DarshanTalks Podcast

Narrator: This is the DarshanTalks Podcast. Before this week's podcast auditing artificial intelligence and augmenting pharmacist options in interview with former FDA auditor, Patrick Stone, Darshan will introduce this episode with the recap for the week of Thursday, July 23rd, 2020.

Darshan: This week was really interesting because there seemed to have been two separate issues that have grabbed a lot of the headlines. The first seems to relate to the FDA's announcements. The second relates to clinical trials. Let's talk a little bit about FDA announcements, the most important one, from the perspective of what a lot of people were waiting for is that the FDA just came out with a draft guidance on how to do cannabis related clinical research.

The cannabis community has consistently pointed out that the FDA seems to withhold research and discard research. So the idea of putting out guidances on how to achieve that furthers the FDA's position that it wants to encourage the research as appropriate. Second announcement that I saw is the idea that the FDA is extending enforcement discretion for certain regenerative products or regenerative medicine products.

Darshan: That should be interesting as well because, regenerative medicine has gotten a lot of FDA issues and while certain types of 361 CTP S have not received attention, some have, so the FDA is continuing to extend its enforcement discretion. The other things to look at is the fact that the European Union is still putting out some more information. And big question is, are companies ready for the clinical trial regulations that are coming out? In the context of transparency, the big one is the fact that there will be a central website that will allow for companies to talk a little bit about the type of clinical research they're doing.

That goes to the spirit of transparency. This EU clinical trial portal and database will be a single central portal or platform for sponsors to submit applications and notifications. And it's built to allow one time submission across multiple European countries. That should be interesting for a lot of companies. At the same time, there have been other interesting announcements in the context of clinical research. People are starting to question whether in this era of diversity, why are patients diverse, but clinical research primarily being done on white individuals.

Darshan: There is also some question about... well, the FDA also announced for example, that they will resume domestic inspections and foreign inspections probably will be soon thereafter. But outside that piece of clinical research, the other bit of information that did come out is that the US is accusing hackers of trying to steal coronavirus secrets for China. Recently there was another allegation that Russia was doing something similar. So coronavirus is causing companies and countries to try to save lives and why I think that that is inherently a good thing.

I'm not sure that stealing researchers is how you get to it, but maybe there needs to be a discussion about how do countries share data in the context of a pandemic. And if all these countries are trying to steal US data, the question then becomes is US really paying for research in the beginning itself? Are other countries carrying their weight in other times. The other questions that keep coming up are just ways companies should consider doing research, health tech companies are beginning to complain that, while there are concerns around privacy or government surveillance, the fact that there wasn't a coordinated nationwide pandemic response shows the innovation is problematic in the healthcare industry.

Darshan: Now inherently, that's not news because I think that everyone knows that that progress ...

Narrator: This is the Darshan Talks Podcast. Before this week's podcast, Telemedicine and its New Opportunities, an Interview With Anjali Dooley, Darshan will introduce this episode with a recap for the week of Thursday, July 16th, 2020.

Darshan: Hey everyone. Welcome to another episode of Darshan Talks. It's been a really interesting week so far. I am already looking at some new news and it says that the FDA was looking at an Indian pharmaceutical company, Vega Life Sciences, and they were upset that they were deleting data from faulty solvent testing. So again, there's a rule in general that if something isn't recorded, it didn't happen. However, the converse of that is not true, if you don't have it recorded, but if you've deleted it, it doesn't mean that it didn't happen. So keep that in mind. Obviously, that caused some problems for this company.

Darshan: The other thing you should probably be looking at is how virtual clinical trials are becoming the new normal. I've done several podcasts that I'm happy to link to in here. Feel free to look at them, but people are talking about virtual clinical trials, and if they're becoming the new normal, are you ready for more of those studies?

Darshan: Additionally, if you start looking at data privacy, CCPA is coming into effect and companies are asking whether they can have some delays, especially in light of COVID. However, California is not necessarily changing its mind about its enforcement deadline.

Darshan: There are some other interesting issues. For example, there is a question about using the homeless population in phase one drug trials. And that borders on unethical. I'd love to hear your thoughts and comments on whether it's unethical to use homeless people in phase one drug trials, even if they want to be part of it. Similarly, there was a Washington Post article on a patient's experience in the coronavirus vaccine trial. And the reason I find that to be interesting is the fact that it reminds us that patients continue to talk even when the trial is on, so there's a whole discussion about, well, what happens if they unblind the study mistakenly? What is the impact of that? Well, patients are talking, whether or not you choose to accept that, it's still happening.

Darshan: There's another writeup out there about this gentleman who was a sales rep for Novartis in 1999 and he ended up actually bribing doctors and wearing a wire for the feds. So for those of you who think that no one's listening, someone in your own office could be the one listening if you're behaving unethically.

Darshan: There are some discussions about what happens when COVID meds come out. Bill Gates thinks that should go to those people who need it, not the highest bidder. The question is, who needs it? Is it the patients? Is it caregivers? Is it healthcare practitioners? Or is it the rich guy who can afford it? And obviously Bill Gates doesn't think it should be the richest guy, or woman, obviously.

Darshan: There is an interesting article out there from UMass where a professor examines the ethics of biomedical research on soldiers. And that's always been an interesting conundrum. Can soldiers truly give informed consent? What does that look like? Is it a violation if your superior officer asks you, well, orders you to do it? Can you say no?

Darshan: Additionally, there was a discussion about whether bioidentical hormones that are compounded are safe and efficacious. And it turns out the FDA did some research and they aren't happy with the evidence so far. So stay tuned about what this actually looks like in the future.

Darshan: I may have discussed this before, but keep in mind that several companies are coming out and they're talking about whether they want to work with ...

Darshan: Hey, everyone. Welcome to another episode of DarshanTalks. We have Justin Goodarz. And I've known Justin for probably about 10 years, but we've sort of always been the same circles. I have some very good memories of us hanging out. I think it was DIA where we hung around afterwards, and maybe it's [inaudible 00:00:24] or something else, but hang around afterwards, having drinks. And this podcast became a great reason to reconnect with old friends. And I have this opportunity to do it again with you, Justin. Justin, do you want to tell everyone what you're up to now, what you did before, and sort of what makes you awesome at what you do?

Justin Goodarz: Yeah, yeah. Sure. Awesome. I'll take it. And I think it was initially when we first met was DIA about eight years ago in Philadelphia. I was brand new to Greenphire at that time, so entry level that we were hosting our Greenphire event there at DIA and they made me walk around to handout flyers all throughout Philly to different restaurants to try to get some traction there. I mean, Greenphire wasn't what it is today obviously. It's a household name now, but I think that was the first time you and I met at DIA, Philadelphia.

Darshan: Can I be perfectly honest? You may not remember this, but you were so new and Greenphire was so new that I remember asking you, at one point it came a bit of a challenge, if I could find the most off the topic thing and you found a way of getting into Greenphire. It was the most awesome thing to watch. It was great.

Justin Goodarz: I mean-

Darshan: We've all sort of grown and it's impressive seeing you do the things you're doing now. So tell us what you're doing now then.

Justin Goodarz: Thank you. Yes. So about three years ago, I made the transition from Greenphire to Trifecta Clinical based out here in Los Angeles. So I made the transition from Philadelphia to San Francisco with Greenphire, and then from San Francisco to Los Angeles with Trifecta Clinical.

Darshan: That sounds horrible by the way. I mean-

Justin Goodarz: Responsible-

Darshan: I mean, just beautiful sunshine. It must be horrible.

Justin Goodarz: Tough life out here. Yeah, it's been a very simple transition for me.

Darshan: Fair enough. Fair enough.

Justin Goodarz: [inaudible 00:02:23] Philadelphia. I mean, I love it out there, still have family and friends out there, but I think LA is home for the foreseeable future.

Darshan: Oh, is that right?

Justin Goodarz: But working for Trifecta Clinical, director of business development, so responsible for the West coast, a couple other key clients globally, and we're doing some cool stuff. So very excited to dive into what we do, but more importantly, talk about the industry and what's changed over the past couple of months.

Darshan: So obviously we'll do a little spiel at the end, but tell me a little bit about what Trifecta does just so we're all on the same page and why you know-

Justin Goodarz: Sure.

Darshan: ... lot about this stuff we're going to get into.

Justin Goodarz: Yeah. Yeah. So what we provide is a critical site communication platform that is used to support three different features. The first is the delivery and documentation of global site training, investigator training. The second is the distribution of safety letters or SUSARs with acknowledgement of receipt. And then the third is regulatory document exchange. What we've seen is by leveraging one platform to support various different processes it enhances site centricity by reducing portals that they must log in to, enhances inspection readiness by maintaining all of that documentation centrally, which would have historically been stored at individual research sites or not even ...

Darshan: Here are the top seven professionals to have when starting your 503B compounding pharmacy. You want access to these people on a routine basis so that you can make smart decisions and grow your company. Number one, you want a CEO. A CEO might be you, might not be you. You want someone who can think strategically, someone who can think across different projects and go, "Where is the market going and how do I get ready for that market?"

Number two, you want to have a CPA, someone who's going to do your taxes, someone who understands your business and the type of capital expenditures you're making, and can advise you if now's the right time to do it or wait, or is something going to be considered an ordinary expense or it's going to be considered a capital expense, and what are the implications of that?

Number three, you want to have a lawyer. The lawyer is going to be someone who's going to be advising you, not only on what type of legal issues to comply with, but also the types of regulatory issues hopefully that you might have to comply with. And you might get lucky in that that person will be one in the same. In my case, obviously, I can do both, but not a lot of people can.

Your fourth one, in case you cannot find a lawyer who can do both, you probably need to have access to a regulatory person. How do you respond to a 483? How do you create a [inaudible 00:01:24]? Can you create the specific product or is it an on the FDA banned substances list? That's the kind of stuff that your regulatory person should be able to answer.

And your last one is having a marketing person. And pharmacists often think that if you open up a pharmacy, people will come to it. No, you probably need a marketing person. But marketing people are often very zealous, and you want to make sure that you control them, train them, make sure that they don't go beyond what they should be doing. So, you need to have the appropriate training and that's what your lawyer should hopefully help you with that.

So, we had a CEO, a CPA, a lawyer, a regulatory person, and marketing. Did you think I forgot a profession? Obviously, pharmacists will be included, but that's if you own your own compounding pharmacy. But if there's anyone else, feel free to reach out, maybe you even consider having a board of directors, but that wouldn't be a profession. But feel free to reach out or hit the like button. Thanks.

Narrator: This is the DarshanTalks Podcast. Regulatory guy, irregular Podcast with host, Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's website at darshantalks.com.

Darshan: Hey, everyone. Welcome to another episode of DarshanTalks. We have our guest, Kenny White, Kenneth White. He is from Willis Towers Watson. However, I do want to make clear, he doesn't represent Willis Towers Watson right now. He's just talking. That just happens to be where he works.

We had a really interesting conversation with him previously about his entry into being in house. Now we wanted to get a little bit more into details to talk about just how does insurance payouts right now with COVID going on, there've been a lot of discussions around the idea of, "Well, will my insurance pay my claims? I've got a ton of business losses that I need to offset or at least offload. Is that really possible in this world?" Then there's a whole discussion around payers. We'll see how far we get.

But Kenny, do you want to do a quick introduction for yourself?

Kenneth White: Sure. I'm Kenneth White. I'm the national managed care practice leader for Willis Towers Watson, which means I oversee the group of people who provide corporate risk and broking services to the managed care industry.

I'm a healthcare lawyer. I practiced as a trial attorney for 28 years before I took this job six years ago. As Darshan said, I am not speaking on behalf of Willis Towers Watson.

Darshan: Very cool. Let's ask the big question of the day. How are insurers dealing with the idea that, "You know what? I bought business insurance. I, in some cases, even have that it'll cover cases like SARS," which happened to be... I think SARS was a coronavirus. Are my COVID losses going to be covered?

Again, we're not talking to Willis Towers Watson in this specific instance. We're talking about just generally, how is the insurance industry dealing with this?

Kenneth White: Well, so Willis Towers Watson primarily is an insurance brokerage entity. We don't actually provide the insurance. We work with entities for... They will have the right insurance and the right amounts from the right companies.

But people who run insurance companies traditionally are not dumb. So when communicable disease outbreaks happen and they are left holding large claims that they have to pay out for which their premiums were not actuarily determined to include that risk, they are now in what they refer to as an upside-down, or we could think about it you do your lease.

I only got in $100, I've got to pay up $200. This was not a good deal for me.

They will use language, terms, and conditions to exclude certain claims from coverage. So that when the mold and mildew claims came about a number of years ago, you saw significant numbers of exclusionary terms and conditions coming into property claims, especially GL claims, general liability, or umbrella policies to eliminate a claim being payable for mold and mildew.

Same thing when the SARS, swine flu, bird flu, whatever we called it before. When that happened, you saw another crop of coverage terms coming out in insurance policies to limit the insurance carriers' exposure to that type of a claim.

You see the same thing in cyber where your traditional professional liability or E&O, errors and omissions, coverage would provide you breach coverage. They have eliminated that almost entirely now as the network security and privacy, most of us call it cyber, insurance industry has become mature. You can still get the coverage, it's just not going to be under that policy. It will be under your cyber policy.

With COVID, obviously the first things that people think about are either health claims or they think about property claims. My company had to get rid of everybody, clean our offices 19 times. We lost use of all of our facilities. We may have lost income as a result.

Darshan: If you were going to start your own pharmaceutical company, these are the top five tools I'd recommend you consider using from the beginning.

The first one, Google Calendar. One of the key things that you're going to have is competing priorities, and competing appointments. Google Calendar is going to be your friend.

Number two, Gmail. Again, I'm picking one but if you have some kind of online system to track your emails, that would be extremely useful. Gmail allows you to import/export using multiple corporate accounts, so that becomes really useful as well. So I'd consider having a calendar tool like Google Calendar, Gmail, to track your emails.

Your third one would be something like Slack. And Slack is actually a system for collaborating, and allows you to bring different people together, and talk to each other. So instead of using texting one place, and WhatsApp another place, and I don't know if you're still using AOL, but whatever those tools are, you're putting it all together using Slack.

So you've got Google Calendar, Slack and Gmail. Your fourth one would be Trello. And Trello, it uses a Kanban system. Essentially, it allows you to track where things are and where the progress is being made, and you can transfer ownership of projects so that you know who's handling what and when they're supposed to come back to you.

Your last one is, well, so let's make sure we got that. We've got Google Calendar, Gmail, Slack, Trello, and your last one is if you're going to be opening up either a pharmaceutical company, a medical device company, a compounding pharmacy, you're probably going to start talking to a bunch of different individuals, often sharing a concept or an idea. So you'll probably start having contracts. In those situations, you probably want to use a tool like DocuSign, which tracks and allows you to have electronic signatures. Make sure that you have an attorney who allows for your electronic signatures to be valid, but overall, that becomes a great tool to have as well. So your five tools are Google calendar, Gmail, Slack, Trello, and DocuSign. Did I miss anything? Do you think I should have had something else on there? Feel free to leave a message. Otherwise, hit the like button. Thanks.

Narrator: This is the Darshawn Talks podcast, regulatory guy, irregular podcast, with host Darshawn Kulkarni. You can find the show on Twitter at Darshawn Talks, or the show's website at Darshawntalks.com.

Darshan: Hey, Kenny.

Kenneth: How's it going?

Narrator: This is the DarshanTalks Podcast. Before this week's podcast, Consultant Lawyer or Going In-House, an interview with Kenneth White, Darshan will introduce this episode with the recap for the week of Thursday, June 25th, 2020.

Darshan: So this week has been, as expected, a bit of a continuation from last week. However, what we're starting to see is the government is now taking a lot of the lax regulations that it had and it's now starting to enforce a lot of them. We're starting to ensure that not only are products available for people, but that they actually meet the standards that these products should have, the medical products should have. So for example, the Department of Justice has charged a manufacturer for exporting misbranded masks. At the same time, there was a writeup recently about stem cell companies selling hope for COVID-19 and that also has been deemed to be problematic because there are no proven therapies for the treatment of COVID-19. There was also, as you know, hydroxychloroquine and there was a question about whether it could be effective or not. And the FDA came out and revoked the emergency use authorization for hydroxychloroquine and basically said that it doesn't meet the standards that are necessary.

The other interesting things happening this week were that the EMA came out and it's talking about providing free orphan drug advising to academia. So if you're working with orphan disease states, this becomes really quite interesting, especially if you are the early phases and you're in academic institutions. There is some interest right now, a New Jersey doctor came out and sued the ... Reached out again, the NIH and USPTO under FOIA and accused them of unfairly denying his requests for records over DNA. So if you look at the newsletter, you might find some more interesting notes about that. What I thought was really interesting was that the FDA also took this opportunity to look at its pilot program on patient reported outcomes from cancer clinical trials and it's putting some of that information out. So stay tuned, that could be relatively game changing as we continue.

This was also the week in which, if you are a general counsel, the U.S. Supreme Court ruled that the Title VII protections extend to LGBTQ employees. So you may want to update your employee handbook and the like as you continue. If you have any questions about how any of these apply to you, feel free to reach out, obviously you can reach me at DarshanTalks, but I like to use these opportunities to talk about some of the other issues that are popping up.

This was also a week in which I actually saw my first personal protective equipment with a company brand on it. And is that the future of healthcare where people walk around with drugs with company logos on it? And you might say, "Well, don't you already have the drug company's logo on it?" Yeah, I guess that's part of it, but I'm not sure how I feel necessarily about another company's logo on your drugs or your medical devices. Maybe things will change, maybe I will change, but I just thought that was interesting. If you think that that is unusual, if that's a step too far, feel free to leave me a message, tweet me on Twitter, and I'd love to hear from you.

Narrator: This is the DarshanTalks Podcast. Regulatory guy, irregular podcast, with host Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's website at darshantalks.com.

Darshan: Hey everyone. Welcome again to another episode of DarshanTalks. We have a really special guest, we have Kenneth White. And I've known Kenny for almost a decade at this point and one of my favorite memories with Kenny was enjoying a really cool meal in S...

Darshan: Here are the top five movies every pharma practitioner should watch right now.

So as we all know, what's happening right now is we've got the COVID crisis going on. You've got the entire world that's shut down and here are five movies that almost capture what a Aaron Tobias or Mike Rowe might look like. The first movie is a movie called Contagion, and it's a Steven Soderbergh's movie. And it's known for the terrifying death Gwyneth Paltrow early in the movie and it's front loaded with dread. So if you're not into some level horror, this may not be the right movie for you.

The second movie, and I actually happened to have just watched this over the weekend, is a movie called Outbreak. And that's the one that Dustin Hoffman, I believe it was Cuba Gooding Jr as well. And it's set in a fictional California town that's quarantine and becomes ground zero for Ebola like outbreak in the U.S. It's about using the CDC and military medical researchers and how they actually deal with this type of patient. And again, you've got some drama associated with the U.S. government trying to bomb the city or something, but that's your second movie. So you have Contagion and you have Outbreak.

The third one is a movie I haven't seen. It's called Cassandra Crossing and it starts Sophia Loren and Martin Sheen and Ava Gardner and Burt Lancaster. And it's about a European train that's attacked by Swedish terrorists. Well, you don't really see that so much, but it's effective with deadly pathogen and it's also speeding towards an unstable bridge, but no one on the board is being allowed off. So it seems like a mix of Outbreak mixed with Speed with a Keanu Reeves movie. So, that's kind of interesting. That was number three.

Number four is World War Z. And that is a Brad Pitt movie that features the largest mass of sprinting zombies ever put on screen. Pitt plays a UN investigator who agrees to make his way through an infected landscape to find the source of the outbreak and hopefully a cure before everyone falls to the epidemic. This is one of the things that I actually don't know enough about. I'd love to hear from someone who understands why patient zero matters so much. I understand that they would have the original genome, but wouldn't that have changed. So if you know the answer, please leave a comment. I'd love to hear more from you. If not, just hit the like button. I'd love to hear from you anyways, and know that you appreciate the content being put out.

And the last movie, so we had Contagion, we have Outbreak, we have Cassandra Crossing and we had World War Z. Last one is one of my favorites, which is I am Legend with Will Smith. And it talks about a hollowed out Manhattan. He's fighting vampiric monsters and essentially it uses this measles vaccines that was intended to cure cancer, but instead of kills 90% of humanity and the opportunities that come out of that.

So if you're in the mood for monster slash pandemic type movies, these were the five movies you should be watching. Contagion, Outbreak, Cassandra Crossing, World War Z and I am Legend. I can't wait to hear from you. Stay tuned. If you disagree, if you think I forgot a movie, please leave a comment for me.

Narrator: This is the Darshan Talks Podcast, regulatory guy, irregular podcast, with host Darshan Kulkarni. You can find the show on Twitter at Darshan Talks or the show's website at darshantalks.com.

Darshan: So one of the big questions that pharmacy students asked me is rather routinely, "What do I do after getting a PharmD degree?" This question is often led with, "I think I should go get a residency." This often leads to, "I don't know what else to do." Well, we're going to answer that question right now. Here are the top five degrees pharmacists can often get after their PharmD. Degree number one, I might be biased, but a Juris Doctorate degree. So you might be able to do your PharmD and then go get your JD. Another one that I've seen that's extremely common is getting an MBA. And the reason for the MBA is you can go into hospital management. The JD obviously, gives you the opportunity to start working in compliance, to start working with pharmacy-related issues. People like to call it pharmacy law. There's no such thing as pharmacy law per se, but there are people who do a lot of work in the pharmacy area.

Then there are, as degree number three, getting an MPH. So we're talking about coronavirus, we're talking about COVID, MPH degrees, especially in the context of pharmacy become really useful because someone's got to talk and advise on what are the public health implications associated with pharmacy and whether you're going to use hydroxychloroquine or if there's something better out there, and what is the impact on population dynamics? And that becomes a really interesting degree to have as well. Similarly, a very common degree to have, and that's number four now, is getting your medical doctor degree. So pharmacists often say, "You know what, I've learned how to treat, what I'd like to learn how to do is diagnose and I'd like to play quote-unquote quarterback for my patients' health." And an MD does allow for that to happen.

So the 4 degrees we have so far is a JD, an MBA, an MPH, and an MD. The fifth degree that does pop up is actually someone who goes from getting a doctorate in pharmacy to getting a bachelor's in informatics. And you'll see that often done because people are starting to work more and more with Epic and Cerner and other systems, and that's the advantage you get with a bachelor's in informatics.

If you have questions, if you've done any of these degrees, feel free to reach out to me or click the like button. And I look forward to hearing from you.

Narrator: This is the Darshan Talks Podcast. Regulatory guy, irregular podcast, with host Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's website at darshantalks.com.