FDA Direct: Stanford Physician-Scientist: FDA welcomes Dr. Tidmarsh as CDER Director

Here's the text with all time codes removed:

All right, we're live. We're doing this.

This is happening right now. Hey, Marty

Makary here. I'm here with Sanjula. And

we have a special guest. Actually, one

of our own now we can claim. And that's

George Tidmarsh. Uh, great to see you,

George. Welcome to the FDA. You're our

new director of CDER. And we thought we

would just pull you out of the office

here and uh have a little conversation

so people can get to know you.

Now, for our audience who may not know what CDER

stands for, it's probably important to

clarify that's our Center for Drug

Evaluation and Research. Yeah,

welcome.

Great. Welcome. Yeah, so great to have

you. So, um, you have a gosh, such an

impressive resume, just impeccable

credentials. Um, and so we'll talk about

that just for a quick second, but we

want to get to know the man behind the

credentials and um, and a little bit

about you and your story. You are coming

from the faculty of Stanford University.

You are trained in uh, pediatrics and

then dual board trained in pediatric

oncology and neonatology.

That's correct.

So double trained. And then you've had a

interesting career where you've been uh

both academic and led, well why don't you

tell the story you led a center at

Stanford. Yeah.

Well thanks. Um yeah Stanford's been my

home since I went there as an

undergraduate in 1979 and uh I've been

affiliated for most of the however many

years 40 some, 44 years since then. Uh

there was a short break but um I I as

you said I I did my undergraduate in

microbiology. I did my pediatric

residency and then well medical school

PhD pediatric residency and then um two

fellowships. And that's a whole story in

and of itself how I ended up with two

very disparate fellowships. Um as a

physician you would know how unrelated

seemingly neonatology and pediatric

oncology are but uh they're both loves

of mine. I stayed clinically active, but

I got pulled into biotech

uh by my PhD mentor, Irving Weissman, and uh I

asked, "Hey, can I come back in the lab

and do some work?" And he said, "Hey,

I'm starting a company." So, that worked

out pretty well. And and um I was

clinically active for a number of years

while I was in biotech. But, um yeah,

it's been been a great ride. And I just

want to thank you all for welcoming me

here in such a warm way. This has been

really a fantastic day. I I uh met with

so many people and what I told uh the

group the staff within CDER today is

that 30 years I've worked with FDA and I

as a sponsor and I developed a a just a

a real respect for the quality and

integrity of the people at FDA and that

went up a magnitude today meeting with

everybody.

Yeah. How was your first day? I know you

met with the leadership at CDER. We met

with uh Jacqueline Corrigan-Curay who's just

been outstanding and and has been a

great resource. Um so how's your first

day been?

You know busy uh it's a whirlwind

for sure. Some of it you know

administrative obviously but incredibly

informative and again as I say that the

the warmth and the enthusiasm I just

didn't expect. Um so

I'm sorry we didn't give you heads

up we were going to do this today. It

was just a surprise.

No, that's all right. Well, Marty said

Marty said, "Hey, we'll we'll do a

podcast." I'm like waiting for questions

and some kind of preparation. I see

that. I see that. So spontaneous from

the heart. So that's great.

Now, you did something amazing this last

weekend. Uh tell us about that.

Uh the uh Trans Tahoe swim relay. So

it's uh uh Lake Tahoe in California and

Nevada. So, if for those of you who

don't know, um the state line between

California and Nevada goes straight down

the middle of Lake Tahoe. And so,

there's this annual swim. It's been on

for I want to say almost 40 years. 30

years.

What's the size of Lake Tahoe? Is it

like the Indian Ocean? Is it like Gulf

of America?

Um it is a oblong body of water that's

about 28 miles long and about 11 to 12

miles wide. So, we we swim the width.

It's six swimmers. 28, not the

long. So, right. So, some some uh solo

swimmers have tried to swim the 28 and

many don't make it. The it's it's one of

the toughest open water swims. Um not

only because it's that long. Um but it's

also at 6,300 feet altitude, so it's

high. And the water temperature is

fairly low.

So,

Like how low? I'm a Florida girl, so I can

only swim in warm water. How?

For those of you on the Fahrenheit, it's

low 60s. It's, you know, 63. Um, but you

know, you're starting the race at 48

degree ambient air temperature. So, you

know, you bring warm clothes and plenty

of coffee. So,

yeah. Wow. No,

I know exactly what it's like. I I run

to the tip of Mount Everest every month.

Uh, something I just like to do as a as

a hobby. So, I know exactly what it's

like. Yeah.

Oh my gosh. How did you get into

swimming like that?

You know, it's very interesting. So, I I

restarted my career as a swimmer at

about 40. I swam in high school, very

competitive program and one year in

college and then um you know what

happens when you hit these milestone

birthdays like 40 which was uh 1980 um I

got back into um swimming just for

health and and actually what happened is

I my first son my oldest son was four

years old and I was teaching him how to

swim and then I decided to swim a few

laps and I just felt I felt horrible

so I said I got to do something. So I

got back into training and then

competition and then I was um in a

venture group, venture capital group um

you know uh pitching to start my first

company threshold and the guy basically

one of the partners said basically you

have to come swim on my team if you want

funding is basically kind of what he

said.

Wow.

And um wasn't quite that harsh but it

was implied certainly.

It's quite a skills test for funding.

Yeah. So that's how it started and I

loved it and then um I've been with many

of the members of the team for 20 a

little over 20 years.

Wow.

Yeah. Some years we end up having to you

know I mean COVID was a rough time and

there were some you know it was only

about two or three years over that

period we did not do the race.

Wow. And just to make sure it's clear, I

I swam on that for uh since you know the

early 2000s up until 2023.

We won it we've won it a total of nine

times over that period of time. Um and

then I opted to try to go out on top.

And so now I um set the whole thing up.

I drive the boat. I organize it. Um, but

I passed on the captainship to a friend

and colleague that's been with me on

that race for 20 years.

Wow.

Have you found your new training pool in

White Oak, Maryland?

You know what's really interesting and

wonderful, and this is the way swimming

community is, I've had several people

within FDA reach out to me and say, you

know, hey, glad you're here. I swim,

too. And so, I I felt like that was

going to happen. It tends to happen. Do

we have a swimming club that we need to

No, there's, they're local masters

programs. Um but I'm going to find out

more from some of the FDA employees who

reached out to me for sure.

Wow. And that was all today. They

reached out because just I guess last

night or this morning it became public.

Yes.

And um

so wow. So incredible swimmer um sailor,

drug developer, scientist, inventor,

academic, teacher. So pretty impressive.

What skill set did God withhold from

you?

Well, that's uh very complimentary. I

really appreciate it. Um I I think the

number one thing that you know I need to

work on is motivating people. I think

you know that's the one thing that that

that's most important I think coming

here and is and and and dealing with

large large groups of people. So, and and many

people that that I have to, you know,

manage underneath me because I've

started companies and I usually have

turned it over to someone else when it

got to a certain size. La Jolla

Pharmaceuticals was probably the largest

about 600 people. Um, this is maybe the

principles are the same, but um, you

know, I think I have to be comfortable

in that larger role. Yeah.

I can I ask so you know you have such a

phenomenal career, right? And you've

done so much, but coming here is very

different than what you were doing

before. I'm sure it's a lot of sacrifice

both, you know, for you and your family,

moving cross country, all of that. Why

did you agree to accept the job?

Well, I'll tell you, he's sitting right

across from me. Okay. For sure. Okay.

And I'm not blowing any smoke there.

So, I met Marty um last October at the

Stanford conference that Jay Bhattacharya

put on and I was very impressed. And

then um when Jay came out to was

nominated came out to DC to prepare for

confirmation. I came out too and was

helping him and you know by you know

just uh proximity met Marty and I one

night we were the three of us were

having dinner I looked at Jay I said Jay

you know I'm I'm more suited for FDA

than NIH for sure. And then Marty and I

were talking and I just really gained a

massive amount of respect for you,

Marty. And um and and you know,

Courtney, my wife, could see it and and

she said, "You have to do this." So I

listened to her. I've known her for 40

years. So when you have somebody like

that, um you you just got to listen. But

I I don't think there's anyone else

necessarily that I would have stepped

out of what I was doing while I'm

teaching at Stan was teaching at

Stanford. You know, I was really

semi-retired and um you know, I was

chopping wood at our place in Colorado

and sailing.

And um so you know, it it is it is a

sacrifice, but

it's the most wonderful and easy

decision I've made, really, in my life.

Wow. Well, we're so

glad you're here. Um I was wondering if

he was going to say it was the talk of

the farmers market now twice a week that

really closed the deal, but um sounds

like there are a lot of reasons and uh

people at CDER are very excited about

you being here.

Thanks.

Have you seen our gym?

I did go by there, but I didn't see the

pool yet.

Okay. I'm not sure we want to show it to

him because.

Do we have a pool?

No, we don't have a pool.

Okay. And I I was going to say I'm not

sure he'll be in his office if he sees a

gym and a pool with the same, you know,

high quality facilities that we have

here. It

very high quality facilities. It's very

nice. So yeah.

So I have to ask, so if I remember

correctly, you've kind of brought, is it

seven FDA approved drugs to market,

right, throughout your career.

What are you most excited about now?

What do you think the FDA's opportunity

is from all the things you've learned in

through that process and kind of what

the future holds?

You know, to so over that 30-year

period, I've seen a lot of changes in

FDA. And, you know, I I'm a little bit

of a student of the history of FDA. And

what I can say is the FDA has evolved

and improved over time and certainly

over the 30 years. And

so we to say we need to improve FDA does

not imply anything negative. That's

right. Okay.

It's a wonderful agency. It is the

backbone of the health of of Americans.

My experience has been incredibly

positive from the sponsor side, but I've

also seen growth and improvement. And so

I think there's more to to grow and

improve. And um that's you know

improving just the the um efficiency of

the process um improving the

communication.

Uh, with the outside homogenizing things

so that one sponsor doesn't hear one

thing and another another thing when

they're working on the same disease

state. So, um, the point is this, that

FDA, as great as it is, like anything

else, can be improved, and I've seen a

massive amount of improvement, and I'm

hoping that I can be a part of even

more.

It is kind of cool on the um listening

tour that we've been on with drug makers

and and CEOs, we hear those themes.

Consistency, reliability, communication,

um, and modernization of the agency. So

we have opportunities that we've just

never had before because of technology

and other things. So this is an exciting

time for the agency to modernize and it

you're exactly right. It's not a

statement of criticism of past

performance. It's just saying we've

never had this opportunity before. We

never had opportunity before to do big

data post-market surveillance and

bringing in AI and trying new pathways

and innovating with gene therapies such

that we can have a plausible mechanism

pathway so that a baby KJ can get the

gene therapy and and that kind of is

right up your alley the whole baby KJ

story because of your background in both

neonatology and oncology.

What's it like for you to hear that the

FDA

uh adapted its regulatory process to

enable a in utero baby to get a a gene

therapy such that as a newborn um and

the therapy was uh shortly after birth I

believe but but the diagnosis was in

utero then they started working on this

gene therapy as I understand it and then

here you have a discharge from a

hospital after a gene therapy that you

know did not result and any

complications that we know of so far.

It's amazing. Um the you know progress

in not only the diagnosis but the the

therapy for uh heritable genetic

diseases is is stunning. I mean we you

know when I trained we did not have the

tools to even diagnose most of the

genetic disorders were diagnosed mostly

through a combination of you know

doctor analytical skills lab tests and

some specialized tests. Um, but you know

when I trained we didn't even have

really genetic analyses. I mean to so to

think it's come to that point where you

not only know the targeted genetics

sometimes a you know a base pair

mutation and correct that is phenomenal.

The challenge is is that that's a lot of

work for one patient. So, we have to

somehow be able to generalize that and

um there's always going to be a balance

um between hard empiric evidence and

clinical evidence. Um it it's it's

a challenge and in larger populations of

course you need to demand the the

strong you know irrefutable data of

statistical and clinical significance,

but there's going to be times that

judgment has to come into play.

Especially for very small populations.

Um, so that's a that's to me a fun

balance because, if you think if you look

through the history of medicine, many of

the great breakthroughs were by a single

case study that was, you know,

diagnosed and treated in a way and that

led to great breakthroughs for large

populations.

I mean, Sanjula, when George and I had

conversations,

um, not with any intentionality, but

just, you know, talking about science

and regulatory science, I was really

impressed at how he would talk about

common sense, right? There's a lot of

reforms that just stem out of common

sense while maintaining gold standard

science. So obviously he's got

impeccable credentials scientifically,

but uh thinking about things with a new

lens, with a fresh perspective. And in

general, um people here at the agency

have told me that when there's been a

vacancy at a job at the FDA,

historically,

nine times out of 10 or 9.5 times out of

10, it went to an internal candidate.

And now it's a little bit more like

50/50. And so I think there's value in

the incredible institutional wisdom of

folks that have been here and know the

process that is incredibly valuable. But

also there's value to fresh new

perspectives and fresh ideas.

Right. But with context, right? I mean

you were familiar with the organization

and the agency just from a a different

point of view and you kind of answered

my my question for you Marty, right?

Like what attracted you to George? What

were you looking for? And I have to say

as you're building out your team, I

mean, you really have a credentialed

bench of people across the country, wide

expertise, and it's really cool to bring

those perspectives together to tackle

these these big questions.

Yeah. Yeah. You know, it was just sort

of we I remember chatting with George

about some of the biggest controversies

of our day. And I and I just remember

George just sort of approaching these

issues with such an open mind because

you can you can tell in conversation

who's got very strong opinions, who's

listening, who's openminded and I

personally think what makes somebody a

great scientist, a great physician, a

great leader is their willingness to

adapt their view as the data evolves and

show some humility. So that's I would

say that lead characteristic.

Little did you know that that dinner was

really a job interview then? Huh?

I didn't think so.

Well, I certainly never felt that way. I

I think that the uh it was a wonderful

evolution of a collegial and and

collegial relationship and a friendship

at the same time. And um that's a great

thing to walk into in a new position to

have somebody that you trust. You trust

their judgment. You trust their

personality. You trust that you're

fundamentally thinking about things in a

in a framework that's similar so that

you're not going to get um sideways with

each other. And that's ultimately was

the deciding factor because Courtney

would say, you know, boy, yeah, Marty's

a really wonderful guy. I listen to some

of the way you talk and I haven't heard

you this excited or or this sort of, you

know, engaged in something for a long

time. Even, you know, as I got to build

the M-TRAM program, the Translational

Medicine Program at Stanford, you know,

and she witnessed a lot of that. I loved

it because I loved teaching, but it

still wasn't the same. I didn't have

somebody to, you know, bounce ideas off

of that, you know, while you're not

exactly the same way. You don't want

people to think the same way, but you

approach things in the same way.

Yeah. And I I think you'll find a very

academic tone here. A sort of open civil

discourse and that sort of discussion of

ideas is very uh invigorating, very much

like a university. And we want it to

feel like an academic culture here for

those that where that's important to

them.

It really is. I actually just got a a

great email this morning from one of our

staff here who was saying just even

through these conversations um you know,

she was learning a lot and really

enjoyed that you she I'm learning so

much. And I was like, wow, I'm so glad

you shared that. And so I'm I'm excited

to have you on more often and we can

talk about some of these these

interesting topics.

And I will say one thing I remember

about George very distinctly is this guy

gets stuff done. Like we asked him since

he has this neonatology

uh training about the infant formula

issue and man not only did he was

incredibly responsive. Came back with

literature citations, summaries, uh

tapped other experts and suggested names

for uh the infant formula round table

which we had was extremely successful.

Really the world's top infant formula

experts and they didn't have to agree on

everything but we heard from all of them

and we heard common themes of common

sense reforms that we have to make in

that infant formula space. So, I just

remember George just got things done so

fast. And I found out later he gets up

at like What time do you get up? At like

3:00 a.m. or something?

Yeah, it depends. But yeah, roughly

pretty early. Pretty early. Seriously,

you have like a morning ritual.

No, no, but well it has been,

it has been swimming and you know

because swimmers traditionally get up

very early because you only have can fit

so many people in the pool, and you know

um so I'm sort of conditioned over time

and then of course doctors tend to get

up pretty early too. So I do get up

pretty early.

I was just joking around about the 3:00

a.m. but I think it's true. It's not

that far.

Something tells me you probably wake up

that early too. So.

Yeah, I go back to bed though.

Well, I know I have so many more

questions, but I want to be mindful of

time, especially it being day one, but

maybe we could end around where you

started. You know, Marty, you mentioned

it's an interesting combination of

clinical specialties you have. So why

did you choose those two specialties and

enter medicine?

Um, so I love them both. Um, my PhD is

in cancer biology. So, you know, that

was was trained, you know, from a

scientific standpoint. And I um my uh

mentor was a a uh immunology stem cell

person and he really sort of started the

uh field of of stem cells as a

generation of cancer, which is now kind

of mainstream. And um I worked on uh the

transformation of bone marrow stem cells

by a leukemogenic virus called the

Abelson murine leukemia virus. So I

really had that scientific background

and so I was kind of destined I mean

everybody's like okay you got to go into

pediatric oncology and kind of the but I

when I did a rotation in in the NICU I

loved it because of the intensity of it.

I I do like the intensity of that. It's

a very numbers oriented. It's very

action oriented. You get immediate

results when you resuscitate a baby when

they come out you know with without a

heartbeat. um and you resuscitate them

and then you see them through till they

go home. It's a pretty special feeling.

Just like it is also special to you know

um admit a you know 5-year-old little

child with acute lymphoblastic leukemia

and watch their progress while they um

you know mature and and are cured. And

it's amazing. I'm now getting emails

from parents and patients that are, you

know, the patients are now in their 30s

and 40s and they want to reconnect. So,

it's a very rewarding field. But

actually, how it happened was I was

accepted into the uh very prestigious

bone marrow transplant program up at uh

University of Washington Seattle. And I

went up there in the thick of winter and

it was so miserable.

It was just like I could not do it. And

um I came back and said, "I'm not

going." And um the head of oncology,

hematology oncology at Stanford said,

"Well, you can't come into this program

this year because that, you know, the

the principles up there I know and love

and they'll think I recruited you and

now they're short of person, so you can

take a year off." So I decided to do

neonatology.

How generous of him to give you a year

off.

Yeah. 
And and and then they and and

everybody worked together to allow my

schedule to to work to do both. So, um

and I ended up doing some degree of

specialty

um in in newborn um malignancies. So,

down syndromes patients are oftentimes

born with Acute myelogenous leukemia. Um

there's a lot of blood cell disorders.

So anyway, um it happened kind of out of

chance, but I love them both both areas.

Wow. So much to learn from you. I I

can't wait. Looking forward to working

with you.

So impressive. George, we're so glad

you're here. So many people have already

come up to me, told me they had a chance

to meet you. They're so excited about

you. So, uh welcome to the FDA and we're

looking forward to a great new chapter

here.

Thank you for having me.

All right, George.

Great. Thanks.

Okay. See you. Thanks. Byebye. Great.

All right, everybody. Thanks so much.

We'll do it again.