Rapidly Discovering and Extracting Natural Pharmaceuticals

 


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Mental health issues have been on the minds of many as athletes are under tremendous pressure to perform perfectly at the Olympics, and Filament Health is on a mission to get safe, natural psychedelics into the hands of everyone who needs them as soon as possible. 

Today's guest is Ben Lightburn, CEO and Co-Founder of Filament Health, an exclusively natural psychedelic drug development company. Ben talks about rapidly discovering and extracting natural pharmaceuticals. 

Ben is an entrepreneur specializing in the research, development, and commercialization of novel extraction technologies. He applies his background in botanical extraction to this emerging class of medicines. 

Filament Health is building a platform to support the treatment of mental health conditions through GMP-compliant and FDA-approved psychedelic extracts from lab-grown and regeneratively harvested plants. 

Key Highlights:

  • Insights on building a core team comfortable with operating in a startup environment
  • Approach to patenting and clinical trial process, as well as regulations for psychedelics
  • Common misconceptions about natural pharmaceuticals

Show Notes: 

Filament Health

Filament Health - About Us

Filament Health - Our Technology

Good Manufacturing Practice (GMP)

U.S. Food and Drug Administration (FDA)

FDA - Breakthrough Therapy

U.S. Drug Enforcement Administration (DEA)

Health Canada

Mazza Innovation

Application to be on the show: From Lab to Launch

Qualio

Music by keldez 

Transcript

We seek to transcribe the audio as accurately as possible. Please excuse any minor grammatical or misspellings. 

Grant: Hi, everyone. Welcome to today's show, From Lab to Launch. The podcast has been on a bit of a holiday during the summer months, but we're excited to be back at it again. Today, we're talking to Ben Lightburn, CEO and co-founder of Filament Health, an exclusively natural psychedelic drug development company. Filament's mission is to get safe, natural psychedelics in the hands of everyone who needs them as soon as possible. Their approach is what was so unique about them. 

This interview is very interesting on many fronts. They're focused on novel extraction technologies, purification technologies, and standardization technologies that are GMP-compliant and FDA-approved. That's a tall order when you think about natural extractions, but they seem to be doing it. 

Ben shares his insight about building a core team that's comfortable operating in a startup environment. He shares Filament's approach to patenting and clinical trial process, as well as the regulation landscape for psychedelics. He takes head-on common misconceptions about natural pharmaceuticals. Yes, I used the words natural and pharmaceuticals in the same sentence there.

Overall, a lot of great takeaways and wisdom from our friend, Ben, who's approaching something very unique in a very unique industry at Filament Health. Let's get to it.

Ben, to help us better understand Filament Health and where you're coming from, just tell us a little bit more about your company mission and your product.

Ben: Thanks for the warm intro. Filament Health is an exclusively natural psychedelics company. We probably were seen a lot in the news about the resurgence and the renaissance of the psychedelics industry, but what struck me and some of my former colleagues from previous companies is that there didn't really seem to be many companies focused exclusively on naturally-extracted psychedelic substances.

It's important to remember that these psychedelic compounds that we hear about—psilocybin, LSD—all were once natural compounds. They were found in nature. Over time, it's become common practice to synthesize these compounds—we recreate them in a lab, a synthetic process—but we believe very strongly that it's important that there be a natural option because after all, people prefer natural products wherever they can get them. There are not too many people that prefer synthetic caffeine to a cup of coffee. It's a really simple analogy.

What we did is we started a company. Our mission, as you said, is to bring safe, standardized FDA-approved, naturally-extracted psychedelic compounds to the market. We don't know yet what form exactly that the market will take. Likely, there will be a pharmaceutical component, but we're also seeing in various states that state-regulated markets will also be opening up. 

I think Pennsylvania just announced a bill or a ballot measure just the other day similar to cannabis where you might have some kind of state-level, regulated market in the absence of some federal approval. We think naturals have many advantages over synthetics, not least of which as I mentioned is the consumer preference for natural, but also because when you make a natural extract, you extract more than just the primary compounds.

The example for magic mushrooms is when you make a magic mushroom extract, you extract more than just the psilocybin. You extract the several other compounds that are naturally present in the mushroom. It's possible that this natural combination of different compounds—after all did evolve in nature for some purpose probably—it's possible that therapeutically, these mixtures could be more beneficial than just the single-compound, synthesized product. 

That's the 30-second overview or the 3-minute, 30-second overview of Filament and what we're all about.

Grant: Very awesome. Tell me a little bit about how you got started in this field with natural extracts. You mentioned before we jumped on the call that your team had almost done the same thing before, where you built and sold a similar company. How did you get into this space and what led to the company mission?

Ben: It's a really good question. I often wonder why I found myself in this relatively esoteric and narrow field of botanical extraction. Even narrower than that, it's actually in the field of commercializing novel botanical extraction technologies.

I actually got into it just totally by coincidence. I was looking for a job as an undergrad, getting my physics degree at university. I was put in touch with someone that had a startup company which was commercializing a new kind of botanical extraction technology that was using microwaves to extract cancer drugs from different kinds of plant species. The rest was history.

I began working there after I graduated. I stayed in the field, I went back to school, I got a business degree, and then I joined another botanical extraction company. This was called Mazza Innovation. This was a company that had a technology to replace solvent extraction with just using water and getting the same or better results.

That company, we sold it in 2018. With some of the former colleagues that I had, we're really all looking for a new job because we didn't really enjoy working for the acquirer. That's where we spotted the opportunity in psychedelics, to bring all the experience that we had gained, making extracts for the cosmetics industry, the nutritional supplement industry, the food flavor, fragrance industry. Bringing all that experience to bear in the psychedelics industry and also realizing that there was an opportunity because there weren't very many other people looking at doing things that way for psychedelics.

Grant: Very interesting. With that core team that you had, another question that just came to mind is we talked about a lot of companies who were hiring and trying to build their core team as they're building their companies, and trying to launch their products to market. Getting that core team is so fundamental. Can you talk a little bit how you decided what type of talent you looked through to build that team? 

There are a lot of things you need across product development, across bioengineering. You need quality folks as well, finance. There's a ton of talent that needs to be filled in with somebody starting a life sciences company today. Walk me through how you built your team and how you think about that.

Ben: One of the main reasons for starting this company was to have an opportunity to work together with my colleagues from the former company, really, because at this former company, we built it from pre-pilot all the way to full commercialization, even selling the company.

At the time, I didn't realize probably well enough how special and how lucky we were to have such a good team with such good chemistry and such good capabilities. It was only after we sold the company and we found ourselves embraced in the grip of a completely foreign culture from a much bigger company that I saw our precious team, culture, and chemistry all disappearing. It was only then that I realized what we have lost.

A team is just by far the number one most important thing when you're building a company, any company especially in life sciences. As you said, you need experts in so many different fields. You need so many different people working together in concert with each other, that all respect each other, that know each other's strengths and weaknesses, know when to push buttons, and know when to back off. 

Now, having been able to recreate with four or five people from that company some of that magic that we previously had and get the old band back together again for an encore has just been a real pleasure, and it makes it much easier when you're expanding the team. If there's already a core culture and chemistry already established, it's easier to decide when you're adding pieces to the puzzle whether they will fit or not. It's much easier than when you're just establishing something out of the ether and you don't know what form it's going to take. You don't know what kind of culture there's going to be. We had the pleasure of being able to see it with an already half-formed culture.

Grant: That's really great. So much of the companies that you work with come from your personal network. Those are the kind of people you want to work with anyway.

From that lesson there, what advice would you give to somebody who is trying to build out their team or trying to establish that initial startup culture? That's so important in terms of recruiting other team members. Is there anything that you've done at Filament Health that has helped establish that culture that other entrepreneurs in the space could learn from or apply in their companies?

Ben: Team building in the startup environment is challenging. In an interview, you say, oh, are you used to wearing many hats? Are you used to a fast-paced work environment? Yes, for sure. Definitely I am, 100%. But then when it comes time to actually do those things, is the person actually that kind of person? 

Again, especially in life sciences, finding the right person who can be both your GMP compliance officer and also be comfortable working in a startup environment, knowing when corners can be cut and when they can't be cut, when we can bend down to the startup environment and when we can't, is very hard.

Advice I would give is to take chances on people. Basically, the main thing I do is I throw people headfirst into the fire. Give them a chance to sink or swim. Give them the support that they need. But you need to find out really quickly whether they are suitable for a startup environment. If they aren't, that's okay. Not everybody is. 

Most people aren't comfortable enough with the uncertainty that it brings. It's like, oh, well, my paycheck might not arrive. When do we get our benefits and all this? Questions like that quickly belie perhaps somebody that is better suited for a more structured work environment. But if you can find someone that thrives in that environment, you hold on to them for dear life. You find these people, you give them everything they need to succeed, then you get out of their way and let them shine.

Grant: I like that. I've heard other places and other books that are business material saying that it's okay to hire somebody, but then if you just know it's not going to work out, it's actually to the person's benefit to let them go early, too, if you give them a chance. But then after talking, a lot of people know I'm not good for this environment, you coming to them as a leader and saying, hey, listen, I'm not sure this is going to work out, let's talk about this, a lot of times, that can be very alleviating for people. So, kind of what you said there—throw them in, see if they're comfortable doing it, if they can do the work, and then from there making a decision that's mutual.

Ben: I agree 100%. Over time, I've learned that you should almost look forward to these kinds of tough HR conversations because 99.9% of the time, the other person agrees with you 100%. Like, look, it's not working out. I agree. Okay, great. We agree. Thank you for the three months that you've been here. It's been great getting to know you. I wish you all the best. We're going to recommend you for this and that and the other thing.

There's usually a sense of mutual relief and an understanding. Like I said, just dealing with that issue, getting them into an environment where they're more suited for, and then opening up that spot potentially for someone that can thrive in that spot, you got to treat it as a not as a celebration, but you don't want to treat it as a thing to be avoided. You want to try to address it head-on.

Grant: Wise words there. Looking at your team on your website, you have a very, very well-rounded team. The management team there, the advisors—there are a lot of people—board of directors. You've got a lot of great people on your team. It seems like you're doing a lot of things well there.

I don't want to go too much into that. I feel like we went into talent. This isn't a recruiting podcast, but there are a lot of good insights there and something that I wanted to double-click on.

Another interesting thing about your company is you have one of the first GMP facilities in the world. You also have a Health Canada Dealer's License. How did you go about that? It sounds like you're trying to bring a lot of things in-house, which is one approach of some of the people who will outsource it. Walk me through your thinking in doing that.

Ben: We knew that our strength would be in the manufacturing and in generating intellectual property on the technologies that we establish in order to do that manufacturing. To do that, you need to have the manufacturing in-house. You're not going to use a CMO and also have full control and know what's going on.

We also knew that from our previous expertise in getting facilities built, getting licensing, and getting manufacturing up and running that this would be a competitive advantage, so why not (as you said) double-click on that and press forward to our advantage?

Now, here we are today. As you said, we're one of the only companies—maybe only a handful in the world—that can make GMP-grade psychedelic substances, natural or synthetic. Because they're controlled substances, you need a special license from the DEA in the United States and from Health Canada in Canada, which allows us to manufacture these controlled substances. Having that plus the GMP capabilities to get them into human clinical trials sets us apart.

How did we get to this point relatively quickly? Again, with our experience in getting these kinds of facilities up and running. I've probably, at this point, not single handedly but have been involved in the construction of two, three, or maybe four botanical extraction facilities. We know what to look for. We know what kinds of pitfalls to avoid. We know how to communicate with regulatory authorities because we've done it before. I would just chalk it up to our experience, having done the same thing previously.

Grant: Got it. Another thing that I've seen on your website is your patent family and your process there. You mentioned there that you can get a lot of these things into human clinical trials relatively easily compared to other companies out there.

Tell us more about how you went through that process. Your patent family and your clinical trial process. If somebody wanted to do that themselves like you're doing, what are some things they should look out for? What are some things that you would tell them?

Ben: One of the realizations that surprised us as we've commercialized a lot of plant extracts before is when you go to make green tea extract, you search in the literature about green tea extract. There are thousands of papers, journals, and things that tell you everything you need to know. For natural psychedelics, that's not the case. There is a real lack of literature out there, so that surprised us. Also, what surprised us is that a lot of the things we are discovering in the lab was actually counter to what a lot of the published literature was.

Grant: Can you give me an example of that?

Ben: An example of that is it's been commonly described to make a psilocybin mushroom extraction to just do a cold water extraction. Through experimentation and with proper analysis in the lab, we've established that cold water extraction does not work at all. There are things that happen in the magic mushroom extraction that when you extract with cold water causes the psilocybin actually to degrade into other forms and eventually into non-bioactive forms. 

This was surprising to us, but it also presented an opportunity. If there's very little literature and if some of what's out there is actually wrong, here's our chance to develop processes which for the first time can provide stable, standardized, natural extracts of psilocybin and other natural psychedelic species.

What we decided to do was file for patent protection on some of these technologies which (like I said) for the first time have yielded stable, repeatable, GMP-grade, highly-standardized, natural psychedelic extracts. We've actually had pretty good correspondence back and forth with the patent examiners and we're quite hopeful to have somebody issue patents in the near future relating to these technologies. 

We're talking about extraction technologies, purification technologies, standardization, technologies for controlling the ratios of different alkaloids that come out of the extraction, as well as different compositions of matter necessary for making these extracts into deliverable forms for human consumption. Of course, those go into our clinical trials.

Early on, we didn't know that running clinical trials in-house was probably a little bit outside of the scope of our capacity at the time, so what we decided to do was partner with a leading psychedelics research institute at the University of California, San Francisco.

We've partnered with them to run all of our clinical trials. They have a lot of experience running clinical trials in psychedelics and they were very excited to work with our first-ever natural psychedelic clinical trials.

We have two clinical trials which will be up and running in the next couple of months. The first is a phase one trial in which we'll look at our naturally-extracted psilocybin and compare it head-to-head with a compound that we've identified in the magic mushroom that we believe will be more therapeutically beneficial than psilocybin. This is a compound that has not been administered in any clinical trial ever before—natural or synthetic—so we're very excited about potentially showing that maybe there's more to magic mushrooms and just psilocybin.

As I said earlier, there are many compounds in the magic mushroom. It's very possible that one of them is better than psilocybin. There's no rule that says that psilocybin is the best psychedelic. That's the phase one trial.

The phase two trial will administer our naturally-extracted psilocybin in patients with major depressive disorder. The innovative thing that we're doing in that trial is we're using ketamine as a very active control condition in an effort to increase the amount of blinding and placebo control that can occur in the clinic, because a major problem that's holding back all psychedelics research is the fact that there's been relatively little in the way of effective placebo controls. 

Because the psychedelics elicit a strong hallucinogenic response in the clinic, it's possible for the patients and a therapist to know which group got the placebo dose and which group got the hallucinogenic dose. By administering ketamine as a placebo which produces a similar hallucinogenic response, we expect to be able to preserve the blinding of the therapists and the patients.

Grant: Interesting. I never would have thought that that would have been an issue in clinical trials, the blind aspect of it with the researchers.

Ben: That leads to something called the expectation bias. The people are in a psychedelic trial for the treatment of depression. They already have some idea that psychedelics might help them with their depression, which is great. The problem is if they know whether they got the psychedelic dose or the placebo dose, if they know they got the psychedelic, they will then expect their depression to get better.

Depression is actually quite susceptible to this expectation bias, as are psychedelics. There are cases of people reporting that they got high on psychedelics even though they didn't get a psychedelic at all. They were just told they got psychedelics.

It's very important that we can employ some innovative, high-quality clinical research techniques like this in order to further the evidence for psychedelic therapies of all kinds, not just for ours actually.

Grant: You mentioned this a little bit earlier. I'm just curious. How do you compare yourself to other things in the industry? Like cannabis for example. You mentioned the regulation of state by state on the cannabis industry. I'm assuming there are similar state by state regulations for psychedelics as well.

I guess my question is as we've looked at how cannabis has been evolving in the market over the last decade or so, do you see something similar happening in your arm of the industry? If you were to try to look into a magic ball and forecast 5–10 years down the road, where do you see things landing? How do you compare yourself compared to what we've seen in the past?

Ben: That is the million-dollar or the billion-dollar question. At least in the United States, the biggest difference with the cannabis rollout is that in psychedelics, specifically for psilocybin, you actually do have the FDA seeming to be a proponent of pharmaceutical legalization of psilocybin. 

There are a couple of phase two, FDA-approved psilocybin trials underway. The FDA has actually given what's called breakthrough therapy designation to psilocybin which gives it a gold star stamp of approval and means that it can be ushered through the approval process quicker. The FDA is signaling that they like psilocybin, that they think it's a safe and effective treatment, and you didn't have any of that with cannabis.

That presents an issue. If it becomes federally legalized as a pharmaceutical, will the state markets that are opening up be allowed to exist? They're being set up as an alternative way to the medical pharmaceutical pathway that is emerging because people in those states and the people behind these ballot measures are afraid that if it's only the pharmaceutical medical market that distributes these psychedelics, that will lead to very high costs and low access. 

If there are millions of people that can stand to benefit from these psychedelics, should we have them in this very expensive, low accessibility distribution model as they feel is represented by the medical pharmaceutical distribution framework? That's why they're proponents of an alternative state-regulated market system where there's a system of therapists and clinics that aren't doctors and it's not pharmaceuticals. The idea is to give more access to more people.

Incidentally, we at Filament tend to agree. We also think that in these state-regulated, pharmaceutical markets, people will prefer natural products just because again, like I said, people prefer natural. The backers of these kinds of markets are already connected to the underground world and the underground world is all using natural products. They're not administering pharmaceutical synthetic psilocybin. They're using magic mushrooms essentially, so it will be a natural choice for them to use that magic mushroom extract rather than a synthetic product.

Grant: Got it. Thanks for walking through all that. It's just a question that came up as you're talking about it. That is the billion-dollar question. If we can solve that, then it feels like we're in a very good place. Awesome.

Hey, Ben, I really enjoyed the conversation today. We're running up at the end of time here, but I guess two more questions if you have time. One question is what are perhaps some common misconceptions people have about the natural psychedelic solution? There is a lot of hesitancy in the market and generally with consumers around cannabis and stuff. I can see some of that applying as well here. What are some of the common misconceptions that from a branding or marketing standpoint, you need to overcome so that people feel comfortable with what you're doing?

Ben: That's a great question. There are a number of commonly-held misconceptions (I would call them) around natural. The first and foremost is people commonly assume that natural means that it can't be pharmaceutical. They don't think that natural products can become pharmaceutical products. That's not true at all. In fact, over 40% of all pharmaceuticals that get approved have some kind of natural origin of some kind or another.

Another anecdote is that the largest-selling cancer drug of all time is actually a natural extract. Few people know that. That natural products form a very, very important piece of the traditional pharmaceutical market. That's first and foremost the misconception that we battle against.

Then, there are others. That natural products are too variable, they can't be standardized, and they're not GMP. Again, it's just not true that natural botanical raw materials—of course, because they grow in nature—are not 100% uniform. They're not synthetic, they're not robots, they are living organisms, and they all differ. 

But that's where the process of extraction, where you extract all of the target compounds out of the raw material, you purify them, and then you standardize them so that you can have an exact repeatable dose every time. In doing so, you end up with a standardized GMP product. That's another misconception.

Then, the last one would probably be cost. People assume that growing mushrooms and extracting them is very expensive, but in fact, what we're showing with our modeling is that it will be much cheaper than chemical synthesis. 

Nature is fantastically efficient. These little mushrooms grow in the dark. They want to grow. They produce these alkaloids inside of them at relatively decent concentrations. It's just a matter of knowing how to get them out efficiently and how to standardize them. Why not let nature do the heavy lifting and we just do a little bit of refinement at the end? 

I would say those are the three misconceptions, that natural does not equal pharmaceutical, that it must mean some kind of nutritional supplement. Oh, you're just a recreational company. No. You can make natural pharmaceuticals. They do exist. Two is that they can't be standardized or not GMP. Again, it's not true. Then, the third is cost. We think that we can actually provide natural psychedelics for a lower cost than synthetic psychedelics.

Grant: Interesting. Thanks for walking through all that, Ben. You're opening my eyes to this whole world that I was previously uncovered. This is fascinating for me.

We need to end the interview here. I appreciate your time for joining From Lab to Launch today. We'd like to sign out with one question, which is if you were to leave a piece of advice or a tweet that everyone in the industry—whether that be in your industry specifically or just life sciences in general—what kind of a piece of advice or or something like that, with the length of a tweet, let’s say, what would you say? And you knew everybody was going to read it.

Ben: I would definitely say let's bring psychedelics back to its natural roots. By historical coincidence—because of prohibition and because the first person to identify and recreate them was a Swiss pharmaceutical synthetic chemist—psychedelics have over time become divorced from their natural origin. I would say natural is a viable option. In fact, it will likely prove to be the preferred option, so let's give nature another chance.

Grant: I like that. Well said, Ben. I love having people like you on the show. They're doing something very bold and very different, the innovators and shakers in the industry. It's fascinating to be able to talk to people like you.

Thank you for sharing your insight and your wisdom today. Wish you all the best and all you're doing at Filament Health. We'll check in with you over time and see how things are going, but for right now, thank you so much for joining. I look forward to following what you're doing.

Ben: Yeah. Thanks for giving me the opportunity. This was fun.