0:00

Ask me MD medical

0:00

school for the real world with

0:03

the MD Dr. DJ Verret

0:06

Greetings, and welcome to another edition of Ask me MD medical school for

0:08

the real world. I'm Dr. DJ

0:13

Verret and today we're talking

0:13

with Dr. Ken Pienta, professor

0:16

of oncology in urology at Johns

0:16

Hopkins University and acting

0:20

chief medical officer of Q

0:20

biopharma about his experience

0:24

in academics and pharmaceutical

0:24

medicine. We'll talk to Ken

0:29

right after this

0:30

Ask Me MD medical

0:30

school for the real world.

0:52

Commerical

0:52

Here

1:14

Welcome back to ask me MD

1:14

medical school for the real

1:17

world. I'm Dr. D.J. Verret. And

1:17

today we have the great pleasure

1:21

of talking with Dr. Ken Pienta,

1:21

professor of neurology and

1:25

oncology at Johns Hopkins and

1:25

acting CMO of Cue Biopharma.

1:29

Ken, thanks for joining us.

1:31

I'm glad to be here. Thanks for inviting me.

1:34

So for

1:34

all of our listeners out there

1:36

who may not know, can you give

1:36

us a little bit of history of

1:39

your background and kind of how

1:39

you got where you are today?

1:43

Sure, I trained

1:43

in internal medicine at the

1:46

University of Chicago and then

1:46

went on to do an oncology

1:50

fellowship at Johns Hopkins. And

1:50

after that, I moved as an

1:56

assistant professor to Wayne

1:56

State, and then the University

1:59

of Michigan where I spent 20

1:59

years running a translational

2:03

research lab, basically focused

2:03

on prostate cancer metastasis

2:09

and therapeutics, and at the

2:09

same time building up a practice

2:12

in advanced prostate cancer. And

2:12

then after 20 years of doing

2:17

that, at the University of

2:17

Michigan, I moved to Johns

2:19

Hopkins, where I directed

2:19

started to direct urology

2:24

research, as well as develop the

2:24

precision medicine program for

2:29

Johns Hopkins. And that brings

2:29

us here to today.

2:35

For for

2:35

folks out there that may or may

2:38

not really understand could you

2:38

kind of explain what precision

2:42

medicine is. I hear that term a

2:42

lot. But I don't know if

2:44

anyone's ever succinctly

2:44

explained it to me.

2:49

Well, their their

2:49

precision medicine is, you know,

2:53

to use the tried and true

2:53

definition is treating the right

2:57

patient with the right drug at

2:57

the right time. And now in 2020

3:03

at the right place. And that's

3:03

especially true now with COVID.

3:07

In that we have found that we

3:07

need to be much smarter about

3:12

how we treat people and where we

3:12

treat people do we really need

3:16

to bring them into the hospital

3:16

to treat them. So part of

3:20

precision is actually developing

3:20

methods to do video medicine

3:25

when it's appropriate and

3:25

understanding when it's not

3:28

appropriate. That's all about

3:28

precision.

3:32

That's an interesting evolution. I hadn't thought about the the right

3:34

place. But but it continues, I

3:38

recently interviewed the CEO of

3:38

a mostly rural hospital system.

3:43

And he brought up the potential

3:43

for virtual hospitals, that

3:47

they're starting to talk about

3:47

kind of in line with what you're

3:50

you're talking about?

3:51

Yes.

3:52

What what

3:52

kind of drew you to academic

3:55

medicine? Why did you why'd you

3:55

want to go in academics over

3:59

some other practice opportunity?

4:01

Well, for me, I loved

4:01

the research. And I loved the

4:07

bench research part of it, the

4:07

translation, and so to be

4:11

successful, and that what I

4:11

understood very early, was that

4:16

I was going to have to narrow my

4:16

clinical focus that it was going

4:22

to if I was going to study

4:22

prostate cancer in the lab,

4:25

which is what I was trained to

4:25

do. It made the most sense to

4:30

work with prostate cancer

4:30

patients, and therefore they

4:34

became my clinical laboratory.

4:34

And I would seamlessly do what I

4:38

would look at what I was doing

4:38

in the lab and then apply that

4:42

to my patients in the clinic as

4:42

I tried to develop therapies and

4:45

then I would use their blood and

4:45

bone marrow and biospecimens and

4:49

tissue to take back to the lab

4:49

to help me do better research

4:55

and then as I was developing

4:55

those resources programs, I

5:01

realized it was very difficult

5:01

to take any type of research,

5:07

whether it be predictive

5:07

biomarkers or clinical

5:11

therapeutics, all the way across

5:11

the finish line to an FDA

5:18

approved product that would help

5:18

actually help people across that

5:23

sort of gap. And so they started

5:23

working more and more with

5:28

industry to to understand and

5:28

translate what we were doing in

5:33

the lab, to patients, and then

5:33

from patients clinical trials,

5:39

all the way to approval. And you

5:39

can't do that alone anymore,

5:44

maybe 30 years, 4050 years ago,

5:44

you know, you've heard about

5:48

people developing drugs at the

5:48

bench and then taking them all

5:52

the way to to, to the clinic and

5:52

beyond. It takes a village, it

5:57

takes a team it takes biotech

5:57

by, you know, pharma, academic

6:03

labs, etc, to do all that entire

6:03

translation across the spectrum.

6:08

And that's why I started also

6:08

working over the years with, you

6:13

know, biotech and pharma.

6:17

What do

6:17

you find most rewarding about

6:20

your involvement in the whole

6:20

drug design and development

6:23

process?

6:27

You know, I find the

6:27

bottom line is we're here to

6:30

help people and to try to make a

6:30

difference and find ways that

6:35

decrease morbidity and

6:35

mortality. And I find that each

6:41

step along the way, on any given

6:41

day is really exciting. And I

6:46

have the great privilege of

6:46

being able to do that dance of

6:51

of working in the lab, working

6:51

in the in the clinic, but then,

6:57

through my connections to

6:57

biotech, actually develop those

7:02

clinical trials into into large

7:02

multicenter trials to work

7:07

towards FDA approval. And I've

7:07

been able to do that now in my

7:13

life for not only drugs, but

7:13

also imaging agents as well as

7:21

bio biomarkers. Like for

7:21

example, I was the guy that

7:25

developed circulating tumor

7:25

cells for prostate cancer as a

7:31

diagnostic marker.

7:34

When we

7:34

were talking earlier, I use the

7:37

term non clinical medicine,

7:37

which I think a lot of people

7:40

would say, when you're involved

7:40

in pharma, you're, you're in a

7:43

non clinical job. But But you

7:43

brought up a really good point

7:47

that, that no, it's not non

7:47

clinical. Can you kind of

7:50

explain your thoughts on that?

7:52

Yeah, I, you know, I

7:52

use that we were talking offline

7:57

and you use that that term and I

7:57

took some umbrage.

8:02

That's

8:02

true. I was I was kind of put in

8:04

a different way. But yes.

8:07

The reason why is

8:07

because, you know, we need smart

8:11

people in every step of this

8:11

process of drug development,

8:17

and, and what I tell my

8:17

students, my, my PhD students,

8:22

my clinical fellows, is that

8:22

it's where you find your joy,

8:27

but specifically, you know, for

8:27

MDS, we need MDS who are trained

8:33

to take care of people who

8:33

understand illness, who

8:36

recognize side effects, to work

8:36

in industry, whether that's

8:40

biotech or pharma, as we develop

8:40

drugs, so, for example, is to be

8:48

a medical director or a medical

8:48

monitor, for a clinical trial of

8:53

a first inhuman drug requires,

8:53

you know, that you have

8:59

expertise, that you can

8:59

recognize what side effects are,

9:04

and that you can recognize when

9:04

your first inhuman drug might be

9:08

having an adverse side effect or

9:08

adverse event. And that's it. So

9:14

you're you're taking care of

9:14

people, and you're watching the

9:19

drug develop. And you're and you

9:19

Although you're not laying your

9:23

hands on them, you are directly

9:23

involved in their care, you are

9:28

making lifetime decisions about

9:28

whether they should continue on

9:32

a drug. You know, the recent

9:32

halt of the of the Merck study

9:38

with COVID is because there was

9:38

an MD in pharma. Not seeing

9:44

patients but recognizing that

9:44

there was a weird side effect.

9:48

That that is that is clinical

9:48

medicine to me. And I think

9:55

folks who are switching over to

9:55

industry potentially from

9:58

academics or from private

9:58

Practice to industry, because

10:02

they they just don't want to do

10:02

for example, the day to day

10:06

clinical patient caridy anymore.

10:06

They can, that's a very

10:12

rewarding track to to be able to

10:12

take care of people that way.

10:19

With your

10:19

experience kind of being on the

10:22

clinical side, the academic

10:22

side, and then the pharma side

10:25

now as an acting cmo with a with

10:25

a biotech company in clinical

10:29

trials, what advice would you

10:29

give to physicians that may be

10:33

looking to transition into some

10:33

of these pharmaceutical jobs?

10:38

Yeah, my, my, I guess

10:38

my number one piece of advice is

10:42

to really clearly determine for

10:42

yourself, what what you're

10:50

interested in doing what you're

10:50

excited to do every day. And

10:55

they're the spectrum of, for

10:55

example, biotech. That means

11:01

that, you know, are you more

11:01

interested in immunology? Are

11:04

you more interested in

11:04

Rheumatology? Are you more, you

11:07

know, find fight, you can find

11:07

there's so many companies out

11:10

there. And so many

11:10

opportunities, you can really

11:14

find the type of position that

11:14

you want to with the kind of

11:19

drug you want to if you want to

11:19

just dabble, you know, to say,

11:24

is this interesting to me, that

11:24

many of these companies have

11:28

advisory boards that you can

11:28

become involved in as they try

11:33

to develop agents and they're

11:33

looking for a, for example, how

11:37

will this drug be used in the

11:37

clinical practice you were in?

11:42

Whether and it doesn't matter

11:42

whether that was academics, or

11:45

private practice or large

11:45

groups, there's a lot of

11:49

opportunity there. The other

11:49

thing you have to think about

11:53

is, do you want to be in

11:53

biotech, which tends to be a

11:57

small, you know, smaller

11:57

organizations where you're going

12:00

to be the MD, and they're going

12:00

to be looking at you for your

12:03

for clinical acumen. And

12:03

understanding how a drug affects

12:09

patients. Where or do you want

12:09

to be part of a larger

12:13

organization, like a pharma, a

12:13

big drug company, where you

12:18

might be asked to, you know,

12:18

develop a particular agent

12:22

across multiple countries or do

12:22

it, you know, we already know

12:26

the toxicities and what they

12:26

need somebody to run a phase

12:29

three, study. The, the also, the

12:29

other thing you can do is, you

12:35

know, depending on your

12:35

training, you can get involved

12:39

in, quite frankly, on the non

12:39

clinical side, do you want to

12:43

develop help develop FDA

12:43

packages, you know, the the ind

12:49

investigational new drug

12:49

packages. And to do that, again,

12:53

you can there, there are ways to

12:53

do that, where you can sort of

12:57

dip your toes in to say, this is

12:57

something I want to learn, and

13:01

figure out how to do.

13:03

I was interviewing a friend of mine from medical school who ended up

13:05

going into hospital

13:08

administration. And one of the

13:08

things that he said that stuck

13:12

with me was, when you're looking

13:12

to leave a clinical practice for

13:16

some other ground, always go

13:16

towards the job, don't run away

13:22

from a job. And so I wanted to

13:22

get your thoughts on that. It

13:26

sounds like you were kind of

13:26

leaning towards towards that

13:29

statement. So I wanted to get your thoughts on it.

13:31

Yeah, I think that's a

13:31

beautiful, a beautiful way to

13:34

put it. I think with any move,

13:34

there's a push in a poll, and

13:39

you have to make sure that

13:39

you're aware of what, you know,

13:43

put the pushes are number one,

13:43

like why do I want to stop doing

13:47

what I'm doing? And that doesn't

13:47

have to be a negative. You know,

13:52

people tend to think, Oh, you

13:52

know, I'm burnt out, I got to

13:56

get out. I'm working too many

13:56

hours. The pay, you know, too

14:00

many people are dying, or, or on

14:00

the other end, I'm tired of

14:05

taking care of diabetes and

14:05

hypertension, and I'm bored. You

14:10

know, those are all that doesn't

14:10

have to be a negative statement.

14:14

Right? It's just you're you're

14:14

evolving in your life. You're,

14:19

you're saying what I was doing

14:19

for the last several years is

14:23

not what I want to do. And some

14:23

people come to that very

14:27

quickly. I had a friend who was

14:27

a fellow in oncology back when I

14:32

was training, who jumped to

14:32

industry in the space of about

14:36

two years because he went, you

14:36

know what, I made a wrong

14:41

decision. I don't want to take

14:41

care of cancer patients that

14:43

every day, it's too much for me

14:43

so So recognizing that is a

14:49

powerful thing. It's not a

14:49

negative. That push you that I

14:54

think, you know, is not a is not

14:54

a recognition of defeat. It's a

15:00

recognition that your brain is

15:00

evolving that you're thinking

15:06

that differently. In fact, it's

15:06

not a defeat, it's actually a

15:10

powerful statement that says, I

15:10

want to evolve, and I'm not

15:14

going to accept who I am right

15:14

now. And just put in the time,

15:19

life's too short to just put in

15:19

the time. So you have to find

15:23

what you enjoy doing and what

15:23

you're passionate doing. And

15:25

whether you switch to an in you

15:25

know, biotech or pharma, or to

15:30

administration or to working in

15:30

a law firm, working in patents,

15:35

you know, firms working VC, all

15:35

of those things can be fun, you

15:40

just have to find out what's

15:40

fun. And, and so what's the poll

15:45

is very important. But I think

15:45

even more important in the

15:49

moment is understanding that the

15:49

push is not a negative.

15:55

I think

15:55

that's also a great expansion on

15:58

what my friend was saying, just

15:58

to be able to recognize where

16:02

you want to be in and what you

16:02

want to change, because I

16:06

totally agree with you. It

16:06

life's too short not to be in a

16:09

job that you're happy with. A

16:09

couple of the terms you use

16:13

biotech versus pharma or

16:13

biopharma? Can you kind of

16:17

explain the differences in those

16:17

because I hear those terms a lot

16:20

as well.

16:23

Yeah, well, I'm sure

16:23

there's official definitions, my

16:28

definition basically, you know,

16:28

a biotech a technology company

16:33

is generally formed around a

16:33

particular idea and is

16:40

developing either diagnostics or

16:40

therapeutics, based at least

16:45

initially on a very narrow

16:45

ideas. So, for example, q

16:50

biopharma is an immuno oncology

16:50

biotechnology company that was

16:56

formed on technology out of

16:56

Albert Einstein to develop

17:01

specific molecules that we call

17:01

immuno stats that are going to

17:06

very selectively deliver an

17:06

antigen to a protein that T

17:13

cells should recognize for

17:13

cancer therapy, is it at the

17:19

same time, it is not developing

17:19

a targeted agent for diabetes,

17:24

for example, it is, you know, on

17:24

a path based on this, this this

17:29

drug platform, and that's

17:29

important. So, biotech tends to

17:35

be small, you know, the company,

17:35

at least early tends to be, you

17:39

know, companies with, you know,

17:39

10 to 100 people that are all

17:43

working to get develop agents

17:43

around a particular platform in

17:49

a particular disease setting. As

17:49

they get as, as they grow, they

17:55

can take on other things, but

17:55

they're basically formed around

17:59

a specific IP, intellectual

17:59

property and technology. And if

18:05

they're, they're often

18:05

developing first and human

18:07

drugs, doing phase one. And

18:07

phase twos. Farm pharma is a,

18:15

you know, companies like

18:15

Novartis and Bristol Myers are

18:18

are large, multi 1000 member

18:18

companies that are developing

18:24

drugs and get delivering drugs

18:24

that are already approved, as

18:31

well as tending to run phase

18:31

three trials where they're

18:34

trying to develop more drugs. So

18:34

you'll often see if if a company

18:39

a biotech company has an agent

18:39

that looks promising, they often

18:45

get gobbled up, they get bought

18:45

by a large company, who will

18:49

then do the phase three trials,

18:49

which often cost hundreds of

18:52

millions of dollars. So the way

18:52

I think about it is pharma.

18:57

pharma is trying to do has

18:57

multiple drugs 10s, if not

19:02

hundreds of drugs in their

19:02

portfolios across a wide variety

19:06

of diseases, and generally are

19:06

only running phase three,

19:10

generally running phase three

19:10

studies as well as giving drugs

19:15

to people, you know, by

19:15

prescription. So

19:18

what I'd

19:18

like to use your your

19:21

introduction into cue to talk a

19:21

little bit about your acting cmo

19:24

job and and just the thought

19:24

process that goes into

19:28

development of a drug trial. I

19:28

think that's extremely

19:31

interesting. And also just the

19:31

process for the drug trial,

19:35

because people hear a lot about

19:35

phase one, phase two, phase

19:38

three, but you don't hear a lot

19:38

about all of the work before you

19:42

can even start that phase one.

19:42

So just to start, can you kind

19:47

of describe what that pleat pre

19:47

clinical work looks like in the

19:52

development process, just from a

19:52

50,000 foot view?

19:56

Wow. Yeah. Well, that's

19:56

that's an exciting area. area.

20:00

And basically, that's what we

20:00

did I did with Q, which was, you

20:04

know, developed here we had this

20:04

this molecule that we wanted to,

20:09

to give to people. So to do that

20:09

you have to do what are called

20:13

ind enabling studies, which are

20:13

investigational new drug

20:18

studies. And that includes

20:18

developing all the assays,

20:24

outside of animals or people

20:24

that demonstrate that your drug

20:29

has activity, for example, does

20:29

it bind to a T cell in a ditch,

20:34

and then you have to do in vivo

20:34

studies in in in basically in

20:41

mice and in in rats to say, Oh,

20:41

we have anti cancer activity.

20:47

And then you have to do what's

20:47

called tox, colic toxicology

20:51

studies, where you have to prove

20:51

that your drug was through a

20:57

variety of doses is going to be

20:57

safe for rats, as well as

21:02

potentially dogs or monkeys, and

21:02

demonstrate, and not only that

21:08

the drug should be safe. But

21:08

determine the starting dose for

21:13

your drug in humans through a

21:13

set of complex formulas that are

21:19

complex, but easily learnable.

21:19

You then take that in package,

21:24

and simultaneously, you're

21:24

developing your drug, you're

21:30

putting it into vials under good

21:30

manufacturing processes, to be

21:35

able to say that it's sterile

21:35

and not has the right pH and the

21:41

right you the right vehicle that

21:41

you can actually give it to

21:45

people, whether it's IV or

21:45

orally. And then as you're doing

21:50

all those studies in parallel,

21:50

you are also writing it all out

21:55

and developing what's called the

21:55

investigational new drug

21:59

package, where you will present

21:59

that whole body of evidence to

22:04

the Food and Drug Administration

22:04

to say, let us give this to

22:08

people. It's a really exciting

22:08

process.

22:13

When and then once you give it to the FDA, the FDA hopefully will tell

22:15

you, okay, you can give it to

22:19

people. But that's also the

22:19

start of another whole process.

22:24

Because the drug design in that

22:24

phase one is is actually pretty

22:29

important, right?

22:31

Yeah.

22:33

Right, so so once, as

22:33

part of that package, you have

22:38

to develop a phase one trial

22:38

design. Yet generally, there are

22:45

multiple phase one trial

22:45

designs. But the most common is

22:49

what's called the three by three

22:49

design where you give three

22:51

people a drug at a first dose,

22:51

if it's safe, you then move you

22:56

move up the dose and give it to

22:56

another three. And if it's safe,

22:59

you give it to another three.

22:59

But if you find one, got one

23:02

person gets sick, then you out

23:02

of those three, enroll three

23:06

more people. It's a it's a well

23:06

known design that's been

23:11

developed over the last 20 years

23:11

that almost all phase one drugs

23:16

use. And that's, again, it's all

23:16

about determining safety and

23:22

determining your ultimate dose

23:22

for the next set of trials,

23:26

phase two, where you're actually

23:26

trying to determine efficacy.

23:32

But when you talk about the phase one, I know with q in particular, you

23:34

not only you're giving it to the

23:38

patients, but you're looking at

23:38

data on the back end as well. To

23:44

not only determine safety, but

23:44

to try to get some information

23:47

about how the drug works. Correct. Yeah,

23:48

yeah. Sorry. I didn't

23:48

realize that's what you were

23:51

looking for. Yes. So with with

23:51

whenever you're getting a drug

23:54

for the first time, you also

23:54

look for two other effects

23:58

pharmacokinetic effects or PK?

23:58

Which is how fast is your drug?

24:04

Get clear the system? Does it do

24:04

it through the liver does do it

24:08

through the kidney? What How

24:08

long does it stay in the blood?

24:13

Those kinds of questions, those

24:13

pharmacology questions. The

24:17

other thing that we're doing is

24:17

you draw blood, so you have to

24:20

draw blood from the patient and

24:20

determine that and get tissue

24:24

from them if you can. And the

24:24

other part of that is the PD or

24:27

pharmacodynamic effects, which

24:27

is where gosh, you know, we're

24:32

trying to turn on antigen

24:32

specific T cells. So we're going

24:36

to draw blood from patients

24:36

after they've gotten our drug

24:40

and from before they got their

24:40

our drug and then put their

24:45

their blood in with our naive T

24:45

cells and see if we turn them

24:50

off. And that that is basically

24:50

the pharmacodynamic effects and

24:58

and no matter what drug you're

24:58

doing. Developing, whether it's

25:01

an immunotherapy or a targeted

25:01

agent, you're always looking for

25:05

on the back end from your

25:05

patients, the PK and PD assets.

25:12

And I

25:12

also found it interesting that

25:15

phase one isn't, you know,

25:15

people say phase one. And you

25:18

may think, Oh, it's it's pretty

25:18

standard, as you mentioned,

25:21

there are different trial

25:21

designs, but also their

25:23

different patient populations,

25:23

you may give your drug to

25:27

depending on what kind of drug

25:27

it is, right?

25:30

Yeah, absolutely. And,

25:30

and the cancer world as well as

25:36

all medicine has really evolved

25:36

or about that. They've just

25:40

become more precise, right? So

25:40

so we only give our drug, for

25:45

example, and we had to work with

25:45

the FDA for this. We were

25:49

targeting HPV positive Human

25:49

Papilloma Virus driven cancers,

25:55

we could have picked head, neck,

25:55

cervical, and you know, penile

25:58

cancers. And so, we we

25:58

specifically, you know, with the

26:05

FDA, they said, Let's pick one

26:05

disease type, and develop your

26:09

drug and one disease type. And

26:09

then as you get your dose move

26:13

into other other treatment

26:13

groups, so every time you're

26:19

doing a phase one, it used to be

26:19

that it was sort of like, oh,

26:23

anybody who has nothing, no, no

26:23

disease, no drug left to try for

26:29

whatever their disease was, we

26:29

were going to give them a phase

26:33

one agent, because it was all

26:33

about just determining the

26:36

safety of that drug. That's

26:36

really rare. Now, almost every

26:42

agent that's going into clinical

26:42

trial now is around a specific

26:47

disease type. Looking at you

26:47

because we want to look worse,

26:51

even in the safety population,

26:51

you're still looking for signal.

26:57

It's it,

26:58

it's a

26:58

lot, you know, when I first kind

27:01

of started getting involved with

27:01

these companies, you think I

27:04

always thought, oh, phase one,

27:04

you just give the drug to

27:06

somebody, but there's a lot that

27:06

really goes into it. Where did

27:10

you learn through that process?

27:10

Did you start as an investigator

27:16

for drug companies? Or was there

27:16

some class you took? Or? I mean,

27:21

how did that evolve? For you?

27:23

Wow, yeah, yeah.

27:23

It's, it's, it's what you're

27:26

always learning. And, and you

27:26

can't be afraid to say what you

27:31

don't know. But I, you know,

27:31

I've started out first by, you

27:36

know, an academic investigator

27:36

running trials for companies

27:42

drug because they had drugs I

27:42

was interested in and, you know,

27:47

understanding number one how to

27:47

write a clinical trial. And that

27:52

is something, you know, you you

27:52

learn through training, although

27:55

there are classes for it also.

27:55

But the classic way back when I

28:00

was doing it, you know, was

28:00

here, go, right, this trial,

28:03

here's a previous example,

28:03

right? But there, you know, it's

28:08

all on the web now, right. And

28:08

then there's a lot of all the

28:11

materials of how to what you

28:11

need to do to develop a drug is

28:15

all available from the like, the

28:15

FDA websites. And then I also

28:19

started to consult for companies

28:19

and understand, you know, as

28:24

they were developing there, as I

28:24

was an investigator, they would

28:27

ask me to come to an

28:27

investigator meeting, and I

28:29

would see the process they used

28:29

to get there. And as I wanted to

28:34

learn more about that, I would

28:34

ask them questions and ask,

28:38

could I be involved in that in

28:38

any way so that I could learn

28:43

the processes by which you go to

28:43

the FDA, how you put together an

28:47

ind package. And then again,

28:47

lots of reading lots of

28:53

learning, there's papers on

28:53

this, there's books on it,

28:56

there's websites on all this,

28:56

and then every time we hit a,

29:00

you know, sort of a roadblock of

29:00

knowledge, you just, you can

29:05

find the answers out there. And,

29:05

and so it gets and it gets

29:11

easier every time but also every

29:11

drug has a little bit of a

29:14

different, you know, weight that

29:14

needs to be developed. But for

29:19

example, the the tox studies are

29:19

our standard, pretty much

29:25

standard across the industry.

29:25

You got to do two species, you

29:29

got to do a rat and a monkey or

29:29

a rat and a dog, you know it

29:32

and, and so what you sort of do

29:32

it once and it's like a bike,

29:36

you know, you just have to plug

29:36

your dragon and do it.

29:40

But I think the the important take home is it was an evolutionary

29:42

process for you. It wasn't like

29:46

you woke up one day and

29:46

congratulations, you're acting

29:48

CMO of a company.

29:51

Absolutely correct. Yeah.

29:53

What one

29:53

one quick thing we didn't talk

29:55

about in that phase process

29:55

after you get your FDA approval.

29:59

That's also part of the

29:59

regulatory process, you still

30:03

have to get if you stopped to

30:03

get IRB approval at each one of

30:07

your institutions as well, which

30:07

is a whole nother process that

30:11

involves more physicians, correct?

30:14

Yeah. So as we in, for

30:14

example, for the FDA approval,

30:19

and then, you know, you have to

30:19

write the first write the the

30:23

IRB template, so we have to

30:23

write an IRB template. And we

30:28

also have to write an

30:28

investigators brochure. And we

30:31

have to write a pharmacy manual.

30:31

So there's three pieces of large

30:36

pieces of work there, that

30:36

you've written, the trial that

30:40

you want to do, the IRB, that

30:40

consent that goes with it, the

30:44

investigators brochure that goes

30:44

with it, which is sort of like a

30:47

drug insert, and then the

30:47

pharmacology manual, which is

30:51

how you want them to give the

30:51

drug. So you write all of those

30:55

and you submit them to every

30:55

place that you want to do the

30:59

trial. They then modify it to

30:59

their individual idiosyncrasies,

31:04

which is a good way to put it.

31:04

It's each institution and each

31:08

IRB has their own

31:08

idiosyncrasies, and, and that's

31:13

how that process works.

31:16

Ken, this

31:16

has been fascinating. I really

31:18

appreciate the insight into I

31:18

won't use the term non clinical

31:22

medicine, just hire clinical

31:22

medicine, but it really

31:26

appreciate the time. Thanks for coming on.

31:28

Yeah, you bet. Take care.

31:30

We've been talking with Dr. Ken Pienta, professor of neurology

31:32

and oncology at Johns Hopkins

31:36

and acting chief medical officer

31:36

of Cue Biopharma. You're listeni

31:39

g to ask me MD medical school f

31:39

r the real world. I'm Dr.

31:44

J Verret. Thanks for joining u

31:44

. Until next time, make it

31:47

n awesome wee

31:49

Thank you for joining

31:49

us for another episode of Ask me

31:52

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31:52

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31:57

ave a question or an idea for a

31:57

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