I-SPY 2 to GBM AGILE and Beyond

Judith: Welcome to Berry's In the
Interim podcast, where we explore the

cutting edge of innovative clinical
trial design for the pharmaceutical and

medical industries, and so much more.

Let's dive in.

Scott Berry: All right.

Welcome everybody to in the Interim.

This is a podcast where we dive
into clinical trial science, uh,

clinical trial design, innovation
in the clinical trial space.

We frequently do it from a statistical
standpoint, but we'd love to jump

into multiple innovative trials,
and we have a wonderful guest today.

We have Dr.

Meredith Buxton joining us today.

Meredith is at GCAR, but her history of.

Innovative trial design goes back
a long ways, so welcome Meredith.

Meredith Buxton: Thanks.

Thanks for having me.

I, I think back to, I think it's
about 15 years in terms of my.

Time with hanging out with you and
Barry and working in this space with you

directly, but probably a little bit more

Scott Berry: Yes.

Yes.

Uh, and, and a longer history with Don,

Meredith Buxton: Yes, much longer.

Scott Berry: Yes.

So, uh, your history goes back,
uh, lots of platform trials.

It starts with I spy two.

Um, and it might be nice to talk
a little bit about I Spy two.

Um, maybe I'll let you
introduce I SPY two.

Meredith Buxton: Sure.

So I think it goes back even a little
bit, uh, further than that, which was

the original I Spike program, which
was designed to be just a correlative

study for patients with Neo, uh,
getting neoadjuvant breast cancer

care and, uh, trying to understand, I.

About that patient population.

And then once that study was
completed, the question was, can

we now look at how patients respond
to investigational therapies?

And there had been some
concern that it had.

Been in the cooperative group space
and uh, it took time to get each

trial up and running in that space.

And that wasn't unusual.

Clinical trials take a lot of time to
build and operate, and then we tear them

down and then we build the next one.

And so I.

When the team came together,
Laura Esserman, Anna Barker,

Don Berry, uh, myself, a large
group of clinical investigators.

Um, the decision was like not to, to sort
of accelerate those timelines, that they

didn't wanna wait in line, they didn't
wanna wait to go through this process

every time of building new programs.

So I-SPY2 was, was born.

And It served as one of
the first master protocols.

So building a platform in which we could
study many different investigational

agents against standard of care for, uh,
women getting, uh, neoadjuvant breast

cancer care, and um, you know, just.

Really trying to figure out
the space as we went along.

So what does a protocol look like in
that situation where you're building

it once and using it many times?

What does the operations look like?

What is the, you know, what are the
data collection tools, etc And so it

really was at the forefront of that,
uh, in terms of trying to accelerate

timelines for evaluation of drugs.

Scott Berry: Yeah, so, so in, in
many ways, a, a precursor of many

of the modern, uh, platform trials.

But you're, at the time now, you're
doing a trial where you're bringing

multiple investigational arms in,
you're doing, um, personalized medicine

in the sense that you've categorized
women in eight different subtypes

by the way you created terminology.

Meredith Buxton: Yes.

Scott Berry: a, a subtype was a.

A creation of something you had
to avoid subgroup, you didn't want

to use Strat, you couldn't use
things that had already been named.

So a subtype is a, A characteristic,
and it was their hormone receptor

status, or HER two status, and
their MammaPrint status, and you're

looking at differential efficacy.

Compared to a common control,
you're doing adaptive randomization,

a among the different groups,
uh, Bayesian model driving this.

At one point you're
updating RAR even daily

Meredith Buxton: Yep.

I remember.

I mean now we've realized that may
have been a little bit aggressive,

but yes, there was updates to and
building systems to be able to handle

all of that updating of data and
updating of probabilities in real time.

Yep.

Scott Berry: Yeah, so a, a
huge part of this story is

probably the operations of this.

The, you know, the, the ideas of this
are, are, are groundbreaking in many ways,

but to then run this, to have the data,
to have an algorithm, to run this, to

update the RAR, the data aspect of this.

Now this is a phase two trial.

Uh, within this setting, and you ran
this entirely within UCSF entirely what

became Quantum Leap, uh, and in some
ways created technology to run I Spy two.

Meredith Buxton: Yeah, I mean, actually
one of the biggest supporters up front

was the foundation for the NIH, who
served as the initial sponsor and really

got the program up and running with.

Uh, the team at UCSF and, and the
20 medical centers around the US and

then it moved over to Quantum Leap.

Another, uh, you know, in that case,
uh, a nonprofit that was really designed

to be a vehicle for this as well.

Um, but we were, we, you know,
you go, I go back to what you were

saying before, we were creating
terminology terms like graduation.

Right.

And, uh, futility arms would graduate
and that would allow us to know that they

would maybe be successful in a subsequent
phase three or, or, or drop for futility.

We were not seeing benefit above and
beyond standard of care, et cetera.

So we were creating terminology,
we were creating new ways

to think about data access.

About blinding in a trial, right?

So traditionally in a trial you would
might be a placebo controlled and

blinded to it, like the assignment,
it was an open label trial, but

we were blinding you to an arm's
performance, and that was unusual.

So that meant you couldn't know how many
patients were on an arm at any given time.

And so just really trying to bring
the community together under this

new construct, you know, industry.

The clinicians, the advocates, the IRBs,
just with this whole new idea, I think

was, uh, was, was a lot of the battle.

Right.

And it really set the foundation for,
I think, a lot of the subsequent trials

that have come out, including ones, you
know, that I have, uh, built subsequently.

Yep.

Scott Berry: Yeah.

Yeah.

And, um, I, it even announcing a
particular arm and being able to provide

the data for that, while other arms
are still in the trial and all that.

How do you publish this?

How do you publish the results
within a subset of patients?

Uh, do you do the model,
do you give the data?

Uh, it, it was incredible innovation
in this, even backing up, you're

writing a master protocol and
probably the first master protocol

that was written very modularly.

Where there was an overall master
protocol and you would just insert

a modular appendix for a new drug.

Um, and it, it didn't change the protocol.

It would be there and you could
remove it and the, the master protocol

would, would continue on like that.

Really the first time this
was probably ever done on.

Meredith Buxton: Yeah.

And then the other part is the.

The two part consent, right.

I think it's now become a bit
standard with, um, master protocols.

Now when you're adding many different
investigational arms, you consent

patients to the screening process and
then you don't wanna overburden them

with too much information with regard to
many arms that they may not be eligible

for or may not, uh, be randomized to.

And so creating this screening
consent and this treatment

consent, and that was really.

Built in the early days of I spy,
sitting down with the IRBs, sitting

down with the patient advocates,
you know, sitting down with the

clinicians and the sites and saying,
what do you think would be feasible?

And that came out of those conversations.

Actually, the patients who said,
we, we want less information.

We wanna be informed more regularly,
and we want less information at each,

so we can really make clear decisions.

So, um, you know, that
was all built out of ipy.

Scott Berry: Yeah.

And you guys did something
really quite cool.

Is.

You could, you were concerned about
IRBs, so you essentially brought

them all together in a single
get together where they could all

talk and you could explain this.

Meredith Buxton: Yeah, and it
was, this was really the, uh,

the genius of Laura Erman.

So she said, we're gonna
bring them into a room.

We're gonna get them all to agree and.

Uh, it was funny.

The position was, okay, these are the 10
things we're gonna get them to agree to,

and if everybody will walk out of the
door, you know, it was sort of understood.

What are we gonna agree to upfront and.

Get them on board for that and really,
you know, sort of like not let people

leave the room until we were all aligned.

And I think that accelerated
the timeline, right?

That was the biggest
concern is with the startup.

And it does, master protocols do take a
little bit longer to ramp up when you're

trying to open this many sites and you're
trying to get agreement for a longstanding

infrastructure with lots of different.

Uh, complex elements, like you've
said, the adaptive randomization,

the now, the time machine was built
in, I spy the original time machine,

so using the, the non concurrently
randomized controls, all of that.

And so, you know, getting agreement
upfront really accelerated that timeline.

And in fact, the IRBs in
the end did not have issues.

When they came back to us, we got a
conditional approval for the, the review

pretty quickly was more around how we
were communicating this to patients.

So it was more about the patient facing,
not the concepts of the trial, but

how do you explain this to patients?

And so those were the pieces we were
sort of, uh, tinkering with in the

end to get the IRBs up to approve it.

But I think we were all surprised,
but pleased that that process.

Of bringing them together, um,
uh, really did accelerate it.

And that's really was always the spirit
of I spy, bring everybody together.

I think even in the design phase,
so way back in, uh, the mid to late

two thousands when it was being
designed, bring everybody together in

the room, industry, pa uh, patients.

Clinicians, uh, research scientists
and say like, what, what's questions

we wanna ask and how do we ask that?

And so, uh, getting buy-in early was
always really important to its success.

Scott Berry: Yeah.

And, and, and I, spy two
was an amazing success.

Uh, 28.

Plus or more arms, I think
it's now morphed on to IPY 2.2

and, and that, so, so you're,
you are there, you joined Barry

consultants for several years.

Uh, uh, founded our clinical trial
strategy group where we really saw

the, the beauty of IPY two, the
beauty of platform drives the amazing.

Um, efficiencies of platform trials
and we want to lean into this.

So you came to Barry to help us with that.

Um, working on a number of
platform trials at the time

and a number of other diseases.

We'll talk about them 'cause they
end up at GAR sort of interestingly.

Um, but then, and a big question at
that time, and we were, we were working

on the design of a number of trials.

A big question is who's
the sponsor of this trial?

And it was a design.

You're working with a
patient organization.

GBM Agile was a discussion
of a huge number of groups.

And there's a big question, and there
was a, a hole in this as to who's

going to actually sponsor the trial.

Uh, within this multiple pharmaceuticals,
companies may can't come in, and in

some ways this is the beginning of GAR.

Meredith Buxton: Yeah, I mean, I think
the time at Barry was really, and the

clinical trial strategy group was really
about the fact that the I Spy two model

could be replicated in other spaces.

It required a lot of curating, right?

It wasn't just a matter of you could
write a protocol and you, you could

hand this over to anybody to run that.

There was a real.

Uh, sort of complex inner working of
statistics and operations and et cetera.

Um, and so the clinical trial
strategy group was really about how

do we disseminate these learnings,
uh, around, uh, the space.

And, and then GCAR, uh, came
about sort of in that same idea.

So.

Um, and how, how do we disseminate, how
do we support the community in terms

of these learnings and, and building
and running these trials effectively?

Because we know, just 'cause you write
a trial doesn't mean you can operate it

well, right in, in this complex space.

So the thing for GCAR that's
really interesting is the

trial that GBMA Agile trial.

So it came about really
from the community.

You know, Anna Barker brought
together a large group of

community, you know, statisticians,
scientists, international, US-based.

Uh, pharma companies, et cetera.

And they took that model of Icey
two and said, well, how can we do

this in the, the glioblastoma space?

And then came up with this design,
worked very closely with the FDA, you

know, turned it into not just an a
phase two study, but to have a component

that allowed for drug, you know, new
drug uh, applications, a phase three

component, a confirmatory phase.

And then the question
became who would run it?

And it didn't naturally sit in any
one home, so it couldn't really sit.

Although, you know, obviously
pharmaceutical companies run their

own platform trials to evaluate their
drugs or their drugs in combination

with other, uh, investigational
drugs from other companies.

It really needed to be drug agnostic.

Right.

And company agnostic, just like about
testing and learning from the disease.

So that wasn't the right fit.

It couldn't really sit
in one academic center.

We're talking about a registration level.

Program international.

It needed a, a certain amount of, uh,
infrastructure bill that I don't think

any one academic center could have.

And, uh, advocacy groups like
the, uh, pancreatic Cancer Action

Network who have the resources and
did build a master protocol, I.

That those are not, that's not
really the sweet spot, right?

The sweet spot is not to run a a,
a research unit within an advocacy

organization, so that didn't really
make sense in the GBM space either.

And so GCAR was really
founded out of necessity.

Really the fact that I.

There wasn't really a home for this.

There was a commitment from the, from
a, the community to run this and how to

build sort of an independent nonprofit to
serve as the sponsor for this trial, but

not just this trial to like disseminate
the learnings from this trial to.

Run other programs in the space and really
in a lot of ways, serve, serve as an

honest broker of all the collaborators,
the clinicians, the, the patients, the

advocacy organizations and the industry
partners and, and regulators as well.

So that's how GCAR was founded,
and it was really founded with the

support of a few members of that
original like network of investigators

involved in the uh, GBM Agile build.

Yeah.

Scott Berry: Okay, so GCAR is,
uh, uh, an acronym for the Global

Coalition of Adaptive Research.

Um, and, and it's a non-profit.

Um, and it originally, the first
trial it was involved in is GBM Agile,

agile, as you described in that,
but it's now adding more trials.

I an interesting part of the, the
development of this, um, within this, um.

Is, uh, the people behind it?

Far Mars, uh, feels like a hero
in the development of GCAR.

Meredith Buxton: Yes.

So he, uh, farmers EF today
is our chairman of the board.

Um, he came to GCAR
through, uh, some of our.

Leadership, Tim Klossy, Brian
Alexander, others like that.

Sue John Baugh, who was, uh, is
at the National Foundation for

Cancer Research and was part of
that original knowledge network.

Unfortunately, you know, his family
was, was hit directly with, uh, you

know, hi his, his wife passing away
from GBM and had really wanted to be

able to support, felt the importance
of this program, felt the importance of

this organization and really I think.

Was the reason, you know, that
really brought the group together

and formed the organization.

He and Sue John, uh, Tim and Brian,
uh, you know, are the founding members

of the organization, again, with a
real commitment to, to the space.

And has continued to be, to be so,
and really again, this idea that

we are, as a nonprofit, we have the
ability to support other initiatives.

We have the ability to
build other initiatives.

Like our goal is really to be that, uh,
collaborator with many players in the

space and not just in the GBM space.

So,

Scott Berry: Yeah, so, so GBM Agile's
created, you're the sponsor of GBM,

and I'll come back to sort of what
that means and, uh, how much time

you spend talking to pharma and,
and you know, where your time gets

spent in all of this, um, in it, but.

Uh, soon after this covid hits.

Um, and Remap Cap is a global trial.

Oh, well, it's not global because it's
sort of everywhere, but the us um, and

it's running in the uk, it's running in
Australia, running in New Zealand, the eu.

Uh, and I, I do want to not, um,
minimize the role that I Spy two played

in Therapeutics Discovery in Covid.

So, uh, essentially every government
operation, warp speed, the UK

government, every government, um,
uh, remap cap, the only way to, to

explore what works as a therapeutic,
let's ignore vaccines in this.

What works as a therapeutic for
treating Covid was a platform trial.

You couldn't go out and spend
two years and design a single

trial for a single drug.

Take it down.

Everything had to be a platform trial.

So Remap Cap is one of these global
platform trials, and I think it's hard to

believe these would've been as productive
as they were, as strong as they were

without ICE by two i, I don't know what
would've happened without Ice by Two.

But then Remap Cap comes and GCAR
becomes the US sponsor for remap Cap.

Meredith Buxton: Yeah, I mean,
it was really interesting.

I think we all felt when the world shut
down in February and March of 2020,

we all felt a little helpless, right?

And wanted to do something, especially
those in, in research, right?

We felt like, and in healthcare we had
an obligation, um, to do something.

And I think, uh, the lead in the US
and one of the original drivers with

you with REMAP Cap, Derek Angus, I.

Uh, came to Brian Alexander, one of our
board members, and talked about some of

the challenges and find again, with this
idea of needing an organization that

could serve as the regulatory sponsor, uh,
and bringing together US sites contract.

You know, we can talk a little bit later
about what that means, but, uh, and so we

immediately, when, when I got the phone
call from Brian immediately said, yes.

Like, we felt this was our way to
help in any little way we could.

Funnily enough, I kind of laugh at that.

All my friends were, I thought,
you know, it would be a quiet time.

It was probably the
busiest I've ever worked.

I mean, remap was like 24 hours.

My friends were like making
sourdough starters and you

know, learning new hobbies.

And I was 24 hours a day trying
to kind of turn this into a.

A trial that could evaluate,
because it started as a

comparative effectiveness study.

And then try to elevating it, especially
in the US to support registration, right.

To really evaluate drugs
at a different level.

And so, uh, we came in to do
that and really, you know, I.

We, the design is just sort of the
next level of I spy, and I think the

next level of GBM Agile in terms of
the ability to layer in different

treatments and the modular nature of
the protocol and the consent form.

And, you know, it, it's really
the next level, um, uh, under

the in and then the way that the
community worked together globally.

I think we not only served as the
US sponsor, but we really tried

to help other regions as best we
could to try and bring up some of

the standards as they needed it.

You know, obviously many of them
are very experienced trialists, but

for example, I think in Japan it was
sort of a new space for them helping

them to get up to the, the, the
processes and standards they needed

to meet the registration requirements.

So,

Scott Berry: Yep.

So now you're, uh, it really, so GCAR
is looking to get involved in a number

of these efforts, um, and it's, it's
incredibly needed within the space.

While, while we advance the
science of platform trials,

it's still relatively novel.

It's new.

Amazingly effective.

So GAR is now involved in GBM
Agile, it's getting involved.

It was involved in CO uh, PTSD
platform trial, multiple other ologies,

neurofibromatosis, uh, pancreatic cancer.

Biac TRA Tract cancer.

Ovarian cancer, multiple diseases.

And I know you're talking to other
groups in this, so tell me about it.

Maybe individually one of these GBM
Agile, uh, and, and I know you're

working daily on pancreatic cancer.

A huge part of this is.

You build this trial, the
infrastructure's there, the, the,

the operations part of it's there.

You're working with regulatory,
now you need arms in the

trial, which is largely pharma.

How much of your time do
you spend talking to pharma?

Meredith Buxton: lot.

I mean, especially with, I think what
happened, the reason why we have several

initiatives in development is I think we
really, again, feel like we can support.

These different communities is needed.

And I, you know, if we were to
just do it at a time that was easy

for us to say, okay, once this one
is open, we'll open the next one.

I think, you know, it, it, that
would be ideal, but I think we

feel really compelled by all
of the, the need in the space.

And so we jump in as quickly as
we can to help in any way we can.

So, you know, I do spend a lot of time in,
you know, we have a team led by Rob Murray

within our organization who's really.

Does most of the, the
heavy lifting around that.

But I think, um, you know, spending a lot
of time educating on the value of this.

And it, it isn't right for every company,
it isn't right for every patient.

We know that.

And so educating on the value of it,
um, we, we spend a lot of time with,

with industry creating comfort level.

I mean, in a lot of ways they think about
it as they're giving away their baby.

Uh, to you and that they'll see them when
they graduate college and you know, like

you're handing off at a very important
critical development time in their life.

And we keep explaining, no, we're
raising them together, right?

It's a collaborative effort.

And so there's a lot of

Scott Berry: Sponsors tend to be
helicopter parents to their drugs.

Is that, is that the

Meredith Buxton: Well, understandably,
you know, you're not, it's not the

norm if you're looking at a clinical
development plan that includes, you

know, an approval path where you would
hand it over to somebody else, right?

You wanna, it, it, so that's,
it's understandable the level

of, um, commitment, uh, you
know, nervousness they have.

And so, you know, we spend a lot of
time creating the comfort level with

the ability to kind of run it here
and, and to show them, especially with,

with GBM Agile, I think we've done.

Enough.

Uh, we have enough data, and we probably
should write it up at some point to

show the, the value proposition that we,
we have sped up evaluation timelines.

Uh, we have been able to cut the costs.

We've done, um, you know, they've done
fair market assessments and then looked

at our price because we've got this
infrastructure that GCAR's invested in.

And we are not rebuilding it every time.

There's a natural cost savings with
that, the shared control arm, etc So

yeah, I would say it's a good, good
part of my, it's a good part of my day.

Scott Berry: Yeah, so I, a lot of people
ask about that discussion in pharma is

I, and a lot of these, these platform
trials, I was involved in one effort,

epa, it was a EU based trial and it
never enrolled a patient, it never

brought a pharmaceutical company in.

So I figured the, these really need the.

Four really important stakeholders
for them to be successful.

Patients have to want to come in.

Um, pharma has to want
to bring a drug into it.

Regulators have to like the trial
and like what comes out of it.

And then sites have to want to be a
part of the, the, the platform in this.

And the mo, I get asked
a lot about pharma.

Um, that discussion you have with
them, part of it is financially

this is a good deal for them.

Uh, part of it is a huge part of
this is then timelines and the

regulatory perception of the data
they're gonna have out of this.

How do those discussions have, is
it, is it hard to convince pharma

to come into the a platform trial?

Meredith Buxton: Uh, you
know, yes and no, right?

I mean, I think once there's comfort
level, you always start with the

concept and the design, right?

There's gotta be comfort
level with this approach.

Um, then we talk a lot about the.

Operational elements and how we've built
it to meet standards that would, uh, we

hope industry would feel are equivalent.

And then we talk about pricing.

So we really feel like the
story speaks for itself.

Like if you jump to pricing.

You know, it's, it's a little, um,
it's a little, uh, challenging, right?

Because they don't know all, people
don't know all the pieces of it.

I think a key thing is regulatory buy-in,
though, you know, the perception is what

do the regulators, uh, think about these?

And so we do try to
communicate and get feedback.

Uh, from all the stakeholders, including
the regulators pretty early so that

we are not coming in, in and building
a program that maybe an, you know,

investigators would love to see,
but industry isn't interested in, or

FDA doesn't think is like the right,
doesn't answer the question, right.

So it is, it's sort of a
dance between all of those.

But, um, I think, you know, in
a lot of ways you could say this

is a great vehicle for small.

Biotech, right?

That they may not have the
resources in-house and they're,

they're handing it over in a way,
although we're not a CRO, right?

We're giving them all
the kind of services.

But we've had large industry
partners too, because I think they

see that the community working
together the patient community, the

clinicians is at a level that's hard.

It's hard to build on your own.

So I think there's value for
lots of different stakeholders.

Scott Berry: And is that
conversation a lot easier?

So A GBM Agile has had multiple arms in.

You've had great success enrolling
patients, collecting data, you can

show them that, that this, this
happens, uh, and you have others where

you haven't enrolled a patient yet,

Meredith Buxton: It is much hard.

The first arm is always
the hardest, right?

I mean, it was in I spy two,
uh, it was in GBM Agile, right?

Uh, and then if.

So that's always the hardest is to
get the, and then I think sometimes

once you get the engine running,
others see, really understand.

So as much as you can reference
another program and the successes

of it, I think that helps.

But ultimately there is some
element of, there's a benefit to

being the first partner, right?

You get a lot of say in
the initial build, right?

You get

Scott Berry: well, but, but to
back up, the worry might be,

do they have to pay for a more
startup cost being the first one?

Are you able to finance this in a way that
they don't have to pay for the startup?

And so it is a good thing
to be the first one.

Meredith Buxton: Yeah, I mean that's, that
is, that's the, you know, the, there are

certain elements around not having, so
we, we didn't sort of dig into this, but.

The time machine, right?

Not having a bank of controls that you get
to use in terms so as the first, you don't

have that, so that is a negative, right.

In a way, at the same time, you
get to have, you get to be part

of the design at the front.

Not to say there isn't arm specific
customizations or companies can't

customize as we go along, but there
is a different level of, you know.

Picking vendors and picking
processes that they get to have.

Uh, but in terms of the infrastructure
build, I think that's the part

where GCAR, uh, you know, we
have been around for enough time.

We have received enough
philanthropic support.

We continue to work with
our advocacy partners to.

Uh, to gain additional
philanthropic support.

We do, uh, we, it shouldn't, it shouldn't
cost the initial pharma more than others

because we have that the infrastructure
supported through external means.

So.

Scott Berry: Yep.

Yep.

Uh, so you have a number of great
efforts and, and by the way, a number

of these are patient and advocacy groups
coming to you because they want see

more drug development in their area.

GBM Agile was a big part of that.

You, you haven't jumped into
easy diseases off the tree Yes.

In this, and there's a

Meredith Buxton: yeah, I mean, I kind
of laugh because people will be like,

well, have you gotten an approval?

And I say, well, you know, we hope to
soon, but you know, it's been 40 years

in, in glioblastoma and what we, we've
been Eva able to evaluate, you know,

five drugs and we're on our sixth and you
know, the sixth drugs are in the trial.

Seventh is entering in a
couple of, in a month or so.

The eighth is on its
way, it's in development.

Like we are accelerating timelines
and hopefully we will get a win.

We will get a win soon.

But, um, to your point of the
advocacy organizations, each, each

program is a little bit different
and even the way we work with our

collaborators, so you're right, some,
in some cases they've come forward.

The children, uh, the Children's
Tumor Fund has come forward and,

um, they are really driving this
effort in neurofibromatosis.

And had been part of an effort in
Europe called EU Pearl to build

out a master protocol for that.

And so they've really been a
driver in that and brought us in.

Um, you know, when I think about the
Cholangiocarcinoma Foundation, and

they've had a seat at the table since the
beginning, they, their CEO or executive

director Stacy, their CMO Juan, he is.

Side by side helping us build
this as our medical lead, so am

along with the clinical community.

So these are models that, and where we've
really partnered in a different way with

the advocacy groups, whereas in others
it may be they are a partner, but they're

not involved in the day-to-day of the,
you know, the build and the, you know,

industry engagement, community engagement.

So,

Scott Berry: Yeah.

Okay.

So now, now I'm gonna ask you
to look forward a little bit.

So, so Ipy two, you started
working on Ipy two, and I don't

know if you envisioned the.

Amazing innovation that Icey
two was when you're, when you're

day to day solving problems.

But, um, the amazing effect that
had on covid, the amazing effect

it's had on clinical trial science.

And you see the huge efficiencies of
these platform trials working in the

different diseases and all this, you
know, looking ahead 10, 15 years, is

this the new way of drug development?

Are we gonna be able to do this
in tens and hundreds of diseases?

Meredith Buxton: I hope.

I mean, I hope so.

I don't think it's right for every
disease, but I definitely, I feel

like we could still do it better.

We can, there's still refinements
and innovations in the design.

And the operations particularly that
we're, we're trying to push forward.

You, you know, but I, I do.

It would be ideal in the future
if we're looking in the future,

if these could really be embedded.

I think the way that REMAP
in the US was trying to do it

within clinical care, right?

They were enrolling patients
right in there, in the clinic.

They were collect, they weren't
collecting separate data.

They were pulling data from the EDC.

I think if we could embed it, that's
if we could do that, I think these

could be more standard because again,
I think there's a lot of inefficiency.

We all know that in the clinical
trial space, I think these are one

solution to improve that efficiency.

So.

You know, I, I see a
longstanding future for them.

And you know, even as we think about
other models where we think about external

controls or, uh, you know, synthetic
controls or things like that, it does

feel like there that the future of this,
there's, there's so much more we could

be doing with regard to platform trials.

Scott Berry: Yeah.

Oh, that's awesome.

That's awesome.

So, so Meredith, I appreciate,
I appreciate you coming on.

It was fantastic.

Um, and we will be talking some more.

So thank

Meredith Buxton: Yeah, I'm sure we ha

Scott Berry: the interim.

Meredith Buxton: I'm sure we, I'm
sure we have a meeting in the next

day or two about some trial, so.

Scott Berry: Yes, yes.

All right.

Appreciate it.

Thank you, Meredith.

Meredith Buxton: Okay.

Take care.