Speaker 1: Welcome to Pharma Talk Radio. This podcast is focused on
Speaker 1: designing clinical trials balancing simplicity and complexity from the twenty
Speaker 1: twenty five Chief Medical Officer Summer three sixty. For more
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Speaker 1: visit CMO three sixty dot org. Thank you and enjoy
Speaker 1: the podcast.
Speaker 2: We thought it would be really helpful to get the
Speaker 2: cmos and data input onto how do we actually physically
Speaker 2: do this and what the challenges are to being able
Speaker 2: to do that. And part of it is that we
Speaker 2: live in a complex world, so it's quite challenging. So
Speaker 2: let's start out by doing introductions. Chris, why don't we
Speaker 2: started that and we'll work this way.
Speaker 3: Yeah. Thanks. I'm Chris Morribido.
Speaker 4: I'm the Chief Medical officer at a company called Astrio Therapeutics.
Speaker 3: It's allergy and immunology.
Speaker 4: We have one phase three asset, one phase one asset,
Speaker 4: and I'm incredibly sobered up by the conversation since that
Speaker 4: we heard this morning.
Speaker 5: Hello everyone, I'm Eric Scalfrow, CEO and founder Rivia. I
Speaker 5: found a Rivia to help sponsors stay in control when
Speaker 5: trials get complicated by helping them bring all their data
Speaker 5: together to bring clarity and momentum. I'm really excited for
Speaker 5: the conversation today, in particular to understand how we can
Speaker 5: improve outcomes with smarter oversights, and that smarter oversight starts
Speaker 5: at the design stage. We're seeing over twenty active trials
Speaker 5: at RIVIA right now, and I'm excited to share some
Speaker 5: of these observations I've had over the last couple of years.
Speaker 6: Wonderful. Hi.
Speaker 7: I'm Judy Nung Cash and I'm the chief medical officer
Speaker 7: of Novotech, where CRO really focused on serving the biotech community.
Speaker 7: While I'm at nov Tech now I can say I've
Speaker 7: had twenty years in the industry across large sponsors, small
Speaker 7: biotech and larger CRO. So I hope to bring kind
Speaker 7: of a balanced perspective to our topic today.
Speaker 6: Great, Thank you.
Speaker 8: Hi everyone. I'm Bertillion Markham, the chief medical officer of Bicopharma.
Speaker 8: We're a Scandinavian biofarma focusing on IPF and angiotens into
Speaker 8: type two receptor agonists, which is quite unique. I think
Speaker 8: everyone can do anything complex, but doing it simple, simply
Speaker 8: and simple, that's the trick.
Speaker 6: And Buru, what phase are you in?
Speaker 8: We're in phase two with the compound. So we're starting
Speaker 8: a big two hundred and seventy patient study in IPF,
Speaker 8: so lots of things to coordinate and ninety seven sites.
Speaker 6: Great.
Speaker 2: So, you know, Ken talked a lot about pivotal and
Speaker 2: phase three trials and we're gonna I'm going to kind
Speaker 2: of break this down into the challenges we see with
Speaker 2: earlier phase trials and what we need to do with
Speaker 2: biotechs and with vendors, answer key questions we need to
Speaker 2: get for how do we risk manage our programs, make
Speaker 2: investors happy and be able to fund our company and
Speaker 2: also move things forward, and then we'll switch over to
Speaker 2: the pivotal at the end. Although with development right now
Speaker 2: in particular in a lot of these phases are kind
Speaker 2: of blurring in the biotech world, so a lot of the.
Speaker 6: Questions are the same.
Speaker 2: So let's talk a little bit about what the challenges
Speaker 2: are in early phase trials of what you're trying to
Speaker 2: solve for first and how that makes your trials complex
Speaker 2: and how you deal with that to be able to.
Speaker 6: Make them more doable. So what you know, do we
Speaker 6: want to start with the Let's start with the christ.
Speaker 2: And will work away across.
Speaker 4: It's I mean that's a key question. We have so
Speaker 4: many stakeholders, and I mean all of us are incredibly
Speaker 4: curious people, and we're scientists by heart, and we want
Speaker 4: to do the right thing for patients by heart, and
Speaker 4: we want to do the right thing for our company
Speaker 4: and for investors, and for the FDA and for the EMA.
Speaker 4: So many stakeholders, and there are only so many questions
Speaker 4: one can ask or one should ask in early phase trial.
Speaker 3: So you know, one thing that we've started doing is
Speaker 3: asking the hard questions, what are these data for?
Speaker 4: Who are these data going to be shown to, what
Speaker 4: is an expected expectation of these data? And what kinds specifically,
Speaker 4: what kinds of questions must we answer versus what kinds
Speaker 4: of questions would be to answer? And for a lot
Speaker 4: of us in biotechnology, we live and breathe by our data.
Speaker 4: That's what funds us. And uh, you know, it's it's
Speaker 4: often difficult to have to ask the question, how do
Speaker 4: I get the right data for an investor versus the
Speaker 4: right data to get this in front of an end
Speaker 4: of phase two meeting. So the FD is going to
Speaker 4: be happy with our selection of our clinical trial designer
Speaker 4: for phase three.
Speaker 3: It's a tough. It's a tough intellectual balance. So you know, it's.
Speaker 4: What we've what we've opted to do is work through
Speaker 4: this step by step in in fact, in fact hierarchy, hierarchical,
Speaker 4: hierarchically rank who we're trying to please and who we're
Speaker 4: trying to address with our data, such that we could
Speaker 4: design the most simple trials. Almost always has been said,
Speaker 4: and as we learn from Ken this morning, simple is better,
Speaker 4: but simple isn't always best.
Speaker 3: So it's it's uh.
Speaker 4: Limiting to the most precise questions that we can ask
Speaker 4: in order to please the right stakeholders.
Speaker 5: Maybe if I could just react to that, you know,
Speaker 5: I think you can't simplify what you can't see, right,
Speaker 5: I think there's a gap between the designs and the
Speaker 5: reality operationally that they bring. Bettiel had some eloquent way
Speaker 5: to put it before that they're very theoretical.
Speaker 3: And I just had one anecdote.
Speaker 5: I was speaking to a CMO on Friday who has
Speaker 5: an open label phase two in a variant of IBD,
Speaker 5: and in this dose escalation, he first needs to review
Speaker 5: every patient before they're escalated and then discuss that with
Speaker 5: the PIS and make a joint decision if that makes
Speaker 5: sense right now, that actually brings quite a lot of
Speaker 5: operational burden, right, fifty patients, each patient takes a couple
Speaker 5: of hours to do that. That's already several hundred hours
Speaker 5: to do that review on paper, pretty simple, and so
Speaker 5: bridging that gap of considering the operational reality with the designs,
Speaker 5: I think is a is an important step.
Speaker 3: Yeah.
Speaker 6: Well, you know, it's funny.
Speaker 2: I'm from Philly and uh you know we have a
Speaker 2: famous basketball uh thing where Alan Everson said practice, I
Speaker 2: don't need practice, right, And what we find is that
Speaker 2: sometimes you win these before you start. And Judith, you know,
Speaker 2: as somebody that's a cro how much up front work
Speaker 2: does it take to get your trials to be simplistic
Speaker 2: even in a complex world.
Speaker 7: I think that's a great question. And I think, you know,
Speaker 7: Chris got to the heart of it. I think, you know,
Speaker 7: coming from a big pharma background where you know you're
Speaker 7: really designing for the health authorities right for approval, you're
Speaker 7: looking at this long long development program and trying to
Speaker 7: do things in a stepwise fashion. And what's very different
Speaker 7: working with biotech is all the stakeholders, right, and I
Speaker 7: think what we observe with our early phase biotech.
Speaker 6: Sponsors, is it.
Speaker 7: That prioritization is rarely done right, and so you're trying
Speaker 7: to please everyone, which just adds more endpoints, because what's
Speaker 7: meaningful to the regulators might be different than what is
Speaker 7: going to be a value inflection point for you with investors.
Speaker 7: And so I see, I do observe sponsors trying to
Speaker 7: add everything in but not appreciating the potential operational risk
Speaker 7: that they incur and that that ultimately might result in
Speaker 7: a problem with your data integrity. So it is a
Speaker 7: conversation when you have a biotech who doesn't have operational
Speaker 7: experience in it to really say can we can we
Speaker 7: trade off? And it's a lot of work, and depending
Speaker 7: on the background of who you're interacting with, that sort
Speaker 7: of conversation may or may not hit well yeah.
Speaker 8: Yeah, no, I think there is kind of many many
Speaker 8: flavors of complexity, avoidable and unavoidable because you start with
Speaker 8: the drug and you start in therapeutic area, so you
Speaker 8: have some kind of complexity to begin with, but then
Speaker 8: you add on and I remember many years back in
Speaker 8: ASTRA people suggested that we have a cutting manager that
Speaker 8: actually tried to cut down on the number of things
Speaker 8: that people heaped up on studies. So I think that
Speaker 8: mindset is extremely important. So you make it as simple
Speaker 8: as you possibly can while still answering the key questions.
Speaker 8: And then I think there and there's a degree of
Speaker 8: blindness because the companies often try something new and already
Speaker 8: in the design phase, you are kind of blind to
Speaker 8: the problems that you will anticipate. Actually the pis and
Speaker 8: the sites might actually help you. And then of course
Speaker 8: we spoke about the patients and the sort of simplicity
Speaker 8: that understanding the patient bird brings, So I think there
Speaker 8: are those things that can help.
Speaker 6: Yeah, it's a great point. I think Ken talked about
Speaker 6: it a little bit this morning.
Speaker 2: I'd be interested to hear how when you start to
Speaker 2: think about your programs you start to think about patient burden,
Speaker 2: site burden, do ability. Are you designing programs that are
Speaker 2: actually people are able to do? And how do you
Speaker 2: take that into account and what kind of feedback you
Speaker 2: get to be able to achieve that?
Speaker 6: So look, you hear left from the group.
Speaker 3: So yeah, yes, absolutely.
Speaker 4: From the beginning, as a patient orient in company, we
Speaker 4: take a lot of time and care to talk with
Speaker 4: the patient groups. We've established patient advisory councils working closely
Speaker 4: with patient advocacy organizations. And the advocacy organizations have been
Speaker 4: incredibly helpful by themselves, but the advisory councils.
Speaker 3: Are one step better.
Speaker 4: These are people that we can talk about strategy with
Speaker 4: but then talk about operations with as well. And you know,
Speaker 4: when we propose clinical trial operation elements, these are the
Speaker 4: number of site visits.
Speaker 3: This is what we want to do.
Speaker 4: At each side visit, they come with pencils and pens
Speaker 4: and they mark it up and they give us the
Speaker 4: feedback and this is not going to happen or you
Speaker 4: need to do that.
Speaker 3: It's incredibly helpful because if we can.
Speaker 4: Then go to our sites and said, we designed this
Speaker 4: with input from your patients, and this is what they
Speaker 4: feel like they can do in a clinical trial. Operational
Speaker 4: burden therefore is therefore is decreased, so please help us
Speaker 4: enroll this trial.
Speaker 3: So far that seems to work. It's an evolving landscape.
Speaker 5: Though, I think there what's important is that you know,
Speaker 5: complexity is a choice, not a consequence, in the sense
Speaker 5: that right we saw mister Getz's staring numbers on more endpoints,
Speaker 5: more procedures, et cetera. Now, what does that really imply operationally?
Speaker 5: How does that compound risk and variability? Right? I have
Speaker 5: several of our sponsors are now undertaking decentralized trials, and
Speaker 5: what I hear is there is a discordant reduction in
Speaker 5: burden decentralized trials the premise that it reduces patient burden
Speaker 5: for the people running the trial, it actually potentially increases
Speaker 5: it because instead of just doing the monitoring at the site,
Speaker 5: you now have to do monitoring at the site and
Speaker 5: at the patient's home, and you have to make sure
Speaker 5: the data is collected in consistent ways, and so there
Speaker 5: the complexity is perhaps more of a consequence than a choice,
Speaker 5: or maybe not fully thought out. So I think it's
Speaker 5: important to reflect on those different compounding elements of complexity.
Speaker 7: I think that you know, especially for you know, our
Speaker 7: biotech sponsors, the the technologies that are being studied are
Speaker 7: by definition super complex. Right, So there is operational complexity
Speaker 7: that you can't like what you were saying, virtiularly, that
Speaker 7: you can't avoid there maybe there's a cold chain, supply
Speaker 7: chain or something like that that is unavoidable. But I
Speaker 7: think when you can, I think the complexity from the
Speaker 7: sponsors is often driven by a risk aversion, right, that
Speaker 7: we're going to not collect the right data, that someone's
Speaker 7: gonna one of our many stakeholders is going to ask
Speaker 7: for data we didn't collect, and why don't you collect that?
Speaker 6: And I'm not going to invest in your company.
Speaker 7: And I think taking a risk based approach to what
Speaker 7: must we have and can I accept the risk that
Speaker 7: maybe someone down the road some day is going to
Speaker 7: ask for this other thing?
Speaker 6: And let's omit that.
Speaker 7: I think it's hard math when you're a physician scientist
Speaker 7: and you just want more data because it's convention that
Speaker 7: more data.
Speaker 6: Is better, right.
Speaker 3: Yeah.
Speaker 8: I guess if you like a clinical study with going
Speaker 8: on an expedition, you kind of you can't pack everything,
Speaker 8: so you have to unpack and limit and that's a
Speaker 8: hard choice. And I guess the complexity has three time
Speaker 8: segments in a way, it's before the study, is during
Speaker 8: the study, and it's after the study. One of the
Speaker 8: key aspects that I'm quite interested in is the data
Speaker 8: and the access to data. At least my experience is
Speaker 8: that sort of there is a little bit of a
Speaker 8: power game sort of who accesses the data and who
Speaker 8: can really understand the data in depth in a clinical trials,
Speaker 8: both during the trial blinded data and after the data
Speaker 8: when you try to connect this to the next sort
Speaker 8: of phase in the program. And I think accessing blinded
Speaker 8: data during studies is extremely important. I know that Rivia
Speaker 8: is working with that Capacious and other companies that you
Speaker 8: will see here where you can have sort of data
Speaker 8: dump and actually understanding the data during the trial because
Speaker 8: that helps you actually plan for the next segment. And
Speaker 8: I think that's super important to reduce complexity.
Speaker 2: So, Chris, you talked about site and Bernald you talked
Speaker 2: about this to cite and patient input and having you know,
Speaker 2: folks review your protocols. Any of you institute actually walking
Speaker 2: through your visits and looking at your visits and seeing
Speaker 2: what you're asking patients to do with your visits. Have
Speaker 2: you done that in your child I'd be curious to
Speaker 2: folks in the audience as well of actually having your
Speaker 2: folks just pretend they're a patient or a coordinator and
Speaker 2: actually make them do a visit, as has anybody on
Speaker 2: this panel thought about her?
Speaker 6: Have they done that to see what the burden really is.
Speaker 3: I've asked my clinop's team to do it, but I
Speaker 3: haven't done it myself.
Speaker 6: Yeah, yeah, I think I think you see that happening
Speaker 6: at sponsors.
Speaker 7: Not really, but it's a great idea because I think,
Speaker 7: you know, that experience really helps you understand what's necessary,
Speaker 7: what's not necessarily, what's a burden. I think asking people
Speaker 7: is a good idea. And you know, one thing, you know,
Speaker 7: this conversation is making me think. You know, it's so
Speaker 7: competitive to enroll the patients, and the sites feel it,
Speaker 7: the sponsors feel it, and so anything you can do
Speaker 7: to like hit the easy button for both of those
Speaker 7: populations might actually give you a competitive advantage in a
Speaker 7: crowded you know, indication.
Speaker 8: Yeah, I think the idea of walking through a visit
Speaker 8: or the visits is really important. The number of visits
Speaker 8: and the complexity is extremely important. And I was starting
Speaker 8: to think of a clinical study as a board game basically,
Speaker 8: because you do you have the the sequence of events,
Speaker 8: but you also have the the what if kind of
Speaker 8: questions that will that will happen during a trial that
Speaker 8: you don't spend enough time to walk through.
Speaker 2: And eric you help folks think through their databases but
Speaker 2: also their data entries, So do you do that with
Speaker 2: sponsors where you actually have them sit through and simulate
Speaker 2: a patient and have them entered their data or think
Speaker 2: through that.
Speaker 4: Sure.
Speaker 5: More so, we have two chief medical officers in our
Speaker 5: founding team and did pretty much the exercise you're describing
Speaker 5: with their teams, more so on a softer side, to
Speaker 5: humanize the trial, to really understand because a lot of people,
Speaker 5: including myself, are very far moved from the patients and
Speaker 5: the reality of the data collection at the site and
Speaker 5: you just becomes a lot of emails and data points,
Speaker 5: and so they've brought them for a few visits to
Speaker 5: really understand the reality of what it takes. More from
Speaker 5: really an empathetic, humanizing perspective, I think it softened a
Speaker 5: little bit to the frustrations when things are or when
Speaker 5: things are maybe not the quality that they desire, because
Speaker 5: there's there's a tough reality.
Speaker 7: To it as well.
Speaker 2: So, Chris, you I'm going to shift this a little
Speaker 2: bit because we've been talking about patient burden and site burden,
Speaker 2: but you raise another thing at the beginning, and that's
Speaker 2: all the stakeholders you have to answer questions for and
Speaker 2: be able to produce clinical trial results for. And I'd
Speaker 2: love to hear from the four of you. Who where
Speaker 2: you think your biggest challenge of complexity comes from. Does
Speaker 2: it come from your self, does it come from the
Speaker 2: from the board, does it come from your investors, does
Speaker 2: it come from the regulators? Where do you think or
Speaker 2: does it come from the scientific community. Where do you
Speaker 2: each think that the complexity arises from? If you had
Speaker 2: to pick a point where it comes from, where would
Speaker 2: you think that comes from?
Speaker 4: So I think each of those and those stakeholders that
Speaker 4: you identified wants a simple trial. The challenge, of course,
Speaker 4: is that they want a simple trial asking different questions.
Speaker 4: So ultimately the complexity is on us because we're trying
Speaker 4: to put all of those questions into one trial. You know,
Speaker 4: it's it's no longer sufficient just to say I'm going
Speaker 4: to do a safety study in phase one. You know,
Speaker 4: you're throwing in biomarkers, You're throwing into all these exploratory
Speaker 4: things to look for some efficacy signal that will translate
Speaker 4: into potentially a value inflection. And that makes it very
Speaker 4: complex even for a phase one study, which are generally
Speaker 4: operationally simple. So you know, this is why we do this.
Speaker 4: Prioritization is trying to, you know, try to limit the
Speaker 4: number of people that are forcing us to ask these
Speaker 4: complex questions.
Speaker 5: Yeah, and so from my perspective, what becomes challenging is
Speaker 5: deciding what's essential and cutting what's not and seeing how
Speaker 5: that priorization might change as the trial's unfolding, right, and
Speaker 5: responding to various stakeholders. So kind of being like by analogy,
Speaker 5: you know, the bird at thirty thousand feet or a
Speaker 5: hulk and knowing at the right time to go and
Speaker 5: peek down and then come back up and resurface. I
Speaker 5: think that's tremendously difficult, but also where there's a lot
Speaker 5: of potential and opportunity.
Speaker 7: If I had to pick one of the stakeholders that
Speaker 7: the one stakeholder that drives complexity, I might say the investors,
Speaker 7: only because what they want out of an early phase
Speaker 7: trial is so much right. And you know, for what
Speaker 7: when we used to do phase one, it was just
Speaker 7: healthy volunteer sad mads and simple and let's move on
Speaker 7: to the next phase. But the funding pressure and the
Speaker 7: time pressure, I think drives adding all this other stuff
Speaker 7: in that drives complexity. So even though we'll say this
Speaker 7: is not powered, it's exploratory, people want something at the
Speaker 7: end of that right because they invested and they want
Speaker 7: to turn around and or you know, an increase in
Speaker 7: value or whatever it is. So I think that on
Speaker 7: the sponsor side, especially for the CMO population, we're just
Speaker 7: trying to do a good trial that is safe or
Speaker 7: has the appropriate risk benefit for the people who are
Speaker 7: you know, volunteering to be in this experiment.
Speaker 6: And then you add on from that.
Speaker 8: Yeah, I think it's easy to kind of blame everyone else,
Speaker 8: but I think the cmos are driving complexity as well.
Speaker 8: And obviously you have you have your guiding star with
Speaker 8: the regulators and the science and the drug and you
Speaker 8: try to get that into package. But actually then there
Speaker 8: are kind of some kind of inertia and some kind
Speaker 8: of momentum that builds in company where you add stuff,
Speaker 8: but you have to restrict and keep yourself a bit calm,
Speaker 8: even as a CMO.
Speaker 6: I think and do you think that.
Speaker 2: It's a good point. Do you think that getting involved
Speaker 2: earlier in the program, when the prequinical programs are designed
Speaker 2: would help you streamline some of the things that you're
Speaker 2: trying to collect or target so that you get that
Speaker 2: one answer out of your phase one two that's meaningful
Speaker 2: when you've thought about it when they put the drug
Speaker 2: into a mouse or or.
Speaker 6: A monkey or something like that. Thought about that about.
Speaker 2: Our companies bringing cmos in too late to think about
Speaker 2: the holistic design their programs.
Speaker 6: Is that adding to it?
Speaker 3: Yeah?
Speaker 4: Maybe, But I think honestly that kind of question that
Speaker 4: you're asking goes with every single phase change. I mean,
Speaker 4: I think that we should be thinking deeply along the
Speaker 4: way of all of the data that informed a high
Speaker 4: pos in the clinical trial that you're about to start.
Speaker 4: And I think that absolutely does include the pre clinical space.
Speaker 4: One of my former mentors that actually is in the
Speaker 4: audience today taught me a long time ago that you
Speaker 4: should never ask a question you don't really know the
Speaker 4: answer to. You should pretty much be sure you're going
Speaker 4: to get an answer that you've predicted. And there are
Speaker 4: lots of tools like doing more translational research, enabling model
Speaker 4: informed drug development and pharmacometrics to give you confidence in
Speaker 4: the question that you're about to ask.
Speaker 3: So yeah, absolutely.
Speaker 7: But it is also, though, Chris my observation that with
Speaker 7: smaller companies with constrained funding, that up front.
Speaker 6: Pre clinical work is.
Speaker 7: Not thought of as a must have to get into
Speaker 7: the clinic. It's a nice to have, and it's unfortunate
Speaker 7: because that helps you do a better early phase trial.
Speaker 8: Well, I happen to be lucky because we are extremely
Speaker 8: close with the pre clinical guys, and you know, the
Speaker 8: whole question about sort of exposure, exposing humans to a drug.
Speaker 8: I think that's so so serious and so interesting that
Speaker 8: you need to absolutely understand what's going on, both in
Speaker 8: terms of in terms of potential side effects and potential
Speaker 8: exposure and the drug concentrations and everything. So you need
Speaker 8: to really hook up with the pre clinical guys and
Speaker 8: work closely.
Speaker 2: So we'll shift over to pivotal a little bit because
Speaker 2: Ken talked about that this morning, and I think, you know,
Speaker 2: a couple folks made some comments about learning from early
Speaker 2: phase and are we getting enough out of our early
Speaker 2: phase studies to be able to target and design much
Speaker 2: more simplistic pivotal trials that ask the questions we need
Speaker 2: to get approval and access and whatever, or we you know,
Speaker 2: asking too many questions out of our early trials and
Speaker 2: not getting enough to be able to design simplistic pivotal trials.
Speaker 6: Is that what's contributing here. My observation is that.
Speaker 7: Complex early phase studies lead to complex pivotal studies exactly
Speaker 7: because there's not enough data with all those exploratory and
Speaker 7: points to make people feel confident that they can start
Speaker 7: eliminating them. So they just continue that on because we
Speaker 7: already measured that in phase one, so let's keep measuring it.
Speaker 8: And were just in the face of designing a sad
Speaker 8: MAD with the kidney disease cohort, and we were thinking, okay, okay,
Speaker 8: should we just do PK, should we do PK tol ability?
Speaker 3: Should we do eight days?
Speaker 8: Should we do like a month? And then you start
Speaker 8: thinking about the underpower, the risk of underpowering all these things,
Speaker 8: so you need to limit and we started thinking esoteric
Speaker 8: blood flow measurements and stuff like that. But then we
Speaker 8: were advised, well, they're not that that sort of high precision,
Speaker 8: so you may end up with just a gray cloud
Speaker 8: of uncertainty. And of course, the more stupid uncertainty you
Speaker 8: bring with yourself, the more questions you might be asking
Speaker 8: in the next phase.
Speaker 3: So it is tough. It is tricky.
Speaker 4: I think the answer to your question isn't so simple.
Speaker 4: I think it's complex. I don't mean to make a
Speaker 4: pun about it. I think I've seen lots of examples
Speaker 4: of phase retrials that have been simple despite lots of
Speaker 4: complexity early development, and I've seen the converse. I've seen
Speaker 4: companies push the difficult questions to phase three because they
Speaker 4: want to get through phase two faster to get to
Speaker 4: a value inflection to fund phase three, making FACE three
Speaker 4: is more complicated. And on top of that, the payer
Speaker 4: market right now, the pero dynamics right now are really complicated,
Speaker 4: and you have to throw in all kinds of quality
Speaker 4: of life and other pyros into your assessments that add complexity.
Speaker 3: I think part of this is the regulatory burden. If
Speaker 3: you're going into a rare.
Speaker 4: Disease, the regulatory pathway may not be as well defined
Speaker 4: for you, which, no matter what you do in early development,
Speaker 4: makes FACE three complex.
Speaker 3: So ultimately, I don't know the answer to your question,
Speaker 3: but I.
Speaker 4: Would say that it is on us to do whatever
Speaker 4: you possibly can to make phase three as uncomplicated as
Speaker 4: it possibly can, just to make sure that trial gets
Speaker 4: done well.
Speaker 2: So I love the end sessions with if there's one
Speaker 2: bit of advice to make your trials simple, what would
Speaker 2: it be? So why don't we start down there? We'll
Speaker 2: start down this.
Speaker 8: I'd actually go to sites and ask them what makes
Speaker 8: this the most sort of competitive study that that that
Speaker 8: would would help us run.
Speaker 7: I was going to say the same thing. Thanks for
Speaker 7: still in my thunder. I think coming back to the
Speaker 7: beginning of this conversation, when engage early with your patient
Speaker 7: population and your investigator population to understand what really makes
Speaker 7: sense and what they what do they want to participate in,
Speaker 7: I think that's a good start.
Speaker 5: Yeah, just to bring it back to my three observations,
Speaker 5: which were, you can simplify what you can see. Simplify
Speaker 5: simplification needs discipline, and make complexity choice not a consequence.
Speaker 5: And with that in mind, consider designs with the operational
Speaker 5: reality that they bring exactly what that Deal and Judith
Speaker 5: are talking about, right.
Speaker 4: And then mine would be make sure you know your
Speaker 4: company's primary objective before you put pen to paper on
Speaker 4: their protocol.
Speaker 2: Great, and I think we're out of time. I don't
Speaker 2: know if we have time for no questions. Okay, great, Well,
Speaker 2: thank you very much, this is great.
Speaker 6: Thank you.
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