DarshanTalks Podcast

Technology is occupying a more central role in different industries. Is technology the solution to most problems companies face? Join Darshan Kulkarni as he talks with technology expert Jim Nasr about the changing role of technology, and the potential problems it may cause. Plus, we’ll discuss the dangers posed by ransomware.

Darshan: Hey everyone. Welcome to another episode of DarshanTalks. We had a really fun, special guests with us. We have Tim Styer and Tim is gonna be talking to us about, uh, like one of the conversations we've been having. We've sort of come out of this recession, uh, starting to come out of this pandemic in a way where we're going. Um, people are losing jobs. People are having a hard time trying to figure out how to make their money. And some of it's related to obviously the fact that, um, the, like the jobs simply went away, but some of it's related to the fact that these jobs are actually farther, farther away. And the people who are getting those jobs are either, uh, people who live close to that location, um, or, or simply are, uh, what's the word I'm looking for? Uh, they, they, they have, I forget the term right now, privileged. They have certain privileges, um, that, that some of the others, some of the other people may not. And this may sound like a weird thing to say. I let Tim explain a little bit more about what he does, uh, to explain a little bit more about how this plays into pharma in the life, sciences and health and what kind of go from there. So, Steve, Tim, great having you on, tell us more about what you,

Tim: Yeah, first of all, I'm the president and CEO founder of Ride to Work and we're a limited liability company. And so our focus has always been on transporting, working with companies and nonprofits who do workforce development, transporting folks that are on the lower rungs of the economic scale from inner city, Philadelphia, the decent pain entry-level jobs out in the suburbs that they, that public transportation can't get them to. One of the things that we, uh, that occurred to us, and this was back in June when we started. And this was like when the numbers started coming in for the pandemic and we looked at it and what struck me Darshan was the fact that, um, I had seen some data from Philadelphia works, which is the workforce investment board for this Philadelphia and entire region that indicated that unemployment claims went up 132% in Philadelphia and 85% of those folks were from black and Brown communities in Philadelphia, Philadelphia, you may or may not know, had to dubious distinction of being the poorest large city in the United States.

Tim: We had a Florida pandemic poverty rates of up to 24%. It's been an implacable issue for a number of years, and there's a lot of different theories out there that, that that's, you know, point to the reasons why we are looking at like a little slice. So when we talk about the recovery of a region like Philadelphia, we understand that we can't do it the way that we've always been doing it. In other words, we cannot neglect some of the poor areas in Philadelphia and the poor population, and that also bought away includes. And let me just, you know, we're, we're looking at this totally data-driven evidence-based for instance, right now in Philadelphia, unemployment is about 15% in black and Brown communities in some zip codes in Philadelphia, it's 20, 24% with those who are just coming home from incarceration. It is as high as 48%.

Tim: Conversely, on the other hand, there's a lot of supply chain jobs that are warehouse jobs working in, um, um, distribution and so forth. That doesn't require a lot of skills that are in places that you can't get to, that people can't get to because they don't have a license. We fill that gap. And we feel as though that we can sort of close that poverty gap by at least providing people what we call like a first step into employment and getting socialized back into the workforce and, you know, be part of the recovery of this area. And it makes good business sense also.

Darshan: So talk to us about that more,

Darshan: Hey everyone. Welcome to another episode of DarshanTalks. We actually are live on Periscope and on Facebook live and we have Nirpal Virdee with us from sir, Tara and Nirpal are famous for those of you who don't know he was on the NASDAQ building yesterday. He had two different pictures on there cause uh, the company went live, uh, when had an IPO yesterday. And, um, we're really, really excited to have him. Uh, but Nirpal is going to be talking to us about Brexit. And um, for those of you who, who have gone, wait what's Brexit, it's been a while since we've heard about that. Um, we will talk a little bit about what Brexit is, but more importantly, how did that impact, how, how the UK approved the COVID vaccine first and what are the implications of that on future?

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

Nirpal: Yeah. Hey Darshan, nice to be on again and live. Every time is a, is a slightly different experience. So this is fantastic. We're on camera as well. So, uh, you know, I've had to sort of beat myself up a little bit though. I didn't have time, so this is great. Um, so I'm there Paul being on your show before I head up transparency and disclosure, um, here at Sitara. Um, so you know, all the things that, you know, we generally like to talk about in terms of, you know, sort of, uh, getting data back out to patients and healthcare practitioners, all the regulations and laws, uh, normally falls under my purview, uh, within Sitara. So, um, uh, it's going to be a fascinating conversation cause I know we ended our last talk on Brexit and surprise, surprise we're back on Brexit again. So let's see how we go.

Darshan: Let's ask the basic question. Cause there's some people, uh, especially in the U S where we kind of go, if it's not happening to us, that doesn't happen at all. So, so what is Brexit again?

Nirpal: Yeah, million dollar question. Um, so, so the, the UK is, uh, has decided in a referendum a few years ago now, uh, to leave the E U and there's been a, uh, sort of, uh, you know, a process that's been going on a transition process, but we've actually got a period now, which, you know, we're, we're getting towards. Um, D-Day so, um, you know, the, the end of this year is when the UK officially leaves Europe and we become out of this transition period. So you've probably been hearing on your side some news about final negotiations to try and get some level of, of agreement, uh, you know, for a future relationship. That's a, on a sticky wicket, I would say at this point. So let's see how that goes. Whether we get a deal or come out with no deals, that's Brexit. And obviously it has a lot of implications in many areas, but it has implications too to the space that we work in. So, um, I think that's where we can sort of dive into to see where it affects healthcare.

Darshan: Great lead in. So, so what are the implications that we've already seen? Because again, we haven't even had an official, um, leaving yet, if you will, for lack of a better term. So what do we already know is going to be different as soon as, uh, the UK leaves or even before the UK leaves?

Nirpal: Yeah. I mean, we'll talk about some other, um, you know, sort of topics that are intertwined with this. Um, when we get into some of the, the vaccines and COVID and all of the sort of, you know, potential repercussions it could have on our transport network to even get the vaccine in from Belgium. Um, but yeah, I mean, in terms of, in terms of our space, you've seen that, um, you know, we had a conversation in our, in our last broadcast, uh, just on the fact that, um, you know,

Darshan: Hey everyone. Welcome to another episode of DarshanTalks. We have a very special guest. We have, Mike is Tanya. Mike is, um, the CEO of mankind, uh, not, not, not humanity of mankind, the corporation. And, uh, he is, um, he's gonna be talking to us about some really interesting things because we had a little bit of a conversation right before we jumped on. And what we're going to talk about is how do you, how do you approach, um, the standard of care and how do you sort of approach engaging patients in a way that's meaningful

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: We're using the term engaging rather broadly where we're thinking about cost. We're thinking about actually talking to patients, we're talking about, um, what role clinical research clinical plays in this process. So, so Mike, you wanna introduce yourself before I jump in, do many of these questions?

Mike: Sure. Uh, thank you for having me today. I appreciate it. And that's been a busy week cause we get ready for holidays. But, uh, so my is Mike Astonia. I, uh, been at mankind almost four years now. It's been a turnaround company where the makers of inhaled insulin were the only inhaled insulin on the market. And the only one that'll be available for the next, probably 10, 20 years that we can see. Um, and my background is pharmacy. I've been at the pharmaceutical industry 23 years. I've done a lot of turnarounds, less, 15 years and worked for great places like Novartis and Bristol-Myers and Amgen. And I've had a fantastic career. I was actually a part-time pharmacist and pharmacy tech for 15 years. So for me, healthcare, I live, breathe, eat, and sleep. I love healthcare. I love what we do for changing people's lives. And a great thanks. Thank you. Looking forward to the dialogue today.

Darshan: So, so let's let's and thank you for being on, um, let's, let's start talking first of all, with this concept of you will be the only inhaled insulin for as far as you can tell 15 to 20 years, inhaled insulin has sort of been, I remember going to pharmacy school around the same time you did actually. And, uh, full disclosure, Mike and I went to university of the sciences then called the Philadelphia college of pharmacy around the same time. Uh, I was 2002 and I think you were in 2001, is it right?

Mike: Is that right?

Darshan: So, um, I remember hearing about inhaled insulin then, and I remember it being the panacea. Um, and now what I'm hearing you say is as a turnaround company and you're hearing about how there's no one gonna cut, come on. What happened? Why is the panacea not, not as great as we all thought it would be? Or why is it as great and people aren't jumping on so

Mike: Well, when you, when you used to get inhalants and you would get this box called Exubera. Okay. And so when you think about where we were back in mid two thousands, right? This, this was the first thing that everyone was so excited about, which is even more amazing. You look at it 20 years later, 15 years later, this thing was a bomb. That was your inhaled insulin. Oh, wow. Okay. Right. And so Al man, our founder was, it was a very successful businessman. He built the insulin pumps. And at that time, you know, he, you know, he looked at this thing saying, well, God, if that's what Pfizer spending 3 billion on, I can make that better. And that's what Al Mann spent. Our founders spent a billion dollars of his own money to build mankind. And he wound up taking the product from what I just showed you to the small little inhaler.

Mike: And you know, this is a Fresno, it's the only inhaled insulin,

Darshan: Hey, everyone. Welcome to another episode of DarshanTalks. I had actually promised not to show my face when I was talking to Tia a few seconds ago, but I seem to have forgotten all about that.

I have a very special guest. I have Tia. You guys met her, I want to say a couple of weeks ago. We had her on the podcast and it was a hit, and we're welcoming her back. Tia is entrepreneur extraordinaire.

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: She's going to tell you all about herself, but what I do like to point out is, she's breaking boundaries. She is leading the way for black and brown entrepreneurs in Philadelphia, and in the East Coast, really, for advancement in the life sciences. So, Tia, tell us more about yourself before we jump into the conversation today.

Tia: First, thank you for having me, Darshan. Founder and CEO of LucasPye BIO, as well as HelaPlex. LucasPye BIO is a medicine manufacturing company. HelaPlex is the first life science co-working space with a built-in accelerator.

So, I have 20 years in the biotech industry, myself. Working my way up literally from, I guess you say the benchtop, and rolling patients into clinical trials as a intern, to, senior manager was my last title as far as being an employee in big pharma.

Then, now I have my own two companies as a, I guess you call it C-suite executive. So, [inaudible 00:01:41]... Keep going?

Darshan: Keep going. I mean, I love hearing about you, because I [crosstalk 00:01:44].

Tia: Keep going? I am a HBCU graduate of Howard University. I got my bachelor's in biology from there. Later on, I went back and got my master's in entertainment business from Full Sail University.

I actually have a chronic condition myself. I thank about two-and-a-half years off, and during that time, I ended up following my friends to LA. They're all in music and film, so I got into the music area as far social media marketing and all that stuff when it was super, super hot, and at the beginning of Twitter's hype and all that stuff at that time.

Then, when I was cleared by the doctor, I went back to biotech. In that time, I got my second master's in regulatory science from University of Southern California. Regulatory science is the study of taking food, medical devices, and drugs, of course, from benchtop, or research, or another country, for food perspective, and bringing it into the commercial market, whether it's in the US or any other country around the world.

So, that's a bit of background around me. I love science. I've been science nerd since day one. I got [inaudible 00:02:47] nerd out on biotech feature, bioconference, a few years ago.

Darshan: Oh, I love it [crosstalk 00:02:54].

Tia: Happy to be here, and glad to speak with you today, Darshan.

Darshan: Thank you again, Tia. So, Tia, we're actually going to have... We're both in Philadelphia, and we've been dealing with some riots and some protests in the last few days. We're going to tangentially get into that, but I want to use this opportunity to actually have a discussion about how to... Actually, you phrased it better than me. Say it again about what our discussion's going to be, because I was like, "Yes, that is exactly what I want to talk about."

Tia: Got you. So, our topic of discussion today is to, as entrepreneurs, or any other business, how to attract people of color for employment. More specifically, how to retain them, and more specifically than that, how do you retain and attract African-American men into these respective roles, and how do you go out and search for them?

A site management organization (SMO) provides services to the investigator at a clinical site. How does this business model reflect a franchise model? Join Darshan Kulkarni as he talks with clinical trial expert Dan Sfera about the stigma associated with SMOs and how the SMO business model really works. We’ll also discuss some common pitfalls related to SMOs.

The FDA has already granted several emergency approvals to COVID-19 vaccines, and the UK is just beginning its first round of vaccinations. Is approval of these new vaccines premature? Join Darshan Kulkarni as he talks with guest Maria Chester about how the COVID vaccines may perform as they’re being deployed. Plus, we’ll discuss the importance of durability in vaccines.