Growing New Livers to Save Lives

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I'm Jacob Goldstein.

This is what's your problem.

And my guest today is Michael Huffard.

He's the co-founder and CEO of a company called LiGenesis.

Michael and his colleagues are working

on a new kind of medical treatment.

If it works, it will save lives.

And I have to say,

the way the treatment is supposed to work is wild.

It's for people with end-stage liver disease

who don't qualify for a liver transplant.

And what LiGenesis does is

they take healthy liver cells,

just cells,

and they inject those cells into the patient's lymph nodes.

And then the patient grows one or more

little new livers in those lymph nodes.

This has worked in experiments in animals

and now they're trying it in people.

In our conversation,

Michael told me about the science of why this might work.

He told me what it would mean for patients

if it does work.

And we also talked about why it might not work.

And then we talked a little bit about the future

of regenerative medicine more broadly.

And the possibility of a world

where no one dies waiting for an organ transplant.

But to start,

Michael told me some truly interesting facts

about the liver and Greek mythology.

It is remarkable because it's the only organ

in the human body that will naturally regenerate.

So you can lose 70% of your liver.

And over a course of just a few weeks,

you will regenerate that liver entirely.

And that's true only for the liver.

And ironically,

it's something we've known for 3,000 years, right?

The myth of Prometheus,

if you might remember,

the titan that stole fire from Zeus and gave it to man

was punished by being chained to a rock

and that eagle would come every day and eat his liver.

And the punishment was eternal because his liver

would regenerate and the eagle would have more liver

to feast on the next day.

I was vaguely familiar with the myth of Prometheus,

but I was not familiar with the fact

that the liver regenerates itself.

Do you infer that the Greeks knew that?

Yeah, absolutely.

I think they did know that.

I think probably through the experiences and battling

what have you,

they could see that you could sustain a dramatic injury

to the liver and that unlike any other organ,

it would regenerate.

But at the same time,

it's taken us 3,000 years to get to the point

that one, we can successfully transplant it, right?

That was the pioneering work of Dr. Tom Starsel.

We first attempted it in 1963.

We got it to work in 1967.

It saved tens of thousands of patients' lives since then.

And now Lygenesis is really standing on the shoulders

of folks like Dr. Starsel

and now trying to regenerate the liver

in other places in the body.

Let me ask a nitpicky question before I ask a real question.

Is the skin an organ and does the skin regenerate itself?

That's a good point.

The skin has some ability to regenerate itself for sure.

And in fact, in children,

if a small child loses the tip of a finger

in an accident before the age of seven,

you can actually regrow the tip of your finger.

But we lose that remarkable ability

to regenerate as we get older

and the only organ that retains that capability is the liver.

So you mentioned liver transplants.

Incredible life-saving technology.

Let's call it a technology.

Why do we need Lygenesis?

Like what is the limit of liver transplants?

Liver transplants, we have about 9,000 patients

on the US currently for a liver transplant.

15 to 20% of those patients will die each year

awaiting a liver transplant to become available.

So I would say there's really a fundamentally a twofold problem.

One is supply and demand.

Today, one donated organ treats one patient.

Using our technology, a single donated organ,

because we're isolating the individual liver cells

or hepatocytes from that liver,

a single donated organ could treat 50 patients.

So one, we're kind of fixing

and really upending the supply-demand calculus

when it comes to, you know,

instead of one donated organ treating one patient,

with our approach, one donated organ can treat up to 50 patients.

But the other problem is what

often times people aren't aware of,

which is for all the, you know,

the understandable human drama of a liver transplant weight list,

of all the organ transplant weight list,

where people are waiting for this life-saving gift of organ donation.

Many patients are too ill to even make the list.

So in the US, you have about five million cases

of in-stage liver disease in one form or another.

You have 85,000 deaths.

At least 50% of the patients that could benefit

from an organ transplant don't qualify,

because we know that they simply won't survive the procedure.

Because it's a big open surgery

that involves a lot of trauma,

and if you're very sick already,

you'll probably die from the surgery.

Yes, correct.

So you co-founded the company with scientists

with a researcher named Eric Lagasse, right?

And it was based on research that he had done.

So tell me about meeting him where you were

and what was the work he had done

that you found so compelling that you had to go start a company with him.

Yeah, absolutely.

So Eric Lagasse is a professor at the McGowan Institute

for a generative medicine and pathology at the University of Pittsburgh.

At the time, I was an entrepreneur in residence

at the University of Pittsburgh,

and I'd spent 25 years doing drug development

and had been fortunate to work on a number of very innovative programs

and had started and sold a number of companies

and so was working with the University of Pittsburgh

because they get almost a billion dollars of NIH funding annually.

It's remarkably through remarkable research enterprise,

both at the University of Pittsburgh

and the University of Pittsburgh Medical Center or UPMC.

And so they wanted to get more companies spun out

as a function of that funding.

And so one day, a colleague of mine took me to meet Eric Lagasse.

And what Eric told me was a remarkable story in two ways.

One, he showed me these remarkable pictures

from his publication in Nature Biotechnology,

showing that he could regrow organs in the lymph nodes of mice,

that he could take liver cells from a mouse

and graft them into the lymph node of another mouse.

And these animals had a genetic liver disease.

And so as a function of that liver disease,

they would otherwise die from that liver disease.

But when he engrafted these hepatocytes into their lymph nodes,

those lymph nodes acted as living bioreactors

and they literally grew those animals miniature livers,

so that instead of dying from their liver disease,

100% of them were rescued from that otherwise fatal liver disease.

So he had these pictures that were truly jaw-dropping

of these actopic organs and places in the body

that they should not otherwise be.

So I just want to repeat what you just said,

because it is the central extraordinary fact

of the thing that you are doing, right?

What Legastid was, he had put liver cells,

just cells, into the lymph nodes of these mice

that had liver disease.

And within the lymph node,

there grew a teeny liver that worked,

that did what the big liver needed to do,

and the mice didn't die.

Like, why should that even be true?

Yes, so two things.

One, over time, the lymph node disappears.

The lymph node acts as a temporary bioreactor

to get that ectopic organ,

and by ectopic, we just mean in a different place in the body.

That ectopic liver to grow.

And in fact, those ectopic livers in mice

could grow to 70% the size of a normal liver,

so he could grow really quite large ectopic livers

using these lymph nodes.

And that doesn't mess the mice up.

Or a lymphatic system or something like that.

Yeah, so remarkably, we've seen no untoward effects

on the immune system.

Now, partly because let's stop and talk about lymph nodes

for a second, right?

So lymph nodes in the human body,

we have 450 to 700 lymph nodes spread throughout our body,

a majority in our gut area, right?

And they've helped us as a species survive infection, right?

Because what a lymph node does

is its primary evolutionary function is help bioreacty cells.

So when you develop a cold,

you have a sore throat,

and you feel that nodule,

that kind of marble,

or maybe even large marble underneath your jaw,

that's a lymph node that's bioreacted billions of t-cells

to help you fight that infection.

When you say bioreact, you basically mean grow, right?

Yes, yes.

It is admittedly biotech jargon term for grow.

That's exactly right.

Okay, so the lymph node is a really good place for cells to grow.

That's one reason it works, or it works in animals.

You said there were two reasons.

What's the other reason?

The other is what's special about the liver

and why even the Greeks knew that it would regenerate

under the right circumstances

is the fundamental cell of the liver is the hepatocytes.

Hepatocytes are naturally regenerative,

and so Eric's fundamental scientific discovery

was that if you combine that natural regenerative potential

of the hepatocytes with the natural ability of the lymph node

to bioreact cells,

you get this remarkable effect,

and you could think of it as the flip side of the cancer coin.

Many people are aware that cancer probes the environment

to form tumors,

and very often cancer will grow tumors

in someone's lymph nodes.

In fact, the classic sort of staging question in cancer

is, has it spread to the lymph nodes?

And if it has, in the case of cancer, that is bad.

That is bad, exactly right.

Precisely because lymph nodes are such effective bioreactors

and they are agnostic as to what they bioreact.

They're so good at growing cells.

Yeah, exactly right.

So if a cancer cell gets in there,

the cancer cell thinks,

man, this is a fantastic place.

I have access to blood and nutrients,

and I have a confined space that I can focus on growth,

and what you end up are these,

is the spread of these tumors.

Right.

Well, what Eric realized is that you could turn that biology

to a therapeutic instead of a malignant potential.

So by putting a cell therapy,

like a hepatocyte into a lymph node,

you could generate functional tissues

that exerted life-saving effects.

And so he showed me those first pictures from his study,

and it really was jaw-dropping.

And I asked him that afternoon,

what I thought was the Gacha question,

because it's so often is with academic-minded professors.

I said, well, you know, that's great, Eric.

It's incredibly impressive.

What about large animals?

Right, it's good news for mice, right?

You must, exactly.

You have the phrase micely and primates exaggerate.

Drug development.

I love that.

I had not heard that.

No, somebody told me that 25 years ago.

That's fantastic.

I'm going to steal it, actually.

That's wonderful.

So, and he said, oh, yeah, Michael.

And in fact, his colleague, Dr. Palofantes,

who was our co-founder and chief medical officer,

showed that the exact same principle applied in pigs.

So they showed that you could take a pig

that would otherwise die from a fatal liver disease.

And you could rescue that pig.

Using the exact same procedure.

And they even tried a different model,

where they surgically injure the liver.

So there's something called a porta-cavel shunt,

where you can go in and kind of rearrange the plumbing

of the liver, so to speak, to deprive it of blood flow,

which was a procedure that Dr. Starrzel had pioneered

as a way to test and develop the procedure

that would eventually become liver transplantation.

And again, rescued those animals.

And he told me something that as a drug developer,

you virtually never hear.

He said, Michael, I can't get this not to work.

And as a drug developer, I'd spent my entire career

and the entire industry really is focused on

getting the exact right drug delivered in the exact right way

to the exact right patient, the exact right dose.

Oftentimes, at the exact right time of day,

and you hope for an effect.

And what Eric was telling me was that nature

had kind of primed this approach between

the natural originative capacity of the liver,

the natural bio-reactor capabilities of the lymph node,

and that when he said he couldn't get it not to work,

quite literally the hairs on the back of my neck stood up.

And I said, okay, let's back up and go over this whole story again,

and really that day was the genesis of the company.

So you start the company nine years ago?

Is that right? 2017?

Yeah, times flown.

Yeah, I mean, it takes a long time to develop new therapies, right?

This is regenerative medicine, cell therapy,

a hard new thing to do.

So where are you now, nine years later?

Yeah, so we are now running a first in human phase 2A clinical trial.

So this is a clinical trial in patients

with in-stage liver disease.

These are patients.

Most of them, not all, most are on the liver transplant weight list,

and they can come into the trial.

They may have any number of different types of liver disease,

but we're going for patients who have in-stage liver disease

that typically have a life expectancy of many months or a few years.

Okay.

Because we know that one limitation of our approach

is that when you engraft these cells,

they do take time to organize themselves.

It's not like the next day you have a fully functioning actopic liver.

We know that it takes probably two to three months as our best guess.

And so we want to make sure that these patients have the time

to have the potential beneficial effects of the therapy.

So we've now transplanted our first cohort of patients.

There were four patients all done at the Houston Methodist Hospital.

Typically, the phrases, you start low and go slow.

You start low and go slow because you're not sure what the effect will be.

And so the FDA had counseled us.

This first trial is just going to be 12 patients.

Okay.

So we have three different dose groups.

We've completed that first dose cohort,

and we had a data safety monitoring board meeting

where they look at all the safety data,

and the efficacy data to date, and they said,

okay, you know, it's looking good.

Let's go on and dose escalate as per the protocol.

And so that's what we are in the midst of right now.

When are you going to know if it worked?

If this trial, you know, had a positive result

that will allow you to move to presumably the next bigger trial?

Yeah, we should have a very good sense of that

in the middle part of next year.

Okay.

So the middle part of 2027, and then, yeah, move on from there.

So let's talk about how it works.

So there's a patient, as you've said,

who is, you know, has liver disease,

has some liver function left,

but it's not looking good for them.

And then there is what?

A donated liver?

Like, what actually happens?

That's exactly right.

When an organ becomes available,

if the organ is eligible for transplant,

then it's transplanted into a patient that needs it.

Some organs, though, are not eligible for transplant.

And that can be for any number of reasons.

You may have been injured because of the cause of death.

They might be a little fatty,

where when the transplant surgeon looks at the organ,

they think, ah, you know, that's not going to be a great fit

for this particular patient,

and so that they pass on it.

When they come to us,

we then have a facility at Houston Methodist currently,

where we can take that organ,

and it takes us just about four or five hours.

It's a 70 plus step process,

but we start with the full organ,

and after 70 steps and about, you know, four to five hours,

we've isolated and suspended those hepatocytes into a solution

that we then career over to the endoscopic ultrasound suite.

And so just to be clear,

when you say the hepatocytes are in a solution,

it's like a bottle full of liver cells in liquid.

Yeah, that's exactly what it is.

It's a small syringe, really,

because we're only injecting about one milliliter

of the cell's suspension,

but it's literally like a brown, thick liquid.

Yeah, so a syringe,

like what, like you'd get in a shot,

but instead of a vaccine,

it's liver cells from a donated liver.

Okay, so then you career that over to go on.

Yeah, and so the patient is put under light sedation,

and just the way you might have an indoscope,

you know, to look to see if you have an ulcer

or to, you know, have any number of diagnostic procedures.

Yes.

Basically, an endoscopic takes that indoscope under sedation

down through the mouth of the patient,

and then threads it down their GI tract,

kind of into their gut area.

And at the end of that indoscope is an ultrasound.

Okay.

And so the ultrasound,

you can basically look adjacent to the gut wall,

and lymph nodes there show up is,

they almost look like bubbles to the untrained eye, right?

So they kind of look like these bubbles

that come into view via the ultrasound.

Okay.

And the endoscopist takes a five-foot needle

that threads down through the indexing.

Yeah.

It then goes through the gut wall

and punctures into the lymph node.

So it's like a shot.

It's like a shot.

But it's going into your stomach across the wall

of your stomach and into the lymph node.

That's exactly right.

That's exactly right.

And so this takes about 10 minutes

to find the lymph node and inject the cell suspension.

And so we inject one milliliter into that lymph node.

They withdraw the needle and pull the scope out.

And the procedure itself at that point is done.

The cells are in the lymph node.

The patients put on immune suppression.

Right. The patients put on immune suppression

because these are cells from somebody else.

It's just like if you get a transplant,

your body cells will be like, oh, that's foreign.

I'm going to get rid of it.

That's exactly right.

Yeah. Okay.

So the patients put on immune suppression.

And then if it works, what happens?

If it works, what happens is those cells find themselves

in an environment that they find very comforting

and very nourishing.

And so they use those bioreactor aspects of the lymph node

begin dividing because they're natural stem cells.

And they begin organizing themselves

into liver lobules, which are these little hexagonal collections

of cells that are kind of the functioning filtering unit

of the liver.

And from all of our preclinical data in both small and large animals,

that division will continue to go on.

And the vascularization will then occur.

So the lymph nodes are well vascularized anyway.

But what you find is that these ectopic organs

recruit cells from the patient's body

to form additional vasculature,

so additional blood flow to that ectopic organ

so that over time,

and again, our best guess is it's over a few months of time,

what you'll be left with is this functioning ectopic organ.

So I'm picturing one tiny little mini liver.

I don't know.

How big is it?

Is there only one?

How big does it have to be?

Or how many do there have to be for it to be clinically useful?

They can get quite large.

In small animals, you can get up to 70%

of the native liver grown in a lymph node.

In the larger animals, it was a smaller percentage.

And your question about clinically meaningful,

when you talk to hepatologists

or folks like our chief medical officer, Dr. Fontez,

who's treated these patients across his entire life,

if you can bump the functional amount of liver

for one of these patients by 10 to 20%,

you will alleviate a lot of the signs and symptoms

of their in-stage liver disease.

And in fact, in-stage liver disease is a problem

because very often patients don't know

that they have advanced liver disease

until pretty far along,

because it is a redundant system.

As a species, we have very large livers

to help us with the various things that we might eat

and get exposed to.

So it's a redundant system,

and by the time you know you have a problem,

you really have a problem.

And so that's why we think,

if we can even bump it up by 10 to 20%,

I think this will be a transformative therapy.

So we envision clinically the potential,

both to treat patients that are never going to get in organ,

because they simply don't qualify for the list.

But for others, it may be more clinically

what you're doing is just buying them time

so that an organ can become available for you.

We're going to take an outbreak right now,

and then we're going to come back

and talk about a bunch more things,

including why what Michael and Legenesis

are working on might not work.

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I want to go back to one detail or one step

you mentioned of what happens inside the body

in this process.

And that is after the cells have been injected.

They're just cells.

They're just random liver cells floating around.

And you said they organized themselves

essentially into a liver, into a little liver.

You didn't say into a liver, but that is essentially what's happening.

That part, that seems like the central shocking thing

that is going on here.

Right?

And I've talked to a couple of other people

doing regenerative medicine in other ways.

Somebody doing bones, somebody doing blood vessels.

And they both use this term that I think I've seen you use elsewhere

and that I'm reminded of here.

And that is more of a phrase.

That is that cells are intelligent.

Cells have some intelligence, which is not intuitive,

but I'm reminded of it here.

Like what's going on?

How does that work?

It's a great question.

And in fact, it's almost a testimony to why

hygienicists exist, that many academic researchers

that never found companies can get not distracted

because it's really the fundamental scientific pursuit

of why and how.

But to Eric's credit, when he discovered...

This is a long you don't know.

This is the answer you don't know.

You're absolutely right.

The short answer is we don't know.

The longer answer is...

Well, short answer is we don't know too.

I think you're right.

The cells are remarkably intelligent.

And we know there's those dozens of pro-growth signals

from the disease liver.

We know they play a role.

But exactly how it works.

I'm thankful, let's put it this way,

that Eric focused on trying to get it not to work

because he ended up finding that it was so robust.

Yeah.

Where a lot of researchers would spend their whole life

trying to understand the why and how.

Well, and clearly in other organs or body parts,

like I remember in the case of blood vessels

and this is a classic challenge when people are trying

to grow organs or many organs,

is they do a lot of work to create the scaffolding,

to create the structure, right?

And so the fact that in this instance,

it is naturally self-organizing,

solves what seems to be the largest problem,

or at least a key problem for many other organs.

I would just say, yeah, it is better to be lucky than good.

Yeah.

And that really is a case where...

Yeah, we pick the right organ.

Nature has really engineered this in a lot of respects, right?

Like as a drug developer,

so often you're trying to trick the body, right?

Like you're trying to trick it to do something that's unnatural

and have to fight against it all along the way.

I think what excites me about regenerative medicine,

but like Genesis in particular,

is that we just have a lot of headwinds

because of evolution and biology,

then the naturally regenerative capability of the liver,

the natural ability of the lymph node

to buy a react of a variety of tissues,

because Eric shown that it's not just hepatocytes

and ectopic livers,

he can grow...

he can put pancreatic eyelets

and rescue animals that have diabetes

by putting those eyelets into lymph nodes.

We put the thymus from a young animal

into the lymph node of an old animal

and help reboot that old animal's immune system.

And in fact, the whole animal starts to look more youthful

physiologically as a function of that.

So I think the lymph node is going to act

as a platform for a variety of different tissues.

And so at like Genesis,

the liver is certainly the most, you know,

far along of the acids we have,

but we also have this work on the thymus

and the kidney and the pancreas.

Because as I said, the lymph node is...

it's just remarkably agnostic about the type of tissue

that it bio-reacts.

And just to be clear, that other work,

that is not yet in humans, right?

That is earlier.

That's correct.

That's exactly right.

Yeah, correct.

In the liver trial,

which is the one that's the farthest along,

so let's talk about that.

What might go wrong?

Why might it not work?

In terms of what might go wrong,

our body's ability to reject,

what's called allergenic,

which is just the medical term, right,

from another person, say,

from another animal.

Our body's ability to do that

has been central to our success as a species.

And as a result,

when you try to get around it,

you have to use very powerful drugs

to try to convince it not to reject those cells.

And so I think acute rejection,

especially when you're injecting a relatively small number of cells

as compared to a very large organ.

I think that's one thing that you worry about.

Oh, the small number of cells

because it's like easier for the body

with its immune response

to wipe out a small number of cells.

Exactly right.

Yeah.

Dumb question.

I mean, I sort of know the answer,

but presumably the patients with liver disease

have some of their own liver cells left.

Yes.

What if you took some of their own liver cells

and put them in the lymph node?

You wouldn't have the rejection problem.

That's a great question.

And we get that a lot.

For the patients that were targeting

with in-stage liver disease,

the liver is also prone

to potentially catastrophic bleeding risk.

And so the notion of biopsying,

a fibrotic liver,

is one that has very significant medical risks

associated with it.

Okay.

Another one.

I'm this one I'm just making up.

Can you do like induced pluripotent stem cells

from the patient

and turn them into liver cells?

That is exactly our vision,

actually, for our second generation therapy.

So our first generation therapy

is going to be these allogeneic cells.

The second generation will be exactly that.

The hope,

and there are labs around the world

working on this.

No one's solved it yet.

But induced pluripotent stem cells

where you take a skin cell

and you push it back to a more embryonic-like state

and then bring it forward as a different cell type.

We've had tremendous success

in a variety of cell types.

To have a fully mature human hepatocyte

is something that no one's been able to do yet.

No one's been able to get a stem cell

to turn into a mature human liver cell.

Exactly.

So, okay.

So immune rejection,

that's one problem.

What else?

One thing that we didn't worry a lot about,

but just because we had

endoscopic colleagues that assured us

this was a very safe procedure.

But, you know,

I've taken several drugs first into human.

You always worry.

And so, with patients with bleeding risk,

you know, the endoscopic ultrasound

is something that you want to make sure goes well.

But again,

we're using incredibly talented endoscopist.

They do the same procedure

to look for patients

who've been newly diagnosed with pancreatic cancer.

The good news is

we're asking endoscopist to do something

they're very familiar with,

using equipment they're very familiar with.

But still,

you always worry about,

you know,

you're going through the gut wall

with a needle and into a lymph node.

And, you know,

you always want that to go well.

And at this point,

we've had no serious adverse events

from the administration itself.

But that's something,

you know, that's why you start low and go slow,

as they say, right,

in these first and human trials.

And then, so,

these are the sort of

technical risks or medical risks.

Is there, like,

running out of money?

I mean, a biotech company

with no product.

Like, how's that part of it?

Sure, yeah.

There's always business risk.

You know, I was told a long time ago

that the definition of a biotech

is a company unencumbered

with revenues.

And, you know,

you don't have to worry about the profit of the loss.

Exactly.

Only half of it.

The DNL is very,

yeah, we only have half of it.

So, I will say that,

yeah, you always worry

about running out of money.

Drug development always takes long time.

It always takes longer

and costs more than you hope it will,

even when you've done it a long time.

It's always surprising challenges.

I will say, you know,

we're fortunate to have wonderful investors

that are patient with us,

despite the inevitable setbacks,

as we push forward,

as a drug developer,

you're always taught

that great drugs

are killed at least three times,

right, before they actually

make it over the finish line.

So, we have folks that are with us

and supporting us.

And we've tried to be very

capillary efficient.

Like, Genesis is just half a dozen people

and we've raised under $40 million

to date, where when you look

at the typical cost

to get an investigational new

drug clearance by the FDA

or an IHP,

that usually costs hundreds

of millions of dollars.

And just, you know,

we've been fortunate

to not need a staggering

amount of capital to get

to where we are,

which is in the clinic,

in part because of the NIH funding

that Eric Lagasse had

at the University of Pittsburgh,

and it really is why the NIH cuts

that we've seen happen

really are undermining

the kind of future potential

of so many new therapies

and technologies

that you're simply not

going to hear about

because the funding wasn't available

for them to move forward.

But thankfully,

Eric's work was very well funded

by the NIH,

and so we've been able

to take it forward.

So, I just want to talk

for a minute more broadly

about...

I was trying to decide,

should we talk about

cellular therapy

or regenerative medicine, right?

You're kind of both.

Yeah.

I mean, we're sort of

reading the world, right?

But I'm not sure...

I mean, I recognize

that what you were doing

is distinct in particular.

But it does seem like

there is this broader landscape

that you were part of

where people are using cells

to treat disease.

And people are thinking

about how to create new versions

of skin and of blood vessels

and are working on new ways

of thinking about organs

and transplantation.

I mean, what is the broader

landscape look like

from your point of view?

And where do you fit into it?

And like, what are the big shifts?

Like, what do you expect

to see in the next five,

10 years?

Look, I think in 10 years,

there is the realistic possibility

that at least in some cases

like a liver transplant

that those are relegated

to medical history books.

Yeah.

That the notion of

being on a waitlist for an organ

will hopefully seem

as foreign and strange

to our children and grandchildren.

Like, you talk to a grandparent.

You're like, wait,

there were these sanatoriums

with ironed lungs everywhere.

So I think there's this opportunity

that we really are going to be

turning the page

from medical history perspective.

And that there is the potential

that in the really foreseeable future,

you're going to be the source

of your own medicine.

You're going to be able

to engineer your own cells

to avoid the problems

of immune suppression.

And use them in ways

to induce remarkable

regenerative outcomes,

both in terms

of organ regeneration,

potentially in terms

of limb regeneration.

And do things

that again seem

like science fiction today.

Now, things always take longer

and cost more than you hope.

But I do think

when you look broad brushstrokes,

we really are on the cusp

of a very exciting time.

We'll be back in a minute

with the lightning.

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And now we are going to finish

with the lightning round.

You were a practicing clinical psychologist

before you got into the drug development business.

Briefly, how did that happen?

Briefly, I was very fortunate to work

on some research methodologies

that were used widely in clinical psych,

but had a lot of applicability in drug development.

And so got involved in consulting

in that kind of niche area of research design.

And really just love the intersection of science and business

because you saw how much more rapidly

you could make progress

and how many more lives you could affect

than just writing publications.

And I'll also say when you meet with the FDA,

having those group psychotherapy skills

can come in remarkably helpful.

So I feel like you're not joking

when you say that.

It plays in your joke.

But you're right on that.

You kind of joke about the skills

of a clinical psychologist.

But those key skills in business settings

being able to kind of take the perspective

of other people very rapidly

and pick up on concerns they may have.

That actually ends up being

incredibly essential in regulatory interactions.

So you did research on smoking cessation

in your previous professional life.

What's one thing that you learned about addiction

in your research?

You know that when you're trying to understand

why some people return to substance use,

so much of it can come down to momentary decisions

and small slips and how a single slip

can lead to a full blown relapse.

But from that single slip,

people can recover and rebound.

And finding out how these fleeting life stressors

can play an incredibly large role

in just kind of that chaos of life

that kind of pushes us on different trajectories

that ends up making you a smoker or a non-smoker.

So is it just random?

I mean, what do I...

What is the inference from that?

Like, what does that mean?

Yeah, you know, some of my work was actually

in something called catastrophe modeling

which was a subset of chaos theory

that kind of fundamental of the butterfly wings

causing the tornado, right?

That these very small changes in life

can have this outsized impact.

And it was hard to avoid that conclusion

when you look at real-time monitoring

of folks trying to quit smoking.

So I understand you also run a nonprofit

called Harm Reduction Therapeutics

that brought to market a generic

over-the-counter version of Naloxone.

That's correct.

Briefly how that happened.

There was a huge unmet need,

as you know, as the opioid crisis unfolded.

Naloxone had been FDA-approved since 71.

It had been off patent since 85.

It was an incredibly effective,

incredibly safe opioid overdose and adult.

But for profit companies,

we're refusing to take their products over the counter

because they were making such high margins

on them as prescription products.

They got extraordinarily frustrated

with that set of circumstances

when you had over 100,000 Americans

dying annually of opioid overdose.

So my colleague, John Pinion,

I formed a 501c3 nonprofit pharmaceutical company

and ended up bringing in over-the-counter

three milligram Naloxone nasal spray.

And doing it as a nonprofit,

we entered the market at about $36.

We're at $33.

Now at the time Narcan was $140.

And lo and behold, you can buy them now

for about mid $30 per pack.

So the hand of the market did its job.

So we forced other folks to go over the counter

with their product,

force them to lower their prices.

And yeah, that's something that was a

very satisfying professional accomplishment

to kind of help the whole field move forward.

So our product revive

is now this FDA-approved over-the-counter

three milligram Naloxone nasal spray

for emergency treatment of opioid overdose.

Last one.

You've written that if you're running a startup,

you could only have three out of the following five things.

Family, friends, sleep, exercise, and hobbies.

Which are your three?

Oh, man.

I'm very fortunate to have a family that I adore

and cannot spend enough time with.

So I would say family.

I do exercise regularly.

Oh, I was so hold on.

What were the other?

So you have to choose now one from the following three.

Friends, sleep, or hobbies.

I don't see near as much of my friends as I would like.

So I guess I would say hobbies

are the other thing that keep me grounded.

Also, you don't sleep.

Unfashionable.

It's unfashionable to sleep.

Yeah, exactly, exactly.

Not as much as I'd like.

What's the hobby?

Amateur musician, so kind of singer-songwriter

and yeah, so amateur musician in my very spare time.

Is there a song of yours we should play

under the credits of today's show?

Can you play us out?

I'll think about it.

Sure.

I'll sing you something you can play out.

Okay.

I was delightful to talk with you.

Thank you for your time.

Jacob, it was really, really nice.

These were wonderful questions.

I actually really enjoyed the conversation.

I'll sing you something.

Michael Hufford is the co-founder and CEO of Light Genesis.

Today's show was produced by Gabriel Hunter Chang,

edited by Lydia Jean-Cott and engineered by Sarah Bougare.

I'm Jacob Goldstein.

We'll be taking the next couple of weeks off,

and then we'll be back.

In the meantime, you can email us at problematpushkin.fm

or you can find me on LinkedIn or on X.

I'm at Jacob Goldstein.

Thanks for listening.

We'll be back in a few weeks.

Oh, sing it.

Sing it.

And joy doesn't come around.

It doesn't come around.

Oh, sing it.

Sing it.

And joy is come around.

And we'll be back in a few weeks.

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