of what the new drug is going to be. My question really has to do with, do you feel like innovation and the idea of using new tools for clinical trials - is it reaching all personas that might be involved? Are principal investigators - for instance - are they forward thinking? Are the people writing protocols? Are they forward thinking? And if they're lagging or dragging their feet, does that make this whole thing hugely inefficient and not successful?

 

Michelle Shogren: (12:56)

I think it's an interesting question because of the fact, I think in general, people want to be forward thinking and some of them really think they are forward thinking, but then we have this little glitch in the system, which is almost built into our DNA from caveman times, even I would say, which is our protector mode where, you know, back then it was, Hey, don't touch the fire, cause it's hot. Now we use the protector mode for our families, as well as our work environments where we're out there to say all the challenges that we see as soon as we see something new, like, Ooh, step back, watch out. You know, this could cause this problem or that problem. And these are the risks could be associated with it. And we have a hard time being willing to jump that hurdle. Then when we identify all these potential risks of maybe sometimes just the unknown and this holds us back in several different areas, there's a mix of people in every job and every role, some of them are groundbreakers and they're pushing the envelope every day and every night other people are working the opposite side saying, Hey, that sounds great, but it poses too much risk for us.

 

Michelle Shogren: (14:04)

And that's where we have the little bit of the battle. But one of our biggest battles I think is having even awareness about our clinical trials and having enough patients to recruit, to be able to go into them. And that seems to be the biggest slowdown for getting drugs to market.

 

Janet Kennedy: (14:20)

Now, does that mean you need more principal investigators across the country? Does that mean you need just a better way to communicate trials to patients?

 

Michelle Shogren: (14:30)

I think it's definitely a better way to communicate trials to patients. One of the things that came out of COVID was the fact that everybody has heard of a clinical trial at this point. And many people feel like they're part of a really big one, right? So in one way, I think that's helped some for the awareness, but people don't always realize that there's clinical trials out there and available for a multitude of different reasons. And it's not necessarily a one stop shop. We know that amount of people that actually hear about a clinical trial as a care option for them is in the single digits of percentages, which is just crazy. We have to find a way to democratize access to clinical trials and share the awareness to patients as well as community doctors and having the right PIs and the right sites out there are really helpful. But having been on the site side of things, I can tell you, you know, sometimes it's just trying to find somebody who would reply to an and for a clinical trial can be challenging or having the right patients. Once you get through all the crazy inclusion, exclusion requirements for the trial is also a challenge. So we might have enough PIs out there, but we could always use more in different communities and add some diversity into our clinical trials as well.

 

Janet Kennedy: (15:46)

You know, when I think about myself, for instance, and admittedly I've been in healthcare, so I'm a little more aware obviously of what a clinical trial is or about, but I'm like, "Eh, I take a little of this and I take a little of that, but gee, nobody would want me in a clinical trial. I'm healthy. I don't have a rare disease. I don't have a hugely debilitating condition." So of course it wouldn't even occur to me that somebody would be looking for someone like me.

 

Michelle Shogren: (16:12)

Yeah. And I think that's one of the biggest problems. Like how do we increase the awareness? I remember my dad was lucky actually he had high blood pressure, pretty simple. Right. And why would you need a clinical trial for that? And my mom reached out to me and she was like, "Hey Chelle, I gotta tell you, they just offered Joe a clinical trial." And I'm like, "Wait, what? For what?" And she said, "For his blood pressure." I'm like, "He's a horrible patient. Why would they offer him a clinical trial?" And she said, "Oh, because of the fact he is a horrible patient. They really think he needs more monitoring. He needs somebody to help him get on a good path going forward and take the medication on a regular basis." Because he was great about taking it for about a week. Once he got a new one.

 

Michelle Shogren: (16:51)

And then you didn't go back to the doctor for three to six months. So he'd take it for about a week before he saw the doctor again and who knows what happened in the middle. So they thought, you know what, he's really having a hard time with his heart. He needs to have more structure to it. So by going into a clinical trial, he was going in every four to six weeks and he was able to take a medication that didn't give him some of the swelling and other problems that the ones that he had tried before did. So he was actually more willing to take it. So it turned into a really nice thing for him and people just don't realize those kind of studies are out there.

 

Janet Kennedy: (17:24)

Well, it's funny, you mentioned that cause I'm going through some interesting challenges with my own parents, but part of their problem is they're just beyond the digital divide. I mean I've noticed them not being able to interact with the television as easily as they used to just a few years ago and indeed traded televisions with them because I had a simple Roku remote that only had six buttons - and that's still a challenge. So we also have an issue of being digitally savvy. And as you looked at tools for your company or for the other panels and scenarios that you were a part of, how do you think digital intelligence digital experience comes into play with some of these tools?

 

Michelle Shogren: (18:08)

Well, I definitely see a difference between our digital natives, which have grown up with technology their whole lives and the digital immigrants as we call them for the ones who had to come over to this way of working. But it's also an interesting thing that we found that through our mythbusting sessions, sometimes we would have people that were in that digital immigrant category, helping us to troubleshoot and problem solve when the technology went bad. So they were sometimes even more savvy than we were. So it's not a one size fits all approach, but there is definitely a difference for how much bandwidth somebody can handle at what time. And this is also where we run into a little bit of problems because a one size fits all approach, seldom does. So how do we ensure that when we bring technology into a trial, we can hit these different needs and capabilities of our patients while they're in the study and really make them feel supported while still achieving the goals that we have.

 

Janet Kennedy: (19:04)

And does the patient have a role in this process, a physical role - a person who actually represents the patient at the table?

 

Michelle Shogren: (19:14)

Yeah. So that's one of the big things that I pushed for. I call myself a 'patient passioneer,' which was a word that came up from somebody within our organization. And I absolutely loved it and I have kind of stolen it from him. Thanks Oliver, if you're out there! But I feel like we have to do better here. A lot of times when we were first starting, we were saying, "Okay, it makes sense. You know, I would see that a patient would need this or would like this." And we thought we understood them. And sometimes we even talked to doctors and doctors of course knew what the patient needed or wanted, because they saw them face to face. So we trusted them. Then as we move forward, we started seeing, we were rolling things out, and there were problems. And there were difficulties for the patients.

 

Michelle Shogren: (19:56)

They were trying different things than what was intended. And it became a bit of an eye-opening experience that, hey, maybe we didn't think this through all the way. Or maybe the people that we thought knew didn't know as much as we had hoped because there's so many different variables out there. And that's where we started really trying to bring the patient voice in. And as an industry, this is something that we talked about for a few years. And now I think it's something that we're doing for the last couple of years as well, but we can still do better. And we also have to bring it in earlier in the process. A lot of times people are throwing this in right before they launch a trial. Like just to see, is there an oh crap moment ahead? And we need to come up with a quick help desk support plan for it before it rolls out. It's too late in the process to really make big changes. So we've gotta do it sooner. And we even need to think about it in the design process at the very, very beginning. And we're just now moving as an industry towards that, but I'm really excited that we're having those conversations.

 

Janet Kennedy: (20:58)

Do you see more and more patient advocate committees or designators at pharmaceutical companies?

 

Michelle Shogren: (21:06)

Yes, definitely. There are some companies which were faster moving than other companies and there's some still lagging. So it's a nice call to action for those laggards out there to bring more patients in. But I do see this changing and moving, especially if you look at now versus probably five years ago, it's dramatically different. And even with having COVID and that crisis out there, we've managed to bring patient voice in through different means. Maybe sometimes an interview that's on the phone. Sometimes it might be a survey with a couple of people they could do at home. Other times it might be with a focus group or a sounding board that is probably more digital lately, but it's happening more and more. And I'm really excited when I see things where brand teams have now added some type of a patient committee or at least a patient advisor into the overall conversations on a regular basis and then go to them on maybe a quarterly basis saying, "Okay, this is where we're at right now. What are your thoughts about X, Y, and Z?" That to me, shows progress

 

Janet Kennedy: (22:09)

Putting on your industry, prognostication hat for a second; obviously the pandemic was a game changer on pretty much every level. What do you see from the past has been the most important changes that have come to clinical trial innovation as a result of the pandemic. And looking ahead at just a few years, because there's no point looking further ahead than that for right now -what do you see being the biggest game changers in the industry?

 

Michelle Shogren: (22:40)

Well, I think with the pandemic, one of the big things that we realized is we were kind of getting in our own way when it came to technology sometimes because the sites embraced it and often offered it before we were ever ready or prepared to have the conversation. So where we were thinking that the sites wouldn't wanna do it, or they were worried about the burden, they were the ones saying, Hey, we're already doing telemedicine visits with our patients. And some of the sites were already FedExing medication to the patients. And we were like, oh no, we have to figure this out. Um, so one big learning was that there might be more of an appetite when there's a need than when it was a nice to have. And I think the study teams also were quicker to embrace it because they realized we always put our patients safety first and foremost in everything that we do.

 

Michelle Shogren: (23:26)

So they needed to make sure how are we gonna keep our patients safe if we can't bring them in the office all the time. And if we're not able to do those blood draws in the clinic, because a fear of contaminating them with COVID. So hopefully all of these things that we learned will be able to continue. And I'm one of the people that signed up for the #NoGoingBack pledge. And I hope everybody listening to this did as well, but I'm already starting to see some seepage back into the old ways of working where we say, "Okay, we only did this because of the pandemic. We don't have to do this anymore." And you're right. We don't have to do it anymore; but we could do it. And it might decrease burden on patients. And we might be able to really make a big difference to someone who wasn't previously able to do a trial by leveraging things like telemedicine visits, for example.

 

Janet Kennedy: (24:13)

Well, excellent. Michelle, this has been a fabulous conversation and one that I would like to pick up in the near future. I can't thank you enough for being a guest on People Always, Patients Sometimes.

 

Michelle Shogren: (24:25)

Thank you so much, Janet, for having me.

The rare disease community has found strength in small numbers by banding together to share their stories. On this rare disease day, we would like to take a moment to recognize and celebrate the patient advocates and organizations that keep the focus on these underserved communities. Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. I'm proud to announce that today's podcast will be the first in a series of conversations with leaders in the rare disease community. Our host, Janet Kennedy, welcomes Eden Lord to the People Always, Patients Sometimes podcast. Eden is the founder of the Dash Alliance and 24 Hours of Rare: a Global Celebration of Rare Disease. I hope you enjoy their conversation as much as I did.

 

Janet Kennedy: (00:49)

As we celebrate Rare Disease Day, I have the honor of bringing somebody to the podcast that, in my mind, overwhelms me with her initiatives and dedication to helping create community and conversation in the rare disease community. Eden Lord is the founder of multiple rare disease initiatives, including the Dash Alliance, the Rare Fare, 24 Hours of Rare, and Rare 72! So much happening to make it easier for folks who are in the rare disease community to come together for conversation. So on this special day, Eden, welcome to People Always, Patient Sometimes.

 

Eden Lord: (01:34)

Thank you so much for having me.

 

Janet Kennedy: (01:36)

You know, I actually had a chance to meet Eden a few years ago when I was invited - and I'm very proud to say - to sit on a panel during one of her virtual events. And it was a real eye opener. And, you know, we talk about imposter syndrome; I'm very fortunate in that I am a generally very healthy person. And when you are surrounded by people who are feeling the struggle of their health, every second they breathe, it sure does put things in perspective. And I was honored to be part of that program, but also humbled, by what a challenge life can be in living with a rare disease.

 

Eden Lord: (02:18)

It definitely is, but there are so many blessings that come with the path that you walk in the disease community and so many people - like yourself - that you get to meet who really have an understanding, or want to have a better understanding, of what it's like to be a patient or raising a patient and what that path looks like and how people can help. It's the attitude that we look for when we're building our communities. And it's definitely a hard road, but it is definitely a blessed road as well.

 

Janet Kennedy: (02:46)

Tell me a little bit about your background and how you became such an advocate for rare disease.

 

Eden Lord: (02:54)

Well, I, myself am a third generation rare disease patient. So it started with my grandfather, passed my dad, myself, and now we are raising four kiddos who all have a chromosome microdeletion, and it has manifested in multiple rare disease diagnoses for two out of our four kids, likely going to be three out of our four kids. So been hoeing this row for a while now.

 

Janet Kennedy: (03:18)

So from a rare disease perspective, I think the first challenge might be even figuring out that you have a rare disease?

 

Eden Lord: (03:26)

Definitely has been a struggle to walk that path towards diagnosis. And, you know, everyone's story is different. For us, the story that stands out is our daughter who was not caught on newborn screening panels with her condition. And it was four months before we reached a diagnosis and it was a significant medical crisis that precipitated her diagnosis. So that's definitely something that we're cognizant of is the path that it takes. I think, on average, it's seven years before you actually have that diagnosis in hand. And that's if you're one of the lucky ones; a lot of the times you won't have an answer and you will go undiagnosed. And then you're at a point where you're just treating symptoms.

 

Janet Kennedy: (04:02)

Now to be qualified - and I'm doing air quotes here - as a rare disease patient, that means you're one in what? Is it one in a million, one in 10 million? How do you qualify as a rare disease patient?

 

Eden Lord: (04:16)

Well, it's gonna depend on a couple of things. One, it's going to depend on what country you live in and what the prevalence is. And that changes frequently, because again, we don't have everybody diagnosed that needs to be diagnosed. But here in the US, we would say it's one in every 10 or about 10%. So if you put population somewhere around 300 million, we're looking at 30 million Americans who are living with a diagnosis right now.

 

Janet Kennedy: (04:41)

Well, that's actually quite a significant number.

 

Eden Lord: (04:44)

It's not small. Factor in who's still waiting for a diagnosis; you know, I suspect that number climbs significantly, and those are the people that we really want to also reach as a community and support, even though they don't have a name to put with what's going on in their lives.

 

Janet Kennedy: (05:02)

Now I have to say that I think the rare disease community is very fortunate in that you and your husband have a unique set of skills that have enabled you to say, well, not only are we gonna manage and deal with our family's health issues, but we're gonna do something to help other people. So tell me a little bit about how what you're going through as a family ended up actually becoming the profession that you've committed to.

 

Eden Lord: (05:28)

Well, for us, it was kind of a frustration post-diagnosis for our daughter because we literally left the hospital and didn't even have a sheet of paper with her diagnosis written on it. In this instance, she suffers from something called panhypopituitarism, and the only way I could remember what that diagnosis was, was Peter Pan, and thinking, I need to go home and research the heck out of this and figure out what's what, because this was prior to smartphones and I didn't have a laptop with me, so I was kind of on my own as far as research because the hospital didn't provide that information. So for us, it's really been an opportunity and a challenge to take our backgrounds in tech and education and try to build resources and tools that make things like, you know, diagnosis support, or different medical devices, medical treatments, more accessible to people and give them a place where they feel like they're connected and engaged, even if they can't travel to a conference. Even if they're struggling to figure out where to start, we just wanna try to be that touchstone and point people towards the best resources available for the diagnosis and the situation that they're living in.

 

Janet Kennedy: (06:37)

And what does that mean from the standpoint, if I were to go to the web, how would I find that information? How would I interact with you and your husband, Jeff?

 

Eden Lord: (06:45)

So we have a couple of different channels right now. We have the Dash Alliance, which is kind of our main umbrella organization. And under that, we work with several different organizations to help them become more patient-centric, to amplify the patient voice. We kind of worked across the spectrum with different stakeholders in the rare disease community there. It absolutely also means that patients and caregivers in other industries, stakeholders, representatives have access to our virtual events, which for us is a goal to try to bring as many people together in the same room and kind of do away with the hindrances of travel, the cost, the, just physical challenges of managing oxygen or a wheelchair or whatever that may be, and give people a space to gather that is safe, where they know that their voices are being heard, and that they can network with other experts in the field or other patients who are just living the same or a similar story that they are are.

 

Janet Kennedy: (07:39)

You know, it's interesting you mentioned the travel; COVID aside, it is essential that patients participate in national conferences and be face to face with the pharmaceutical medical communities. However, even before COVID, that was not an easy trick. Aside from the financial impact, it's not easy for a lot of folks who need to be seen and heard to travel, get on a plane, go to these places, and actively participate. So it doesn't matter that COVID showed up; you really needed to have a virtual event in order to support these patients.

 

Eden Lord: (08:18)

Absolutely. And that's kind of why we launched this in the first place with the virtual platform and virtual events is because I was doing quite a bit of travel and I was attending conferences. And it was fantastic because you build really solid, good relationships with people at the events. And then you see them a few months later, but the problem was you saw the same faces in every room, no matter what side of the country you were on. It's very frustrating when you go in and you say, okay, this person would benefit, this person in my network would benefit, but I know they couldn't be here because Delta's broken their wheelchair twice, or this has happened, or this has occurred with their oxygen, or they just can't travel because it's an expense, or who's going to watch their kids if they come to advocate for their loved ones in DC. There's so many barriers that should not necessarily be there, and the virtual event platform was our way of telling everyone you're welcome here. So our first year, our theme was "welcome to the table, we saved you a seat." Because there is a place for you, and there is a place for your voice, and we will do our very best to amplify it and connect you with the people who need to hear it the most.

 

Janet Kennedy: (09:26)

So what's the virtual event that's tied around Rare Disease Day?

 

Eden Lord: (09:31)

So that's something that we started last year that was so much fun. We had an absolute blast. What we do is for 24 hours solid, we skip around the globe and we get updates from people who are actually in the field doing the work. So nonprofit organizations, patient organizations, industry - everyone hops on board. They give us an update, and it hits noon at the local time, depending on which time zone we're in. So if we're in California, it'll be lunchtime. And that's the hour that that will pop up and air. And it's really fun to just get different updates and to kind of celebrate the advances that people are making across the globe. And it just shows us that we're all connected and we're all unified in our mission, which is to improve the lives of our disease patients and families.

 

Janet Kennedy: (10:13)

Okay. That sounds really cool. Where does the day start then?

 

Eden Lord: (10:18)

We are starting in the UK, so it will be 12 o'clock their time, 7:00 AM Eastern. And we've got a fantastic panel from Rare Revolution Magazine, and they're kicking everything off, talking about turning the tide on rare disease, and then it just skips across the globe from there. But it's pretty fun. Lots of caffeine is consumed during that 24 hours, but it's a blast.

 

Janet Kennedy: (10:38)

Okay. So I'm trying to figure out how you can manage that by yourselves; you must be exhausted. So where does it end if it starts in Great Britain, it ends in...?

 

Eden Lord: (10:48)

We are actually ending in Paris this year. We have a speaker - we're kind of jumping a little bit - we have a speaker who is currently hospitalized with COVID and has asked for that time slot and thinks that he will be up and raring to go. And we said, "You know what? We will do what we need to do. You tell us where you wanna be planted on the schedule and that's where we will put you." So he is a very distinguished physician. We're very, very lucky to have him and glad that he's recovering.

 

Janet Kennedy: (11:13)

Is there a chance for folks to engage and interact during this? Or is it just a series of speakers?

 

Eden Lord: (11:18)

No, there is definitely always interaction in our events. That's where the best stuff comes from, is from the interaction and, you know, the opportunity to connect with other people. We actually, this year, made the decision to incorporate working groups into our schedule. So by continent, with the exception of the very cold ones, we will be incorporating working groups where anyone is welcome to attend, discuss what they're currently working on, what their current challenges are on their continent, and how we can support those challenges and needs.

 

Janet Kennedy: (11:48)

Oh, that's amazing. You must have a very busy weekend getting ready for Monday. Whew!

 

Eden Lord: (11:52)

We do. But we're excited. I mean, this is, this is what we all live for. This is like our superbowl, right? You know, showcase and highlight and raise awareness.

 

Janet Kennedy: (12:00)

That's amazing. Okay. Tell everybody what the website is.

 

Eden Lord: (12:03)

The website for this is www.24hoursofrare.com.

 

Janet Kennedy: (12:08)

Okay. And that is 24hoursofrare.com. Oh, no spelling, that was, that was a bad idea. Okay! But here's the thing; if you happen to be listening after the 28th of February or the 1st of March, be aware that this content is still going to be available to you. So where can they find this content: on the same web link?

 

Eden Lord: (12:34)

Yes. Same web link, which will take you out to our YouTube channel, which is where we house all of our previous sessions and just really great content, really great speakers. We're so fortunate that we've had the participants we've had over the years.

 

Janet Kennedy: (12:47)

Tell me a little bit about running a virtual event for this community. We obviously need to get more voices at the table. Are you getting, not just patients, but are you getting the people that need to be hearing from patients to attend?

 

Eden Lord: (13:03)

I think we really are. We are definitely seeing a shift, not just with the events that we produce, but the events that we're hosting for other rare disease nonprofits, and organizations. They're really using this as kind of the platform to bring everybody together, regardless of where we go from here with physical, in-person events. So we actually have, I believe two hybrid conferences on the books for this spring; might be three, I'll have to check. But people know that "virtual's not going away." It's imperative that we continue to bring content and amplify the voices of those at home. So when you're able to do that in a hybrid situation, say, "Okay, I'm gonna have my people on the ground. I'm gonna have pharma on the ground." But one of the things that we're now able to do with a hybrid model is hand a tablet to that person in the booth and say, "Here, you can still connect with people who are attending from their living room." You can still have access to that booth rep for that pharma company or that medical device company. It is such a huge game changer. It really changes the landscape and how things look going forward. So I would be very surprised if people do not continue to implement the hybrid models going forward, just because of the need to continue the conversation that we've already started during COVID.

 

Janet Kennedy: (14:21)

You know, I am curious since you are very savvy about how to connect with folks online, about your experience dealing with a grandfather and a father, and now yourself and now having a child; so four generations. What's the difference in how they managed - meaning your father and grandfather - how they managed information gathering and connecting and learning about their situation, versus say your daughter's generation, who you could consider a digital native. From the standpoint of empowerment, engagement, getting involved in their own care, what do you see generationally as the differences?

 

Eden Lord: (15:07)

Such differences, Janet. And you make just excellent points about being digital native and what that means now. So, you know, when my grandfather was first diagnosed with multiple different things - multiple myeloma, Alzheimer's - that in itself was a struggle; dealing with an Alzheimer's diagnosis, in addition to cancer, and eventually pancreatic cancer. My grandpa was an attorney and he was a highlighter. So if you wanted to do you research, my grandpa would highlight things. He would underline things in books. So it was all medical books, and what could he read about his condition when he was able to do so. And my uncle was the same way. You know, my mother's the same way. We were all raised to be highlighters and underline the material that's important. So we would go in as caregivers and really oversee setting up his medication for the week. And it was very much, we're going to take care of you, kind of an attitude; patriarch of the family, we're here, whatever you need, clean the house, you know, keep up on your medical appointments with you, things like that.

 

Eden Lord: (16:06)

It was we're here. We're rallying for you. With my father - my dad was highly educated, very, very intelligent, but did not really want to know all the specifics. He had been through so much medical minutia and things that, you know, no one typically goes through as a healthy person, starting from when he was very, very small with accidents - he spent a lot of time in the hospital as a child - so he just didn't want to know. So I kind of took it very seriously as my responsibility to know everything. He ended up with a five way bypass at one point. He ended up with a diagnosis that I had to ask for the blood test for. They diagnosed him with amyloidosis - which I always butcher that word - and I had to ask for the multiple myeloma test.

 

Eden Lord: (16:46)

So that was really taking the research skills that I knew from taking care of my grandfather and seeing kind of that example given to me, and going out and doing the same for my dad, because he didn't wanna know the details of what was going on. He was showing up for procedures, but he just didn't wanna know the background. And then with Cambria it's been very much, "How do we keep her away from the stuff we don't want her to see on the internet?" if she wants to go out and do that research, because for her, she wants to know everything there is to know. She wants to be informed. She wants to know what the rest of her life is going to look like, and she wants to know where the tools and resources are to improve her life right now. So it's just been a huge spectrum kind of on down the line of how we approach and how we take care of things and what we entrust to people. And, you know, it's generational in part too.

 

Janet Kennedy: (17:35)

So are you finding that basically anybody after the baby boom, is more empowered as a patient, more engaged as a patient, or are we still dealing with there's different personalities? There are folks that jump all in and say, "I'm gonna be really a part of my diagnosis and get a handle on this." And there are folks who just still, "I'll do what the doctor tells me."

 

Eden Lord: (17:57)

I think there's always gonna be the personality of, "Hey, you know, I might not speak up just because I'm an introvert and I'm used to just accepting status quo, cause that makes me comfortable." And there's nothing wrong with that. But definitely post baby boomer generation, there is not the hesitancy to question a physician. And back in the day it was 'the neurologist says to do this, the oncologist says to do this, so this is what we're gonna do.' And there was no brooking an argument, there was nothing. It was just, that's the way things were. And now very much, we go in kind of armed with information and say, "Are you sure that you feel confident in that diagnosis? And have you seen this journal article?" And you kind of pull out your pad of paper with notes or you pull out your phone with notes and the doctor looks at you and kind of rolls their eyes.

 

Eden Lord: (18:42)

And you know what they're thinking, "Oh, you're one of those." But that's really the key in rare disease, is you have to press, you have to know that you're doing the best thing for yourself as a patient or your loved one as a patient. And there's all this information out there. So now it's a question of health literacy and how do we educate people on the best medical information that is out there? So while they're empowered and while they're taking action and they're taking control of their diagnosis, that's fantastic. But how do we teach people what information is really medically sound and the stuff that you should be relying on?

 

Janet Kennedy: (19:16)

So I was gonna ask you a question about that. We know that COVID has proved to be very challenging because of misinformation, but do you find that in other rare disease situations?

 

Eden Lord: (19:28)

Unfortunately. I think there are still a lot of misconceptions about what might constitute a valid medical resource. So we do a lot of work to dispel what's qualified and what's not. We teach people how to evaluate a resource. It's the old saying, "teach someone to fish," right? Teach them how to evaluate those resources for them selves and really be able to make judgements and decisions based on the quality information from people who are working in the field.

 

Janet Kennedy: (19:59)

Yep. I think that health literacy and critical thinking skills are going to be more and more important as we go forward. It's such a challenge now that the internet is such a giant ball of string; trying to figure out where the end is and what's relevant, what's accurate, what is going to help you? That is such a challenge for everyone. So it's bad enough that you have this complicated diagnosis you don't understand. You also then have to have the mindset to read everything with a grain of salt and make sure you're getting valid, accurate information.

 

Eden Lord: (20:35)

Exactly.

 

Janet Kennedy: (20:36)

Well, let's ask folks how they can reach out to engage with you. What's the best way to find you on the interwebs?

 

Eden Lord: (20:44)

We are across social media. Obviously I think everyone is now, but the best way, depending on what your needs are, is just to reach out to us through thedashalliance.com. That's kind of our main hub and portal that leads to everything else.

 

Janet Kennedy: (20:59)

Excellent. Well, to officially kick off on Rare Disease Day, a focus on conversations with rare disease, patients, advocates, and those working to improve the state of health and medicine for rare disease patients, I couldn't have thought of a better person to have on the podcast. Eden, I find you so inspirational and the work you're doing is hard, hard work, and I am really, really proud of what you're doing and, in a very small way, proud to help elevate your message. So thank you very much for being on the podcast.

 

Eden Lord: (21:37)

Thank you so much. And you know, thanks for making me tear up because, you know, you saying you're proud of me - that goes a long way, kid. Thank you so much, cause I value what you add to the conversation. And you know, if you recall, you came in on that one panel and saved all of our backsides and really guided the discussion on media and rare disease in a very eloquent way. And I'm still very grateful for that.

 

Janet Kennedy: (22:02)

Well, it's a pleasure working with you and I consider it an honor to continue to do so in the future.

 

Eden Lord: (22:08)

I will see you very soon.

The last two years have been driving many discussions of the need for change in the pharmaceutical industry, particularly in the clinical trial arena. Discussions have not always led to actions, however. Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. As we look towards 2022, I believe we will record this as a year of make it so. The time for moving on from debate is here, as patients are demanding action and forward momentum on today's episode of People Always, Patients Sometimes, our host Janet Kennedy has a conversation with the new executive director of the Clinical Trials Transformation Initiative, Sally Okun. Sally brings a unique and essential perspective to CTTI, as a former nurse and VP of Patients Like Me. They have a detailed discussion of the Transforming Trials 2030 initiative, one that Spencer Health Solutions is 100% behind. I hope you enjoy this episode of People Always, Patients Sometimes.

 

Janet Kennedy: (00:59)

It's very exciting for me to have today's guest. Sally Okun is now the executive director of the Clinical Trials Transformation Initiative. The last time I spoke with her was on the Get Social Health podcast, where she was the vice president of Patients Like Me. So interesting that we're going to have another conversation, but in a totally different role, and yet, still very patient centric. So please join me in welcoming Sally Okun to the People Always, Patients Sometimes podcast. Sally, I'm so glad to have you here. I know it's been very, very odd over the past few years in working and collaborating and life transitions, but we had an opportunity to talk to your predecessor, Pamela Tenaerts, who was the executive director of the Clinical Trials Transformation Initiative. We spoke to her pre-COVID. So now we're in the middle and maybe hopefully heading towards the end. And there are a lot of exciting things happening at CTTI. So welcome to the podcast, and I'd love to hear a little bit about how you ended up joining CTTI.

 

Sally Okun: (02:09)

Janet, it's so nice to be here, and I really appreciate the opportunity to talk more about the Clinical Trials Transformation Initiative, and certainly the shoes that Pam left are large, and I'm still trying to find ways of filling them, and I think that's gonna take some time. How did I get to my current role? Well, interestingly enough, I had left Patients Like Me in 2020 and I was working on a variety of interesting projects at the time across the health spectrum. You know, I was consulting on a variety of different things and also enjoying some newfound freedom of semi-retirement, which was an interesting experience for the first time in my career. You know, by about mid 2021, maybe in light of the time that we were all spending at home as opposed to spending out enjoying each other's company socially or professionally, I started thinking more and more about the next chapter of my professional career.

 

Sally Okun: (02:57)

So it wasn't long after that, that I was approached about the position of executive director at CTTI. And frankly, initially I didn't see the fit for me. You know, I've not spent my career in clinical trial work. I've spent a lot of my career in research and clinical research with patients and others, but hadn't really focused specifically on clinical trials and the clinical trial enterprise. So at first I really wasn't exactly sure it would be a good fit for me. However, after talking with some trusted colleagues and others, including the chairs of CTTI's executive committee, I was truly intrigued by the organization's impressive portfolio of work. I really hadn't been aware of just how much they have done over the last 15 years, 14 years, in terms of contributing to the improvement overall of the clinical trial experience, not just for participants, but for investigators as well as sponsors and others.

 

Sally Okun: (03:48)

So, you know, I then looked a little more closely at the transforming trials vision, and I thought, you know what, here's an organization that is setting goals as a priority to be seeing clinical trials as patient centric and easily accessible as its number one pillar. And I thought, well, you know what, I think maybe this fit might be just right. So I spent a bit more time thinking about it and then made the leap in October of just a couple months ago - just hit my two month anniversary.

 

Janet Kennedy: (04:13)

You mentioned something just now about the Transforming Trials 2030 program. What is that?

 

Sally Okun: (04:20)

Well, you know, a couple of years ago, again, under Pam's leadership, they discussed the need to set some milestones to really stop sort of talking about improving clinical trials, but actually putting some stakes in the ground or pillars up to suggest that we need to have a goal for that transformation; that have to have things that we're working towards as a community in order to be able to achieve a better experience for everyone involved in clinical trials.

 

Sally Okun: (04:49)

So what came out of that initial discussion was a set of five pillars that actually articulate quite specifically what we believe clinical trials should be like by 2030. And each one of them has a host of different objectives beneath the goal, that actually really describe how we might ultimately get to the point where we can say, "Yes, indeed, we have clinical trials that are now patient centered and easily accessible," for example, for the first pillar. But each one of them is complex. Each one of them requires a lot of understanding of what needs to get unpacked to better get at the kinds of things that need to get changed. So we are in the process right now of beginning a strategic plan for doing just that: taking each of the pillars and starting to think about how will we know that we've achieved success on this pillar? What will be the metrics we need to start thinking about for those.

 

Janet Kennedy: (05:42)

Alright. So let's do some metrics here. What are the other four pillars?

 

Sally Okun: (05:46)

Number one, as I said, is that clinical trials will be patient centered and easily accessible. And if we don't reach that, then some of the others are almost irrelevant. So that is actually the place to begin. But then the second one is that they're fully integrated into health processes. So that gives us an opportunity to really begin thinking about the continuously learning health system, where we embed within the care environment, the opportunity to research and learn, and then put that learning back into the care environment again, so that we have a full circle loop. The third one is that they are designed with a quality approach, and CTTI has done an incredible amount of work on something called quality by design.

 

Sally Okun: (06:27)

It has a whole set of recommendations around how to determine how the quality of your trial based on a variety of different things - whether it's your recruitment numbers or other aspects of what the trial efficiency looks like. The fourth one is that clinical trials take full advantage; they maximally leverage all available clinical and nonclinical data, including data that's collected now with digital technologies to ensure that we max - minimize - the collection burden of getting data and actually improve the opportunity to make data more meaningful and impactful as part of the trial experience. And then lastly, although not least, is that clinical trials contribute knowledge to how to prevent diagnosis and treat disease. And that becomes something that's an objective around improving population health and the health of our people.

 

Janet Kennedy: (07:12)

Okay. Those are very large topics, very large goals. Who is the Clinical Trials Transformation Initiative? Who's going to do this work?

 

Sally Okun: (07:23)

We are a group of people who have come together within the organization that includes project managers who oversee our projects, and then strategic and engagement and communications team that oversees all of our communications with our steering committee members in our member organizations. So to give you an idea of what that structure looks like: we have a steering committee that includes about 80 organizations who are actually members of CTTI, Clinical Trials Transformation Initiative, and they commit to have a person assigned as a steering committee representative. So as we begin to think about tackling a new topic or a new initiative, we go to the steering committee and we make available to them the opportunity to join the project team. That project team then starts to create the infrastructure for accomplishing that project, which can include, first of all, the project plan and setting the aims and the objectives.

 

Sally Okun: (08:17)

In many ways, it's creating a research study for the topic under consideration with that. Then they set out to consider what's the literature already say? Who are the expert people we need to be speaking to? So there's a lot of qualitative interviewing that goes on as part of the social science team from the Duke Clinical Research Institute; that is a connection for our team to be able to work with. And then the findings from those interviews begin to shape the recommendations that will come out about a particular topic area. For example, thinking about trials in healthcare setting; what do we need to know about the various barriers for those and the opportunities for those as well as the current landscape within which the clinical experience might or might not include participation in research activities? So there's an entire project management approach that is put on any topic we tackle.

 

Sally Okun: (09:08)

The problem with it; it's an incredible opportunity for us to be able to map out these topics and really think about the issues as a group, but it's a labor intensive and time consuming. It can take up to two years to complete some of our projects because they are so intense in terms of diving deep into the problem and trying to come up with resources and tools to address it. So where we are faced today is thinking about how will transformed trials by 2030 if we continue to take this much time to get through our project? Which is why we're now starting to focus quite specifically on each of the pillars, and in many ways, making a project around that pillar. So if we take the first one, for example, and we say trials will be patient centered and easily accessible. The first question I have is how will we know that?

 

Sally Okun: (09:55)

So we're starting to look at ways of being able to measure whether clinical trials today are, or are not patient centered. And that can be evidenced by whether or not patients were involved in the design of the trial, which is work we've already done in some other projects that we've done. Also, how is the enrollment handled? Did it include a diverse population? A variety of different ways of able to measure patient centricity around a trial. But you're right, each one of these has a lot embedded in it and our strategic approach to it right now is taking each one. I've assigned a project manager to every pillar. And we are now just beginning the process of setting a goal for the metrics for each one, and then identifying where we will go next in terms of what resources we know exist already within CTTI that we can map to it, and then what resources may exist in related efforts, whether it's transCelerate or the Multi-Regional Clinical Trials Initiative, others that are related efforts and aligned with our work, and starting to see where their resources could help to get us closer to realizing that particular vision or that pillar.

 

Janet Kennedy: (10:59)

Now, I know your members represent nonprofit organizations, for profit organizations; I think you even have some patient volunteers who are part of your program. But where does the funding come from to make these things happen?

 

Sally Okun: (11:12)

Well, you know, we are a public/private partnership with the FDA. We have been very fortunate to have an excellent relationship with the FDA over the last number of years, their interest in having us be available to tackle some of the more problematic issues that they are not in a position to do on their own. So the funding comes through a grant that supports that public/private partnership. Also our members, depending on the type of organization or company that they are, pay a membership fee to participate. And so that helps to offset some of the costs as well for maintaining our team and the other resources that we put to bear to get the work done on a regular basis.

 

Janet Kennedy: (11:50)

And then how does it actually get done? So if you come up with these guidelines or these recommendations, is there a commitment on the part of these for-profit organizations that they'll actually start to modify, or is the science and the evidence so evident that it makes no sense not to implement these changes?

 

Sally Okun: (12:10)

Yeah, that's a good question. It would be nice if everything seemed that intuitive. That yes, indeed, this is something we ought to be doing because it's just the right thing to do, right? And many of our recommendations would fall into that category. And I think many of our organizations commit to ensuring that they make attempts to incorporate those recommendations into the work that they're doing. Right now, we do have a method of identifying as part of the project itself. Towards the latter part of it, opportunities for adoption of the recommendation. So what that project team will think about is, so now what? How will we see these things come to life in the real world? So opportunities for providing some insights into how they might be best adopted are offered as part of the overall project deliverable at the end of the day. Now at the same time, we don't have an accountability measure to be able to say, "Yes, we believe these recommendations should be incorporated into the clinical trial on this particular topic area, and we expect that you will deliver on that."

 

Sally Okun: (13:09)

So that is, I think, a professional courtesy that we afford to our members to say, "We appreciate that you committed a lot of time to helping us get to the point where we have these recommendations; now what we'd like to ask of you is to start sharing your experiences of using these recommendations and resources." So we actually - just this past year created the Building Better Trials case study exchange. And it's a portal where our members and non-members actually can contribute their experiences of using CTTI tools and resources for a particular purpose within their organization to advance or improve the efficiency and quality of clinical trial experiences. And those have been great. It's a wonderful opportunity for us to showcase how members and even non-members, as I said, use the CTTI resources in a way that actually do have an impact. And it's also a place where, from my perspective, most importantly, we can have continuous and shared learning. So what one group might have learned as a result of incorporating the recommendations for a single IRB, for example - that can be brought forth for others who are now facing the need to do that, the kinds of challenges and other ways that the organization actually met the recommendations that were set forth.

 

Janet Kennedy: (14:23)

And for those listening, if you visit the website and go to this podcast episode, I'll make sure that there is a link there. Tell me a little bit about the patient's role; obviously you come in with a very unique background and a very wrong patient-centric experience and support system set up. So how are patients involved? Because let's face it, they don't have the kind of money it would take to join an organization. They may not even have the time to commit to some of the work that's being done here. But how do you incorporate the patient voice into the work of CTTI?

 

Sally Okun: (14:55)

Well, it is an incredibly important voice and we pay a lot of attention to ensuring that we have mechanisms to get that. We actually have three members of the steering committee who are patient representatives and they come into the role with that responsibility. So they are - similar to being an organization - they have been identified through an application process as people who are willing and interested in contributing in a very substantive way to our understanding of what it means to be a patient in the context of clinical trials. So there's three of them on our steering committee itself, and one of them is actually a caregiver and the other two are patients, one living with breast cancer and the other with ALS, or Lou Gehrig's disease. And so the opportunity for them to be a part of the steering committee team, when a project comes up is wide open.

 

Sally Okun: (15:44)

So we're always looking for ways of having them be involved. Now at the same time, we have many patient organizations that are members. You're so right; these organizations and patients individually don't have the resources to be able to pay a membership fee that would be sort of out of their range. Our membership fees vary on a sliding scale depending on the organizational type and the revenue that those organizations have. So a patient organization would - I think the highest amount is a $500 membership fee. And I think, you know, obviously, thinking about other organizations that may even be a challenge for, we would certainly work with them and talk with them about how we could make a membership opportunity come to fruition. So the other thing that we do is we do have a relationship with the FDA in terms of being able to help them support their patient engagement collaborative.

 

Sally Okun: (16:31)

Now, this is a group of sixteen individuals who again, apply to be a part of the patient collaborative, and we actually help support that group. And it's an opportunity for us also to work more closely with FDA on how they can have access to patients in a way that helps them better understand the patient experience. So I think we try really hard to ensure that all of our projects have a patient representative on them, whether it's a patient individual or a patient group, or potentially having some relationship back to the patient engagement collaborative at FDA itself.

 

Janet Kennedy: (17:03)

I think the work you're doing is so exciting and so important. I worry a little bit that your projects are huge, and you do have, you know, your goal of transforming trials by 2030. However, you know, in order to get there, you gotta take a few steps. So will you be releasing work along the way?

 

Sally Okun: (17:24)

You know, as I said, one of the things that I did right from the very first day I arrived was to start talking with the team about measurement and data. As you know, coming out of Patients Like Me, one of the things that was a hallmark of our work with data, and we just felt like we needed to be data driven in order to be able to answer important questions for patients. It's no different here. It's very much the same. In order to be able to achieve these lofty goals of this transforming trials vision, we have to know where we're at now. What's the baseline data we know about the percentage of trials that are currently patient-centric? I really have no idea. We have to start thinking about ways of being able to find metrics that will tell us some of that. What's the evidence of a trial being patient-centric?

 

Sally Okun: (18:04)

And there are tools out there that we will be starting to inventory and start to determine whether or not these will be ones that we'll put into the ways that we think about this. The short answer to your question is my objective with taking each pillar and intentionally unpacking it, is to better understand where do we need to begin? How will we know that we're making some progress? And that will be metrics and data. And then what are the resources that we are gonna need to start thinking about beyond just adoption? So it's not simply gonna be enough to say, "Here's the recommendations we're making about patient-centric trials for you to be able to, you know, have available to you." We'd like very much to start thinking about the ways of being able to have a bit of a scorecard on that. How do we know we've made a difference?

 

Sally Okun: (18:49)

How do we know that some of the work and the learnings that we've been generating are actually going to translate into something that happens at the clinical trial level itself? And those are still things in development, but they are very important, to me personally, as part of my own work, but also for me as the executive director of the organization today to say, "Let's start measuring how well we're doing on every one of these," and better understand at what point we believe we've actually shifted the needle enough to be able to say, "We're reaching closer to that goal." Now, will we get there by 2030 on every one of them? You know what, I'm gonna remain optimistic. But I also recognize that there's so much that can happen between now and then that could interrupt our progress. And just taking into example, the COVID pandemic over the last year and a half, that stopped so many other kinds of research because we had to focus on that.

 

Sally Okun: (19:40)

Our hope is that in some of the things that we've taken away and learned from that, as we look at each of these pillars, we wanna be able to say, will this stand up during a time of public emergency. Also are the things that we're coming up with applicable beyond the US. That's another important aspect that we have to start thinking about; clinical trials take place everywhere. And in fact, more people are recruited outside of the US than they are in the US. So we have to be thinking about that quite intentionally. And then lastly, the one area that we have not worked specifically in integrating into our prior projects is how can technology itself enable the success on this particular pillar? What are the opportunities that are available today and even tomorrow or two years from now that weren't available previously, that we can start to take advantage of that, help us move that goal closer to achieving it?

 

Janet Kennedy: (20:30)

Well, you come in at an interesting time where you probably were interviewing during the process of all the stopping and starting and having to rethink about how clinical trials were going to go ahead in the midst of the pandemic. And now you've started when, you know, we thought we saw the light at the end of the tunnel and things have managed to pick up, and a lot of companies were able to pivot and use digital technology to move some clinical trials forward. However, I'm curious to know, as you come in and you were getting feedback from your steering committees, did you hear them say that this pandemic has accelerated our vision for decentralized clinical trials for the use of digital health technology?

 

Sally Okun: (21:14)

Yes. And I may not have been hearing that because I wasn't here at the time, but definitely the projects that we had that as a result of some of the work being done through COVID and some webinars that we ran with some of our esteem colleagues - including Rob Califf and Harlan Krumholz, and Deb Estrin - just the idea that we have learned a lot as a result of the COVID experience, and we do need to ensure that what we've learned and those things that actually have benefited the clinical trial experience, not only for participants, but potentially for investigators as well, and outcomes more coming more quickly, that we have to ensure that these are not compromised as we move forward. That we don't fall back simply because it's a little easier to fall back and then it might be to fall forward. And that we take advantage of the things that we've learned, especially that technology is now a new enabler for improving the efficiency and quality of clinical trials. When used appropriately, when used in the right context, and when used with tools that actually have the ability to be used for regulatory decision making. You know, we have to ensure that we're not just simply falling back onto technology for technology's sake. We have to ensure that we're using the kinds of tools that actually can be helpful and useful for regulatory decision making.

 

Janet Kennedy: (22:30)

Tell me a little bit about incorporating patient voice through patient reported outcomes and real world evidence. Is that something that is now you would almost consider mandated as part of a clinical trial?

 

Sally Okun: (22:42)

Not so sure we're at mandated yet, but I think we can recognize just how important and valuable real world data is to understanding the real world experiences of real people, right? And yet I think we still have a fair amount of work yet to do on translating that - all of those different types, disparate types of data - into the totality of evidence, within which real world evidence will be one piece of it, that then contributes to a regulator's understanding of the sponsors data. So I think, yes, I think real world data and real world evidence have definitely achieved the validity of being important as part of the clinical trial and clinical research experience. And we're seeing, increasingly, opportunities where that's now starting to become more important to regulators. For example, you know, FDA is continuing to meet its mandate from the 21st Century Cures Act, where it was required to issue guidance on the use of real world data and real world evidence for regulatory decision making.

 

Sally Okun: (23:42)

So they now have I think issued, I wanna say four of the four, but the last one or two are still in draft and will have no final rule yet. But those are important considerations; to think that the regulator themselves has now put forth what they feel will be required for the use of real world data and real world evidence for their ability to make good decisions. Additionally, EMA just recently stated a vision that enabling the use of real world evidence and establishing its value for regulatory decision making is going to be required in Europe by 2025. So these, you know, different entities are putting a stake in the ground and they're saying okay, similar to what we're doing with our vision, right? The idea is that we need to ensure that all the data that could contribute to our understanding of what it takes to have a medicine or device developed so that it can be used to improve outcomes for people needs to come to bear.

 

Sally Okun: (24:37)

And we can't simply just look at it and say, "It's too complicated, or it's too difficult to translate that data into something that's understood by the regulators." We have to figure that out. And I think there's going to be a lot of work in the coming year or two on that very topic. You know, there's a lot of work being done. For example, Duke Margolis has had a point of care working group now for some time that I've actually enjoyed being a part of, and they're aligned very much with our work being done in trials and healthcare settings. So you can see those two things are both totally aligned and related. We're working at it from a different perspective. Duke Margolis, a little more from the policy side and CTTI, a little more from sort of the actual operational side, and bringing those groups together, some of which actually - some of our senior committee members sit on the Duke Margolis's working group too. So there's definitely starting to see this overlap of the attention paid to the value and the importance of this data. So I don't think it'll be long before it becomes something that's just a part of clinical trial experiences. But I think we still have a little ways to go before we actually see it integrated into every clinical trial.

 

Janet Kennedy: (25:41)

Now before we started recording, we talked a Little bit about where and when we'll be able to interact with CTTI in public, and it sounds like you're shooting for a live meeting about a year from now?

 

Sally Okun: (25:53)

The meeting we were talking about in fact was our steering committee meeting. So we have two meetings a year where we gather our executive committee and our steering committee for two days of meetings. One will be in March, which we're going to be doing virtually. And the other will be in September. In the meantime, throughout the course of the year, we actually do a number of webinars and other events that actually are open to the public to learn about some of the work we're doing. And we will definitely continue to do those. Those right now are quarterly, but we might likely start to increase those depending on how the work is going on. Each of the pillars for the transforming trials vision. But the September meeting will be the first time our steering committee and executive committee see each other in person since the pandemic. So we're very excited to shoot towards that. And obviously we'll be flexible and adaptable as needed, but right now we've made that commitment that we will see each other in person in the fall.

 

Janet Kennedy: (26:44)

That is exciting. And I hope we get to meet in person sometime in 2022. The conference season looks like it's kicking back in with protocols in place, but that we're gonna be face to face more than we have been in the last two years. So hopefully I will get a chance to run across you at one of the conferences coming up in the spring.

 

Sally Okun: (27:05)

I would enjoy that very much, Janet. Yes, I've actually just recently had my first foray out into the professional traveling again. And that was a quick trip to Boston and followed by a quick one to D.C. Both of which felt very odd, but also at the same time felt very good. And it was wonderful to see friends and colleagues that I just haven't seen in way too long.

 

Janet Kennedy: (27:26)

It is surprising what good friendships are developed in the professional environment. We talked a lot about family and COVID'S impact on family units. But for many of us, our colleagues are also just as much our family members, and not being around these people who stimulate our minds and get us really interested in new ideas; it really is very draining and disappointing not to be near some of these amazing people.

 

Sally Okun: (27:55)

That's such a good point. I mean, I know I thrive on just having conversations with people face to face and hearing their ideas about what they're doing or giving me some feedback on a presentation I just did. You know, I just always loved the after experience of being a part of a panel or part of a, you know, presentation that was being held at a conference, and just the feedback you would get from people on the things that you talked about is, was just - really provided me with professional learning that I couldn't get anywhere else, frankly.

 

Janet Kennedy: (28:22)

Absolutely. Alright, well, hopefully a cup of coffee in real life is going to be on our agenda sometime in 2022. Well, Sally Okun, executive director for the Clinical Trials Transformation Initiative, thank you so very much for joining me on the People Always, Patients Sometimes podcast.

 

Sally Okun: (28:40)

Janet, it has been my true pleasure to connect with you again, and I look forward to many times of having the opportunity to see you and spend some time again. Thank you so much. And thank you for the highlight for the Clinical Trials Transformation Initiative and our work. We really appreciate it.

 

Janet Kennedy: (28:55)

Absolutely.

Spencer Health Solutions was founded knowing that pharmacies are an integral part of the patient's health journey. Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. Pharmacy partners are key to supporting Spencer in patient homes for clinical trials and commercial programs, especially specialty pharmacy partners. To dig deeper in the specialty pharmacy and learn about some of the challenges and changes coming to the industry, we invited Sheila Arquette, CEO of the National Association of Specialty Pharmacy to come onto the podcast. I hope you enjoy this conversation with Sheila and our host, Janet Kennedy, on People Always, Patients Sometimes.

 

Janet Kennedy: (00:43)

We are honored to have as our guest, Sheila Arquette. She is the president and CEO of the National Association of Specialty Pharmacy. She joined NASP in 2017 and has been focused on increasing the value of the NASP membership. Some of her initiatives under her tenure have resulted in a substantial increase in their membership, also in member benefits and value, and she's expanded the annual meeting at expo that's held every year in the fall. Specialty pharmacy has a critical role to play in helping patients live their best lives, and I'm thrilled to have her on the People Always, Patients Sometimes podcast. Welcome Sheila!

 

Sheila Arquette: (01:24)

Thank you so much, Janet. It's a pleasure to be here with you today.

 

Janet Kennedy: (01:27)

Now I gave a very quick high level look at your background, and I'd love for you to fill it in a little bit more for us. Your relationship with NASP didn't start in 2017, did it?

 

Sheila Arquette: (01:37)

No, it didn't. I started in a volunteer capacity with NASP way back in 2013, in 2014, and I started off volunteering to serve on the membership committee. And then I was asked to co-chair our government affairs committee and just really loved the mission of this organization and the incredible group of people that were so passionate about specialty pharmacy and patient care. And so I started to get more and more involved and then helped with our first ever specialty pharmacy law conference. And one of our board members, Rebecca Shanahan, it was her vision to establish the Specialty Pharmacy Law Conference and provide continuing legal education credits for lawyers and specialty pharmacy, because it was really challenging to try to find those credits. And then she was also incoming president of the NASP board. And so she knew at the time that she was gonna need help running the organization. And so that's when they reached out to me and asked if I would consider coming on board, full-time.

 

Janet Kennedy: (02:38)

You know, Spencer joined in the not-too-distant past, and we're now members of NASP, and one of the first and frequent emails I get is about what's happening in Congress. And that is amazing, all the work that you're doing there. So what are the big topics that you're covering in the political affairs and government committee?

 

Sheila Arquette: (02:58)

We're very, very focused on ensuring that we have a competitive landscape in a fair imbalanced marketplace. That specialty pharmacy patients have access to the medications that they need and appropriate access, meaning that it's the right drug for that patient at the right time during their clinical treatment. But we also want it to be from the pharmacy of their choosing, right? So we wanna make sure that our pharmacies have access to networks. That reimbursement is fair, and it's not being used to keep them from participating in different payer networks. And we wanna make sure that patients have access and choice. And we're very focused on pharmacy DIR fee reform, right? And ensuring that pharmacies are compensated or paid for their performance and that, you know, that we're all driving to the same end goal, right? We're looking at enhanced clinical outcomes. And we also wanna decrease total cost of care because it's a huge issue, right? We don't have an infinite amount of money or resources.

 

Janet Kennedy: (04:01)

And do you feel like the pharmacy section of healthcare has got a voice that they need to have, or is this something you're trying to build and sustain to a higher level?

 

Sheila Arquette: (04:13)

So with respect to specialty pharmacy, it is something that, you know, we had to start from ground zero, right? When we would meet with members of Congress or, you know, different offices of the administration, or even CMS, when we would talk about specialty pharmacy, there really was a huge learning curve and a lot of education that we had to do because fortunately not very many folks still to this day are treated with specialty medications. It's only still around two or two and a half percent of the total number of prescriptions that are dispensed. So when you would talk about pharmacy, the image that comes to everybody's mind is that corner drug store, right? Your community pharmacy in the middle of town, or that you've always frequented. Then when you started talking to them about, you know, specialty pharmacy and the nuances and the distinctions, there was this kind of scratching of their head. Like, no, not sure what they're talking about. So we really had to start and lay the foundation about, you know, this is what specialty pharmacy is. This is why it's different. And pretty much, this is why you should care about it.

 

Janet Kennedy: (05:11)

Is that NASP's primary goal, or do you have multiple goals for the organization?

 

Sheila Arquette: (05:17)

We have multiple goals, Janet. We have four foundational pillars. One of which is advocacy, but then we also are focused on education, certification, and then also on the membership. And what I mean by the membership is providing all of the resources, the tools, fostering the connections and the networking that leads to enhanced patient care, right? It takes a village, right, to make a specialty pharmacy patient. So we wanna make sure that our members have at their fingertips, everything that they need to better care for their patients.

 

Janet Kennedy: (05:51)

So I am a layperson in the conversation. I don't come with a pharmacy background. I've more of a marketing background. So I'm gonna ask a couple of questions because I know there are a few other folks out there like me who need to ask this deeper level of question. So a 'specialty drug' is something that I couldn't walk into my corner drug store and get?

 

Sheila Arquette: (06:10)

Well, and this is a challenge because we don't yet, still we don't have an established definition of specialty drug. And typically what happens is it's the payers, right? It's the health insurance companies, it's the PBMs. They determine what medications are in their specialty drug program. So back in 2016, members of Congress approached NASP and asked for us to put forth some definitions that they could use as a reference. So with respect to specialty drug, what we focused on was complexity. Specialty medications are complex. It's either in the way that they're administered, dosed, their side effect profile; it could be in the insurance coverage process, that's required to gain approval for patients to receive these medications. There can also be financial barriers that have to be overcome. So typically specialty medications are complex. They may have to be stored or handled in a particular way. Oftentimes you can't get what we consider a specialty drug at your local community pharmacy. However, there are always exceptions to the rule, and as the payers continue to redefine what medications they include in their specialty drug program, sometimes then all of a sudden, you know, these medications are available at your community pharmacy. But typically no, they're restricted to these pharmacies that, you know, manufacturers have selected to work with because of the capabilities, the inherent capabilities that specialty pharmacies have.

 

Janet Kennedy: (07:38)

So how does it work out numbers wise? Is there a specialty pharmacy in everyone's community?

 

Sheila Arquette: (07:44)

No, there's not. And typically most of these pharmacies are closed door. And what I mean by that is patients don't walk in and out, right? There's not a transaction at a pharmacy counter. Most of these patients are managed remotely. You may have a specialty pharmacy with a central fill location where all of the prescriptions are dispensed. And then they have an enormous patient service center type area where all of the patient management services are carried out. So we have folks that will take care of the insurance verification and the benefits investigation, and helping you to understand as a specialty patient, what is your copay for this medication? And if you can't afford it, what are the available options? Then we also will have folks reach out to you to schedule your delivery of the medication and help you with refill reminders. Pharmacists and nurses will also counsel patients, right?

 

Sheila Arquette: (08:33)

Review the medication, take a detailed history, talk about your disease process, make sure that that patient understands what it is they're being treated for and why it's so important to take this medication as prescribed. And what do you do if you have side effects and what are the side effects to look out for? And then specialty pharmacies will also help to coordinate all of this information and interact with other members of the patient's healthcare delivery team. Also, caregivers are really important too. And specialty pharmacist and pharmacy personnel will also interact with those caregivers. So oftentimes no, there isn't going to be a specialty pharmacy in your community, but you will have access to the medications that you need and the support services that you need.

 

Janet Kennedy: (09:13)

Here I was gonna ask my next question about "Gee, are specialty pharmacies patient centric?" and that actually sounds like the very definition of a specialty pharmacy.

 

Sheila Arquette: (09:24)

Absolutely. The patient is at the center of all that specialty pharmacy does. And it's with that mindset that I often say, you know, to my members, you know, you're the reason that specialty pharmacy is special, right? But it is with that patient at the center of all that they do. And that's what drives all of the service offerings, all of the patient counseling, all of the interactions. And it's really interesting because when I took this job at NASP and started learning more about the relationships that develop, you wouldn't think that folks would develop such a fondness for their pharmacist and the pharmacist for the patient, when a lot of this is done telephonically, right? Or now, you know, since COVID, you know, either via zoom, some patients have even elected to be supported through text messaging and emails, but they do develop these relationships.

 

Sheila Arquette: (10:11)

I would tour some of our specialty pharmacy members and, you know, the patient service representatives in their cubicle, they would have pictures that patients sent to them. You know, that they reached a milestone because they were able to be successfully managed on a therapy and get part of their life back. They were able to see their granddaughter graduate from high school, or they were able to attend a wedding or some special event. There'd be Christmas cards. But it was just really interesting just to see how that relationship develops and how important it is. And, you know, most specialty pharmacies have dedicated representatives in patient service folks who will interact with that same patient month after month after month. So they really do develop a deep and personal relationship.

 

Janet Kennedy: (10:49)

You know, while my parents are in their nineties, now, they don't necessarily have any unique medications. And for many years they got their medications at the grocery store. But at this point, their medications are switching up with frequency; It's difficult to keep track of it all. And when they finally said they moved to a specialty pharmacy, I felt so much more relief knowing that they were at an organization that had that administrative functioning that could support them with this deeper level of support. I was always a little bit worried that when they were with a more traditional type of pharmacy, that it was just about, well, what am I feeling right now, as opposed to having a group that was really focused on this big picture, kind of a care management focus of their medications.

 

Sheila Arquette: (11:40)

I'm a pharmacist by training as well. And so I think our community pharmacies do a tremendous job, right, of trying to manage the patient. And oftentimes some of these medication changes are as a result of insurance requirements, formulary decisions. And so sometimes have to wonder, geez, how do they keep it all straight? So I think specialty pharmacy does a really, really great job of managing those patients with these life altering - and oftentimes life threatening - conditions and these specialized medications that perhaps our colleagues in, you know, our community pharmacies, they're just not as familiar with, right? Because they don't see them all the time either. They don't have access to the medication because of a manufacturer restriction or it could be due to a payer restriction. So I think there's a lot of synergy that happens and that we can continue to build on between specialty pharmacists in our community counterparts.

 

Janet Kennedy: (12:31)

You mentioned that certification is a big part of what NASP does, and I'm curious, do you need a higher level of certification expertise, education in order to be a specialty pharmacist?

 

Sheila Arquette: (12:44)

Currently, Janet, that's not required. However, when NASP was founded, the visionaries who knew enough way back in 2012 - because next year we’re coming up on our 10th anniversary - they knew that specialty pharmacy was something, right? Nobody knew to the extent at which it was going to grow, but they knew that the pharmacists that were practicing needed access to more education and more resources and more tools to manage these specialty pharmacy patients, because again, right, the incidence is low. So, you know, if you fill a hundred prescriptions, maybe you might have one specialty medication, while the folks who started NASP, they were very focused on the educational component. They also saw a major role for certification and in wanting to be able to demonstrate that pharmacists taking care of these specialty patients did have that level of competency and expertise and knowledge to effectively manage these patients. And so we are the only association that offers a credential, the Certified Specialty Pharmacist Credential, that allows those pharmacists to demonstrate that proficiency.

 

Janet Kennedy: (13:48)

Well, let's talk a little bit about the certification and the programs that you do. How is the patient journey folded into the mission and the activities of NASP?

 

Sheila Arquette: (14:00)

So I like to tell people that our role here at NASP is to provide the educational tools and the resources and the support that our members need so that then they can focus on caring for their patients, right? That's our number one goal. Sometimes, you know, when I'm talking to my team and they talk about our patients and, you know, the patients that we serve, I try to remind them, well, we don't really take care of any patients, right? But we are the support arm of this model, right? Where we're trying to provide what our pharmacies need so that they can better care for patients and try to lessen the load on them, right? Have this information available at their fingertips. So that they can always ensure that their patients are getting best in class care.

 

Janet Kennedy: (14:39)

Well, I know that next year you are going to actually have an award to recognize a caregiver of the year. What is that?

 

Sheila Arquette: (14:48)

It was an idea from our membership committee. And we realized that, like I said, you know, a little bit tongue in cheek, but it really does take a village to help manage these specialty pharmacy patients. And while it is amazing that a lot of these patients, maybe 10 or 15 years ago, they would've been treated in a hospital, or maybe an outpatient clinic or an infusion center. But because of all of the new medications that have been improved, and a lot of them are able to be self administered, either orally or through, you know, an injection that somebody can do at home, these patients are managing these life threatening, life altering conditions at home. And so oftentimes have to rely on caregivers and that support structure around them to manage day to day. So we just really wanna shine the spotlight on the incredible job that our caregivers do. And I think sometimes it's harder to be the caregiver than to be the patient. So we are going to have our first ever caregiver of the year award next year at our annual meeting and expo in September.

 

Janet Kennedy: (15:48)

Oh, that's so deserved and so important because the caregiving role is exhausting and huge burnout. It's something you can't literally walk away from in many cases.

 

Sheila Arquette: (16:02)

No. And, they're oftentimes, you know, they're balancing being that caregiver perhaps with employment, right? And the responsibility of being either a full-time or a part-time employee somewhere, and then their own, you know, other family responsibilities; if they have children or maybe elderly parents. So yes, it is. It just never turns off for them. And so definitely want them to know how very much appreciated they really are.

 

Janet Kennedy: (16:25)

I am curious about the pharmacist patient relationship. When I think about how often I see my doctor - could be three times a year if I'm having a healthy year. Whereas I see my pharmacist every single month. How has that changed in the last 10 years? What kind of things have evolved in pharmacy and the business of pharmacy and the relationship of the pharmacist to the patient?

 

Sheila Arquette: (16:49)

So I think especially, you know, with respect to specialty medications, we've had a boom in specialty drug approvals over the past few years. Like I said, we have now cancer patients being treated in the comfort and convenience of their own home when maybe just 10 short years ago, that would not have been possible just because of the available treatments. So I think we now have a deeper appreciation of the role, the vital role that the pharmacist and specialty pharmacist plays in that healthcare delivery team. As I said, they're responsible for ensuring that this patient receives the maximum benefit from this medication and knows what to do in the event that there's, you know, a side effect or there's some type of issue; the patient's not feeling well, they need a dosage reduction. Also, a lot of these medications - we hear lots about this in the news - are very, very expensive, and patients have difficulty affording them. So specialty pharmacists, step in and try to bridge that gap. And not only do you want a patient to start on their medication, but you want them to be able to afford to stay on their medication. And, you know, not having to choose between some of the other things that they have to spend money on, like rent or heat or food and their medications. So I think that we continue to see that, that important pharmacist patient relationship, and it just continues to grow. It's an exciting time to be in specialty pharmacy.

 

Janet Kennedy: (18:08)

I'm curious about some of the changes coming outside the industry being, in essence, pushed toward pharmacy: things like digital health, and the ability to capture a lot more data than we've ever been able to have in the past. So for instance, the collection of patient reported outcome data and pharmacists' role in monitoring that information. What kind of things are happening in the industry and what are you excited about and what are you concerned about?

 

Sheila Arquette: (18:36)

Sure so I think, you know, patient reported outcome data is critical. You can take, you know, not only the data on the surface, but then as you kind of peel back the layers of the onion and you can see what's driving patient behavior. And then how, how do I use that information to tailor my approach to this patient, right, with respect to medication adherence and compliance, and what can I do better to help this patient along their journey? And so I, I really find it fascinating. And as we continue to see such a focus on personalized and precision medicine, I think the way that we approach patients right, has to be that as well, because what works for you may not work for me. And so I think just taking some of what patients report back to you and really studying it and trying to get at what they're telling you is very, very impactful.

 

Sheila Arquette: (19:22)

And I think it's exciting, right? We're, we're gonna treat patients as the individuals that they are. We continue to learn more and more about the human genome, right? What medications you might respond to, and I'm not going to respond to. And it's really just gonna turn healthcare upside down, right? No longer will we be requiring that people try and fail a medication because we think it may work for you. We're gonna know that it's gonna work or it's not gonna work. And if it's not gonna work, why would we subject you to it? So I think there's tremendous opportunity to do things differently and to really enhance some of the processes and some of the things that we do in healthcare that aren't so efficient right now.

 

Janet Kennedy: (19:57)

Have you looked at an opportunity to bring more awareness of digital health initiatives to your annual conference?

 

Sheila Arquette: (20:05)

We do. You know, I continue to focus on how do I diversify my membership? And right now we're close to 150 corporate members, 2100 members in total with our individuals. But again, how do I bring more organizations into NASP, into our community, so that our specialty pharmacies know what's available to them and who can they engage with to make their jobs easier? We hear all the time, you know, we want you to practice at the top of your license. Well, that's what I'm trying to do. I'm trying to put in front of them resources and organizations that have come up with just incredible technology, right? To help them so that they can work smarter, not harder.

 

Janet Kennedy: (20:42)

So tell me a little bit about some of the other programs and benefits that NASP offers your members.

 

Sheila Arquette: (20:47)

All of our benefits tie back in some way to those four foundational pillars on which our organization is built; those being advocacy, education, certification, and the needs of our membership. Then our annual meeting that we've talked about a little bit is the opportunity to bring together all of the industries, the best and the brightest, just kind of share best practices and to network and to participate in educational sessions, and just shine the spotlight on what makes specialty pharmacy special. So, as you said, since I joined NASP back in 2017, I've been very focused on how do I increase the value of NASP membership, both for our corporate members, and then also our individuals. So we now have a plethora of membership benefits that in my opinion, we do offer something for everybody. So we have best in class educational programs and we offer CE credit for pharmacists nurses and pharmacy technicians.

 

Sheila Arquette: (21:41)

We also have a specialty pharmacy law conference that we host. I mentioned to you, that's how I got brought into the fold here at NASP. And we also offer continuing legal education credits in conjunction with that pre-conference workshop. We offer our members annual meeting discounts for registration and sponsorship and exhibitor packages. Also preferential speaking opportunities at our annual meeting that goes to members, that always applies to members. Next year, something new: part of our certified specialty pharmacist credential, part of earning that is taking an exam. And you have to submit an application, or we're gonna have discounts on those fees for members for new applications, and then recertifications. We also have federal and state opportunities to advocate and to get involved, to meet with your elected officials. We also have grassroots advocacy tools that make that easier. And we try to amplify our collective voice and make sure that our elected officials know that these are our issues, and we really need your help with them.

 

Sheila Arquette: (22:43)

And we also have ways that we try to increase our members' visibility, not only, only with other NASP members, but across the industry. So we have lunch and learn programs. We have our corporate member of the month program. We have our round table webinar series. Something new that we're starting next year is our lunch with the lawyer webinar series. We have six or seven law firms that are members of NASP who are so willing to share experience and their expertise with our members. We also have a student chapter program and a scholarship program just demonstrating our commitment and our investment in our future leaders of specialty pharmacy. We have a job board. We have the NASP marketplace, which is a forum for NASP members to showcase their product and service offering and offer other NASP members a discount. Next year, we're starting our own women's leadership book club. So there's so much that we have available for our members and that's not all of it.

 

Janet Kennedy: (23:41)

Well, and you couldn't have all of that if your members weren't engaging. And I think that's key to any professional organization. Is it just something where you can put a logo on your website, or are you actually going to grow and improve your skills and network with other people and really make it a valuable membership?

 

Sheila Arquette: (24:00)

Oh, absolutely, Janet. Right now we have nine active committees and we have close to 300 members that volunteer to serve on one or more committees. And it's really this volunteer army of folks that we have these members who are so passionate and dedicated and committed. It's the backbone of our association. It's the reason why we get done what we do: because of their support and their involvement.

 

Janet Kennedy: (24:24)

I did think it was neat that when we joined earlier in the fall, you actually have a member who kind of walks you through the process. And it's really neat to feel like you're being welcomed into the fold.

 

Sheila Arquette: (24:35)

Absolutely. It's called our membership buddy program. Another idea of our membership committee. And I think something that's unique to NASP too, is if you join NSAP and you, you sit on a committee, you really do have the ability to not only shape the future of the industry, but of our organization. And the membership buddy program was, again, our membership committee said, "Well, geez, what more could we do to make people feel welcome and to make sure that they have an additional point of contact?" People can always reach out to me. And, you know, I love to chat with our members and to get to know them just helps me to better serve on their behalf. But sometimes it's nice to know somebody who's not an NASP team member. And so, you know, the membership buddy program has been wildly successful.

 

Janet Kennedy: (25:15)

Well, that's great. Well, now let's get people excited about joining. How do they find out more about the Organization?

 

Sheila Arquette: (25:20)

They can visit our website, www.naspnet.org, or they can always reach out to me directly. I'm always happy to chat as you know. Love to chat with folks, love to learn more about them and just to discuss the benefits that we have and what I feel that would be helpful to them. So they can reach me at [email protected].

 

Janet Kennedy: (25:45)

And to make it easier for everyone, we will have your email, your social media profiles, and the website in the show notes. Well, Sheila, thank you so very much for joining us. It has been a wonderful conversation and I look forward to an exciting year in 2022 being a member of NASP!

 

Sheila Arquette: (26:03)

Oh, and thank you so much, Janet, for not only inviting me to join the podcast today, but for your support and for your membership. And I'm very excited as well for you to be part of NASP, and to leave your handprint on the organization and help us to move our initiatives forward.

 

Janet Kennedy: (26:17)

Thank you. You've been listening to People Always, Patients Sometimes. This is Janet Kennedy, and I look forward to speaking with you on a future episode.

Pharmacy companies are an important part for Spencer Health Solutions, and pharmacists are an integral part of fulfilling our mission to serve patients in their homes. Hi, I'm Tom Rhodes, CEO, Spencer Health Solutions. We have had the opportunity to bring patient pharmaceutical and digital health thought leaders to previous podcasts. However, today we're speaking with our first pharmacist, digital health advocate and analyst, Timothy Aungst, also known as the digital apothecary. He joins our host Janet Kennedy for an insightful conversation and a call to action to the pharmacy industry on the People Always, Patients Sometimes podcast.

 

Janet Kennedy: (00:45)

Welcome to People Always, Patients Sometimes. I'm very excited that today's guest is Timothy Aungst, the digital apothecary. He is an associate professor of pharmacy practice and also a clinical pharmacist. Timothy, welcome to the podcast.

 

Timothy Aungst: (01:03)

Thank you, Janet, I'm really excited to be here today to talk about, you know, all this stuff that's been going on.

 

Janet Kennedy: (01:08)

It's been a crazy couple of years and that's one of the things that I wanted to talk to you about. I found you because I read your primer, "Digital Health Primer for Pharmacists." You published it in February of 2019. At that time you wrote, "after being involved in the digital health space for almost a decade, I can say with complete sincerity, that the topic is still relatively out of the realm of the general pharmacy profession grasp." Okay. You put a challenge out there. 10 years you've been involved in digital health and you're saying pharmacy is still not up to speed. Would you say that that's true two years later?

 

Timothy Aungst: (01:52)

Yes. I still would stand by that. I would argue that we have seen entrepreneurship within the pharmacy profession gravitate towards digital health at large, but I would also conversely say that as a profession for pharmacists, we have not really actually actively engaged in this area. We still lack a large number of educational roles and trying to get people aware of the space. There is a lack of discussion around it. Most of our public organizations that provide guidance on what our next steps for the profession don't really think about it in, I think it's for that reason, I still would say the gap is there. Now that is changing. I would say that there has been a semi call to action amongst several pharmacy organizations, whether it's say PHA, ACP and several others who are now trying to get the profession up to speed on what digital health is.

 

Timothy Aungst: (02:44)

And that's been a big focus of mine serving as so-called subject matter expert or key opinion leader to help get information out there regarding the topic. But very, at this time it's quite topical just because we are not actively highly engaged with it. I would probably say we're maybe like two or three years behind other healthcare professions, such as the medical community. The American medical association has an active digital health component that they've been pushing, I would say probably for about two or three years at this point, have reports coming out, organizations associated with it. And I think pharmacists have to play catch up to that. And depending on key stakeholders at this current time that may or may not go fast or may go slow. And that's one thing I'm actively keeping my eye on.

 

Janet Kennedy: (03:27)

Well, I'm curious about whether pharmacists or the pharmacy is even included in some of this digital health development.

 

Timothy Aungst: (03:36)

I'm always a person who would've actually separate the two. The pharmacist and the pharmacy, I think are no longer synonymous organizations. You don't need a pharmacy to have a pharmacist. I think it's going to be what we see in the 2020s or 2030s at this point. I think those two things will actually diverge and that will just come down to logistics and also some legal parameters I think people are pushing right now. Technicians will be empowered to take on most of the stuff on site and pharmacists will probably feel remote. That being the case then to accomplish that, and also to get pharmacies up to speed where healthcare is going, I think the pharmacy businesses will engage in digital health activities. For good or for bad. The big news right now, right, is that Elizabeth Holmes is in court with Theranos. And if we look at Thernos, who was one of the biggest backers? That was Walgreens. And I always looked at what happened with Walgreens being burned there is a reason why they actually had a huge number of digital health initiatives back in the 2010s. And I think they pulled back because they got burned so heavily.

 

Timothy Aungst: (04:31)

In the meantime, we see, let's say a business like CVS Health going down a whole vertical pipeline. Now we got Aetna involved, we got long-term care stuff, we got them pushing to go into kidney disease with dialysis treatments. They are partnering up with digital health companies all over the place. One of the biggest ones, for example, was Sleepio for a digital therapeutic that they've been piloting out there, which has actually initial positive results I'm actually reading through right now. So some of these companies are more involved than others. And I think it's going to come down to, you know, what assets they have to really push that. Whether they see the market going a certain way and they want to meet consumer demands because they are also aware of that, with the changing dynamics within healthcare, pharma is going down the digital health path. Payers are looking at this. Employers are looking at this and even the big tech companies are pushing this stuff out there. So are they going to let other people dictate to them the incumbents of what to do, or are they going to be the drivers themselves? And I think that's going to be something that's going to be interesting to watch.

 

Janet Kennedy: (05:34)

Well, so you mentioned the need to separate the pharmacist from pharmacy. So speaking from the individual's perspective, do you hear pharmacists talking about wanting more and better tools to be able to help their patients or are they just basically the Amazon employee at the warehouse where they're just cranking out the work?

 

Timothy Aungst: (05:57)

See, I used to think we're still on the razor's edge between two possibilities: one was pharmacists finding some kind of clinical services they pay for under some, say, value-based care agreements. And by providing clinical services would receive renumeration that would allow them to be so-called clinicians in health care. Or the other one was being fully remote and being consigned to these activities, to these virtual workshops where they basically just review medications that have been turned out by Amazon or other companies like true pill, et cetera. There might be a third path, which is a mix between the two. And that's kind of where I'm more leaning towards right now from a pharmacist perspective. Yes, there is a huge interest in digital pathway as a means to basically call back clinical services and kind of like be able to provide services that could then actually have objective feedback in terms of what they did, that they could then bill for services and, you know, make money from it.

 

Timothy Aungst: (06:51)

But I don't know if that's going to be enough at this current point to actually say, "oh, well, you're now a remote clinical pharmacist that overviews these data's on people's adherence or their information on disease states, and you get this much," because one of the issues is actually even though they're like remote patient monitoring services that we're seeing CPT codes being pushed up by CMS and such, they're in the physician still. So the pharmacist almost has to still be partnered with someone else in order to receive the renumeration. And then at that point in time, you know, it was kind of like, what slice of the pie are you going to get? And I think that's really what concerns me is that from a healthcare perspective, the pharmacist is still really trapped in their other engagements, which has traditionally held us back. And I think this is because we again have very little stakes in digital health and we were coming to the table kind of late. The other people have already kind of figured this out and have already been making inroads. Making propositions to other organizations to get themselves ahead. And we're kind of almost, I don't want to say asking for crumbs, but we're going to have to really do our best claw back some of this stuff for ourselves. And that's going to delay, I think those aspects.

 

Janet Kennedy: (07:56)

And do you see the trade associations being the ones that should be leading this charge?

 

Timothy Aungst: (08:01)

I think the trade associations unfortunately all have different stances out why they would want to engage in this stuff. The trade associations value pharmacists to different extents. And within a pharmacy community, we know with the alphabet soup of different pharmacy organizations, they don't all have one central voice. They don't all have one central take on what is the role of pharmacists. I've heard some people say we have a pharmacist practice at the top of their license. I don't know what that means. To be quite honest, whenever I hear that I kind of have to roll my eyes, because what is the top of their license? I think in their eyes probably is just, you know, sending off for prescriptions. So that's great. That's what they see as the business that they have to focus on. I could see definitely some trade associations making an argument to empower technicians, to move back at scale back the role of the pharmacist as a, you know, as a rate limiting step in terms of evaluating prescriptions and getting them out the door.

 

Timothy Aungst: (08:53)

And also because there are high cost margin right there, and that would reduce the overhead versus some other trade associations are definitely more clinically focused and would push that down too. So within pharmacy, the unfortunate thing right now is there are some tenuous arguments going on about, you know, who has the right step for the profession or which to be used, how to utilize them. And I think those are the conversations, the hard conversations to have to occur now versus later, because this whole approach of them to let's say digital health and such could become very fragmented. You could see some people that operate large corporations would probably want to use digital health for alternative means versus maybe some smaller companies. And I think that's going to really, for me, I have to bemoan them is that's gonna really muddy the waters and I guess, slow down the process of any adoption by the profession. So yes, I think the trade professions will probably be key here, but I would also, or you, because historically they don't always get along or had the same thought processes that this is going to be another area. That's going to be a sticking point where argue about how to do this.

 

Janet Kennedy: (09:57)

You know, I find that health care was still slow to come to digital tools and platforms. I'm curious to know whether, with your ear to the ground, do you find that patients are pushing their desire for digital health into the healthcare system? And do you find that that's being impacted or felt on the pharmacy side?

 

Timothy Aungst: (10:21)

And this is a good question because you know, who's the drivers for change. I think it's one of the things that always comes up. Patients are often said to be one of the major drivers, and I do believe that to a certain points payers are probably one of the biggest drivers I would argue though, overall, because they ultimately are paying the money. Patients themselves are vocal population that can dictate those favorable or unfavorable role, lots of different programs and services at the end of the day. So from that perspective, I think with the ongoing pandemic, we saw this huge push for, you know, delivery of services for the ability to have a so-called digital front door. And you know, what was in the news the other day was that Walgreens got in trouble apparently because they're whole vaccine signup and testing site wasn't secure. And the data is now - someone's getting into it. And this, I think is going to give some feedback to people like, you know, if we have to do remote practice, sign up and go through an app or make an account and et cetera, but you can't even keep my data secure - Is that good or bad?

 

Timothy Aungst: (11:17)

You know, is that a company I'm going to trust? And those are the things that they're hitting people now it's not so much like, oh, you know, I have a brick and mortar business. People come and buy things and they leave. I just had to worry about the credit cards now I have to worry about their online accounts. I have to worry about health history that's been uploaded or shared. This is definitely a new area I think people are considering. Hospitals and health systems have been dealing with this for years. They've been getting hit by malware attacks for a long time. Now people will ask you for cryptocurrency just to unlock their systems, for goodness sake. And because of this, the population does expect a digital front door, digital services. And I think ultimately businesses have had to pivot to address an answer to that.

 

Timothy Aungst: (11:57)

But I don't think they traditionally had that as a, you know, as something that is a high concern for them in the pandemic was a force multiplier that really had to make them rush into, this for good or for bad. I mean, the pandemic is going to go on for awhile. We're going to see this go up in waves, in different parts of the United States. So these companies are going to have a long time to pilot certain programs, but I think many of them have recognized, no matter what, post pandemic, this is going to be a status quo. So whatever works now has to work in the future as well.

 

Janet Kennedy: (12:27)

Well, certainly the pandemic has made a lot of things happen faster; that we have seen an acceleration of the interest in some kinds of digital health, particularly tele-health, which sounds new to a lot of people, but it's been around for 20 years. And I know you've been around in the digital health space for over a decade. So let's step back for a second. Could you tell me a little bit about the digital apothecary and why did you start it?

 

Timothy Aungst: (12:54)

Sure. So the digital apothecary was kind of like just a little passion product, a little thing that I spread out based on my interests. So I started off as a resident during my PGY1. I got an iPad in 2011. So keep in mind the iPad came out 2010. So one of the things that I did was I actually started processing orders in the hospital using my iPad through Citrix. And this is funny because this is a period where we had so-called COWs, or computers on wheels, or WOWs, workstation on wheels, as they're often called now, and people would argue over these things to process orders in the hospital, et cetera. And I just basically started using my iPad to do all this stuff. And people started catching attention, like why is he doing this stuff faster? He's looking for information faster in there and blah, blah, blah.

 

Timothy Aungst: (13:36)

And I was like, yeah, cause I had this device that can do this. I start thinking of something, what is a good app? What is a good thing? And so I started reviewing and looking at stuff and then I joined another group called iMedicalApps and we start reviewing mobile apps. We actually wrote a bunch of papers about how to quantify what is and what is not a good app and to use clinically for patients in patient care. And we gave presentations all over place on this topic. And that was a huge thing for me. And this was when it was mobile health that was my focus. And then circa 2014-15, I moved on to just the bigger digital health space and started writing for different organizations and serving as a speaker advisor consultant for different companies actually were asking a lot of these questions. The years I started thinking with remote patient monitoring, questions about tele-health, pharmacy, how to adopt medication adherence is a big one for me as well.

 

Timothy Aungst: (14:20)

And it kind of really changed my thought process in terms of like, you know, this stuff's just kind of adjunctive to care versus, okay, this is going to be actually part in driving care. Eventually digital health, I kinda thought to myself, is just a interim term. I think digital health eventually turns into just health. It's kind of the same period we went through with like digital banking. We don't call it digital banking anymore, we just call it banking. When you go onto your app cash or check or use Venmo, like no one calls it really digital banking. I think that's where healthcare is at. So I noticed there wasn't that many people around the space. There is one person I look up to is Kevin Clawson, who's now into blockchain for healthcare down at Lipscomb. He was a great mentor for me early on. And it was a few other people I've talked to them such as Brent Fox about this too.

 

Timothy Aungst: (15:01)

And, but the reality is in the academia circles, that generally there was not a lot of pharmacists, I think, into digital health or into this technology thing. So I kind of got into it, talking about it. I had a lot of people say this was like a waste of time. And I really had to take a thought for myself academically - do I really want to dedicate all my time towards investigating and research in this space. Or should I start moving towards something else as an academic? And I chose to keep on it. And I'm actually pleased because now with the, you know, things are really changing the payment like that, people really want to talk more about it. People aren't real into telehealth. And they were like, who even knows about this in pharmacy? Then my name comes up because that's been something I've been talking about for so long.

 

Timothy Aungst: (15:39)

People are looking at different digital health technologies and like, okay, who's in digital talking about, oh, Timothy's talking about it. Timothy's been talking about it for so long now. So it's kind of just in many ways for me, unfortunately, the pandemic has been a driving force around trying to actually get my message out more than it was in the past. I think if the pandemic had not happened digital health would not have seen the rampant advancements that it has, and probably would have been towards the tail end of 2020s that I foresee that would have taken off in versus the early 2020s at this time.

 

Janet Kennedy: (16:09)

One of the things you mentioned in your primer was that digital health definitely isn't informatics. Can you tell me what you mean by that?

 

Timothy Aungst: (16:20)

Oh, this is, this is, this is a good one. Okay. So this is unbearably one of the hardest questions I had to deal with in terms of talking within my community. So there's always been a push in pharmacy, informatics, you know informational management information, using different data streams and such, EHR management, et cetera, et cetera. And that's been a group that's been around for decades. I would probably say early two thousands, 1990s. We saw them out there and there's always been pharmacy informatics people. And it's the, you know, the American informatics Association and such, or AMIA. But you know, when, when I started talking about digital health, one thing that I actually got in trouble with early on was people like, isn't it just informatics. I was like, what do you mean? Like this is technology. I was like, "technology is not synonymous with informatics." Informatics definitely plays a role in digital health and managing all the data streams that come down.

 

Timothy Aungst: (17:04)

But I would argue that the traditional informatics thought processes around management of health. It does not mean lik,e this whole digital health kind of ecosystem. And that's actually where I would have conversations with people like, oh, they'll get all this person, their informatics person, we have the conversation and people will talk about, you know, KPIs, C-Colon and different things in programming. And they'll be like, "Yeah, I don't do any of this stuff. That's not my business. I'm more interested in the clinical workflow design associated with this stuff and how to actually evaluate one technology versus another and blah, blah, blah." And so that does overlap. Yes, it does. But I think some people have assumed that, especially in pharmacy and for pharmacists, that informatics would subsume and take over digital health. And that's one area I'm not too sure on. I think some people may want that. And some people don't. I for one don't. I think informatics works within digital health space in that it's definitely a conversation and there's been other publications around this that kind of delved into a little bit more different therapeutic areas like oncology. But early on, It was very, very difficult actually to separate the two. I think at this time, most of it is separated, but I, that was a early conversation I had had with people.

 

Janet Kennedy: (18:13)

Okay. I'm interested in the amount of data that could be available through digital health apps and how a pharmacist might actually interact with that. So I'm really getting around to a conversation about adherence. Right now, when we think of adherence, it's the next fill - did you get the next prescription filled? But there's 30 or even 90 days in between those fills. If you had that data and it was daily, would a pharmacist be able to actually manage that information, and would they want to?

 

Timothy Aungst: (18:48)

So here is a loaded question. And I mean this, cause this is an area that I'm fully invested - I love this topic. It is too many stakeholders, I think we can go over in detail about maybe some, the big ones like, you know, who cares about adherence at the end of the day? You know, is it, the patient, is it the clinician, is the payer? I would argue payers recognize there's enough research out there saying that on average, a patient takes for medications, hopefully their diseases won't progress and they'll get better. Same with the clinicians and same with the patients who probably think that to a certain extent. But when we look at adherence data, if we look at HEOR and stuff like that, like what do they use as their metrics? Half the time it's like medication possession ratio, right? And I am not convinced that thing is actually really, really useful.

 

Timothy Aungst: (19:29)

I think globally? Yes. I think scalable factor for most organizations, that is the go-to way to doing this. And yet I think about all the patients that I visit in their homes that have boxes of medications still stacked away. And it's like, why are they getting it? Well, you know, I just buy it because I'm told I have to buy it. So you buy your medication and then you store it away, but you're not taking it? And you know, I can't help it go walk away and thinking back my head, like, you know, what? If they show up in a report, people are going to say they're adherent. I just walked into their house and they had like 12 Advair discuses sitting there, and their COPD is still not doing good. Why? No, they're not probably taking and using it correctly, right? But anyone else would probably see that and not make that tie together.

 

Timothy Aungst: (20:10)

So I think the biggest problem we've focused and seen in adherence is there's been no way to actually really assess if people have been taking their medications. So we argue about a topic that is potentially anywhere between $300 and $500 billion, which is really, I think, around medication optimization - which adherence is one of those things. But we've had very little quantitative data to back up our arguments. We've had qualitative data; but from a quantitative side, we've never really been able to scale. Even pharma has struggled with this in their clinical trials. You know, we've seen things like MEMSCAP and everything else out there for years trying to make a market here, and they've never really blown up. And then the 2010s, we had a flood in the market of all these different digital health devices because they recognize that stuff, but not all of them have been successful.

 

Timothy Aungst: (20:54)

And the question is why? And I think it's because we've come to realize that adherence is very, very, very challenging. Human behavior is very challenging. I think humans are very chaotic in terms of adherence and such. So it comes back to the key stakeholders, you know? Why does the pharmacy care about, you know, adherence? To me, if pharmacy cares about adherence, instead of talking about value for the pharmacy, is the more prescriptions that are dispensed equal more profits. So if a patient's taking their medication on time, theoretically and filling on time, then that profit margin, at least is correct - 12 refills a year for a monthly supply versus if they're not, then they're not refilling and then you're not billing and you're not making money from it. So as a pharmacy, clinicians I think also have kind of a mixed feeling around adherence. To be honest, I think this might be actually one of the biggest conversations that should occur is there are therapeutic areas where we want a hundred percent adherence or at least above 90%.

 

Timothy Aungst: (21:47)

There are therapeutic areas where I think we could be fine if people were not truly adherent. If you miss your Metformin a few days a month, am I going to care? Probably not? Your statin, and probably not? You know, and this comes down to, you know, how maybe severe a patient is, you know, how high their co-morbidity is. But there's certain diseases where, you know, what if I miss getting a biologic therapy by a day or two? Is I can really ruin me? Some day, we'll say yes. Some day we'll say no. But there's other therapeutic areas. Like let's say schizophrenia; you know, if they miss your medication, will it be problematic? Yeah. Probably. And the payers are going to be concerned about that. Cause that increases ER visits and hospitalizations, right? So often when we talk about adherence I feel like it's such a global issue that people focus on when it's very granular and it's really around different sensitivities associated with therapeutic areas that I don't really see a lot of people talk about, at large, associate with that technology.

 

Timothy Aungst: (22:40)

That technology always seems focused just on trying to solve adherence from a very global perspective. While I think clinically we've had a lot of research talking about adherence from a very small perspective in terms of what diseases and such does it really impact. And so there isn't this mismatch behind there. So there's a financial aspect, there is the clinical aspects I think. And then there's some design aspects, you know, solving adherence, you know? What does it take to do that? And is actually the money invested really worth it? I think it's one thing that's often not discussed like, you know, just because we can solve adherence; should we? And again, they come back to the fact that we blocked a lot of objective information in many ways. If this goes to your question, would we want to actually have this data?

 

Timothy Aungst: (23:21)

We are opening Pandora's box. We now know more about people's habits than we have in the past. So to gives some examples would be, let's go with inhalers. Propeller both have this interesting study where they evaluated people's utilization of inhalers and found them, I think they found 60, 80% of people were using their inhaler or Saba rescue inhaler incorrectly. Okay. That's actually really, really concerning, right? Because that's higher than what we probably have historically noted in research. Secondly, if these are patients that we've been signing off saying that they've been adherent or a technique is good, this really calls into question what and how well we've actually been approaching this area for decades. And I think that's actually one of the big things I'm actually concerned about. And I think many companies are kind of thinking about is, you know, we're getting a more objective information about people's habits than we ever had a past.

 

Timothy Aungst: (24:09)

And in many ways this could be good, or it could be downright terrible if we're not prepared for the ramifications that everything we thought we knew may be wrong. And I think that's actually an area that most of us may be concerned about because that calls in attention like; okay, we find out that we've been wrong and we've not doing things perfectly. That's great. Well now we've got to fix it. No fix is going to come out overnight. So solving adherence also probably means finding out this data and understanding it while also trying to solve the underlying questions about how do we address some of these issues? Thinking about it clinically, thinking about our workflow. So when pharmacists want to see adherence on a daily basis, I don't think that'd be a problem, but I would throw back then this, what is the value of it? What is the value knowing if someone took their medication on a daily basis? Do they skip through the center pro clinically, is that meaningful? Maybe, maybe not depending on how bad their hypertension is, right? Or maybe heart failure or some other condition? From a peer perspective then maybe yes. And then along with that though, could also be focused on the money that you get for people not refilling on time. So these are the things I think that need to really be questioned.

 

Janet Kennedy: (25:17)

Well, it's also the question of the firehose or the very specific stream of data that's relevant. So yes, any digital solution is going to gather all the information, but you wouldn't need all the information. What you would need is the alert that says based on the parameters for this patient, with these meds, now we need to worry about adherence and it could be on day four or five for a lesser impactful drug. It could be on day two for something that is of imperative nature that they take it. So that's the benefit of course, of being overwhelmed by analytics and informatics is that you can also then design the algorithm that sets the actions.

 

Timothy Aungst: (26:02)

And that is the biggest issue then at this time, because who decides what the algorithm looks like? And this is a question that I throw most companies. And when I actually hear back, is well do it. But do you actually have the clinical staff and know how to do it? That's the issue. So I'm actually very curious if a company will come along, and actually would build this in their backend. You know, like we already have drug information databases out there, right? You know, is someone going to make something like this that they could then sell out to other companies to then utilize? Are they going to build it in-house, or would these alerts be optionable for a clinical site or a business? That would be nice. But you know, if you gave me a package deal and say, "you know, we could default this or you can change it, whatever you want."

 

Timothy Aungst: (26:46)

Then I think that might change the conversation because it's just, you know, how many medications are out there? It's like, you know, NDC codes sitting on the shelf in pharmacies, enormous. So from a theoretical perspective, yes, this could be very possible. For practical perspective, who's going to build it and the timeframe it's going to take to build that is going to be enormous because the fact of matter is we can't build it because we don't know the data around some of this stuff, these questions. And that's the, that's a factor with Pandora's box. It opened up this huge conversation because we have the objective data to back it up now, compared in the past. But we don't know really, you know, what is the right answer? We don't know. If you go through like the literature and start like, you know, going into like pubmed and other things, how many days can you go without skipping his medication? It's not like there's gonna be a publication saying, oh, you can do this, this, this. That stuff doesn't exist, because we've never known.

 

Janet Kennedy: (27:34)

All right. Well that sounds like the call to action to the industry, is we've got to start talking about, you know, when you have this data from digital health, how are you going to apply it and make it be not just an endless stream of numbers, but something that is actionable that supports the patient's health journey?

 

Timothy Aungst: (27:53)

Actionable data is key. The when to have an action is the unknown. And this is where I think companies could freak out users; because it's easy enough for a patient to call me and say, you know, I've missed my medication past three days, and be like, okay, well you should take your medication or titrate back up, or let's have you in the off spot. And having the patients take that on. All right. Cause they self activated and they chose to do this. I didn't know that until they told me, right? So my liability or whatever we want to call it is limited on a patient discretion, because they own what happened to them. The minute you start putting this subjective information out there, that means the ownership and responsibility shifted to some group that never was responsible in the past. So to expect that people like selling them, want this data and use it, you may hear people say, no, not really.

 

Timothy Aungst: (28:43)

And if you peel back the layers, you'll probably eventually find out it's this trepidation around, "I don't know what to do with this data." And I don't really trust the company to tell me what to do with this data, because I don't know where they're pulling that from. So there's gotta be some kind of evidence-based approach around there, but where is the evidence? And then this is where the ground falls out from all of us is, that Aetna says it exists. And that to me, I think is the overwhelming issue around truly objectifying medication here is the fact that we don't know what to do with it this time. And it's very troubling. So for me personally, I think this is great. This is what we should do. Are we there yet? I don't think so. And I think one of the biggest problems has been, it's not the technology. It's not even like the process of logistics; I think it's the overloading clinical scenarios that we never really hadn't think about in the past, and who's going to be responsible for what?

 

Janet Kennedy: (29:37)

Okay. You have now laid some pretty big questions that could take us down another rabbit hole for at least an hour. So I'm going to hold those thoughts for our next conversation. And Timothy, just thank you very much for joining us on People Always, Patients Sometimes. Would you mind sharing how they can find you online?

 

Timothy Aungst: (29:58)

You can find me on LinkedIn, you can find me on Twitter. Usually just my name. If you look it up, you'll find it. My website, thedigitalapothecary.com is also out there where I write about a lot of stuff. A lot of it is theory crafting, a lot of it is focused on next steps and such or issues I see in the industry. So you're welcome to come and contact me and reach out.

 

Janet Kennedy: (30:17)

Excellent. Well, I think we're going to have a part two of this conversation. So I look forward to seeing you on the podcast again soon.

 

Timothy Aungst: (30:24)

Thank you very much for having me.

What happens to a person who finds out they have a rare disease? When you're diagnosed with a condition that affects one in a thousand or one in ten thousand, where do you turn to find information, help, and support? Recognizing the need for that resource, a team of dedicated individuals on Rare Revolution, a magazine dedicated to spotlighting the rare disease community. Their goal is to bring about a dramatic and wide reaching change in conditions and attitudes for the rare disease community. We are honored to bring Rebecca Stewart, CEO of Rare Revolution Magazine, to the podcast. Her conversation with our host, Janet Kennedy, truly reflects our philosophy - People Always, Patients Sometimes.

 

Janet Kennedy: (00:50)

Welcome to People Always, Patients Sometimes. Today we're really taking a patient perspective and we're taking a unique look at patients who really need some attention right now, and those are the patients that reflect the rare disease community. With me is the CEO and founder of Rare Revolution Magazine, Rebecca Stewart, and we're going to be talking about the thousands of patients who may not be getting the attention they deserve and need - those with rare disease. Rebecca, welcome to the podcast.

 

Rebecca Stewart: (01:24)

Thank you very much for having me Janet. It's a pleasure to be here.

 

Janet Kennedy: (01:27)

I would like to think that we really are having a Rare Revolution, but is yours a call to action or a reflection of what's actually happening in the rare disease community?

 

Rebecca Stewart: (01:39)

So to give you some context, there are over 7,000 known rare diseases, which affect globally 350 million people. So we're the biggest, rare community that there is. It's a huge number of patients, but of course, individually, each individual disease affects a small number. But globally it's a huge health crisis.

 

Janet Kennedy: (02:05)

How about how the community is being served? Is this something where individual patients are truly having to learn how to advocate for themselves, or are they growing together as a community to speak and support each other?

 

Rebecca Stewart: (02:20)

I think there's both. So, as a community, the rare disease community have both really good individual disease communities, mostly. Of course, there are those rare diseases that are so rare that there aren't support groups, there aren't patient communities. And so those people find themselves really quite isolated. And then collectively the rare disease community comes together to really help influence policy, to help influence healthcare, to help push for things like interest in orphan diseases, from pharmaceutical companies and research, and to support each other because individually, the individual nuances of each rare disease, whilst those might be very different, collectively people with rare diseases tend to have very similar problems; that's access to expertise, access to healthcare, education, meaningful employment, social services. These are all shared problems. And so they can really support each other across disease. So, you know, really disease, agnostic support as well as the absolutely amazing job that individual support charities and organizations provide on a specific disease level.

 

Janet Kennedy: (03:34)

So what is the Rare Revolution Magazine role in all of this? What is your mission and how do you become involved in this community?

 

Rebecca Stewart: (03:43)

In 2012, my sister, who's also my co-founder, and I actually began a disease-specific support group called Teddington Trust, which is to support families affected by the ultra rare disease Xeroderma Pigmentosum. And through that, what we found was a real gap in our ability to raise meaningful awareness for the work that we did and for the condition and that it was done in a way that we felt was sensitively dealt with and valuable to us as an organization and a community. And we thought, well, we can't be the only people that struggle with this. And of course we discovered we weren't. So Rare Revelation Magazine was founded out of a real gap in rare disease education and awareness materials. And what we wanted to do was to become a platform where it didn't matter whether you were a patient, a caregiver, an advocacy leader, someone from industry, someone from research, or a healthcare professional: right across the ecosystem, you could come to us and both be heard, talk about the work that you're doing, but also gain value and find information and education in what you read. But it was really important to us that the tone, the design, the curation was something that added value and was sensitive to people's lives. And that's really, our mission is to be a source of awareness, education, signposting, so that people can find each other and really be a platform to elevate the voices of our communities. So we don't speak for our community. We're just here to elevate the voices of the community that exists and already do a great job.

 

Janet Kennedy: (05:24)

Well, you know when I look at the magazine, which is digital only, is that correct?

 

Rebecca Stewart: (05:28)

It is. We do occasionally print them if we're going to conferences in pre-COVID times, but you know, it's a digital e-reader and then a website as well. So web based content, and then the magazine itself has produced as a digital e-reader.

 

Janet Kennedy: (05:42)

Well, kudos to you. It is a fabulous looking magazine. It is so professionally produced. The photography's incredible. Your design is great. This is not a newsletter typed out in your backyard. This is an amazingly beautiful magazine.

 

Rebecca Stewart: (05:59)

Thank you. And you know that was actually really important to us that, I think when you have a rare disease or a chronic illness, you spend a lot of your time online carrying out research. And it was really important to us that when we produce this magazine, it was something that told a story, but it was really, it was, we spent enough time on our screens. We wanted something that was really lovely to look at that it was an enjoyable process. Because to us, that means people spend longer in the publication, looking at things and reading articles that they might not normally read and that we have found to be true. Certainly our average time that people spend on the magazine is much longer than you might expect people to spend in digital content. And I think that is down to the amazing job that our two designers and also to our editor and chief creative director, Nicola Miller, who curates and has a hand in overseeing all of the publications that we do.

 

Janet Kennedy: (06:58)

Tell me a little bit about the process of putting the magazine together. You've mentioned over 7,000 rare diseases; well you'd think it would end up being something as big as the Encyclopedia Britannica. So how do you curate and where do you get your content and how is it put together?

 

Rebecca Stewart: (07:14)

Well, we do between three and four core additions of the magazine each year. And then on top of that, we do a number of spotlights additions, which tend to be smaller and more focused. And we will do three of those perhaps in a year. And then we have our online content as well. And when it comes to what themes we're going to tackle, we keep quite a close ear in the community. We see where people are talking, what they're talking about, what the current challenges are. But also people will reach out to us and say, you know, we have this condition, have you ever thought about covering it? And so we'll put together an editorial calendar over the year that are topical things that are going on in the community or areas where we feel we can really reach out to the community and add value.

 

Rebecca Stewart: (08:03)

For example, we have just done an edition on inclusion, equity, and diversity. Prior to that, we have looked at rare bone diseases or rare cancers, rare kidney diseases. You know, what we're trying to do with those core additions is have a very broad topic that we can encompass many rare diseases in under that. Obviously we're never, you know, Nicola and I will not live long enough to cover every rare disease at 7,000 plus, but we're giving it a good shot and we're doing it as best we can with these topics. And then with our spotlight additions, those really allow us to get very, very detailed on very specific subjects. And generally those additions are brought to us by sponsors who have got a particular need to talk in an area and they want to really shine a light on something. And so we will work with those sponsors to produce those spotlights.

 

Janet Kennedy: (08:56)

And how do you vet out in essence, the difference between say paid and editorial content?

 

Rebecca Stewart: (09:02)

In our core additions, we have an editorial sponsor, but that editorial sponsor only has any control over the articles that they give us for that particular edition. Everything else is the copyright of the contributor and of Rare Revolution. So they don't have any editorial control there, which really allows us to make sure that the conversations that we're having are genuine and are not influenced by a sponsor. And even when we do our spotlight additions, which tend to be solely sponsored still in that situation, the sponsor does not have editorial control. And what we generally do in that situation is we will carry out all of the patient patient group and healthcare professional interviews; which again, allows us to make sure that we're asking appropriate questions, that we're keeping all of that content compliant and valuable. And we understand what our readers are looking for. So, you know, we very much have an input in any brief that's being laid out for the spotlight edition. But in our core additions, over 90% of the content will be from individuals and charities. There's very little paid for content actually makes its way into those additions.

 

Janet Kennedy: (10:16)

Which makes it even more amazing that this is a free publication.

 

Rebecca Stewart: (10:21)

Yes. It is a challenge, I won't lie. Our revenue stream for the magazine - we are a not-for-profit organization - but we're not funded by grants. So all of the funding that we receive is through paid for content. So things are tight. We're not sitting here with a big fund or a huge team. We're a very small team of eight. So we have four full-time, four part-time members of team, and they do an incredible job of delivering all of the content that we do.

 

Janet Kennedy: (10:50)

I'm so impressed with the quality of the content. I think it's really amazing considering what a small team you have. It's just absolutely gorgeously put together. So kudos to you. Let me ask you a question about sponsors. And when we say sponsors, what I'm really asking is about some of the pharma community, some of the organizations that are involved in drug development for rare disease; how do you think that they can be more involved in supporting patients? I definitely see that there are more and more companies that are starting to have patient advocates. They're starting to have patient engagement titles, but how are they connecting with the rare disease community?

 

Rebecca Stewart: (11:36)

I think you're right. The role of patient engagement within pharmaceutical companies we have seen, I mean, although it's been something that has been around for more than twenty years, I think really in the last five years, it has really grown and there has been more pressure on companies to really include the patient voice in what they are doing. And it is done very well and it has done very poorly. I think there's still a long way to go, but we are definitely heading in the right direction in terms of how pharma is engaging with patient communities. I think it's a really challenging area for them. Obviously, pharmaceutical companies, quite rightly so are heavily regulated and there are tight controls on how pharmaceutical and biotechnology companies can engage with patient communities. And that is all correct. And as it should be, I think there is a gap in that while patient engagement has grown and become better and become more prolific, the regulatory environment that surrounds that has not matured at the same rate.

 

Rebecca Stewart: (12:43)

And so I think there is still a bit of a disconnect between what could happen and what should happen and how comfortable pharmaceutical companies feel about doing it. I also think that in terms of where pharmaceutical companies go next, there's a huge burden on charities and support groups in engaging with pharma. And they want to do it. Don't get me wrong, It's a burden that they want to take on. However, it's a really complicated landscape and there's an education gap there both for patient groups when it comes to navigating these complex pathways and also pharma and what's appropriate in the way that they should engage. So I think there's definitely some more education piece there that can be looked at to improve that. And I think some of that can be driven and come from regulators and overarching bodies in the space. I think the other area that we need to collaboratively look at is the one of innovative medicines.

 

Rebecca Stewart: (13:43)

You know, we are in an era where we have gene therapies, gene editing, some really innovative therapies and treatments, which are making their way into rare disease, which is absolutely fantastic and amazing. However, with this kind of research and with these kinds of developments, there comes high prices for drugs and at the moment, there's little, that's understood about the way that these drugs will be paid for by payers. And so I think we are beginning to see the problems where we have, you know, I don't know what it is, I think it's several hundred gene therapies now in the pipeline through the FDA and EMA, but we're very, very unclear as to how these will be paid for, especially in countries like the UK, where we have a national health system and we have an approvals process for that. So I think access to innovative medicines is really an emerging problem that really we need to tackle collaboratively.

 

Janet Kennedy: (14:44)

Well, the reality is patients can't afford any of them. So somebody has got to figure that out.

 

Rebecca Stewart: (14:50)

Exactly. I mean, when you've got a single medicine in the region of over a million dollars and upwards, we have to look at how these are going to be paid for because to not have a treatment - only 5% of rare diseases have a licensed treatment. So we are desperate for more treatments within the field of rare disease. However, the only thing that is more desperate than not having a treatment is having a treatment, which has proved to be efficacious and safe and you cannot access it because either insurers or health boards won't pay for it. And so there is a responsibility for everybody, I think to work this out before we suddenly have all of these drugs on the market and patients still not being able to access them.

 

Janet Kennedy: (15:32)

I can't imagine a more heartbreaking situation is to know that there is a potential solution that you cannot afford to have.

 

Rebecca Stewart: (15:42)

Yeah. Yeah, exactly. And I think that's something that really is a matter of priority. We need to be looking at. And some countries are. For example, we've just done some work in the Middle East with a particular additional focused on the MENA region. And some of their health boards are having dedicated advanced therapy panels so that they can look at it, become expert in that particular field of medicine and start looking at it from an advanced therapies point of view. So I think there are countries that are starting to tackle and address this, but we do need to move with some speed, I think, if we're not going to have this kind of potential problem with access.

 

Janet Kennedy: (16:24)

Well it sounds like advocacy has to extend beyond the easy advocacy. Sounds like the media, for instance, could step up and instead of focusing just on heart disease or diabetes or the well-known well-understood, and to be honest, well-funded diseases to really start to shine a spotlight on the rare community.

 

Rebecca Stewart: (16:49)

Yeah. And I think along with that, there is a responsibility for health journalism. And this is one of the reasons we exist is because typically health journalism, when you come outside of those well-known diseases, is relatively poor. And what we tend to find within the rare disease community is that what journalists are looking for is a human interest story. And of course they always want a very sad account of somebody's life. And the problem we were facing with our communities and why we founded was because our patients weren't finding that that was reflective. And they were giving lots of access to journalism to help raise awareness, but then they didn't feel that they were being treated sensitively at the other end of that with some, you know, quite sensational headlines perhaps, or an account of their lives that they didn't really feel was reflective. And I think for journalism, what would be beneficial I think is to move away from just focusing on those human interest stories, to talk about some of the really big challenges that we have within the rare disease ecosystem and start looking at things like drug prices, access, equity, for those with rare diseases.

 

Janet Kennedy: (17:59)

All right. I consider that a challenge now to mainstream journalism, to pharmaceutical companies and to the regulatory bodies that are out there. So folks it's time to step up and let's really take a deeper look and not just look at the cover.

 

Rebecca Stewart: (18:16)

Absolutely.

 

Janet Kennedy: (18:17)

So Rebecca, I'm so impressed with the work that you are doing. How can we as private citizens, as individuals step up and help you?

 

Rebecca Stewart: (18:28)

Well, I think if we think of it globally, one in seventeen, or in the U.S. one in ten people has a rare disease. So pretty much everybody will know somebody that is living with a rare chronic disease. I think in terms of what individuals can do is just help to spread that awareness, be aware that there might be somebody within your community that is living with a really complex and challenging condition. I think we need to be, as we do with all disability, keep ourselves really open-minded really check ourselves to making sure that we're not being discriminatory. You know, it's one of these things that can be so ingrained in us that sometimes we don't even know that we are being discriminatory in our actions. So I think always keeping that in the forefront of our mind and making sure we're being fair. We're giving people fair opportunities and helping our friends and our neighbors and our communities have access and the same sort of life that we would all want. So I think just being very open-minded and aware of who's in your community and who your neighbor is, and just being good members of society.

 

Janet Kennedy: (19:38)

Excellent point. And actually let's do a little focus here on COVID and the Corona virus and how that's impacting the rare disease community. And you get to educate me a little bit here. I am assuming that there are members of the rare disease community, obviously immunocompromised, but who potentially couldn't even take the vaccine. Would that be correct?

 

Rebecca Stewart: (20:00)

Yes. There will be some who can be vaccinated and some who can't. I think we were still in the early days of data from COVID vaccines. And so some of that is unknown. I was involved along with quite a few other people in a project called ARDEnt, which was Action for Rare Disease Empowerment. And what we did was we came together very early on because we could see that potentially COVID 19 was going to have a disproportionate effect on the rare disease community. And we wanted to carry out a longitudinal study to see what that impact might be. And that as things opened up for everyone else, with things and services open up for those within the rare disease community, the same, and actually the information that we collected and the data that we looked up was quite harrowing. The rare disease community felt very, very left behind, very isolated. A huge portion of the rare disease community, where - certainly in the UK, where we had big isolation policies - where for the initial 12 weeks, anyone who was compromised had to completely isolate: as in, they could not step out of their property, not even for shopping.

 

Rebecca Stewart: (21:12)

So I have both my dad and I have a nephew who have a rare disease and they both spent initially 12 weeks and then longer because it was extended. So I think by the time they were able to get out in any capacity, it was about 16 weeks spent entirely just in their home, reliant on people dropping food off on their doorsteps. And so very, very isolating and alone. And then I think as the rest of us have kind of come out and about, there are still those that are very immune compromised that are still very, very cautious. We've also seen, you know, returns to services. So from a hospital point of view, when all elective treatments were stopped to make space for COVID wards, that also applied to many people's rare diseases. And while some of these treatments might be deemed elective and non-essential, actually they are essential in terms of rare disease.

 

Rebecca Stewart: (22:12)

And one example of that is that consultants saw a big decline in those with neurological conditions, not because of disease progression, but because of the lack of things like physio, speech therapy, sensory play. Because these are deemed non-essential of course these were all cuts, all services that were cuts. And we understand why they were cuts. And I don't know that there was a solution to not do it, but the effect has been very detrimental to those people that have not had those therapies and services, which are really essential in their development and disease management. And that's just one example of where loss of services has been really detrimental.

 

Janet Kennedy: (22:58)

And continuing today because of our low vaccination rates.

 

Rebecca Stewart: (23:03)

Well, here in the UK, we are not too bad in terms of vaccination rates. I believe we've had a very successful vaccination program and I think the uptake has been pretty good. We are seeing a return to some hospital services, not as they were for sure, still very much telemedicine triaging, but it's starting to make its way back. However, I think the wait lists now for many things are now running into the years, because there is a huge backlog of things that, of course couldn't happen during COVID.

 

Janet Kennedy: (23:38)

Well, it sounds like Rare Revolution Magazine is serving such an important connection for people to help find their communities to support those within their communities. And to even just educate both the newly diagnosed and those who have been dealing with their condition for many years. What I'd love for you to do is to tell people how to find you.

 

Rebecca Stewart: (24:02)

Yeah. You can find us online at rarerevolutionmagazine.com. We're also on Facebook and Twitter and Instagram and LinkedIn. We are like I say a small dedicated team, but we are very approachable. So do reach out, connect with us on social, connect with us online. Or emails, or you can reach us through email, so do get in touch. And if we can help and support your organization or your voice or your company in anything that we do, then please do reach out and say, hello.

 

Janet Kennedy: (24:33)

Rebecca, thank you so much for joining me for People Always, Patients Sometimes.

 

Rebecca Stewart: (24:39)

Thank you. It's a pleasure to have been here.

Decentralized trials are here to stay, says Dr. Isaac Rodriguez-Chavez, our podcast guests today. Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. We are delighted to have Isaac join the podcast to discuss decentralized clinical trials and why pharma companies should embrace digital technology for the benefits of patients. A former FDA officer who was instrumental in the review and approval of digital health technology in clinical trials, Dr. Rodriguez-Chavez is now the Senior Vice President for Scientific and Clinical Affairs and Head of Strategy for Decentralized Clinical Trials for Icon. I hope you enjoy this conversation with our team member, Janet Kennedy, on the People Always, Patient Sometimes podcast.

 

Janet Kennedy: (00:46)

I can't tell you how thrilled I am to have finally landed Isaac Rodriguez-Chavez as a guest on the People Always, Patient Sometimes podcast. He is an industry leader that is someone that everyone listens to, and it's really exciting to have him here today. He is formerly the FDA officer focusing on clinical research methodology, regulatory compliance, and medical policy development, and recently joined the private sector as the Senior Vice President of Scientific and Clinical Affairs, Head of Global Center of Excellence, DCT Strategy for PRA Health Sciences. So he's got a foot in both camps and it's going to be a very exciting conversation. Isaac, welcome to the podcast!

 

Isaac Rodriguez-Chavez: (01:30)

Thank you, Janet for having me and all the listeners, I am delighted to be here with all of you, sharing some thoughts on information that is really, I hope, pertinent for all of us.

 

Janet Kennedy: (01:43)

You have been very active as an FDA member and as a member of the PRA Health Sciences in promoting and discussing decentralized clinical trials, and it's time is now. However, for the one listener who might not realize who you are, I'd love to explore a little bit of your background, what work you did with the FDA, and then what made you decide to come over to the private sector. So can you tell me a little bit about your background and how you came to be where you are today?

 

Isaac Rodriguez-Chavez: (02:14)

Absolutely. I'd be happy to do so. The FDA, I was a senior officer for clinical developing medical policy and working internally. Also leading a program on decentralized clinical trials and supporting the modernization of clinical trials in general, including the implementation of digital health technologies in modern clinical investigations. The FDA is an amazing place. And my colleagues there are really wonderful, friends more than colleagues, because the work that we do really matters and impacts the entire nation. Essentially, I was a professional consulting internally and externally on decentralized clinical trials implementation of decentralized clinical trials. I believe in the modernization of clinical research. So I am a basic scientist by training with specialties in immunology and biology, but I became a clinical scientist also by training and experience over 20 plus years ago, conducting clinical trials, doing clinical research, being a sponsor, being the auditor, being essentially in multiple capacities, engage in investigations.

 

Isaac Rodriguez-Chavez: (03:32)

So for me, my passion is really what I discover is the direct impact on the patients and their lives, and clinical research, along with the infectious diseases, which is at the end of the generic or the bigger umbrella where my expertise lands, are the things that I like and I enjoy doing. Direct impact to patients and their lives in clinical investigations, with novel products and in infectious diseases and even in vaccines, which are also a love of my life. And that's what I did at the FDA. And then I transitioned to PRA Health Sciences to lead the strategy of a newly created global center of excellence for decentralized trials. The idea really for me was about to transition from the regulatory world and diversify into the real world in how the trials are conducted and essentially lead the strategy and implementation. We are in a transformative time in clinical research because of all of these modernization efforts that are happening building decentralized trials.

 

Isaac Rodriguez-Chavez: (04:43)

So I ended up believer in doing things better, and for the benefit of the patients, and PRA offered me essentially the venue to do so. So I am truly excited to be here with a group of professionals that are outstanding and they believe as strongly as I do in providing essentially end to end solutions and creating partnerships with multiple vendors, so that together and in unison, we can deliver the best in class and in the field in regarding decentralized clinical trials enabled by digital health technologies. And for the benefit of the patients and with efficiencies on the trials and the steps that can represent benefits for the sponsors, for the science - benefits for everyone engaged in the clinical investigation. This is the place, right now, as you said - now is the time, now is the place - in which everyone benefits. It's positive. There are multiple advantages for everyone, so, excited to be here. And my journey has been the one of love and passion for what I do and believing in doing things better for our people everywhere.

 

Janet Kennedy: (05:55)

I'm very interested in the three-legged stool of the organizations that are involved in clinical trials. You have, of course the FDA, you have the pharmaceutical company, and then you have the groups like PRA, the clinical research organizations, that really are much more involved in the implementation of the clinical trials. What I'm curious about is, is that stool steady? In other words is one leg, a lot shorter than the others? Are all three of these organizations moving forward at the same speed? Or do you find that maybe the CROs might be ahead of the game and trying to get pharma to catch up a little bit with decentralized clinical trials? Or are you finding that partnerships with pharmaceutical companies - that everybody is about at the same place?

 

Isaac Rodriguez-Chavez: (06:42)

I could say I see these more as a round table with multiple legs and multiple parties being engaged. One thing that is happening right now that is historically never seen is a different type of collaborations and the level of collaborations and the frequency of the collaborations between multiple entities is unprecedented. The COVID-19 pandemic really has put everyone on the discussion table to find ways to continue the traditional clinical investigations that were happening when we were hit by the pandemic. So the way to do it was the implementation of elements of decentralization. And with that, the creation of hybrid decentralized clinical trials in which some elements of decentralization are happening, and others are still happening in the brick and mortar site - the traditional clinical research site. Now days. And what we're seeing is essentially the business beyond the pandemic. The transformation that is happening really is permanent, is driven by multiple factors, and the engagement is at all levels.

 

Isaac Rodriguez-Chavez: (07:58)

So the industry, the regulatory agencies, the clinical research organizations, such as PRA health sciences, are really making huge efforts to work together, to drive this transformation. Of course we are in a learning curve and a learning process. All of these happened suddenly. And though we are embracing decentralized clinical trials and technologies to modernize clinical research, we're still in the transition time, we're still in the changing of how to do things. Everyone is not at the same level. Everyone's not at the same speed. There is a spectrum in terms of the uptake and implementation and racing, decentralized clinical trials and technologies; that kind of goal. Everybody's thinking about how to do it in the pharmaceutical industry, in the biopharmaceutical industry - small, mid-size, large size pharmaceutical industry - but the implementation is different. So there is a whole spectrum that can go anywhere between 20% to up to closer to 80%.

 

Isaac Rodriguez-Chavez: (09:08)

And the surveys show that information. But everyone is having conversations and the projections are very strong, that decentralized clinical trials really will become the mainstream of clincal research within the next two to five years. So this is happening, it is irreversible, it is transformative for everyone engaged in the clinical investigation. And the conversations are happening and the collaborative work is happening between multiple parties. So I not only see the regulatory agencies and the pharmaceutical industry and the CROs; I see the vendors, I see multiple vendors engage. I see the science engaged. I see the patient advocacy groups engaged. It's really multiple entities engaged in the conduct of these kinds of investigations. And it's for the benefit of everyone, as I said.

 

Janet Kennedy: (10:06)

So you're saying you really don't think we're going to go backwards to the way it always used to be done - that people have learned, not just that patients want a new way of participating in clinical trials, but this is actually a better way?

 

Isaac Rodriguez-Chavez: (10:21)

Pretty much. Though decentralized clinical trials are not the universal solution for every single medical product that is going to be tested, it is very common to see decentralized clinical trials in multiple therapeutic areas, and in all phases of the clinical investigation. There are multiple reasons and benefits for doing this. Essentially, the potential for enhancing convenience to the participants is a main driver for the implementation of decentralized clinical trials, the opportunity to improve recruitment and retention of participants, participants in the ecosystems where they live - meaning their homes, their towns, their cities, their countries - and not having them to fly or travel to distant places to go to a clinical research site to participate in clinical investigations is a major advantage, is a major driver. The use of technology as never before is amazing. And though technology has been utilized in traditional clinical investigations, the uptake of technology by modern clinical trial designs is very powerful, and it's happening.

 

Isaac Rodriguez-Chavez: (11:41)

And it's happening here to stay. The opportunity to essentially monitor participants remotely with the use of technology, the opportunity to break socioeconomic barriers and geographic barriers are very powerful. And this is all because of technology. Also, if you have technology, which is one of the elements that enable these trials, but you also make plans, proactive plans to increase diversity and inclusion, you break the geographic barriers right there. And if you optimize and you think proactively from the get-go in how to design these trials and not to retrofit a traditional trial, you have a huge potential for cost savings - something that is really appealing for the sponsors. So there is an opportunity to improve efficiencies at all levels of the modern clinical trial design, decentralized clinical trials, use technologies to enable them and maintain the quality. And the regulatory agencies, particularly the FDA, is tuned to all of this. So I think, again, this is enabled by the cities or digital health technologies are here to stay. Traditional trials, they're still exist. They will continue to exist. There will be just an increase in the use of these cities enabled by the colleges. That's what I'm saying.

 

Janet Kennedy: (13:10)

Sometimes I feel like people oversimplify and think of decentralized clinical trials as just the use of tele-health. And yet there is so much more in your current work, or even in what you were looking at when you were at the FDA, what kind of technologies do you think enhance a clinical trial?

 

Isaac Rodriguez-Chavez: (13:31)

There is not a universal answer for your question. Your question is very important, but essentially all technologies are important. And the key point in regards to the use of technology really is the adaptation that has to happen on that technology to support the specific needs of every clinical trial. And that is the point. Each technology has to be verified. It has to be validated to the end user. It has to be justified to measure, for example, the specific end points that are relevant for the clinical investigation that is being conducted. And it has to be usable. Nobody wants to have a two pounds watch on the wrist because it's going to be really difficult to wear that on a daily basis. So the technology has to be usable. It has to be user-friendly. It has to be something that everyone from the clinical staff, to the investigator, to the actual patients need to use in a meaningful way. So technology is here to enable the trials. Technology has to be adopted on a fit for purpose basis, according to the needs of the trial, the specific end points, the specific communication plans that are put in place, depending upon the nature of the disease that we're dealing with. There are many ways of dealing with technology and the bottom line really is to optimize it, to adapt it, and to make it meaningful fit for purpose technology that supports clinical trial. That's what it is.

 

Janet Kennedy: (15:14)

I'm very curious to hear your thoughts on the overwhelming potential for real-world data to come into play. Not that many years ago, the data from patients was sitting in the parking lot of the clinical site where they're filling out their paper diary and going, "yeah, I think I took it that day, and I think I take it that day." And now we're in a situation where not only do we know that you've taken a medication, but we also know your blood pressure or your weight or your glucometer results, things of that sort. Well, that is an overwhelming amount of data. Are the scientists that are dealing with this data, thrilled and excited to have all of this, and is it leading to a whole new level of analysis and analytic skillsets coming into clinical trials? Or do you think people really aren't prepared to know how to manage this? Because I'm thinking from a primary care physician. If I were to turn over my Fitbit data to my primary care physician, they might go, well, what do I do with this?

 

Isaac Rodriguez-Chavez: (16:18)

Definitely the real world data and the real world evidence are important trends that were clearly supported by our legislation. When the 21st Century Cures Act was passed in 2016. That is a different work stream and trend compared to decentralized clinical trials enabled by digital health technologies. They both have in common, the use of the real world settings to collect clinical data to assess the safety and efficacy of investigation or medical products. So in that regard, they both are really powerful. And the FDA uses real world data and real world evidence to monitor, for example, post-market safety and adverse events, and also to make regulatory decisions. And that's what they actually mentioned on the website In the real world data, real world evidence space. They also use computers and mobile devices and wearables sensors. And the idea is to gather big amounts of data - data that is related to clinical research - and that is health-related data that essentially is collected, can be collected at the clinic at the doctor's office.

 

Isaac Rodriguez-Chavez: (17:38)

And so this data can be adapted to allow for better designs and the conduct of clinical trials and studies. And essentially is, in addition to that, it really is a way of developing more sophisticated, new analytical capabilities. And essentially the data can be applied to resolve and do analysis of medical products in ways that were not done before. The same is with decentralized clinical trials. They are conducted in the real world setting. They are utilizing all of these technologies, and there is a need to create new ways of doing data analysis. The data analysis can be done with the use of, for example, artificial intelligence, machine learning, and new ways of doing these and ways of doing it quickly in almost real time or in any real time sometimes. For example, the capacity to see in any of these two in real world evidence trials, or in these CTs an outlier detected by artificial intelligence analytics that might represent, for example, an adverse event and if their protocol that is being monitored, there is an opportunity right there to react in more real time compared to for example, a traditional clinical trial. So yes, these are modernization of clinical research happening in the real world setting with new analytics, a lot of power in place to do things in real time or almost real time. Very powerful.

 

Janet Kennedy: (19:24)

What do you think are the challenges for implementing DCTs or decentralized clinical trials and DHTs?

 

Isaac Rodriguez-Chavez: (19:32)

I could say because we're in a transition time, though the FDA is supporting - and strongly supporting - the implementation of decentralized clinical trials and the assessment of the safety and efficacy of clinical investigations with decentralized clinical trials, and they have a history of supporting these CTs by creating a regulatory framework. That is not the same case for own regulatory agencies in the world. The EMA is in the process of understanding, for example, in Europe the EMA developed COVID-19 related guidances to enable remote activities of trials. The EMA is partnering with the Innovative Medicine Initiative, and they have implemented a center of excellence that is called "Trials at Home" to explore the use of DHTs - or digital health technologies - in decentralized clinical trials. They are developing methods to streamline data collection, as well as to essentially understand patient recruitment and retention in Europe, and use these five trials that they have put in place to inform the development of policy that is supportive of these CTs and technologies in Europe.

 

Isaac Rodriguez-Chavez: (20:54)

The Swedish Medical Products Agency received a grant of about 2 million Swedish, I don't remember their currency, but essentially they received a lot of money to conduct preliminary studies on decentralized clinical trials and examine the conditions and the requirements to conduct safety and efficacy studies using the CT approaches in Sweden. The Danish Medical Agency went ahead of the pack and they just issue in May of 2021, their guidance on the implementation of decentralized elements in clinical trials with medical products. And so there is a clear movement from the European regulatory agencies. In Asia, there are conversations between the regulatory agencies and multiple stakeholders to inform them on the implementation development and implementation of policies that support clinical trials. So we have a spectrum that is led by the US FDA that is really advanced in the regulatory framework that they have developed followed by Europe and the European regulatory agencies followed by the Asian regulatory agencies in the development of policies for decentralized clinical trials.

 

Isaac Rodriguez-Chavez: (22:20)

Meanwhile, we have to go on a country basis to understand the regulatory intelligence and the possibility of deploying multiple elements of decentralization required on each study to implement decentralized clinical trials. So a major challenge really is having the harmonization of policies, procedures, the regulatory framework, the legal framework, across multiple jurisdictions to implement the CTs globally - that it stays there. Another challenge is the digital health divide; we all know and talk about the digital health divide. And so democratizing having equal access to technology by diverse populations everywhere in the world represents a challenge. And it's also an important ethical marker. We are not supposed to include populations because of the lack of access to internet. For example, the lack of access to technology. This is something that becomes a costly enterprise because then the sponsors of the trials may need to provide that technology, that access to internet, while the participants are part of the clinical investigation. Another source of challenge is to bring your own device. For those who already have some of these devices, the use of those devices may represent sources of variability if it's not carefully looked at and controlled before deploying decentralized clinical trials. So these are some of the items that I could say represent the challenge in implementing decentralized clinical trials globally; they are surmountable if we think carefully and we plan carefully. These trials are not again, to retrofit traditional trials with a decentralized solution.

 

Janet Kennedy: (24:25)

Well in thinking about the process of every country having their own regulatory process, their own design; are we at all in the same place with what the data means, or do we also have to worry about the interpretation of the data coming from a decentral trial?

 

Isaac Rodriguez-Chavez: (24:42)

Decentralized clinical trials is all about mapping communications and mapping the data flow to have continuity on the data flow and to mitigate sources of variability. The data can be characterized and understood as coming from remote locations, coming from central locations. And we're in the process of learning right now, sources of variability, but that's one of the beauties of decentralized clinical trials - you can implement and design multiple solutions to mitigate the sources of variability of the data in these trials. And there has to be a customized statistical plan put in place to analyze the data in a meaningful way. We are yet to learn how the regulatory agencies will take all of this data and essentially what level of tolerance they may have, in regards to some level of variability that might exist in the CTs, as exist in any clinical investigation.

 

Janet Kennedy: (25:48)

Now that you've left the FDA and you're working in the private sector, how in your role as the Head of the Global Center of Excellence for DCT Strategy, how does that impact your ability to get conversations going, and what is your role in that?

 

Isaac Rodriguez-Chavez: (26:05)

My conversations are not impacted. I respect and maintain the confidentiality of the work that I did at the FDA. I essentially recuse when I need to recuse from specific conversations with specific entities or products. But other than that, I am not impacted in my daily work by leading the strategy of decentralized clinical trials at PRA Health Sciences. In fact, my level of activity is, I would say very high; I'm very engaged with multiple entities in the industry and in the clinical research field at large. And so one of the things that I do - I wear multiple hats - is to essentially assess the suitability of trials and opportunities to implement end to end solutions from the start to the very end, using decentralized clinical trials, assess technologies that can be put in place in decentralized clinical trials, partner with a great team that we have in PRA Health Sciences, including the team of operations, regulatory affairs, technology team, quality control, quality assurance, the legal team, the qualified vendors that we have to holistically assess the suitability of every opportunity that we engaged on to implement meaningful, customized high impact to end solutions on decentralized clinical trials.

 

Isaac Rodriguez-Chavez: (27:42)

So that is a very dynamic work. I also engage on protocol design, protocol review, protocol assessment for decentralized clinical trials, and I engage on training and education - internally and externally. I am engaged on being a spokesperson for PRA Health Sciences regarding decentralized clinical trials for the industry at large. I also provide consultation services to assess the pipelines of multiple partners and pharmaceutical companies who would like to have a holistic view of their pipeline, and leverage one clinical trial with future possibilities, and to essentially participate as a leader in the field, sharing knowledge and information regarding decentralized clinical trials technologies, the modernization of clinical research in multiple areas, including the areas of infectious diseases, vaccines, immunology, virology, oncology.

 

Janet Kennedy: (28:50)

Well, I have to admit, I am both proud and amazed at your workload and exhausted thinking about all the things that you do. I'm thrilled that you are over on the private side and working for a company that has an office in our area, in the Raleigh area, and I can't tell you how fascinated I am with our conversation so far. And I feel like there's a lot more that I'd love to ask you about, particularly in regards to CRAACO, the Clinical Research As A Care Option, and how patients have both factored into the changes that happen as a result of COVID and also going forward with how they're embracing decentralized clinical trials, but we're going to have to save that conversation for another day. You've been listening to People Always, Patients Sometimes, and my guests, Dr. Isaac Rodriguez-Chavez, who is the Senior Vice President of Scientific and Clinical Affairs, and also the Head of the Global Center of Excellence for DCT Strategy at PRA Health Sciences. Isaac, thank you so much for joining me here today.

 

Isaac Rodriguez-Chavez: (29:57)

And thank you, Janet and listeners for the opportunity to share some thoughts with all of you in regards to the modernization of clinical trials, our services at PRA Health Sciences, on the use of digital health technologies technologies in general, and the unification of clinical research with the standard healthcare systems using the CRAACO principle that we applied to. I look forward to future conversations, and please connect with me in LinkedIn if you would like to continue the conversation. Thank you again for listen.

Understanding the patient journey is an important part of clinical trial development. Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. On today's podcast, we welcome Shazia Ahmad, Senior Director of Patient and Physician Services at UBC. She is a thought leader in the space of patient communities and supporting the patient throughout the clinical trial process. I hope you enjoy this conversation on People Always, Patient Sometimes.

 

Janet Kennedy: (00:31)

Hi I'm Janet Kennedy and I am your host for People Always, Patient Sometimes, a production of Spencer Health Solutions. I am really looking forward to a conversation today with thought-leader Shazia Ahmad. She is the Senior Director of Patient and Physician Services at UBC. Welcome to People Always, Patient Sometimes, Shazia!

 

Shazia Ahmad: (00:52)

Thank you Janet! Thanks so much for having me today.

 

Janet Kennedy: (00:54)

I've been trying to track you down for a conversation for actually a number of years, and I'm so glad I finally captured you today.

 

Shazia Ahmad: (01:03)

Yes, absolutely! So excited to be on.

 

Janet Kennedy: (01:06)

Well, I want to be talking to you a lot about the work that you do specifically as a director of patient and physician services; but first I think we need to set the stage. Can you tell me a little bit about UBC?

 

Shazia Ahmad: (01:18)

UBC was founded in 2003 by industry experts with a passion for innovation and a commitment to working with pharmaceutical and biotech organizations in proving the safety, efficacy, and value of pharmaceutical medicine products. UBC is a leading provider of pharmaceutical support services, and we partner with life science companies to make medicine and medical products safer and more accessible.

 

Janet Kennedy: (01:46)

Now, would you consider U B C to be a C R O?

 

Shazia Ahmad: (01:51)

I would say we're CRO, but we really are proud to kind of stand out as a service provider, I would say.

 

Janet Kennedy: (01:59)

Okay. Well tell me a little bit about what that means to be directing patient and physician services.

 

Shazia Ahmad: (02:05)

At UBC, I have the honor of leading a team called patient and physician services. And what that is, is we're involved in supporting biotech and pharmaceutical sponsors in different services around patient recruitment, engagement, compliance, retention. We offer different services around making sure that we engage patients early on in research to ensure that the sponsor captures everything they need to, to really understand the patient journey and the development of whether it's the protocol design, developing the right strategies for recruitment retention. We're also able to integrate capabilities and services around awareness campaigns, where we use social media, digital outreach, and traditional advertising. A lot of programs that we do work on now at UBC involve the rare disease space. And I think Janet, that's where you and I really connected most over the last few years; a lot of the rare disease work that I lead. So we're able to also integrate different capabilities to really work with patient advocacy groups and really involve them early on in the launch of our programs to ensure that we're not just getting the patient voice by making sure that we work with the patient advocacy group as a partner, and really we work as a bridge to the sponsor with the patient advocacy group to ensure that we have the right strategies in place to support recruitment and retention for our program.

 

Janet Kennedy: (03:41)

So are you actually bringing in these advocacy groups so early that they're participating in evaluating or contributing to the protocol design?

 

Shazia Ahmad: (03:49)

Exactly. Exactly.

 

Janet Kennedy: (03:51)

Well, that's kind of exciting. I'm curious - what sort of feedback have you seen coming from these groups that actually made the sponsors rethink how they had written a protocol?

 

Shazia Ahmad: (04:03)

It's been interesting because there's been cases where we're able to learn something. And this could be in a rare disease indication where something was not thought about before, on what mattered to the patient, even the caregiver or care partner around different end points that were not considered. For example, they've not thought about maybe walking up the stairs would be something important to think about in the protocol design or certain visits to come to the study site and learning those things early on have really helped us integrate solutions to really make it easy for the patient caregiver care partner to participate in the study. And also we're able to integrate the solutions that really make sense for that protocol. For example, we have a clinical trial nursing service offering that we provide to different sponsors, where it makes sense to integrate home nursing for a clinical trial. The other thing that we're starting to do now based on our learnings, working with advocacy groups is integrate more decentralized solutions for clinical trials, which really has been going on a lot pre pandemic. But I think the pandemic has now really invigorated that even more and making sure that we can really bring in innovative solutions.

 

Janet Kennedy: (05:25)

Certainly if you're dealing with a rare disease community that probably has multiple comorbidities - maybe a suppressed immune system - they're definitely gonna want to stay at home. So I'm very curious about the decentralized part. Are you finding that what you ended up developing was just more opportunities to gather data from the home, or were you working around fewer visits to a clinical office, but you tried to get more done at the time you were there? How that actually impact the work that you did in 2020?

 

Shazia Ahmad: (06:00)

Actually it's a combination of all those things where we've been able to do more home visits and be able to really capture real world evidence and really real end points that couldn't be captured before; even things in between visits. So that's been very valuable, especially with the home nursing. And then also with the decentralized trials. One avenue we're actually looking to go to now is we've often had challenges in getting referrals from referring providers to really open up the pool of participants in areas where they want to participate, but are unable to, because they're not near a study active study site. So that's another way that we're able to connect participants patients to trials in their communities and really going to where patients are at.

 

Janet Kennedy: (06:53)

Well, that's interesting. So in other words, in the past, we tended to have our principal investigators in larger metropolitan areas near maybe hospital systems with robust research, but the patients aren't necessarily there. They could be out in the boondocks somewhere. And what you're saying is now with this emphasis on decentralized solutions, you've been able to incorporate more patients - maybe even a broader range of patients from a diversity perspective - because these solutions made that possible.

 

Shazia Ahmad: (07:26)

Exactly, Exactly.

 

Janet Kennedy: (07:29)

So when you talk a little bit about real-world evidence and real-world outcomes, what kind of information are you gathering?

 

Shazia Ahmad: (07:35)

We're looking at, and this could be any therapeutic area, but specifically in the rare disease space, we look at different - and this is more a question, I think, clinical operations, we work with the clin-ops team and developing the outcomes that matter - but what we do is we work with the patient advocacy groups to really hone in on a protocol and make sure the questions that are being asked, whether it's the patient reported outcomes, those things are really elements that matter to the patient. And it could be just the normal six minute walk tests. That's part of usually a pulmonary hypertension study or whether a cystic fibrosis patient had to take a day off from school. So it could be any of those things.

 

Janet Kennedy: (08:17)

Shazia, what kind of key trends are you seeing in the industry regarding patient engagement in clinical trials and in healthcare work?

 

Shazia Ahmad: (08:27)

That's a really good question, and something I'm really excited about. We're starting to see the need and the importance of integrating virtual patient communities. Something I'm really proud of that we've been able to actually start at UBC many years ago with a partner sponsor where we've developed patient communities, where patients can be part of a clinical trial and be engaged in part of a community. And they really, they feel then that they're really being, not just a contributor to the research, but then it's like a community building where they can be brought back or given information, not just about the research they participated in, but they can be informed on other trials that go on and they may be interested to participate in, in the future. So that's something I'm really excited about. I think there's more and more sponsors wanting to do that. And the other thing is the importance of giving back to the participants and making sure that they know what they contributed to participants often many, many years ago, did not receive information about the clinical trial they participated in, but now more and more sponsors are seeing the importance of needing to do that by giving back to participants, by providing lay summaries and a lay summary is really just summarizes the clinical trials, the results in a very patient friendly format.

 

Janet Kennedy: (09:58)

Recently, there were two different Huntington's disease studies that did not come to fruition and announced in the same week, which was, I think very, very disappointing for the HD community. And that I think proves the point that not all research is going to work. But you have to acknowledge the contribution that patients have given and support them, even when things don't work out; help them understand why and explain what was it about the research that didn't allow it to move forward.

 

(10:29)

Exactly.

 

Janet Kennedy: (10:29)

So tell me a little bit about social media and leveraging online communities. How does that take place?

 

Shazia Ahmad: (10:37)

We are able to do this all in-house and we're able to leverage social media, different avenues like Facebook, Twitter, different platforms to really engage potential participants for clinical trial, but also to create education and awareness about a particular disease or indication. Because the touch points are so different, we want to make sure that we are working in a way, not just to recruit patients, but a lot of our campaigns are around education and awareness as well. And we're able to do that by identifying even potential participants, leading them to a pre-screening depending on the program. And as a result, we're able to send qualified participants to a study site, but a lot of the rare disease programs what's really important is leveraging those strategies with patient advocacy organizations. And we do that by working together to create that information.

 

Janet Kennedy: (11:35)

Now I know from experience in managing social media platforms and particularly closed groups, that's a lot of work that takes a lot of information, a lot of moderation. I'm curious when you are working, are you working as a member of an existing community? Or are you actually hosting the organization or the social media group yourselves?

 

Shazia Ahmad: (12:00)

We're hosting them ourselves, but we have to work very carefully and we have to leverage guidelines that are in place with the sponsor and ensure that everything is in accordance of all guidelines with their medical legal, and then we have to follow the IRB.

 

Janet Kennedy: (12:18)

That's Something that takes a long-term commitment. You can't just throw up a group for six months and then be done with it. This is really a very strategic role that needs a lot of support over time.

 

Shazia Ahmad: (12:30)

Exactly. And the importance is making sure that we get the buy-in from the patient advocacy group, because a lot of the education awareness really, we wouldn't be able to get so far without having that collaboration in place. So we work hand in hand with the patient advocacy group in a lot of cases, the sponsors already have a lot of relationships already in place. So a lot of it is done in a very much collaborative manner, so that we're all working together.

 

Janet Kennedy: (12:59)

You've been in the industry for a few decades. So we won't do an age test here, but you've been around the block a little bit. I am curious that, gee, at least a decade ago, pharma was talking about going beyond the pill. And I think slowly coming to acknowledge that there's a bigger role that they need to play in engaging and supporting patients. So just broadly speaking, I'd be curious about your thoughts on the evolution of the pharma patient role over time and where do you think we're going?

 

Shazia Ahmad: (13:34)

Yeah, I think, and I'll kind of answer that question backwards because it's just so exciting. I feel like pharma is going in a way where every single patient that walks into a clinic will have the opportunity to be able to consider a clinical trial. And that's pretty amazing because 10, 15 years ago, that would not even be possible to think about because of not just different geographic locations and other challenges and barriers, but I really feel that every patient that walks into a door will be offered a clinical trial to participate in. And there's been so much invigoration of technologies coming forth now to allow for that, which is really exciting, especially with the decentralized approach to clinical trials. But that's the most exciting thing that I see. But because I started my career early on as a research coordinator at the National Institutes of Health, I spent about five years early in my career at the NIH cross Naiad. Yes, I worked under Dr. Fauci! Really better than that!

 

Janet Kennedy: (14:41)

Yay!

 

Shazia Ahmad: (14:43)

And across different institutes, including the NINDS, but really exciting is to see with the recent pandemic, even more of an awareness amongst the public community, to what clinical trials can bring and do for the communities to amazing. And I think because of that, we'll see more, more interest and just more urgency to help drive progress for all diseases.

 

Janet Kennedy: (15:13)

Absolutely. I have never heard so many people in my Facebook group, in my Twitter group going, "Hey, I got to be in a clinical trial for a vaccine!" Anything that got them a teeny bit closer to being able to experience a vaccine, even if there was a, whatever, the percent - 50, 50% chance - that they weren't getting it; very, very interesting. Plus in this particular instance, people got savvy really fast. "I'm in a clinical trial, and now I'm going to go get a quick test to see if I got anything." And they had to really rethink how they were working with patients in that regard, because you can only be so blinded when I can go to a local drug store and get my antibody test.

 

Shazia Ahmad: (15:53)

Right. Exactly.

 

Janet Kennedy: (15:55)

Well, it's horrible, what happened and is happening as a result of COVID. But unfortunately, when you look back at the history of medicine, it is usually something like a pandemic or a world war that has advanced quickly medical changes and medical innovation. And so as horrible as this has been, and we don't want to minimize it in any way, it has shown a light on a very important aspect of healthcare, and that is early stage medical development, and really brought it front and center to a lot of people who would never have thought about it one way or the other. I think the other thing that's interesting is it has also focused on the rare disease community very early on when we were talking about the need for masks may not have been to protect you, it's to protect people from you, and particularly those that were immunocompromised. I think that's a word that a lot of people had never heard of. And I believe it has raised awareness that there are a lot of people who've been impacted and are impacted by rare disease.

 

Shazia Ahmad: (17:04)

Absolutely, absolutely. And I think what really, what the other lesson learned from there is if we continue to work as hard as we did for the amazing vaccines that were created for COVID-19, we can make even more greater progress for the rare diseases or any other disease.

 

Janet Kennedy: (17:24)

It is going to be a curious conversation that we'll have, is this vaccine was turned around in a year - under a year. I mean, that's amazing, that's unheard of! Some of the rare disease community have been waiting decades for something to happen. Now, again, money is the root of a lot of the issue and that obviously there was a massive global incentive to really support development of a vaccine for coronavirus. However, the process I hope is going to raise that awareness and that look at the difference. For instance, the ALS community faced when you had this viral ice bucket challenge go out, they raised a significant amount of money and they were able to make some significant impact on the study of the Lou Gehrig's disease.

 

Shazia Ahmad: (18:13)

Exactly. Amazing!

 

Janet Kennedy: (18:15)

Well fingers crossed that we will definitely see some good come out of this horrible situation with Corona virus. One of your special expertise is ensuring that the patient journey and the pathway to diagnosis is understood in every program that you implement at UBC. I don't know what that means. Can you explain that?

 

Shazia Ahmad: (18:37)

Absolutely. This is an area I'm extremely passionate about and really something that I like to always take the team to think about early on looking at the disease, from diagnosis to really mapping out the whole patient journey. Because rare diseases often take many years to be diagnosed, it's really important that we look at every indication, look at the different care patterns, which doctors the patient is going to for that particular indication, and then also looking at the involvement of the caregiver/care partner. It's just really important for us to do that, to really develop the right strategies and solutions, to support a specific protocol with a sponsor. And then also take it a step further. It helps us to really develop the right engagement tools for our program. We develop all full house materials to help recruit, retain patients. And we want to make sure the materials we developed to support a participant during the clinical trial also resonate with that patient journey.

 

Janet Kennedy: (19:49)

I'm in marketing, so this is something I can relate to is developing communications materials. And we are changing. Our younger generations - they're all about video and they're not going to want to read a brochure. So are you actually looking at producing materials in all different formats so that whoever, whatever age somebody is, they can find the way that they can relate to?

 

Shazia Ahmad: (20:12)

Absolutely. So we develop video, we do video services where we are able to develop educational videos to not just identify patients or create an education about a particular study or registry, but we also develop videos to really help understand the protocol. And the informed consent process, for example, is really cumbersome and hard to understand. So a lot of our tools, we engage digital technologies like videos and other technologies to really, once the patient's even enrolled. For the younger patients, we've used gamification to keep patients retained during a clinical trial. So a lot, a lot of those things really, really important.

 

Janet Kennedy: (20:57)

Okay. And I know a little bit more about the gamification, because I think that's very cool and I've definitely followed that in other industries, not so much in healthcare. So how would that apply?

 

Shazia Ahmad: (21:11)

Basically, depending on the number of visits for a particular protocol, once the visits completed or prior to a visit there's questions. And this could be for example, on a pediatric program where we could incorporate gamification technologies on completing a particular questionnaire - some tokens are sent through the platform, and then at the end of the study, or during the study, depending on how we have it set up, the participant can redeem a certain gift card, or there could be some kind of value added to something where that could be provided as a donation in their name to a particular cause or organization.

 

Janet Kennedy: (21:52)

I think that is cool! I really like that idea, and definitely want to see an image or a video of what that looks like. So hopefully it will be something we can link into the show notes when this is done. You are going to be speaking, coming up at DIA, what sort of things are you going to be talking about?

 

Shazia Ahmad: (22:08)

Yeah, So I'm really excited. We are looking into speaking on how we have developed patient communities and that platform, and the importance of patient community building for particular sponsor.

 

Janet Kennedy: (22:24)

That's going to be good. I am so fascinated with the work of patient communities and the fact that they now are starting to have a very strong role in drug development. That is just one of the best innovations is the recognition of the patient advocate as an individual or as a group.

 

Shazia Ahmad: (22:41)

Yeah, very excited about that. Thank you.

 

Janet Kennedy: (22:45)

Well, Shazia, I am fascinated with your work and I very much appreciate your presence in social media because I've been able to follow you and learn a lot of things about what you are up to and your thought leadership in the space is very appreciated. And I thank you.

 

Shazia Ahmad: (23:01)

Thank you so much. Thanks for having me on today. Really appreciate.

 

Janet Kennedy: (23:05)

It was our pleasure. And thank you for downloading this episode of the People Always, Patient Sometimes podcast. If you enjoyed our conversation, a review and a rating on iTunes will help us find more listeners. This podcast is a production of Spencer Health Solutions.