Transforming Neuropsychiatric Therapeutics with Dr. Sam Clark, CEO of Terran Biosciences

This episode of the From Lab to Launch podcast, brought to you by Qualio, features Dr. Sam Clark, CEO of Terran Biosciences. With a background in neurosciences from MIT and an MD and PhD from Columbia University, Dr. Clark shares his journey from academia to leading a pioneering company in neuropsychiatric therapeutics. He discusses the challenges and innovations in the development and supply of GMP psychedelic compounds, highlighting how these substances are making significant strides toward transforming mental health treatment.

Dr. Clark also explores Terran Biosciences' approach to overcoming drug development hurdles, emphasizing quality management and patent strategies to ensure the delivery of affordable, effective treatments. His insights offer a glimpse into the future of psychedelics in mainstream medicine and the broader implications for treating various disorders beyond mental health.

https://terranbiosciences.com/ 

Dr. Sam Clark's LinkedIn: https://www.linkedin.com/in/sam-clark-md-phd-133139199/ 

00:00 Welcome to From Lab to Launch!
00:40 Introducing Dr. Sam Clark and Terran Biosciences
01:23 Dr. Clark's Journey: From Academia to Neuropsychiatric Therapeutics
02:48 The Renaissance of Psychedelic Therapeutics
04:36 Challenges and Innovations in Drug Development
08:36 Quality Management at Terran Biosciences
10:23 The Future of Psychedelics in Mainstream Medicine
12:46 Expanding Beyond Neuropsychiatry: Terran's Broader Impact
14:02 Navigating Innovation and Ethics in Patenting
17:48 Advice for Aspiring Scientists and Innovators
20:42 Dr. Clark's Personal Inspirations and Closing Thoughts
22:21 How to Follow Dr. Clark and Terran Biosciences
23:00 Wrapping Up and How to Engage with From Lab to Launch

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Music by keldez

Transcript

0:01

Hi there! Welcome to the From Lab to Launch podcast by Qualio, where we share inspiring stories from the people on the front lines of life sciences. Tune in and leave inspired to bring your life saving products to the world.

Meg Sinclair: 0:17

Hi everyone. And thank you for tuning in to from lab to launch podcast brought to you by Qualio. I'm Meg, your host, and I'm delighted to be here with you today. Before we dive into today's episode, we'd love it. If you could take a moment to rate and share the podcast with your circle of science enthusiasts. And if you're interested in being a guest on the show, please check out the application in the show notes today. We're excited to welcome Dr. Sam Clark, CEO of Terran Biosciences, an innovator of over 200 patent applications. an MD and a PhD from Columbia University and a bachelor's degree in neurosciences from MIT. Terran Biosciences is at the forefront of revolutionizing therapeutics, emphasizing the development and supply of GMP psychedelic compounds to researchers around the globe. Dr. Clark's mission to transform the landscape of mental health treatment, making significant strides toward better care and innovative solutions. You can learn more about Dr. Clark and Terran in the show notes. Let's welcome him in and let's get to it. Welcome to the show, Dr. Clark.

Sam Clark: 1:20

Oh, thank you. Great to be on.

Meg Sinclair: 1:23

I'm really interested to hear about your journey from the world of academia to the world of neuropsychiatric therapeutics and tarot, tarot biosciences. Can you share a little bit about your journey?

Sam Clark: 1:34

Sure. So this all goes back to when I was younger growing up, there were a number of people both in my immediate family and friends who suffered from severe mental illnesses. And also then in my family, there's also a severe dementias. I really wanted to understand how the brain worked and to develop new treatments for those mental illnesses. So I went into neuroscience when I went to MIT, and then I went and did my MD and my PhD at Columbia. But it was really during that time that I found out that the treatments that we have available are just Effective. And there haven't been a lot of new mechanisms really since the 19, you know, the last night, the 1960s through the 1980s, you know, the new drugs are largely just kind of, uh, smaller improvements on existing mechanisms. And so I founded Terran Biosciences with the goal of building a platform company that could make new transformational treatments for patients with neuropsychiatric conditions. Okay.

Meg Sinclair: 2:41

I'm sorry to hear that your loved ones have been affected by those mental health conditions, but glad that it's inspired you on this path. Um, and in recent years, there's really been a renaissance of sorts in the psychedelics, um, for therapeutic purposes. From your perspective, what has led to these new treatments, investments, and momentum to consider psychedelic compounds in treating mental health disorders?

Sam Clark: 3:03

So I think the, it's just a, um, large amount of new data that's really led to this, uh, renaissance. And the thing is that in the past. You know, think about it in the 1980s, uh, MDMA was already being used for psychedelic assisted psychotherapy for post traumatic stress disorder. And now, you know, fast forward, you know, another, um, 40 years is when it's finally up for FDA approval this year. The problem was there was a large, um, crackdown. on all psychedelics where they were labeled as having no medical use and due to that scheduling in the United States as schedule one, it was very hard for researchers to get access to do research on them. And so the research was dramatically slowed down. So it wasn't that psychedelics were, are any more effective now than they've ever been. It's that due to barriers to research that have only recently been relaxed, uh, it's taken a long time for that data to come of how effective they are to come to light. But now that that has come to light, you know, we have multiple psychedelics with breakthrough therapy, you know, psilocybin and LSD both have, um, you know, the breakthrough designation, FDA and MDMA, uh, is, uh, already been submitted for clearance.

Meg Sinclair: 4:23

It's amazing that it can take 40 years when it's going slow, but 40 Months when it's going when you know, those barriers are lifted. It's it's a much different story.

Sam Clark: 4:35

Yes

Meg Sinclair: 4:36

So thinking about navigating the field of neuropsychiatry and it has its unique set of challenges, especially when introducing novel therapeutics What do you see is the biggest hurdle in bringing new treatments from research to reality? And how is Terran addressing this?

Sam Clark: 4:51

So one major hurdle is that a large number of new compounds don't make it through what's called phase one initial human testing. So when you develop a new compound, you have to then show it safe in animals, and then you have to show it safe in humans. Most are found to have some sort of toxic effect before they get to humans. And then from that, the bulk don't make it through. the first phase one trial. So it's actually quite hard to bring molecules that may initially show some sort of antidepressant effect in an early animal model, actually get that to humans and actually be safe and effective. And then finally, you have to remember that even if that molecule may seem to be effective, it has to be a developable molecule. Drug. And what that means is it has to be able to be manufactured at scale, where you can distribute this worldwide to everyone who needs it. Many molecules may appear promising research, but they're unstable. They can't be stabilized. They can't be turned into a pill. You know, things like that can, in addition to safety issues, can, can Eliminate the bulk of drugs, and that makes drug development very, very risky. So what Terran does is we actually have a dual approach here. And what we do is, um, our goal is to do two things. One, bring transformational treatments to patients. And two, to make, to bring affordable, they have to be affordable medications as well. And so what we're doing is leveraging the FDA's 505B2 pathway. And what that enables you to do is, take existing data sets from phase three trials that have already been done that show drugs like psilocybin, MDMA are effective, and after the first drug gets approved, five years later, you can bring your own drug to market, not have to repeat those trials, and get that on the market where it brings costs down for patients. So that's the cost saving part. Then the Addressing that first part, you know, what about, how do we, you know, what about all these drugs that are unsafe, unstable, the way we do that is we target existing drugs and then we improve them for patients. For example, MDMA is a drug that often has to be redosed in the middle of therapy because it's so short acting. So Terran developed what's called a pro drug. And what that is, is you take the original molecule, you attach a little side chain to it. That side chain falls off in the body. and releases just a normal MDMA, but it improves the pharmacokinetic significantly. And that's also eligible for the 505B2 path usually. And so what that means is we've created the world's first long acting MDMA with a prodrug where it can go Theoretically, the whole therapy session without having that redose, we've done similar work with psilocybin. We've improved DMT, making the world's first truly orally active drug that can be ingested pill format and, uh, is orally active. Same with five with oxy DMT, two drugs that previously had to only be smoked or injected or use other methods of administration that Couldn't be placed in a swallowable pill. So it's by leveraging these innovations that we bring improved versions to market for patients, but also leverage the 505b2 path so that we don't have to repeat trials that have already been done, accelerating development and bringing cheap, affordable meds to patients. I

Meg Sinclair: 8:15

think that's an important concept too, and the drug development is making sure you can actually get in the hands of patients who can use them and afford to use them and take them when they need them. So that's a great approach. Um, I love that you were speaking about safety and effectiveness. We're curious about your approach to quality management since we provide an EQMS at Qualio. Given how important it is to maintain the purity and consistency of the psychedelic compounds for research and therapy, we'd Could you share about your quality culture at Terran Biosciences? We'd love to hear about practices you've adopted to ensure top notch standards.

Sam Clark: 8:50

Oh, absolutely. And quality is actually something Terran takes very seriously. And it's one of those things that, you know, people don't talk about as much, as you might be aware. You know, when I first founded Terran, I didn't know much about, you know, quality management and, you know, what, what that role was. But the thing is that, yeah, so we have a robust, um, QMS system at Terran and, uh, SOPs that we follow. And what we do whenever we do manufacturing or clinical trials, we, in addition to when you're working with a manufacturing group, you know, they'll have their own internal quality system, but then Terran has a second level on top of that. We have our quality system. So any of these APIs, the active pharmaceutical ingredients that we are manufacturing. Have to both pass the vendor's QMS, and then it has to pass Terran's quality. And we have a team every time we do, uh, for example, a GMP manufacturing, there's always a team of at least three on there. There's the process chemist to oversee the project. There's the analytical chemist. And then there's the quality control chemist who has to manage all those batch records and make sure everything is, is meeting both the SOPs and meeting the quality that, uh, you know, we, uh, need for, uh, to uphold the highest standards for FDAs, uh, and EMA, um, approvals.

Meg Sinclair: 10:07

As a quality professional, that's music to my ears to hear that you guys got a robust quality system and, um, and also bringing that high level of product and low cost. I think that's a great value to patients out there looking towards the future. How do you envision the role of psychedelics evolving into mainstream medicine?

Sam Clark: 10:28

So I think we are going to see them in essentially two batches. And. The first is these classic psychedelics where the, they come with a hallucinatory trip. Now that can be very effective for certain disorders like post traumatic stress disorder. It's under review right now with MDMA, which is based on life trauma that needs that therapy to get better. But there is a downside to potentially to the trip. That may slow a widespread rollout for other psychedelics like psilocybin or LSD, and that is that for treating disorders like anxiety or major depressive disorder, we know already in the literature, those Can respond to drugs alone without the therapy component, but the trip being so long six hours for psilocybin up to 12 for LSD poses a potential Barrier to a patient adoption because of the cost and time required not everyone has time for the trip Not everyone has the cost to pay doctor. The doctor has to be there the whole time and so One thing at Terran, so in addition, we do manufacture the classic psychedelics for 505b2 pathway, so we get them on the market, cheap and affordable, for DMT, LSD, MDMA, and psilocybin, all the major psychedelics. But then, as the second wave, Terran has found that you can combine a psychedelic, With a selective recept, serotonin receptor blocker that removes the trip and we're developing what we hope to be ultimately a take home medication for disorders like depression, anxiety that have the same, uh, therapeutic benefit of the psychedelic without the trip. And we just showed the first human data that the mechanism of which psychedelics can rewire the brain is fully intact, even in the absence of any trip. That was, um, inventions then that we licensed from major, uh, universities and we're very excited to develop that forward to improve patient access to having the potential power of psychedelics without having to have the, uh, time commitment, uh, and, um, all of the effects of the trip. that can limit access for some patients.

Meg Sinclair: 12:46

Are there any specific areas or disorders beyond neuropsychiatric disorders that you see where you could have impact?

Sam Clark: 12:53

Yeah. STerranyn has, um, Terran's development programs have been very active in the metabolic, uh, space for diabetes and for obesity. And Terran has been working on a number of, uh, different peptides in the space, uh, for the treatment of obesity and as well as different metabolic disorders. And so Terran not only has a, you know, we don't just do psychedelics and traditional neuroscience, but we have a very robust medicinal chemistry team designing these new molecules and improvements. And so Those improvements that we're able to make are not just limited to neuropsychiatry, but also to, um, other, we were able to bring them and bridge into other areas where it can benefit patients as well. We're very excited to be expanding into those areas now.

Meg Sinclair: 13:38

That's very exciting to me, increasing patient access and increasing the amount of disorders and. Um, neuropsychiatry and all of that that you can treat. That's really amazing. Um, we spoke to it earlier in your intro. You have over 200 patent applications under your belt and you're a leading figure in the property protection of IP and neuroscience. How do you balance the need for innovation with the ethical considerations of patenting in the field of medicine and therapeutics?

Sam Clark: 14:08

Oh, absolutely. So it comes, I think when we think about ethical considerations and patents, that comes down to two things. One, every major innovation, new drug launched, you know, usually there's some patent protection that is put in place to reward the developers and incentivize innovation. Uh, innovation without any patents in the space. I don't think we would have any new drugs developed. And we, for example, just, uh, everyone has a smartphone, the technology in the different smartphones are protected by a number of patents. So patents is something that is essential for the development across the landscape. Now here's where it can get tricky. Is that some groups use patents, um, or a little less ethical patent practices to dramatically extend protection on drugs far longer than they were, uh, intended to do through creation of what's called patent thickets and also the 30 month stay, uh, of 505 B2 applications. And what that means is let's say you have a drug that's off patent. In which case, the FDA gives you your five years of exclusivity to your data. But after that five years, it's a company like Terran to come in, reference that data, and get a cheaper, more affordable drug on the market for patients. And that's what we intend to do using 505B2 for many pathways. But what, there's a loophole that's been exploited. And that loophole is called the 30 month cycle. Stay in the orange book. And what that means is if a company has even a single patent on that drug and there's a question of whether, you know, somebody else is potentially infringing at all on that patent, they can file a lawsuit and get a 30 month stay that stops the generic drug from getting in until the courts decide. And the loophole is that many companies have been accused of potentially filing those stays when they know no one is infringing the patent in the first place. So, Terran has proactively anticipated that because of the many, you know, uh, big biotechs don't like it for when other groups bring generics on, although we love it because it's good for patients, that we have proactively filed lots of different salt and polymorph patents. That means that to ensure, as there are patents on the forms of the drug that are developable, to ensure that no one can get those secondary patents and use them to block us from bringing the, what is essentially, generic Or, uh, you know, 505 B2 drug to the market in five years, because if we own the patent, they can't use it in the orange book to block us for another five years, you know, 30 more months. So six years. So, so the idea is that, um, you know, there's a, we're taking these proactive approaches to not only lock down the main IP, but also additional IP. that people could have otherwise used to try to get those extensions of 30 months would not be possible now with the strategies we've taken.

Meg Sinclair: 17:14

Love that proactive approach. That's really smart. Congratulations on all those patents, too. That's no small feat, filing 200.

Sam Clark: 17:23

Thank you. Well, they're not all granted yet, but we have filed them. And part of the benefit of filing is, you know, that, you know, you can, you get your ideas out there. And even if they're not fully, finally granted at the end of the day, no one else can use that idea to block you and block the 505B2 path.

Meg Sinclair: 17:42

Yeah, that's some great defense or offensive defense almost. So I love that. Finally for our aspiring scientists and innovators listening to this podcast, I'm sure they've got lots of ideas now listening to all of your different approaches you've taken by quality and patents. What advice would you give those looking neuropsychiatric treatment?

Sam Clark: 18:09

Okay. So. Um, for people, um, so it depends, you know, in the science field in academia, I would say just, you know, keep pushing forward your inventions and, um, work with your university tech transfer offices to patent them. Because sometimes, uh, what we found in the academic field is academics, they don't have the education usually on IP and patents. So it's okay. Well, if I have a great invention, I'll just publish it. But often if an invention is just. Publish in the public domain. It loses that ability to get funding for development. We like it when people patent their inventions so that we can come and license them and then everyone gets rewarded. The academic who invented it gets Royalties, the university that, you know, set up that whole system to make that invention also gets milestones and royalties. And so everybody benefit and the patient benefits because now it's patented and it can get the money required for development. So in that sense, I would absolutely encourage people to be working with their university tech transfer offices whenever they think they have a potentially patentable invention. That's the first. And then, um, you know, in. In the biotech field for people that are founding companies, you know, pushing things forward. I would give the advice, you know, stay very hands on in development. You know, there's, we've seen many companies fail due to, um, a little bit of a disconnect between management. And the team's running the science and at Terran, we run a very lean team, uh, of highly trained operators that manage these teams of consultants. And I stay very involved in all aspects of manufacturing science clinical, which we found is important to make sure you're really in the weeds and you're not becoming distant where there might be a disconnect or miscommunication that leads to problems down the line. And then the last piece of advice I'll give it on that is just, you have to be outcome driven. independent in your own internal mental state. If you think about all the things that, uh, all the stress that, you know, that people can think over the years, none of that changes the outcome. So you really have to be outcome independent as you approach these things in a logical manner. And, uh, that's what you need to really maintain, uh, the focus to get these drugs developed for the long haul, which is really, it's a marathon, not a sprint.

Meg Sinclair: 20:30

Yeah, that seems to be the theme of the, the question I ask around here is stick with it and resilience and, and all of that. It's a, I like that. It's a marathon, not a sprint. It's a good way to put it. Um, our last question to close us out today is more of a fun one. We like to ask each of our guests. If we ran into you at a bookstore or your local library, in which section would we find you?

Sam Clark: 20:53

You know, I really like biographies and learning about what other innovators have done, what other companies have done, what's worked, what hasn't is you get an opportunity to learn from some of the greatest minds in the world and just, and the past of, you know, what are some of the things people did that, you know, created the world that we live in today. And so learning about those things and even just, you know, um, uh, with modern companies, you know, um, Super pumped the battle for Uber, you know, learning about what happened there, you know, the everything store for learning about Amazon, you know, Steve jobs, Walter Isaacson biography, you know, there's so many good, you know, the innovators dilemma, you know, there's so many good, uh, books out there. And I just encourage people to read as much as you can. It's just really, uh, the best way of, um, Of doing is to learn from other people's mistakes as well. So it's not just about what worked. It's also largely about what didn't work because, you know, the mistakes we make or anyone makes, they're not really unique mistakes. There's mistakes somebody's made before. So if you can learn about it, you know, then you can hopefully not make the same mistake because you know, if you, there's only so much time in life, you know, we only have a, you know, a finite number of heartbeats. So at that point you want to learn it, absorb as much as you can.

Meg Sinclair: 22:08

Yeah, that's great advice for our, uh, future innovators and scientists out there to learn from others mistakes as they go forth and make their own and learn from them. Well, thanks so much, Dr. Clark, for joining us today. Where can those go who want to follow along with your journey and find you and connect?

Sam Clark: 22:25

Great. So we're on LinkedIn, Terran Biosciences, uh, as well as myself. Uh, we're also on, um, you know, Twitter, or I guess it's X now, uh, uh, Terran Biosciences, and I'm on at, uh, Neon Neurons.

Meg Sinclair: 22:40

Great. Well, I will be following along to see all the great work that you and Terran do. Thank you so much for joining us.

Sam Clark: 22:46

Thank you for having me. Really appreciate it.

22:49

Thank you for listening to this week's episode of From Lab to Launch, brought to you by Qualio. If you like what you've heard, please subscribe and give the show a positive review. It really helps us out. For more information about Qualio, our guest today, or to be a guest on a future episode, please refer to the show notes. Until next time.