RX Podcast_Barbara Wirostko: Audio automatically transcribed by Sonix

RX Podcast_Barbara Wirostko: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.

John Shufeldt:
Hello everybody and welcome to another edition of Entrepreneur Rx, where we help health care professionals own their future.

John Shufeldt:
Hello, everybody. Welcome back to another session of Entrepreneur Rx. I'm really excited to have with me today Dr. Barbara Wirostko. She's a co-founder and Chief Medical officer at Qlaris Bio Incorporated. Now, she has a really cool background. She's a serial entrepreneur. She's been on multiple boards and she's an industry leader and has this great track record in the kind of the global pharmaceutical driving device development. Barbara, it's really great to have you on the podcast.

Barbara Wirostko:
Thank you so much, John. Thank you for a very nice introduction.

John Shufeldt:
My pleasure. Ok, so before we start, before we dive deep into this field, I think a lot of people are going to want to say, hey, I want to become, I want to do what she does. Give us your kind of background in health care. How did you get started along that path?

Barbara Wirostko:
So, you know, it's funny. I do get asked a lot, especially from young, you know, younger ophthalmologists, bench researchers, but I don't have a Ph.D. I have an MD. And I always knew that I wanted to do clinical care and clinical research. And I was fortunate enough to enter a multi-specialty practice back in Long Island when I graduated from my fellowship. I was introduced to clinical research at the time and it was sort of the heyday for a lot of these topical eye drops for glaucoma. I was running the clinical studies as a principal investigator, phase two, phase three, phase four. Really was never taught about drug development. And out of the blue, I got a call from a headhunter who was looking to hire someone as a consultant to help launch Macugen. Now, Macugen Was the first anti-VEGF that was going to treat macular degeneration, and it was about to launch. Pfizer was located in New York. I was living in Long Island, and they needed someone to come in a few days a week, basically, and help them launch the product. And it was a great learning experience. And after six months of consulting, I decided that I really wanted to get more in-depth experience, and I joined Pfizer as a medical director.

John Shufeldt:
Wow. OK. So your background is you went to medical school, East Coast?

Barbara Wirostko:
Yep, East Coast to Columbia.

John Shufeldt:
And then residency in ophthalmology?

Barbara Wirostko:
Correct. At Columbia.

John Shufeldt:
And then fellowship in?

Barbara Wirostko:
At Cornell in Glaucoma.

John Shufeldt:
Glaucoma? Is that a year-long fellowship?

Barbara Wirostko:
It's a year-long fellowship, correct.

John Shufeldt:
All right. And then right out of that, you started doing basically investigation and then got pulled into Pfizer as a consultant.

Barbara Wirostko:
Yes. So I was seeing patients, doing glaucoma surgery, running a practice for about 10 years before I got pulled in. And it was really interesting, too. Because again, we, as you know, we don't learn drug development. We don't learn taking a product from the bench into the clinic in medical school. So the learning curve was tremendous and just seeing how a large corporate pharmaceutical company thinks about developing a drug, you know. And we're always told that, oh, it's the dark side, but there's some amazing people within industry. I mean, I think right now what we're going through with COVID is a great example of how we really put patients first and really want to shape medicine. And they have money, you know, instead of us writing grants, sitting in a research lab. There's a lot of money that's poured into research and some really good research to develop drugs.

John Shufeldt:
Yeah. I think COVID, one thing it has done is shined what I hope was a positive light on different drug makers because they rallied so quickly around the cause to get these vaccines out. Literally, it's just mind-boggling how quickly they did it. I mean, they're clearly working. I mean, it is, you know, as well as I do with the patients I see who are sick are not vaccinated.

Barbara Wirostko:
Yes, exactly.

John Shufeldt:
Yeah. So obviously it is working. You're still a Clinical Adjunct at University of Utah, correct?

Barbara Wirostko:
Correct. So like anything with industry, and this is sort of interesting too, is that unlike medicine, where you set up a practice and you see patients for 30, 40 years and you're sort of ingrained in your community, with industry, your job really does fall and rise around what drugs are being developed. And at the time at Pfizer, the product when I rose up in the ranks that I was responsible for, which was Latanoprost, so that that was their 1.3 billion drug was going off-patent and it was basically a cliff and they didn't have anything to fill up the pipeline. And I realized that I really wanted to stay in ophthalmology. Our whole family at the time was interested in moving west, and we came out to Park City and I joined the University of Utah and there what's really unique too, and I would advise anyone that wants to do something like we've done is be mindful of where you work. Different academic institutions actually have different policies, and some are very forward-thinking where you can be an adjunct and you can see patients, but yet you can own and start your own company, whereas other academic institutions are much more restrictive.

John Shufeldt:
You know, you're the first person that has reminded me of that. So thanks for bringing that up and that is so true. I literally talked to someone yesterday who was contemplating going to Mayo, back to Mayo, and it was very entrepreneurial. I said, so, you know, here's what I understand about Mayo Clinic, they own all your IP.

Barbara Wirostko:
Exactly.

John Shufeldt:
No matter what you do, and so that's a great point to bring up. Be careful where you're working and if you want to do something else besides medicine and obviously the University of Utah was great for that for you.

Barbara Wirostko:
Yes, they are. They're very much like MIT. MIT is another very forward-thinking institution where you can own your own IP and sort of have that joint position where you're an adjunct. And I always love seeing patients. So it's been a really nice, you know, combination or marriage.

John Shufeldt:
Yeah, nice duality. Now did you, like going back to when you were in college, in medical school, did you think you'd be out of this entrepreneurial path because you're, you're kind of a hyper entrepreneur now. I mean, you're kind of in the big leagues.

Barbara Wirostko:
Absolutely not. I had no idea, and that's why I always preface it with. I sort of laugh to think when I started my first company and it was running a lab, and as I always say, I did not have a Ph.D., I do not have an MBA, I really learned a lot in, at Pfizer. I also learned the business aspect, and I think that's something that's so critical for anyone that's thinking about taking a compound, device, drug, idea forward is you need to have, it needs to be an unmet need, but there also needs to be IP around it, right? And there needs to be a commercial path forward. And there's so many great ideas that I look at and do due diligence on, but they're either don't have the IP, so they're not investable. There is no, you know, the commercial landscape isn't actually favorable. So it really is this whole sort of mix of what's needed to bring something forward. It's just not the science. The science, of course, is important and critical, but it needs to make good business sense, and that was really something that I learned at Pfizer.

John Shufeldt:
Yeah, it's really interesting because I think a lot of people and I guess that was one of them thought, OK, you know, if I'm going to do this, then I have to have an MBA and I have to do that. But I think you bring up a really good point. There is so much information available now, you don't need to have the letters after your name to be an expert. And like you said, you don't have a Ph.D. or an MBA and clearly you've knocked it out of the park.

Barbara Wirostko:
Oh, thank you.

John Shufeldt:
Without either, I mean, the evidence was there. And so that should be a great positive remark for people who go like I do not have time to get MBA and God knows I don't want a Ph.D., but yet you've been incredibly successful without either one of them. Do you think being an entrepreneur has made you a better physician and vice versa?

Barbara Wirostko:
Absolutely. And I don't know if you've seen the same, but I think about the patient differently. Even from a research perspective. I think I also have a much better idea and appreciation for systemic side effects from medications. Again, having been at Pfizer and just having to look at adverse events that even come from drugs that are not even in ophthalmology, but again, we were privy to that information. But I think it does. It's just, yeah, you kind of think about the patient differently. And I also feel that my patients teach me, and I think that's one thing too, that's been really nice ever since I've been in industry. Even starting at Pfizer is industry realizes that if they've got an MD on their staff in their department, you know, really utilize them because they've got that patient interaction. You know, you pay a lot for market research, but if you've got someone that's actually seeing patients day in, day out, why not take advantage of that and keep that person in the clinic seeing patients?

John Shufeldt:
So it's been symbiotic. One is, they each help, they each help the other one. So let's talk about your new venture. Now, actually most people who had your path would probably not go out and do start a biotech company. What prompted you to do that?

Barbara Wirostko:
So you mean the most recent one? And I always say, am I going to do this again? Because, as you know, it's a roller coaster. I mean, it is trying to raise money, you know, hiring staff, building a company, knowing what you don't know, and learning quickly what you don't know. But I think it's the creativity. You know, I love the ambiance. I love the ability to learn and to start something new. And I've always been creative and I've sort of learned that about myself through the years, which is why I love research, because research is being creative, you're learning. And drug development is very similar. And this company, my colleague from Pfizer, came to me and said, Barb, I've got this opportunity to enlicense a compound, would you want to co-found the company with me? It's back in the glaucoma space. So we had some VCs that were interested. And yeah, it's been fun, working with some really great people.

John Shufeldt:
When did that started, and what's the thesis for the company?

Barbara Wirostko:
So it was started in August 2019. We raised Series A. We got into the clinic within 18 months and we're currently in the clinic, it's lowering IOP. So it's indicated for glaucoma through IOP reduction and the sort of the sweet spot because it's a very competitive area. There's a lot of glaucoma drops that work, but it works on something that has not yet been approved and that it works on something called EVP or Episcopal Venous Pressure, so it's sort of the, you know, the backflow resistance to when the fluid drains in your eye.

John Shufeldt:
It reduces that.

Barbara Wirostko:
It reduces that. So it reduces EVP, and that's how it lowers IOP. So that's a unique mechanism for the glaucoma space.

John Shufeldt:
And when you think this drug will be available. What are the next stages?

Barbara Wirostko:
So we're currently in a Phase 2A. We've actually have three phase 2A's going on small pilot studies. And then depending upon what we see, we could go to a Phase 2B where we have a little bit of a larger patient population, we still need to determine our commercially viable dose, right? We're looking at different doses, we're doing dose-ranging currently. And then it would be a Phase 3. So phase 3 is the longest study, the largest study, and hopefully maybe within four years if everything goes right and many millions of dollars later.

John Shufeldt:
Wow. Now you outsource the testing or do you outsource it?

Barbara Wirostko:
Yeah, we outsource it. Yeah, there's some really good CRO's.

John Shufeldt:
It's funny. I've had a gentleman on recently who is a surgeon, and he basically said, you know what? You outsource CRO's, you have diverging rationales. They want this study to last longer. They make more money the longer the study lasts. He was a drug developer, wanted to be as short as possible, get all the data as possible. So he basically in-house all their own.

Barbara Wirostko:
That's interesting. That's a lot of work.

John Shufeldt:
Yeah, but he's got it literally cuts the drug development costs down by multiples and multiples of money. It was very interesting talking to him.

Barbara Wirostko:
That's a great. That's great if you can do that. We're still a very small company, so we're only about seven individuals.

John Shufeldt:
Wow.

Barbara Wirostko:
But we have, you know, we're hands-on in terms of the clinical work. But we do have a CRO running our clinical studies.

John Shufeldt:
And so, it's four years, is that considered? I mean, as I read, it's usually eight to 10 years from, is four pretty fast?

Barbara Wirostko:
You know, the phase 3 is going to be about a year-long to start and to stop. So it really depends. What we did differently, and what's unique about ophthalmology is unlike other drugs where you have to start off in what's called a SAD or a MAD. So a single ascending dose or multiple ascending dose studies in healthy individuals. In ophthalmology, we can go right into patients, so that, you know, cuts some time off right there. And generally, our initial pilot studies are only four weeks of exposure to the eye drop.

John Shufeldt:
Wow. And then you give them the drop, take and check their pressure, or is it just over time?

Barbara Wirostko:
Yeah. To check the pressure. And sometimes you can see a ... response even within a few hours to a few days, depending upon the drug. So they're really quick studies.

John Shufeldt:
Wow, that's really interesting. Now, you said your last one, what other startups have you run? Because I know you've been on a bunch of boards, what other startups have you started?

Barbara Wirostko:
The other company I started, was my first company I started, and it was called Jade Therapeutics, and we in-licensed a polymer, a hyaluronic acid from the University of Utah to help heal the cornea. So there most of the money we raised was through the Department of Defense and the National Science Foundation, the NSF. So we got upwards of $3 billion between the two organizations over time to basically get the product ready to go into humans. And then we were acquired by a company called EyeGate. So then I came on board as the chief medical officer and we moved the polymer into the clinic.

John Shufeldt:
Wow. So that drug is out and being applied?

Barbara Wirostko:
So that polymer got to a pivotal point of, it was positive. So it was superior actually in our pivotal study. We went down a device path and the company is still, again then it becomes a business issue at that point. So reimbursement path, how are you going to price it? So we finished the clinical development program and it was positive. So it was approvable and the next step is submitting it to the regulatory agency. But that's also when I left the company to start this new venture.

John Shufeldt:
Wow. So you did a TED talk that was very moving and inspirational about your son, who had dyslexia? Can you tell us about that?

Barbara Wirostko:
Which part? The Ted talk?

John Shufeldt:
Yeah. Well, what you're accomplishing with the 501(c)(3), is set up because I read through the brochure and you've obviously changed the lives of thousands of people.

Barbara Wirostko:
Thank you. So, yes, so Joseph was severely dyslexic. Being a house of doctors, we completely missed it. We trusted the education system back in New York to diagnose him, and they missed it. And when he was in high school, freshman year, he was essentially failing everything and he was always good at science and math. He started to fail math, and we questioned why. We learned after the fact that it was because it was word problems, and at that point, the high school basically told us he was not high school material and we had to fight to get him tested, we have to, we had to hire a lawyer, we got his accommodations and he went from failing basically everything, being told he doesn't even belong in high school to high honors, graduating with high honors, and then going on to Montana State and mechanical engineering on Dean's list, and it was because of the accommodations and because we had the resources. So when he was killed, at, 27 years ago, he was camping with his friends, we just said there's got to be other kids like Joseph that are falling through the cracks that maybe the parents don't have the wherewithal, they can't hire the lawyers, they can't fight with the school. And maybe we can help a few of these kids. So we've gotten to the point now over seven years, we've given, oh my god, about it's crazy, it's staggering to think, three hundred and twenty thousand dollars to over a hundred students around the country. And what they tell us is just they thank us because we believe in them, and they share the same stories. One girl in particular, is graduating from Smith's. She's been our student now for four years because we really want to continue to support these kids. Her dad actually was a lawyer. They fought the Legislature system in Massachusetts for 12 years to get her the accommodation she needed. I mean, it's just, it's crazy, it's mind-blowing. And I always say it's probably the hardest job that my family and I do. But it's just so rewarding because these kids are just so incredibly appreciative as, and as are their parents, because they don't know where to go. They don't know who to ask. They don't understand the systems, how college works differently than high school for accommodation. So we try to help.

John Shufeldt:
That's, I mean, when I say thousands of people, it's probably tens of thousands. Did you think of the ripple effect of what those folks can accomplish and the impact they can have on others and the impact you had on them and their family, it's literally the pebble in the pond. And I just started smiling when you said your son went from flunking out of high school to mechanical engineering and killing them in college? What a huge range of upside, yet, and he was never incapable. He just, the systems weren't there to support him.

Barbara Wirostko:
Exactly. And you know, and you'd appreciate this too, because again, you approach things as you know, as a physician, right? So when he was in freshman year and literally slowly failing everything, he was having headaches, ringing in his ears, palpitations, shortness of breath. So what do we do? We do a brain MRI. We send them to an ear, nose and throat, the cardiologist, pulmonologist. It was all anxiety.

John Shufeldt:
Yeah, stress.

Barbara Wirostko:
It was depressed. And these kids do have a much higher likelihood of having anxiety, panic attacks, depression, suicide. Because why? All they hear is you're so smart, but you're not trying hard enough. And that's what we told him. We're like your teachers say you're so smart, why are you not trying harder? You clearly can do the work. And he couldn't.

John Shufeldt:
Wow. That is really amazing.

Barbara Wirostko:
So yeah, it's crazy how you're dealt cards and you got to figure out how to play them, right?

John Shufeldt:
Yeah, make the best out of them. It's, I mean, those kids who have those must be so resilient.

Barbara Wirostko:
Yes.

John Shufeldt:
Because they figured out ways to, themselves manipulate the system so they can learn as best as they can.

Barbara Wirostko:
That's exactly what happens. They compensate until the work gets so hard that they just can't compensate and these kids get missed. So we think the educational system picks them up and grammar school, elementary school, but they're still getting diagnosed in high school and even in college. And unfortunately, by the time they get to college, they basically just drop out and quit.

John Shufeldt:
Yeah, who can blame them? I mean, the system failed.

Barbara Wirostko:
System failed them. Exactly.

John Shufeldt:
And they're labeled. I totally get that.

Barbara Wirostko:
And they're labeled. And the other thing, a really big pet peeve I have, and I think it's really important because as we talk about diversity, equality, disabilities across the board, there is such a range of visibility and acceptance at different colleges. So even in Utah, there's one college where you go in and the disability office is on the main floor next to the admissions office. It's bright, it's cheery, it has windows, there's secretaries, their staffs there, you know, it's inviting. And then you'll go to another university and you can't even find the disability office. And it's in the basement, in the corner, no windows, no staff, dark. And what kind of message for anybody with a disability?

John Shufeldt:
Yeah, I used to laugh in college. I was bigger then and I was throwing discus and I was taking physics and I couldn't fit in the little desk they had so I told them I had test anxiety so I get to sit at a table in a room by myself, but I had to go see a psychologist to prove I had test anxiety. I always remember thinking about this, as God knows the truth, a ton of disabilities yet to be discovered, but I had to fake disability just so I could get out of this tiny little desk where I couldn't fit in.

Barbara Wirostko:
You couldn't even fit in. That's crazy.

John Shufeldt:
Yeah, it's ridiculous. All right. So what do you say to somebody who wants to be you? Because you've got a really cool track record, and what do you say somebody who wants to emulate what you've done?

Barbara Wirostko:
You know, from the perspective of, I think if you're a researcher, so we'll start with if you're a researcher, the key thing that I've learned is don't publish. Talk to your tech office first because again, as academicians we are always rewarded for publishing, but it can hurt you because if you've got your papers and your work published before you file your patents, your ideas are not patentable anymore because it's now in the public domain. So that's like the first key thing that if anybody wants to do something like this, make sure you talk to a good IP lawyer or your tech office. And I always say too, you can't expect to be the expert in everything. So like any company, like any business, surround yourself with people who compliment you and have the skill sets that you don't have. You know, the business side. I am not the business expert, so I work with business experts. Even with drug development, I'm not the tox expert. So I hire a really good tox expert who really understands the toxicology side of drug development. But I think if you have an idea and you want to be creative, it's scary, but it's fun, you know, and talk to people who are like-minded. And there was a quote by Disney, which I always love quoting and it says, you know, "isn't it fun to do the impossible?" No, don't don't settle for status quo. Ask why. Always ask why. And don't take no for an answer. If somebody says no, go ask again to somebody else.

John Shufeldt:
You know, I love quotes and Ihave quotes all of my office, and I've never heard that quote. "Isn't it fun to do the impossible?" I'm going to be using that.

Barbara Wirostko:
You're an entrepreneur. You get it, right?

John Shufeldt:
I love that quote. Oh, hey, you said something really interesting, and it's embarrassing that I actually took IP in law school and it didn't rain. So you said it were like, don't publish because you're right, once you do is in the public domain, it's just not yours anymore.

Barbara Wirostko:
Yes. And you can't get IP around it. And I've seen several really good compounds not progress because there's yeah. And again, if a VC is going to back it, they're going to want to know the strength of the IP.

John Shufeldt:
Yeah, totally. Wow. That's really sage advice. All right. I'm going to remember that one as well. Ok, so final question about resilience. Were you born with it? Did it develop over time? And how important is it?

Barbara Wirostko:
Um, I think I to some degree I was born with it. I always would make up my mind that I wanted to do something and I would try my hardest to make it happen. And I think within industry, I really learned, you know, when I say, if somebody says no, you know, go somewhere else and don't take no for an answer. But it really is developing that story and making the argument and getting people to believe in you to move something forward. And you need to be resilient, and you need to be somewhat of a persistent fighter. If you believe in it, you've got to be the champion. You know, if you're going to push something forward, something every project needs a champion. And if it's your own, then, of course you're the champion. But it's a long, hard road, it's not easy.

John Shufeldt:
But it's, you know, I wouldn't change a thing, it's a lot of fun and it's funny, I realize what a stupid question it is when I ask a woman in medicine if she's resilient when she was. Well, I think to be a woman in medicine, particularly those of us who graduate a little bit ago, you had to be tough as nails because, you know, I'm a six-foot-four male, I had it really easy. I think a lot of women struggled with a total gender bias that even existed today. So hats off to you.

Barbara Wirostko:
Thank you. And you're right. I mean, you look at the board still, you know, they're trying to make a shift not only for women, but diversity and people and men of color and different nationalities. And we're still not seeing that on a lot of our boards and advisory boards, whether it's a company board and advisory board, right?

John Shufeldt:
But I think it's coming. I'm incredibly more optimistic than ever about the tide has changed.

Barbara Wirostko:
I think you're right. I think it is changing. Six-four? Did you play basketball?

John Shufeldt:
I did very poorly. My vertical jumps about two inches, but I threw discus and I, you know, I had a little bit of success in that, but only a little bit. It was an honor to talk to you. So thank you very much. Where can people find out more about you?

Barbara Wirostko:
So they could Google me. They could reach out to me at the University of Utah, and it's barbara.wirostko@hsc.utah.edu, and then also at Qlaris at our company.

John Shufeldt:
We'll publish that on the website. Barbara, thank you so much. It was a real honor to talk with you.

Barbara Wirostko:
Such a pleasure, such an honor, thank you.

John Shufeldt:
Thanks for listening to another great edition of EntrepreneurRX. To find out how to start a business and help secure your future, go to JohnShufeldtMD.com. Thanks for listening.

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