May 15, 2024 • 23 mins
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
Qualio website:
https://www.qualio.com/
Previous episodes:
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Music by keldez
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
(00:01):
Hi there! Welcome to the FromLab to Launch podcast by Qualio,
where we share inspiring storiesfrom the people on the front
lines of life sciences.
Tune in and leave inspired tobring your life saving products
to the world.
Meg Sinclair (00:17):
Hi everyone.
And thank you for tuning in tofrom lab to launch podcast
brought to you by Qualio.
I'm Meg, your host, and I'mdelighted to be here with you
today.
Before we dive into today'sepisode, we'd love it.
If you could take a moment torate and share the podcast with
your circle of scienceenthusiasts.
And if you're interested inbeing a guest on the show,
please check out the applicationin the show notes today.
(00:40):
We're excited to welcome Dr.
Sam Clark, CEO of TerranBiosciences, an innovator of
over 200 patent applications.
an MD and a PhD from ColumbiaUniversity and a bachelor's
degree in neurosciences fromMIT.
Terran Biosciences is at theforefront of revolutionizing
therapeutics, emphasizing thedevelopment and supply of GMP
(01:02):
psychedelic compounds toresearchers around the globe.
Dr.
Clark's mission to transform thelandscape of mental health
treatment, making significantstrides toward better care and
innovative solutions.
You can learn more about Dr.
Clark and Terran in the shownotes.
Let's welcome him in and let'sget to it.
Welcome to the show, Dr.
Clark.
Sam Clark (01:20):
Oh, thank you.
Great to be on.
Meg Sinclair (01:23):
I'm really interested to hear about your
journey from the world ofacademia to the world of
neuropsychiatric therapeuticsand tarot, tarot biosciences.
Can you share a little bit aboutyour journey?
Sam Clark (01:34):
Sure.
So this all goes back to when Iwas younger growing up, there
were a number of people both inmy immediate family and friends
who suffered from severe mentalillnesses.
And also then in my family,there's also a severe dementias.
I really wanted to understandhow the brain worked and to
(01:54):
develop new treatments for thosemental illnesses.
So I went into neuroscience whenI went to MIT, and then I went
and did my MD and my PhD atColumbia.
But it was really during thattime that I found out that the
treatments that we haveavailable are just Effective.
And there haven't been a lot ofnew mechanisms really since the
19, you know, the last night,the 1960s through the 1980s, you
(02:18):
know, the new drugs are largelyjust kind of, uh, smaller
improvements on existingmechanisms.
And so I founded TerranBiosciences with the goal of
building a platform company thatcould make new transformational
treatments for patients withneuropsychiatric conditions.
(02:39):
Okay.
Meg Sinclair (02:41):
I'm sorry to hear that your loved ones have been
affected by those mental healthconditions, but glad that it's
inspired you on this path.
Um, and in recent years, there'sreally been a renaissance of
sorts in the psychedelics, um,for therapeutic purposes.
From your perspective, what hasled to these new treatments,
investments, and momentum toconsider psychedelic compounds
in treating mental healthdisorders?
Sam Clark (03:03):
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 thepast.
You know, think about it in the1980s, uh, MDMA was already
being used for psychedelicassisted psychotherapy for post
(03:23):
traumatic stress disorder.
And now, you know, fast forward,you know, another, um, 40 years
is when it's finally up for FDAapproval this year.
The problem was there was alarge, um, crackdown.
on all psychedelics where theywere labeled as having no
medical use and due to thatscheduling in the United States
as schedule one, it was veryhard for researchers to get
(03:45):
access to do research on them.
And so the research wasdramatically slowed down.
So it wasn't that psychedelicswere, are any more effective now
than they've ever been.
It's that due to barriers toresearch that have only recently
been relaxed, uh, it's taken along time for that data to come
of how effective they are tocome to light.
(04:05):
But now that that has come tolight, you know, we have
multiple psychedelics withbreakthrough 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 (04:23):
It's amazing that it can take 40 years when it's
going slow, but 40 Months whenit's going when you know, those
barriers are lifted.
It's it's a much differentstory.
Sam Clark (04:35):
Yes
Meg Sinclair (04:36):
So thinking about navigating the field of
neuropsychiatry and it has itsunique set of challenges,
especially when introducingnovel therapeutics What do you
see is the biggest hurdle inbringing new treatments from
research to reality?
And how is Terran addressingthis?
Sam Clark (04:51):
So one major hurdle is that a large number of new
compounds don't make it throughwhat's called phase one initial
human testing.
So when you develop a newcompound, you have to then show
it safe in animals, and then youhave to show it safe in humans.
Most are found to have some sortof toxic effect before they get
to humans.
(05:11):
And then from that, the bulkdon't make it through.
the first phase one trial.
So it's actually quite hard tobring molecules that may
initially show some sort ofantidepressant effect in an
early animal model, actually getthat to humans and actually be
safe and effective.
And then finally, you have toremember that even if that
molecule may seem to beeffective, it has to be a
(05:33):
developable molecule.
Drug.
And what that means is it has tobe able to be manufactured at
scale, where you can distributethis worldwide to everyone who
needs it.
Many molecules may appearpromising research, but they're
unstable.
They can't be stabilized.
They can't be turned into apill.
You know, things like that can,in addition to safety issues,
(05:54):
can, can Eliminate the bulk ofdrugs, and that makes drug
development very, very risky.
So what Terran does is weactually have a dual approach
here.
And what we do is, um, our goalis to do two things.
One, bring transformationaltreatments to patients.
And two, to make, to bringaffordable, they have to be
affordable medications as well.
(06:15):
And so what we're doing isleveraging the FDA's 505B2
pathway.
And what that enables you to dois, take existing data sets from
phase three trials that havealready been done that show
drugs like psilocybin, MDMA areeffective, and after the first
drug gets approved, five yearslater, you can bring your own
(06:37):
drug to market, not have torepeat those trials, and get
that on the market where itbrings costs down for patients.
So that's the cost saving part.
Then the Addressing that firstpart, you know, what about, how
do we, you know, what about allthese drugs that are unsafe,
unstable, the way we do that iswe target existing drugs and
then we improve them forpatients.
(06:58):
For example, MDMA is a drug thatoften has to be redosed in the
middle of therapy because it'sso short acting.
So Terran developed what'scalled a pro drug.
And what that is, is you takethe original molecule, you
attach a little side chain toit.
That side chain falls off in thebody.
and releases just a normal MDMA,but it improves the
(07:20):
pharmacokinetic significantly.
And that's also eligible for the505B2 path usually.
And so what that means is we'vecreated the world's first long
acting MDMA with a prodrug whereit can go Theoretically, the
whole therapy session withouthaving that redose, we've done
similar work with psilocybin.
We've improved DMT, making theworld's first truly orally
(07:42):
active drug that can be ingestedpill format and, uh, is orally
active.
Same with five with oxy DMT, twodrugs that previously had to
only be smoked or injected oruse other methods of
administration that Couldn't beplaced in a swallowable pill.
So it's by leveraging theseinnovations that we bring
improved versions to market forpatients, but also leverage the
(08:06):
505b2 path so that we don't haveto repeat trials that have
already been done, acceleratingdevelopment and bringing cheap,
affordable meds to patients.
I
Meg Sinclair (08:15):
think that's an important concept too, and the
drug development is making sureyou can actually get in the
hands of patients who can usethem and afford to use them and
take them when they need them.
So that's a great approach.
Um, I love that you werespeaking about safety and
effectiveness.
We're curious about yourapproach to quality management
since we provide an EQMS atQualio.
(08:36):
Given how important it is tomaintain the purity and
consistency of the psychedeliccompounds for research and
therapy, we'd Could you shareabout your quality culture at
Terran Biosciences?
We'd love to hear aboutpractices you've adopted to
ensure top notch standards.
Sam Clark (08:50):
Oh, absolutely.
And quality is actuallysomething Terran takes very
seriously.
And it's one of those thingsthat, you know, people don't
talk about as much, as you mightbe aware.
You know, when I first foundedTerran, I didn't know much
about, you know, qualitymanagement and, you know, what,
what that role was.
But the thing is that, yeah, sowe have a robust, um, QMS system
at Terran and, uh, SOPs that wefollow.
(09:12):
And what we do whenever we domanufacturing or clinical
trials, we, in addition to whenyou're working with a
manufacturing group, you know,they'll have their own internal
quality system, but then Terranhas a second level on top of
that.
We have our quality system.
So any of these APIs, the activepharmaceutical ingredients that
we are manufacturing.
Have to both pass the vendor'sQMS, and then it has to pass
(09:34):
Terran's quality.
And we have a team every time wedo, uh, for example, a GMP
manufacturing, there's always ateam of at least three on there.
There's the process chemist tooversee the project.
There's the analytical chemist.
And then there's the qualitycontrol chemist who has to
manage all those batch recordsand make sure everything is, is
(09:55):
meeting both the SOPs andmeeting 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 arobust quality system and, um,
and also bringing that highlevel of product and low cost.
I think that's a great value topatients out there looking
towards the future.
How do you envision the role ofpsychedelics 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 classicpsychedelics where the, they
come with a hallucinatory trip.
Now that can be very effectivefor certain disorders like post
traumatic stress disorder.
It's under review right now withMDMA, which is based on life
(10:50):
trauma that needs that therapyto get better.
But there is a downside topotentially to the trip.
That may slow a widespreadrollout for other psychedelics
like psilocybin or LSD, and thatis that for treating disorders
like anxiety or major depressivedisorder, we know already in the
literature, those Can respond todrugs alone without the therapy
(11:12):
component, but the trip being solong six hours for psilocybin up
to 12 for LSD poses a potentialBarrier to a patient adoption
because of the cost and timerequired not everyone has time
for the trip Not everyone hasthe cost to pay doctor.
The doctor has to be there thewhole time and so One thing at
(11:33):
Terran, so in addition, we domanufacture 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 aselective recept, serotonin
(11:57):
receptor blocker that removesthe trip and we're developing
what we hope to be ultimately atake home medication for
disorders like depression,anxiety that have the same, uh,
therapeutic benefit of thepsychedelic without the trip.
And we just showed the firsthuman data that the mechanism of
(12:17):
which psychedelics can rewirethe brain is fully intact, even
in the absence of any trip.
That was, um, inventions thenthat we licensed from major, uh,
universities and we're veryexcited to develop that forward
to improve patient access tohaving the potential power of
psychedelics without having tohave the, uh, time commitment,
(12:38):
uh, and, um, all of the effectsof the trip.
that can limit access for somepatients.
Meg Sinclair (12:46):
Are there any specific areas or disorders
beyond neuropsychiatricdisorders that you see where you
could have impact?
Sam Clark (12:53):
Yeah.
STerranyn has, um, Terran'sdevelopment programs have been
very active in the metabolic,uh, space for diabetes and for
obesity.
And Terran has been working on anumber of, uh, different
peptides in the space, uh, forthe treatment of obesity and as
well as different metabolicdisorders.
And so Terran not only has a,you know, we don't just do
(13:14):
psychedelics and traditionalneuroscience, but we have a very
robust medicinal chemistry teamdesigning these new molecules
and improvements.
And so Those improvements thatwe're able to make are not just
limited to neuropsychiatry, butalso to, um, other, we were able
to bring them and bridge intoother areas where it can benefit
patients as well.
We're very excited to beexpanding into those areas now.
Meg Sinclair (13:38):
That's very exciting to me, increasing
patient access and increasingthe amount of disorders and.
Um, neuropsychiatry and all ofthat that you can treat.
That's really amazing.
Um, we spoke to it earlier inyour intro.
You have over 200 patentapplications under your belt and
you're a leading figure in theproperty protection of IP and
(14:00):
neuroscience.
How do you balance the need forinnovation with the ethical
considerations of patenting inthe field of medicine and
therapeutics?
Sam Clark (14:08):
Oh, absolutely.
So it comes, I think when wethink about ethical
considerations and patents, thatcomes down to two things.
One, every major innovation, newdrug launched, you know, usually
there's some patent protectionthat is put in place to reward
the developers and incentivizeinnovation.
Uh, innovation without anypatents in the space.
(14:31):
I don't think we would have anynew drugs developed.
And we, for example, just, uh,everyone has a smartphone, the
technology in the differentsmartphones are protected by a
number of patents.
So patents is something that isessential for the development
across the landscape.
Now here's where it can gettricky.
Is that some groups use patents,um, or a little less ethical
(14:53):
patent practices to dramaticallyextend protection on drugs far
longer than they were, uh,intended to do through creation
of what's called patent thicketsand also the 30 month stay, uh,
of 505 B2 applications.
And what that means is let's sayyou have a drug that's off
patent.
In which case, the FDA gives youyour five years of exclusivity
(15:16):
to your data.
But after that five years, it'sa company like Terran to come
in, reference that data, and geta cheaper, more affordable drug
on the market for patients.
And that's what we intend to dousing 505B2 for many pathways.
But what, there's a loopholethat's been exploited.
And that loophole is called the30 month cycle.
Stay in the orange book.
And what that means is if acompany has even a single patent
(15:39):
on that drug and there's aquestion of whether, you know,
somebody else is potentiallyinfringing at all on that
patent, they can file a lawsuitand get a 30 month stay that
stops the generic drug fromgetting in until the courts
decide.
And the loophole is that manycompanies have been accused of
potentially filing those stayswhen they know no one is
(16:02):
infringing the patent in thefirst place.
So, Terran has proactivelyanticipated that because of the
many, you know, uh, big biotechsdon't like it for when other
groups bring generics on,although we love it because it's
good for patients, that we haveproactively filed lots of
(16:23):
different salt and polymorphpatents.
That means that to ensure, asthere are patents on the forms
of the drug that aredevelopable, to ensure that no
one can get those secondarypatents and use them to block us
from bringing the, what isessentially, generic Or, uh, you
know, 505 B2 drug to the marketin five years, because if we own
(16:47):
the patent, they can't use it inthe orange book to block us for
another five years, you know, 30more months.
So six years.
So, so the idea is that, um, youknow, there's a, we're taking
these proactive approaches tonot only lock down the main IP,
but also additional IP.
that people could have otherwiseused to try to get those
(17:08):
extensions of 30 months wouldnot be possible now with the
strategies we've taken.
Meg Sinclair (17:14):
Love that proactive approach.
That's really smart.
Congratulations on all thosepatents, too.
That's no small feat, filing200.
Sam Clark (17:23):
Thank you.
Well, they're not all grantedyet, but we have filed them.
And part of the benefit offiling is, you know, that, you
know, you can, you get yourideas out there.
And even if they're not fully,finally granted at the end of
the day, no one else can usethat 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 aspiringscientists and innovators
listening to this podcast, I'msure they've got lots of ideas
now listening to all of yourdifferent approaches you've
taken by quality and patents.
What advice would you give thoselooking neuropsychiatric
(18:07):
treatment?
Sam Clark (18:09):
Okay.
So.
Um, for people, um, so itdepends, you know, in the
science field in academia, Iwould say just, you know, keep
pushing forward your inventionsand, um, work with your
university tech transfer officesto patent them.
Because sometimes, uh, what wefound in the academic field is
academics, they don't have theeducation usually on IP and
(18:30):
patents.
So it's okay.
Well, if I have a greatinvention, I'll just publish it.
But often if an invention isjust.
Publish in the public domain.
It loses that ability to getfunding for development.
We like it when people patenttheir inventions so that we can
come and license them and theneveryone gets rewarded.
The academic who invented itgets Royalties, the university
(18:52):
that, you know, set up thatwhole system to make that
invention also gets milestonesand royalties.
And so everybody benefit and thepatient benefits because now
it's patented and it can get themoney required for development.
So in that sense, I wouldabsolutely encourage people to
be working with their universitytech transfer offices whenever
they think they have apotentially patentable
(19:13):
invention.
That's the first.
And then, um, you know, in.
In the biotech field for peoplethat are founding companies, you
know, pushing things forward.
I would give the advice, youknow, stay very hands on in
development.
You know, there's, we've seenmany companies fail due to, um,
a little bit of a disconnectbetween management.
And the team's running thescience and at Terran, we run a
(19:36):
very lean team, uh, of highlytrained operators that manage
these teams of consultants.
And I stay very involved in allaspects of manufacturing science
clinical, which we found isimportant to make sure you're
really in the weeds and you'renot becoming distant where there
might be a disconnect ormiscommunication that leads to
problems down the line.
(19:58):
And then the last piece ofadvice I'll give it on that is
just, you have to be outcomedriven.
independent in your own internalmental state.
If you think about all thethings that, uh, all the stress
that, you know, that people canthink over the years, none of
that changes the outcome.
So you really have to be outcomeindependent as you approach
(20:19):
these things in a logicalmanner.
And, uh, that's what you need toreally maintain, uh, the focus
to get these drugs developed forthe 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 isstick 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 closeus out today is more of a fun
one.
We like to ask each of ourguests.
If we ran into you at abookstore or your local library,
(20:50):
in which section would we findyou?
Sam Clark (20:53):
You know, I really like biographies and learning
about what other innovators havedone, what other companies have
done, what's worked, what hasn'tis you get an opportunity to
learn from some of the greatestminds in the world and just, and
the past of, you know, what aresome of the things people did
that, you know, created theworld that we live in today.
And so learning about thosethings and even just, you know,
(21:15):
um, uh, with modern companies,you know, um, Super pumped the
battle for Uber, you know,learning about what happened
there, you know, the everythingstore for learning about Amazon,
you know, Steve jobs, WalterIsaacson 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 toread as much as you can.
It's just really, uh, the bestway of, um, Of doing is to learn
(21:40):
from other people's mistakes aswell.
So it's not just about whatworked.
It's also largely about whatdidn't work because, you know,
the mistakes we make or anyonemakes, they're not really unique
mistakes.
There's mistakes somebody's madebefore.
So if you can learn about it,you know, then you can hopefully
not make the same mistakebecause you know, if you,
there's only so much time inlife, you know, we only have a,
(22:02):
you know, a finite number ofheartbeats.
So at that point you want tolearn it, absorb as much as you
can.
Meg Sinclair (22:08):
Yeah, that's great advice for our, uh, future
innovators and scientists outthere to learn from others
mistakes as they go forth andmake their own and learn from
them.
Well, thanks so much, Dr.
Clark, for joining us today.
Where can those go who want tofollow along with your journey
and find you and connect?
Sam Clark (22:25):
Great.
So we're on LinkedIn, TerranBiosciences, 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, andI'm on at, uh, Neon Neurons.
Meg Sinclair (22:40):
Great.
Well, I will be following alongto see all the great work that
you and Terran do.
Thank you so much for joiningus.
Sam Clark (22:46):
Thank you for having me.
Really appreciate it.
Thank you for listening to thisweek's episode of From Lab to
Launch, brought to you byQualio.
If you like what you've heard,please subscribe and give the
(23:08):
show a positive review.
It really helps us out.
For more information aboutQualio, our guest today, or to
be a guest on a future episode,please refer to the show notes.
Until next time.
Hi there! Welcome to the FromLab to Launch podcast by Qualio,
where we share inspiring storiesfrom the people on the front
lines of life sciences.
Tune in and leave inspired tobring your life saving products
to the world.
Meg Sinclair (00:17):
Hi everyone.
And thank you for tuning in tofrom lab to launch podcast
brought to you by Qualio.
I'm Meg, your host, and I'mdelighted to be here with you
today.
Before we dive into today'sepisode, we'd love it.
If you could take a moment torate and share the podcast with
your circle of scienceenthusiasts.
And if you're interested inbeing a guest on the show,
please check out the applicationin the show notes today.
(00:40):
We're excited to welcome Dr.
Sam Clark, CEO of TerranBiosciences, an innovator of
over 200 patent applications.
an MD and a PhD from ColumbiaUniversity and a bachelor's
degree in neurosciences fromMIT.
Terran Biosciences is at theforefront of revolutionizing
therapeutics, emphasizing thedevelopment and supply of GMP
(01:02):
psychedelic compounds toresearchers around the globe.
Dr.
Clark's mission to transform thelandscape of mental health
treatment, making significantstrides toward better care and
innovative solutions.
You can learn more about Dr.
Clark and Terran in the shownotes.
Let's welcome him in and let'sget to it.
Welcome to the show, Dr.
Clark.
Sam Clark (01:20):
Oh, thank you.
Great to be on.
Meg Sinclair (01:23):
I'm really interested to hear about your
journey from the world ofacademia to the world of
neuropsychiatric therapeuticsand tarot, tarot biosciences.
Can you share a little bit aboutyour journey?
Sam Clark (01:34):
Sure.
So this all goes back to when Iwas younger growing up, there
were a number of people both inmy immediate family and friends
who suffered from severe mentalillnesses.
And also then in my family,there's also a severe dementias.
I really wanted to understandhow the brain worked and to
(01:54):
develop new treatments for thosemental illnesses.
So I went into neuroscience whenI went to MIT, and then I went
and did my MD and my PhD atColumbia.
But it was really during thattime that I found out that the
treatments that we haveavailable are just Effective.
And there haven't been a lot ofnew mechanisms really since the
19, you know, the last night,the 1960s through the 1980s, you
(02:18):
know, the new drugs are largelyjust kind of, uh, smaller
improvements on existingmechanisms.
And so I founded TerranBiosciences with the goal of
building a platform company thatcould make new transformational
treatments for patients withneuropsychiatric conditions.
(02:39):
Okay.
Meg Sinclair (02:41):
I'm sorry to hear that your loved ones have been
affected by those mental healthconditions, but glad that it's
inspired you on this path.
Um, and in recent years, there'sreally been a renaissance of
sorts in the psychedelics, um,for therapeutic purposes.
From your perspective, what hasled to these new treatments,
investments, and momentum toconsider psychedelic compounds
in treating mental healthdisorders?
Sam Clark (03:03):
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 thepast.
You know, think about it in the1980s, uh, MDMA was already
being used for psychedelicassisted psychotherapy for post
(03:23):
traumatic stress disorder.
And now, you know, fast forward,you know, another, um, 40 years
is when it's finally up for FDAapproval this year.
The problem was there was alarge, um, crackdown.
on all psychedelics where theywere labeled as having no
medical use and due to thatscheduling in the United States
as schedule one, it was veryhard for researchers to get
(03:45):
access to do research on them.
And so the research wasdramatically slowed down.
So it wasn't that psychedelicswere, are any more effective now
than they've ever been.
It's that due to barriers toresearch that have only recently
been relaxed, uh, it's taken along time for that data to come
of how effective they are tocome to light.
(04:05):
But now that that has come tolight, you know, we have
multiple psychedelics withbreakthrough 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 (04:23):
It's amazing that it can take 40 years when it's
going slow, but 40 Months whenit's going when you know, those
barriers are lifted.
It's it's a much differentstory.
Sam Clark (04:35):
Yes
Meg Sinclair (04:36):
So thinking about navigating the field of
neuropsychiatry and it has itsunique set of challenges,
especially when introducingnovel therapeutics What do you
see is the biggest hurdle inbringing new treatments from
research to reality?
And how is Terran addressingthis?
Sam Clark (04:51):
So one major hurdle is that a large number of new
compounds don't make it throughwhat's called phase one initial
human testing.
So when you develop a newcompound, you have to then show
it safe in animals, and then youhave to show it safe in humans.
Most are found to have some sortof toxic effect before they get
to humans.
(05:11):
And then from that, the bulkdon't make it through.
the first phase one trial.
So it's actually quite hard tobring molecules that may
initially show some sort ofantidepressant effect in an
early animal model, actually getthat to humans and actually be
safe and effective.
And then finally, you have toremember that even if that
molecule may seem to beeffective, it has to be a
(05:33):
developable molecule.
Drug.
And what that means is it has tobe able to be manufactured at
scale, where you can distributethis worldwide to everyone who
needs it.
Many molecules may appearpromising research, but they're
unstable.
They can't be stabilized.
They can't be turned into apill.
You know, things like that can,in addition to safety issues,
(05:54):
can, can Eliminate the bulk ofdrugs, and that makes drug
development very, very risky.
So what Terran does is weactually have a dual approach
here.
And what we do is, um, our goalis to do two things.
One, bring transformationaltreatments to patients.
And two, to make, to bringaffordable, they have to be
affordable medications as well.
(06:15):
And so what we're doing isleveraging the FDA's 505B2
pathway.
And what that enables you to dois, take existing data sets from
phase three trials that havealready been done that show
drugs like psilocybin, MDMA areeffective, and after the first
drug gets approved, five yearslater, you can bring your own
(06:37):
drug to market, not have torepeat those trials, and get
that on the market where itbrings costs down for patients.
So that's the cost saving part.
Then the Addressing that firstpart, you know, what about, how
do we, you know, what about allthese drugs that are unsafe,
unstable, the way we do that iswe target existing drugs and
then we improve them forpatients.
(06:58):
For example, MDMA is a drug thatoften has to be redosed in the
middle of therapy because it'sso short acting.
So Terran developed what'scalled a pro drug.
And what that is, is you takethe original molecule, you
attach a little side chain toit.
That side chain falls off in thebody.
and releases just a normal MDMA,but it improves the
(07:20):
pharmacokinetic significantly.
And that's also eligible for the505B2 path usually.
And so what that means is we'vecreated the world's first long
acting MDMA with a prodrug whereit can go Theoretically, the
whole therapy session withouthaving that redose, we've done
similar work with psilocybin.
We've improved DMT, making theworld's first truly orally
(07:42):
active drug that can be ingestedpill format and, uh, is orally
active.
Same with five with oxy DMT, twodrugs that previously had to
only be smoked or injected oruse other methods of
administration that Couldn't beplaced in a swallowable pill.
So it's by leveraging theseinnovations that we bring
improved versions to market forpatients, but also leverage the
(08:06):
505b2 path so that we don't haveto repeat trials that have
already been done, acceleratingdevelopment and bringing cheap,
affordable meds to patients.
I
Meg Sinclair (08:15):
think that's an important concept too, and the
drug development is making sureyou can actually get in the
hands of patients who can usethem and afford to use them and
take them when they need them.
So that's a great approach.
Um, I love that you werespeaking about safety and
effectiveness.
We're curious about yourapproach to quality management
since we provide an EQMS atQualio.
(08:36):
Given how important it is tomaintain the purity and
consistency of the psychedeliccompounds for research and
therapy, we'd Could you shareabout your quality culture at
Terran Biosciences?
We'd love to hear aboutpractices you've adopted to
ensure top notch standards.
Sam Clark (08:50):
Oh, absolutely.
And quality is actuallysomething Terran takes very
seriously.
And it's one of those thingsthat, you know, people don't
talk about as much, as you mightbe aware.
You know, when I first foundedTerran, I didn't know much
about, you know, qualitymanagement and, you know, what,
what that role was.
But the thing is that, yeah, sowe have a robust, um, QMS system
at Terran and, uh, SOPs that wefollow.
(09:12):
And what we do whenever we domanufacturing or clinical
trials, we, in addition to whenyou're working with a
manufacturing group, you know,they'll have their own internal
quality system, but then Terranhas a second level on top of
that.
We have our quality system.
So any of these APIs, the activepharmaceutical ingredients that
we are manufacturing.
Have to both pass the vendor'sQMS, and then it has to pass
(09:34):
Terran's quality.
And we have a team every time wedo, uh, for example, a GMP
manufacturing, there's always ateam of at least three on there.
There's the process chemist tooversee the project.
There's the analytical chemist.
And then there's the qualitycontrol chemist who has to
manage all those batch recordsand make sure everything is, is
(09:55):
meeting both the SOPs andmeeting 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 arobust quality system and, um,
and also bringing that highlevel of product and low cost.
I think that's a great value topatients out there looking
towards the future.
How do you envision the role ofpsychedelics 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 classicpsychedelics where the, they
come with a hallucinatory trip.
Now that can be very effectivefor certain disorders like post
traumatic stress disorder.
It's under review right now withMDMA, which is based on life
(10:50):
trauma that needs that therapyto get better.
But there is a downside topotentially to the trip.
That may slow a widespreadrollout for other psychedelics
like psilocybin or LSD, and thatis that for treating disorders
like anxiety or major depressivedisorder, we know already in the
literature, those Can respond todrugs alone without the therapy
(11:12):
component, but the trip being solong six hours for psilocybin up
to 12 for LSD poses a potentialBarrier to a patient adoption
because of the cost and timerequired not everyone has time
for the trip Not everyone hasthe cost to pay doctor.
The doctor has to be there thewhole time and so One thing at
(11:33):
Terran, so in addition, we domanufacture 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 aselective recept, serotonin
(11:57):
receptor blocker that removesthe trip and we're developing
what we hope to be ultimately atake home medication for
disorders like depression,anxiety that have the same, uh,
therapeutic benefit of thepsychedelic without the trip.
And we just showed the firsthuman data that the mechanism of
(12:17):
which psychedelics can rewirethe brain is fully intact, even
in the absence of any trip.
That was, um, inventions thenthat we licensed from major, uh,
universities and we're veryexcited to develop that forward
to improve patient access tohaving the potential power of
psychedelics without having tohave the, uh, time commitment,
(12:38):
uh, and, um, all of the effectsof the trip.
that can limit access for somepatients.
Meg Sinclair (12:46):
Are there any specific areas or disorders
beyond neuropsychiatricdisorders that you see where you
could have impact?
Sam Clark (12:53):
Yeah.
STerranyn has, um, Terran'sdevelopment programs have been
very active in the metabolic,uh, space for diabetes and for
obesity.
And Terran has been working on anumber of, uh, different
peptides in the space, uh, forthe treatment of obesity and as
well as different metabolicdisorders.
And so Terran not only has a,you know, we don't just do
(13:14):
psychedelics and traditionalneuroscience, but we have a very
robust medicinal chemistry teamdesigning these new molecules
and improvements.
And so Those improvements thatwe're able to make are not just
limited to neuropsychiatry, butalso to, um, other, we were able
to bring them and bridge intoother areas where it can benefit
patients as well.
We're very excited to beexpanding into those areas now.
Meg Sinclair (13:38):
That's very exciting to me, increasing
patient access and increasingthe amount of disorders and.
Um, neuropsychiatry and all ofthat that you can treat.
That's really amazing.
Um, we spoke to it earlier inyour intro.
You have over 200 patentapplications under your belt and
you're a leading figure in theproperty protection of IP and
(14:00):
neuroscience.
How do you balance the need forinnovation with the ethical
considerations of patenting inthe field of medicine and
therapeutics?
Sam Clark (14:08):
Oh, absolutely.
So it comes, I think when wethink about ethical
considerations and patents, thatcomes down to two things.
One, every major innovation, newdrug launched, you know, usually
there's some patent protectionthat is put in place to reward
the developers and incentivizeinnovation.
Uh, innovation without anypatents in the space.
(14:31):
I don't think we would have anynew drugs developed.
And we, for example, just, uh,everyone has a smartphone, the
technology in the differentsmartphones are protected by a
number of patents.
So patents is something that isessential for the development
across the landscape.
Now here's where it can gettricky.
Is that some groups use patents,um, or a little less ethical
(14:53):
patent practices to dramaticallyextend protection on drugs far
longer than they were, uh,intended to do through creation
of what's called patent thicketsand also the 30 month stay, uh,
of 505 B2 applications.
And what that means is let's sayyou have a drug that's off
patent.
In which case, the FDA gives youyour five years of exclusivity
(15:16):
to your data.
But after that five years, it'sa company like Terran to come
in, reference that data, and geta cheaper, more affordable drug
on the market for patients.
And that's what we intend to dousing 505B2 for many pathways.
But what, there's a loopholethat's been exploited.
And that loophole is called the30 month cycle.
Stay in the orange book.
And what that means is if acompany has even a single patent
(15:39):
on that drug and there's aquestion of whether, you know,
somebody else is potentiallyinfringing at all on that
patent, they can file a lawsuitand get a 30 month stay that
stops the generic drug fromgetting in until the courts
decide.
And the loophole is that manycompanies have been accused of
potentially filing those stayswhen they know no one is
(16:02):
infringing the patent in thefirst place.
So, Terran has proactivelyanticipated that because of the
many, you know, uh, big biotechsdon't like it for when other
groups bring generics on,although we love it because it's
good for patients, that we haveproactively filed lots of
(16:23):
different salt and polymorphpatents.
That means that to ensure, asthere are patents on the forms
of the drug that aredevelopable, to ensure that no
one can get those secondarypatents and use them to block us
from bringing the, what isessentially, generic Or, uh, you
know, 505 B2 drug to the marketin five years, because if we own
(16:47):
the patent, they can't use it inthe orange book to block us for
another five years, you know, 30more months.
So six years.
So, so the idea is that, um, youknow, there's a, we're taking
these proactive approaches tonot only lock down the main IP,
but also additional IP.
that people could have otherwiseused to try to get those
(17:08):
extensions of 30 months wouldnot be possible now with the
strategies we've taken.
Meg Sinclair (17:14):
Love that proactive approach.
That's really smart.
Congratulations on all thosepatents, too.
That's no small feat, filing200.
Sam Clark (17:23):
Thank you.
Well, they're not all grantedyet, but we have filed them.
And part of the benefit offiling is, you know, that, you
know, you can, you get yourideas out there.
And even if they're not fully,finally granted at the end of
the day, no one else can usethat 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 aspiringscientists and innovators
listening to this podcast, I'msure they've got lots of ideas
now listening to all of yourdifferent approaches you've
taken by quality and patents.
What advice would you give thoselooking neuropsychiatric
(18:07):
treatment?
Sam Clark (18:09):
Okay.
So.
Um, for people, um, so itdepends, you know, in the
science field in academia, Iwould say just, you know, keep
pushing forward your inventionsand, um, work with your
university tech transfer officesto patent them.
Because sometimes, uh, what wefound in the academic field is
academics, they don't have theeducation usually on IP and
(18:30):
patents.
So it's okay.
Well, if I have a greatinvention, I'll just publish it.
But often if an invention isjust.
Publish in the public domain.
It loses that ability to getfunding for development.
We like it when people patenttheir inventions so that we can
come and license them and theneveryone gets rewarded.
The academic who invented itgets Royalties, the university
(18:52):
that, you know, set up thatwhole system to make that
invention also gets milestonesand royalties.
And so everybody benefit and thepatient benefits because now
it's patented and it can get themoney required for development.
So in that sense, I wouldabsolutely encourage people to
be working with their universitytech transfer offices whenever
they think they have apotentially patentable
(19:13):
invention.
That's the first.
And then, um, you know, in.
In the biotech field for peoplethat are founding companies, you
know, pushing things forward.
I would give the advice, youknow, stay very hands on in
development.
You know, there's, we've seenmany companies fail due to, um,
a little bit of a disconnectbetween management.
And the team's running thescience and at Terran, we run a
(19:36):
very lean team, uh, of highlytrained operators that manage
these teams of consultants.
And I stay very involved in allaspects of manufacturing science
clinical, which we found isimportant to make sure you're
really in the weeds and you'renot becoming distant where there
might be a disconnect ormiscommunication that leads to
problems down the line.
(19:58):
And then the last piece ofadvice I'll give it on that is
just, you have to be outcomedriven.
independent in your own internalmental state.
If you think about all thethings that, uh, all the stress
that, you know, that people canthink over the years, none of
that changes the outcome.
So you really have to be outcomeindependent as you approach
(20:19):
these things in a logicalmanner.
And, uh, that's what you need toreally maintain, uh, the focus
to get these drugs developed forthe 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 isstick 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 closeus out today is more of a fun
one.
We like to ask each of ourguests.
If we ran into you at abookstore or your local library,
(20:50):
in which section would we findyou?
Sam Clark (20:53):
You know, I really like biographies and learning
about what other innovators havedone, what other companies have
done, what's worked, what hasn'tis you get an opportunity to
learn from some of the greatestminds in the world and just, and
the past of, you know, what aresome of the things people did
that, you know, created theworld that we live in today.
And so learning about thosethings and even just, you know,
(21:15):
um, uh, with modern companies,you know, um, Super pumped the
battle for Uber, you know,learning about what happened
there, you know, the everythingstore for learning about Amazon,
you know, Steve jobs, WalterIsaacson 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 toread as much as you can.
It's just really, uh, the bestway of, um, Of doing is to learn
(21:40):
from other people's mistakes aswell.
So it's not just about whatworked.
It's also largely about whatdidn't work because, you know,
the mistakes we make or anyonemakes, they're not really unique
mistakes.
There's mistakes somebody's madebefore.
So if you can learn about it,you know, then you can hopefully
not make the same mistakebecause you know, if you,
there's only so much time inlife, you know, we only have a,
(22:02):
you know, a finite number ofheartbeats.
So at that point you want tolearn it, absorb as much as you
can.
Meg Sinclair (22:08):
Yeah, that's great advice for our, uh, future
innovators and scientists outthere to learn from others
mistakes as they go forth andmake their own and learn from
them.
Well, thanks so much, Dr.
Clark, for joining us today.
Where can those go who want tofollow along with your journey
and find you and connect?
Sam Clark (22:25):
Great.
So we're on LinkedIn, TerranBiosciences, 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, andI'm on at, uh, Neon Neurons.
Meg Sinclair (22:40):
Great.
Well, I will be following alongto see all the great work that
you and Terran do.
Thank you so much for joiningus.
Sam Clark (22:46):
Thank you for having me.
Really appreciate it.
Thank you for listening to thisweek's episode of From Lab to
Launch, brought to you byQualio.
If you like what you've heard,please subscribe and give the
(23:08):
show a positive review.
It really helps us out.
For more information aboutQualio, our guest today, or to
be a guest on a future episode,please refer to the show notes.
Until next time.
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