Navigating the Regulatory Landscape: Insights from Rik Mehta, Pharm.D., J.D., LL.M.

We just had an amazing conversation with Rick Maida. Rick is the co founder of Lactiga, he is the co founder and chief executive officer of Licentium, and he is also an adjunct professor of law at Georgetown University and he has done a million other super interesting things.

If you are curious about how you might look at things through more of a regulatory lens as you're getting started with your biotech, this is your episode because it is more important than even I knew. I've hired a lot of regulatory people, but Rick really puts it into perspective as to how important it is that everybody in the organization sort of knows what their role might be in the future regulatory process. So that goes a lot smoother when you get there.

Welcome to Building Biotechs, a podcast by Rekryteromics Consulting.

We've helped over 75 biotech, life science and venture capital firms strategize, hire and retain thousands of employees to scale companies that bring life saving drugs to patients.

We speak with those at the forefront of growing biotech techs to learn their tactics on building these companies from the ground floor to the C suite.

We're your host, Karina and Alison. Well, thank you so much for doing this with us. We start every episode the same way. What did you want to be when you were 7?

What are you now?

And how did you get there?

Well, first of all, thank you so much for having me. I'm really excited to have this conversation. So I love that question because I have three boys right now, right? One who's 10, one who's 8 and one who's 6. And like literally every day I'll ask them, so what do you want to be when you grow up? And they'll say, one of them wants to be an archaeologist, one of them wants to be a football player, and the other one wants to be a hacker, a programmer.

Wow.

Okay.

So wild. You know, the difference in dating myself back about 39 years, when I was seven, what did I want to be? I think I've always wanted to be a lawyer. I've always, you know, probably been a bit argumentative with my parents, I'm sure they'll say. But I always was curious and intrigued by the way we govern the government systems and the laws that create the structure that, you know, regulate people and citizens. And so that always got me intrigued. Somehow I meandered away from there, became a pharmacist first, and then subsequently, and my dream come true. I did eventually become a lawyer, ironically not practicing either, so to speak.

So yeah, but the skill SET is so applicable in our space. And I think that I want to dive into that later. You know, how are you marrying those two? And what are all of those. What are all the aspects there? Interesting that you wanted to be a lawyer when you were young, because most people don't know what a lawyer is necessarily at that age. We had a lot of people who say they wanted to be astronauts or pilots and things like that. Did you have somebody in the family? Did you have an influence or a mentor?

I actually became the first attorney in my family. You know, my. Yeah, my father came to this country when he was 19, almost 52 years ago, and, you know, he didn't have much money to his name, and he was a scientist, and really that's what we knew. My family, my sister, my mother, my wife, everyone is in the scientific field, and none of them in the legal field, so. But when I was young, you know, things intrigued me about our democracy. I. I know what really got me interested oftentimes, you know, we'd sit at the kitchen table, my father and I, and have friendly debates. He loved to be the devil's advoc. Play the devil's advocate, and, you know, that kind of area where he kind of forced me to push back and argue my point and support my position and understand what's going on in the world at an early age. I mean, I'd be five or six years old, and he'd ask me questions about current affairs and, you know, forced me to understand that and understand both sides of it. And the want of understanding both sides of. Of a perspective of a story of the law and position just always resonated with me. And I suppose that kind of became the influence, you know, to. To wanting to pursue, you know, a future career in. In law.

Your dad sounds amazing. That's really cool. What a good skill set to start instilling in a child so young.

It helped me win a couple battles against him, too. So I suppose, you know, I don't know if he regrets it now.

You've had an interesting career, too. Can you walk us through a little bit of, like, your actual career journ journey? Because you've done some really fascinating things.

Yeah, I. I like to say I wear a lot of hats and lived many lives. You know, I started my career well, I'll tell you my first job, and arguably sometimes I feel like my best job. I started as a tennis counselor at the YMCA when I was 15. And it. It was really, you know, being outside working with kids really influence kind of shaped My value system in terms of what I wanted to do. And I always knew that I wanted to pursue a career where I could help people, give a voice to the voice. Voiceless. And, you know, again, much like the story of, of my parents, you know, coming from humble beginnings and, you know, we've been fortunate to experience the success we have. You know, whether it's, you know, monetarily or academically, professionally, how we define success, we've been able to achieve that. But it hasn't come without a plight and a story and hard work. And so that really started to shape my values. And I decided to go to pharmacy school after college. I always wanted to be a lawyer, but, you know, again, much like the influence my father had in making me argue, he also said, you know, get a job where you can, you know, get a degree where you can have a job afterwards. Right. I wanted to go and do, you know, liberal arts. Always had a very strong interest in philosophy and history. But he's like, well, is that going to put money on the table? He would always say, you can always do that as a hobby. Right. He may not have been correct about that and his thinking, but I think from his perspective and the way he grew up, he wanted to make sure I was secure, stable, and had a career. But I'll tell you, I got fascinated by pharmacy. I got fascinated by drug development. I got fascinated by innovation. You know, I started pharmacy school in 1995, and this was right at the start of I kind of gene therapy, really the early seminal stages. And it's actually an amazing story. You know, my father was a cancer researcher for a number of years, part of the team at MD Anderson Hospital that discovered and published on Interleukin 2. And a lot of the seminal innovation and findings, the discoveries that set the basis for CAR T and some of the advanced therapies we see today that are standards of care. What amazing innovation. And I was just always fascinated by that. And I tell you, I struggled. I struggled to get through pharmacy school because my real interest was always on the regulatory side of things, not the core scientific. I knew the skills. I, you know, was able to do it, but not as driven by it, but I got through it. I got through pharmacy. I loved it. And then I was like, you know, I got to take a pause in my career here or my academics, I should say, before jumping into law school. And so I ended up going to practice pharmacy. Started at a community pharmacy and then moved over to a university hospital and clinical pharmacy at Robert Wood Johnson went back to do my PharmD. And then I took my LSATs previously and then I said, you know, now is the time. It's either I gotta, you know, pull the trigger and get over to law school or not. And you know, I was fortunate to get into, you know, a great program and graduated from Rutgers. I went to Rutgers Pharmacy, went to Rutgers Law School and was able to work overnights to put myself through pharmacy school. And then when I finished law school, that's when I took my first job at the FDA. So that kind of brings us to about 2008, my professional career.

We heard a lot of people who want to transition into the biotech space from pharmacy. That's actually a pretty common ask that we get from people who are, you know, finishing school in pharmacy and thinking, what are the career paths out there? So you went to the fda. Is that a pretty common path? Are there other ways that folks can get into biotech with a pharmacy degree as maybe that's their first leap?

Well, you know, the thing for me is that I was always intrigued by the regulatory aspects. The, the advantage of being a pharmacist or being in the healthcare sector, especially in the United States, is that there's so many different types of jobs and biotech is an industry. While we call it generically biotech, it touches so many high skilled positions. You know, I, and every day I get to work with, you know, engineers, PhDs, scientists, lawyers, project managers, finance. You know, it touches every discipline and you need that in order to be successful in bringing innovation and commercializing onto the market. So I think FDA is a great position, I gotta tell you, it's probably pretty competitive to get in there, but it's a great position to be at the FDA, to really get the 30,000 foot view, to see the entire landscape of a field of not just biotech, but pharmaceuticals in general. Understand the history of where we've come, I mean the history of drug development in terms of how we regulate drugs, the reason why we do the things we do and why we do so many clinical studies or other studies before, you know, you get that coveted approval by the fda. It's, it's quite a storied way of coming to developing the gold standard of regulating medicine in the country and now arguably the gold standard worldwide. And so I think the FDA is a great position for those that are in the healthcare sector and lawyers as well that are interested in the biotech field. But it's not the only one, right? You can, there's a lot of ways to gain Real world experience working in this industry. And I can tell you, developing those assets, those skills in understanding how products are regulated, regardless of what kind of law you practice or what kind of pharmacy, you know, interest, where you want to go into kinetics, pharmacology, drug development, medical affairs, clinical trials, whatever. I mean, there's thousands. Safety, regulatory, labeling. There's so many different touch points. Understanding how all of that comes together and how it's regulated, the why, why you do what you do, that's an answer you can get being at the fda.

I definitely can see where that, as a first step, too, would set you up for the rest of your career to have a really good foundation.

It really does. From a recruiting standpoint, we often are tasked with finding folks in all of those spaces that you just mentioned that have FDA knowledge. And often that knowledge is somewhat tangential. It's like, well, I worked with the FDA on X approval, but I would imagine working for the FDA would really give you that deep, deep knowledge of all the inner workings that you could then take into your regulatory, your quality, your labeling, whatever role is next and really apply it.

Yeah, and I think one of the advantages of being at the FDA is, you know, it's easy to read the law, it's hard to apply and understand the interpretations of it. Um, and I think, you know, understanding the framework of how FDA reviewers think or how FDA officials think is a skill set, I think can be helpful to read. You know, sometimes the tea leaves. You know, the fda, I think, tries to be as transparent as they can in their communication, but sometimes they're also restricted in terms of how they communicate back to make sure those communications are in compliance with whatever the regulatory standards are. And you see that often in a lot of examples where the FDA continues to be challenged because they've gone beyond their regulatory authority. And even recent case law by the Supreme Court, talking about administrative agencies staying within the confines of their statutory limits, the federal act, and making sure they're not going beyond the authorities that have been granted to them. For example, one comes to mind is the way we have REMS programs, risk evaluation mitigation strategies, and I remember predating that we had risk maps. The FDA was concerned because if you look at it at a legal lens at a high level, the agency is literally going in there to restrict distribution of an otherwise product where their only authority was to determine a prescription status that would restrict the distribution of a drug. Standing on the. On interstate commerce, you know, was that. Which is a congressional authority, was that authority delegated to the fda. And the, the short of it is not really until Congress gave them that act in the next PDUFA iteration FDA in 2008. So that's just one example of how it's. So you know, sometimes from a biotech lens when you're a developer, you're a scientist having that level of appreciation to understand that yes, they're super smart group that are there evaluating for making sure that products are safe and effective and they want to work with the medical legal side, I mean a medical scientific lens. But they also have to comply to the laws and regulations and sometimes it doesn't always translate the same way in these communications when you're, especially when you're an executive or an early stage company like mine where there's no room for error. Like you make an error that could be a hundred thousand dollar mistake of which you may not have the funds to come back from and you have to continue to be lockstep with the FDA and their interpretations in order to de risk your programs. And so yes, that was a long way me saying there is an advantage of those that have had the ability to wear the hat at FDA to understand how they think in order to interpret the communications that come back to be able to read the tea leaves.

Can you tell us about your pivot into biotech? Because I definitely want to talk about your current company but what sort of led you to leave government and to jump into the biotech waters?

That's a great question. And the way I say the two like happiest days of my professional career is the day I got my FDA job. And yeah, and part of that is that you know, with the fda, it's a great job. The truth is, is working in government there are certain restrictions on what you can do. And I've always been an entrepreneur at heart.

Right.

You can't be at the agency that you regulate industries and then go try to start your own. And so I was able to take those skill sets and leave. And you know, frankly speaking, I did move into. And I'll tell you, you know, I said I've lived many lives professionally from the fda. On a quick note, I did work at a local level working, wearing the hat of the chief enforcement officer and deputy director of a health agency at a state level understanding how health professionals are regulated and overseeing the regulations of hospitals, pharmacies, food facilities, you name it, which, which ties into understanding the entire regulatory landscape of healthcare in and of itself. The powers that the states have and the federal. And when I left that job, I Joined established pharmaceutical company until one of my former roommates and a close friend of mine came to me. He's a, he's a self proclaimed nerd and he was a PhD and a postdoc fellow at the NIH and the FDA. And he came to me with this idea and that's when I said, you know, this is a great idea. I think it has legs to stand on. And I was able to evaluate it from a regulatory strategy perspective in order to create what we now know as, as our biotech. So just serendipitously kind of came up to it, the opportunity came and decided to take the shot.

Can you tell us a little bit about what you are doing and how your partnership kind of works? Because being a co founder is really interesting. It sounds like you have really complementary skill set. So how is that kind of division of labor working?

It's been, it's been a really fun journey and I'm always excited to share the Lactiga story. And so what my friend and colleague and former roommate and drinking buddy came up to me and said, you know, he's an immunologist with the background in gene therapy, two postdoc fellows, fellowships and former nih. And he came up with this idea to say, you know, let's look at the therapeutic properties of human milk, breast milk. And you know, breast milk has been scientifically studied. We know it's a nutritional food. I mean the, obviously the first food source and the preferred one for babies. But they're also, while they're full of like fats and lipids and sugars and other great things that could help to sustain life, they're also chock full of antibodies. And we've known for years that plasma proteins and antibodies extracted out of plasma have been developed and FDA approved as therapeutics for immunodeficient patients. We started to really explore what if we can do a similar type of pathway, what can we find in that? And what we've discovered, again not our own discovery, but through published literature and so years of immunological research, is that there's an underdeveloped space in immunology around mucosal therapies, meaning antibodies that can be delivered into areas in mucosal spots versus into, directly into your blood. Um, and oftentimes in immunology, infectious disease, we use more of a hammer when we might need just more of a soft glove, glove tap. And, and I'll tell you, for example, many of the most common pathogens we see right now in circulation, be it Covid Influenza RSV are actually infections of the mucosa. They're mucosa, they start as mucosal infections and then start to spread in the body. And we said, especially for patients that are deficient in these antibodies, can we develop a therapeutic that replaces these antibodies in the mucosal spaces versus what the current standard of treatment is, which is replacing antibodies in the blood? What we've also discovered is that the antibodies that are given in the blood do not raise or fix the deficiency in the mucosa. And so your body really has two layers of defense, your mucosal immunity and your systemic immunity. And all therapeutics to date have been focused around systemic immunity. We're, I guess, arguably one of the first companies trying to pioneer that second layer of defense of your body, which is rebuilding your mucosal immunity, targeting up the population of immunodeficiency and then being even more specific to focus right now on patients that present with low to no immunoglobulin A or IgA, secretory IgA. And that's really our innovation. We've been able to patent the proprietary techniques to pull and make secretory iga, and we're developing it into a first in kind delivery to, you know, rebuild IGA levels in people's immune systems. And we think that that's going to be a major game changer, a paradigm shift in how these patients, which are otherwise extremely sick, will be treated. On another quick note about that, you know, and it's unfortunate, you know, one of the first disease states we've focused on is called common variable immune deficiency. And while we're proud of the accomplishments we've had with the fda, we recently received rare pediatric disease designation for our development program. You kind of take a step back and say, while we're proud of the regulatory milestone, the truth is our company and my credo is always to be patient first. And I mentioned my journey in terms of starting my career as a counselor helping kids. It's very sad for us to know that the mortality rates are 38 times higher in children than they are in adults with patients that are diagnosed with this disease. And we've spoken with people with the disease, we've been involved with the Immune Deficiency foundation and so many. And so we've set out to see if we can change the paradigm in treatment and create innovation that hasn't been done in better half of 60 years for many unmet medical need areas for these patients.

That's amazing that you're pioneering this. Tell us a little bit about these patients. Who are these patients and how is this helping them? Is this a cure? Is this a long term therapy?

Yeah, so, and, and I'll give the disclaimer that I, while I may be a pharmacist, you know, I mentioned I don't really have practice either. I get to be the strategist and business lead. So I'm not the clinician or the scientist per se. But no, you know, in terms of these patients, the reason we picked this disease state is that oftentimes it is a genetic disease and many of these patients it's, it's a rare disease, it's an orphan disease. And I do also have to give the disclaimer that our product is still in early development. So we are non clinical and in fact we have our sight set on hopefully entering clinic, which we're very excited about, teeing up the discussions with the FDA that we plan to have in Q1 of. And so these patients that have genetic disorders do present with usually multiple different types of antibody deficiencies, usually in igg and iga. The issue with these patients is that with the plasma proteins, like for example, intravenous immunoglobulin that they receive, they're A very costly, B, there's a major shortage because, you know, there's oftentimes blood or plasma donation shortages and C, they're extremely expensive. I mean these patients insurance is like over a hundred thousand dollars for treatment. And so what we're hoping to do while these patients, you know, while we may not be able to get all of these patients off of intravenous immune globulin, we are trying to reduce the reliance and introduce an intervention that will help to treat the respiratory infections and recurring infections that these patients suffer from, which oftentimes land them in the hospital. And we already know about antibiotic overuse and in some cases they're viral. And unfortunately, you know, these patients don't have too many treatment options. And so there is a small cohort of an unmet medical need. And if we can bolster their immunity at the mucosal layer early, we would likely. We're seeking to try to stop and mitigate these recurring breakthrough infections that more than 70% of these patients suffer from. Notwithstanding, you know, the other negative health outcomes, the mortality rates, the deformity of their lung structure over time, just for having these types of deficiencies. You know, our focus area, our, our area of research and focus is really going to be on that. We're building a platform and we're looking to see ways in which we can use secretory IgA to build mucosal layers in all of your mucosal compartments. You know, your respiratory, your nasal, your lungs is one area, but so is your GI and your gut. And, and there's, you know, we've probably only hit the tip of the iceberg in terms of what secretory IGA does and regulating those levels in humans to the overall health of your, of your microbiome. And so we're just at the cusp of that type of research.

Hey there. Just a quick break. I wanted to let you know that if you're listening to this podcast because you are exploring careers in biotech, which it turns out, quite a few of our listeners actually are, you might be interested in the Biotech Career Coach podcast. It is brought to you by our sister company, the Collaboratory Career Hub, which is our career development community. If you would like actionable tips on job seeking and career development, that is the place for you. It is a companion podcast to our Career Coach column that we write monthly in biospace, but we go a little more in depth and sometimes we have special workshops and all of that good stuff. So if that sounds interesting, click the link in the show notes or search for the Biotech Career Coach on Apple Podcasts or wherever you get your podcasts back to the show.

I have a couple questions about sort of the organization of Lactigo right now. So you guys are relatively new. You started in 2020. Correct. How big is your company right now?

Oh, we're tiny.

Right.

Like any good shepherds of early stage biotech companies, we've purposely kept a small team. And what we've been very good at, and I'd say really punching well above our weight class, is that we've just been fortunate to be surrounded by amazing partners. And I'll give you an example. We have a bit of a hub and spoke model. You know, our headquarters being down here in New Jersey, you know, the pharma corridor, being at the Bioscience Center. Very exciting. We have, you know, a great study partnership with the Centers for Drug Innovation and Hackensack. We've gone global in the sense that we have study engagement with McMaster University in Toronto. Our research material, production of our therapeutics are our antibodies are done at the University of Georgia. We have a great collaboration with Mount Sinai University Hospital with one of the leading human milk immunologists that sits on our scientific advisory board. I mean, it goes on and on. And so, you know, a lot of this, to your point about operations, comes down to a very strong ethos of organization. And we've used a lot of great tools including Monday.com, hubSpot and others to keep us managed, keep us tracked. We've been the recipients of multiple grants and while that sounds great in the press, the reality is that the management of those grants takes an extraordinary amount of effort. To be on time with grants, not miss deadlines, stay within the confines of the grant and make sure that the grant doesn't shift the priorities of the company when you're taking both non dilutive and dilutive funding both at the same time, when you have a small complement of, of a team. And so we've brought on a project manager, you know, an executive assistant with management, and then of course myself and Viraj Monet, who's our chief scientist and the PhD innovation guy behind the scenes of the, of all of our work, we've had a great collaboration. I, I forgot with Virginia Commonwealth University. There's so many. But you know, one area where I get to be so proud of and blessed about is that this is the one time in my career it's like the confluence of all of my background and degrees. And so sometimes I have to wear the general counsel hat, sometimes I have to wear the FDA strategist hat, the CEO, obviously. And you get to wear many different hats, see the visibility and really be involved at the ground level to building it. It's like, you know, as a kid I used to love playing with Legos and I kind of see it as that where you have this kit and now you have to piece it together and put it and if you have the wrong piece, it's not going to work. And so you have to make sure you surround yourself and quickly with the right team, the right folks, without overextending yourself and staying within the budget you have. The operational side is a really important piece, especially for aspiring startup biotechs. We were not an academic spin out. We own all of our intellectual property in house and you know, we've been very good at that and that's. Oh, and I should mention, you know, in terms of partnerships, they're always talking about scientific partnerships. But early on we partnered with an amazing law firm we use, DLA Piper. They've been an excellent partner and we have an entirely robust set of patents that the company owns that helps us build our assets. So we don't look at them as vendors, we look at them as strategic business partners. And frankly, everyone's human and they're our champions. They want to see us succeed. I think personally they are Invested and they like what we do and we're fortunate to have them.

I'm so glad you mentioned all your partners and you brought that up because that's one of those things we think is so interesting when people are founding a biotech, especially if they're not a spin out. How do you grow this thing without spending so much money and if you don't have the capital. So can you talk to us about maybe how you found and how you built relationships with some of these partners and you know, if someone's listening to this and they're looking for some guidance on like well, how do I even go about doing that? What do you have for them?

Yeah, and actually there's a couple of key partners that are more like connectors that I forgot to mention. But it touches upon this. And so one of the things, and I call it, you know, get your head out of the lab, right. You, we get so consumed by being on the scientific discovery site and you have to be right. That's what's driving the value. But sometimes you gotta take a pause and work on your company, not in your company. And so, you know, we've taken days out where we're just going on the Internet and looking for the right people, the right, you know, strategic partners, seeing who the leading experts are based on published literature review. And I got to tell you, you're burning the midnight oil on this one. You're really staying up late doing your research, making cold calls and phone calls and emails. That's how we actually found some of our partners. I think my partner Viraj has been very resourceful also in getting connected with incubators that have been great. So you kind of start small and build those champions. So you know the innovation factory in Ontario, the New Jersey Commission on Science and Innovation here, the New Jersey Economic Development Program and Bio and J, it's a trade organization, you know, that has had, you know, a little bit more cost effective membership but wow. Their staff has gone above and beyond helping us looking at, you know, tapping into local resources. You know, I happen to have connections on the academic side, you know, wearing the hat between government, academics and private sector. You know, I've given internship opportunities to law students, being a law professor along with, you know, some other pharmacy and undergraduate students. So you know, we reached out to Rutgers and was able to create a small program with their business school to help us do some business assessments. So wherever you can tap into getting free resources where you're giving back to them for a experiential opportunity and they're helping to create, you know, deliverables that can be meaningful. Again. It's not necessarily easy to manage, but there are so many resources out there. A lot of it is just being prudent in your time and knowing which early on which ones are really going to help you and which ones may not be, you know, worth too much time to pursue. So it's, it's not easy. Some of it's just a gut judgment call.

Do we want to talk a little about your licensing company? I think that's really fascinating too.

I'd love to. So this is one that I'm very excited about. So, you know, I mentioned that I wore the hat of the deputy director, senior deputy director and chief health enforcer officer in D.C. and when a doctor finishes medical school, they apply to get their medical license so that they can practice a nurse, pharmacist, I got to sign them and then I also got to enforce and revoke many of them. What I noticed during my time, during that time when I regulated hospitals, food facilities, pharmacies, doctors, nurses, pharmacists, social workers, you name it, over 13 different health occupational boards, like the Board of Medicine, Board of Nursing, I noticed that our systems are a bit broken from an IT operational. And I mentioned as a law professor, you have something, you know, in the Constitution, the 10th Amendment, which gives the police power to the states. And so every state regulates their own healthcare cohort, cadre of health professionals. So if you're in New York, you have to have a New York medical license. You move to New Jersey, you have to have a New Jersey medical license. You know, you can't just practice because you have a New York license. It doesn't work like that. And for good reason, given that, you know, we do live in a republic and we respect state rights. That being said, sharing of information on the operational IT side has been a bottleneck of growth for many companies that want to practice telemedicine, get credentialed and expand access to strong quality medical care. And so I started Licentium as a way to break down those barriers for doctors and nurses and others to cross state lines to practice quickly, more than just travel nurses, but really focused on the telehealth market. And now the business has grown to be more of a SaaS platform that helps providers and healthcare companies manage a lot of their backend administrative processes that are related to regulatory compliance. And so I've been fortunate to build an entire career in regulatory law. And to that I've been able to complement that with building a SaaS technology platform focused on regulatory compliance in healthcare regulation. And so oftentimes we don't. It's, it's an overlooked, you know, evil where nobody wants to talk about compliance. It's boring. It's, you know, what is it? Is it hipaa, is it this, it's that. And yes, but it's a necessary evil and for good reasons. And these laws are in place. And so this tool allows for doctors and nurses, especially those that have multiple licenses, to manage their licenses and get, have accelerated credentialing for healthcare systems to have visibility into their entire, what we call the provider network. So if you're a healthcare system and you have three doctors or 300, the technology builds out your provider network and you can track the expiration dates of every license, the renewals, the continuing education, OIG compliance, like you name it, the entire kit that you would need to manage that. And so it's what I call HR plus, you know, it, it picks up when hiring leaves off.

Coming from California, I had no idea that any of this was a problem because California is huge. And you don't really think about people needing different licenses to practice in different states because California is just massive. And then I moved to New England and going to even, I mean I live in New Hampshire, which is pretty small and I lived on the border of Massachusetts for quite a while. I had no idea the regulatory hurdles of practicing or even visiting a doctor in different states. Your records don't translate. There's all kinds of things. Looking at our biotechs, we also are hiring clinical professionals for biotechs and we're hiring MDs that work in the regulatory space. We're hiring nurses that work in various spaces and it is challenging to relocate them because the licensure doesn't translate. Is that something you could see yourself helping biotechs with also? Is it just hospitals?

Exactly, no. So our platform is agnostic to the industry and I'm glad you brought it up. But yes, you know that, that part of knocking down those barriers. So one of my co founders ran clinical trials at MD Anderson and, and at a pharmaceutical company as well. And that's where the direction we're headed. So we work with breaking down those barriers and it's actually more than just the licensure. We can help the biotechs manage their entire provider network to make sure they're in compliance. Because imagine if you accidentally hired a, a nurse, even if they're a contractor, but they might have been disbarred, had a criminal record, you know, and you might have checked it then, but is it ongoing compliance checks? Are they excluded from oig? You can technically threaten your entire clinical study. And I've seen that come up, you know, in small cases. But why be that one company that just blew millions of dollars because they didn't properly vet their provider staff. So. Yeah, yes, absolutely. And I'll just mention for biotech, because I've worked at established companies that run into the same, obviously same problem anytime. It' it's on two fronts. It's on clinical studies and managing your provider network, your PIs and coordinating those efforts and anyone that touches the patients of your clinical study to protect that, it's also then on go to market launch as well. So when you're talking about commercialization efforts, you're also talking about medaffairs. I ran medaffairs groups, safety groups, obviously regulatory and legal. And from a legal perspective, you also have to vet your medical affairs staff that are out there pitching. You got, you want to make sure they're not part of some OIG exclusion list, that they're not debarred by fa, fda, that they're in compliance, that there isn't any negative action against their medical license. And notwithstanding compliance, you know, some of these things can end up becoming reputational risks as well.

Right.

So again, you can have your general counsel's office or other teams, compliance teams, you know, focused on that. But do you, you know, our technology helps to create like a, a repository and streamlining those check efforts so that, you know, you don't have to kind of worry about those. So even for established biotechs or those that are thinking about clinical or go to market, this is a product that helps to, you know, manage all of that.

Sounds very valuable. So what is some great advice that you would give somebody just setting out on this journey of founding a company?

There are times that are just so rewarding and that there are times that are just like the bottom of the bottom.

Right.

And it's, it's what I like. I tell my kids, you know, life much like the plight of a biotech company, it's, it's a marathon, you know, and you'll have sprints along the way and there's going to be ups and downs, but you got to persevere and then, you know, rely on the data. You know, if the data doesn't speak, then pivot. And if the data speaks, then go with it and be ready to pivot. But be able to manage your budget appropriately in order to make sure that you're a good shepherd of the funds that you raise. Um, and that's, you know, money begets money, success begets success, and you have to continue to grind. And the only other piece from a technical perspective I'll mention get a great tool to manage investor calls is so, you know, every day I want to go in and focus on the science and every day I get pulled into something non scientific, whether it's raising money, capital, investor calls, pitches. Don't be discouraged if people don't know what you're saying and don't believe in you. You know, you know your story. They take maybe 30 seconds to evaluate you and then 30 minutes to listen to you. It's not enough time to convey very heavy scientific information. So for at least for my, my friends in the early stage biotech, don't be discouraged, keep doing what you're doing and know that at the end of the day you'll be able to contribute to some innovation that's going to change some patient's life. And that's what helps to drive us every day. We know the patient population and we know what we're doing is going to be a meaningful change in the way they live. And let that be your guiding light.

Following up on that, what about regulatory advice for someone who's really launching a biotech? Have you seen pitfalls that if you had been able to step in and be like, oh, don't do that. What would you tell people to be on the lookout for in the very early days?

That's a great question and kind of hard to answer, but I will tell you in my practice, you know, I guess I'm fortunate to be an FDA law expert, regulatory expert, but my peers are not. And I make everyone take an intro to fda. There's a lot of free resources out there. You have to take some kind of basic classes. Look at the Food and Drug Law Institute. Fidly puts out some great programs, raps. Raps. Regulatory affairs professionals like, you know, regulatory is not just a siloed discipline. Regulatory touches every discipline. And that is key. If you're in safety, if you're in med affairs, if you're in clinical, if you're a lawyer, if you're in finance or business, I can assure you the FDA touches every single one of your disciplines. You have to know how they work. And I'm not asking for every one of them to become experts, but they should understand at a high level how the FDA regulates and regulates their particular discipline. It's critical to the success. And so I would say One of the major pitfalls is not understanding how the FDA works and then not discussing your program with the FDA early enough. Like sometimes, yes, companies are too early, but after you've spent a bunch of money doing some efficacy studies or whatever, understand what kind of meetings the FDA allows for companies. They want to encourage innovation. They're obviously extremely busy people. But if you have something novel, believe me, they're just as excited and nerdy to listen to it as you are. But they're trying to evaluate everything, right? They're getting meetings. That's the other thing is when you go to the fda, don't be just obsessed on your program. The FDA is not going to be as obsessed about your program as you are about your program. So don't go in with the understanding that they have the same level of understanding either.

Right.

Be ready to articulate your message in a way that you can help bring a learned expert to up to speed in a quick, short amount of time. So you have to be very thorough to document everything that you do. Have a, have a good writing team. You know, I know that can be expensive, but as you're starting to prepare, get generating more and more data, even if it's pilot data, start to summarize that and then have a great repository of being able to organize that into a system. Because I can't tell you how many, how much time people lose because they are looking for files or can't find, you know, X, Y and Z or they, they forgot to get the study report from the vendor that they use. So have all of that teed up. And then early on, understand you don't have to spend hundreds of thousands of dollars in an FDA consultant. Go read the guidance documents. There's a couple key guidance documents that talk to you about how to interact with the fda. Learn it yourself. You don't have to be an expert. They don't always expect you to be a regulatory expert. And that's one way you can not only save money, but there's not going to, there's no one going to be a better shepherd and steward of your program than you. And so if you're the CEO or chief scientist, roll up your sleeves and read those guidance documents.

And if you do end up hiring somebody down the road, either a consultant or a full time person, you're going to be such a better manager of that individual or that firm because you're going to understand what you're doing and what you're asking for and what they're giving back to you. I think That's a big mistake too that early founders make is they maybe want to get something off their plate that they just really don't enjoy, but then they don't know how to know if the quality is there and they're getting what they need.

Yeah, that is tricky.

Right.

And that does take a lot of conversations. I mean, we've been fortunate to have, you know, the five minute bullshit meter.

Right.

We interview consultants all the time and off the bat we know whether they know what they're doing or don't know what they're doing. And maybe one of the ways we've been fortunate to be more effective and punch above our weight class. But, but there's areas that we don't know about.

Right.

When you're interviewing consultants and contractors, that can be tough because they, they obviously command a very high, you know, billable rate and, you know, fundraising is tough. I mean, last year was one of the worst IPOs for biotech industry. So, you know, I think 2024 is starting to look better, but it is becoming a tough market, tough climate and you have to be better stewards of your, of your money and your finances. For sure.

Absolutely. I'm just looking forward to 2024. It has to be better. Right?

That's what they're saying. I was at a pre IPO conference the other day and some of the folks from NASDAQ, Goldman Sachs were saying that, you know, Q2, Q3 is starting to look a lot better. I mean, if the interest rates flatline, as long as they don't go up, they can come down a little again. I think we're going to see some more activity before the election and then things are going to chill again. My, my guess, my guess.

Yeah.

Disclaimer that this is not financial advice, but my musings. I think Q2, Q3 might be a good time for early stage biotech.

Yeah, we asked for the musings because we're always interested and you know, we've got lots of, lots of opinions on here and we'll see. Well, maybe we'll take a pool and whoever wins gets, I don't know, a hat.

I've said it before and I'll say it again, only good vibes on the show. We're only sending out all the good vibes.

Yeah.

So what is next for you? What are you thinking is next in your career?

Well, I'm very excited about the future of Lactiga and Licentium. Licentium's already on the market. You know, it's a revenue profit generating company, working with clients. Lactiga's early stage. You know, we're looking to get into clinical studies next year. I'm really excited about the journey of both and I do agree, positive vibes only. I really do believe that 2024 is going to be a great year for a lot of companies, for America in general, Americans and really excited about that. So for me in my career, I'm staying the course. I'm excited to see my kids getting bigger. It's nice to be at home with them and it's nice to see the companies grow. So for at least the immediate future, we're really. What I keep everyone abreast of is the unique partnerships. We have some really exciting things coming down the pike, so definitely follow along. Both on lectiga.com and licentium. Com. You know, there's some really exciting things coming up for us in 2024.

We'll link those into the show notes so everyone can go to those websites and also your LinkedIn profile if you don't mind. I'm sure people would love to connect with you and stay in touch.

Well, time for my favorite question. What is your favorite book of all time that you think everybody should read?

Gosh, that one always stumps me. Tale of Two Cities, I think, always resonated with me. Probably the, you know, the books of choice that talk about struggle, plight and success for those that have that sort of innovative, entrepreneurial, bootstrapping grit, those are the types of book that really resonate with me.

That is awesome. Well, thank you so much for taking the time to come chat with us. This has been fantastic and I have learned so much. I feel like I only scratched the surface of all of the questions I want to ask you. So we'll have to do round two.

Yeah, yeah, my pleasure.

I appreciate being on with both of you. Thank you.

Building Biotechs is brought to you by Recruitomics Consulting. You can find Building Biotechs in Apple Podcasts, Spotify, Google Podcasts, or anywhere else podcasts are found. Make sure to click subscribe so you don't miss any future episodes and join our mailing list for a weekly dose of biotech news and a podcast overview. And if you need to install a recruitment engine that saves time and money for your growing company, reach out for a free strategy session. I'm always happy to share my expertise and show you techniques to simplify your hiring process and maximize returns. On behalf of the team here at Recruitomics Consulting, thanks for listening.