Speaker 1: Welcome to Farmer Talk Radio. This podcast is focused on
Speaker 1: enhand strategic FDA collaboration working with Cedar and Sieber from
Speaker 1: the twenty twenty five Chief Medical Officer Summit three sixty.
Speaker 1: For more information on the CMO Summit, editorials, podcasts, or webcasts,
Speaker 1: please visit CMO three sixty dot org. Thank you and
Speaker 1: enjoy the podcast. We have.
Speaker 2: A group of panelists with a very diverse experience of
Speaker 2: regulatory interactions and essentially get their advice on the best
Speaker 2: ways of working with Cedar and Seber. Inevitably, with all
Speaker 2: of the changes that are happening in the FDA, we
Speaker 2: may have to address some of those potential changes. But
Speaker 2: the focus here is really on people's experience of how
Speaker 2: best to interact with the FDA that we know and love.
Speaker 2: So with that, I'm going to ask for introductions.
Speaker 3: I'll start off.
Speaker 2: I'm Peter Francis. I'm the Chief Medical Officer in chief
Speaker 2: antipic Officer at Rath Therapeutics, which is an aav gene
Speaker 2: therapy company principally working in the ophthalmic space. I have
Speaker 2: a considerable amount of experience of translating into early phase development.
Speaker 2: Number of indication number of products for principally rare diseases
Speaker 2: in the ophthalmology and other areas.
Speaker 4: Richard Granton, chief medical Officer Lyndrith Therapeutics were an oral
Speaker 4: drug delivery technology out of MIT, but prior to that,
Speaker 4: I worked in the pain space in well and carometabolic.
Speaker 5: Cart preaching.
Speaker 6: Our preaching Chief medical officer at Precision for Medicine. We're
Speaker 6: a global cro focused on oncology and rare disease. Prior
Speaker 6: to my role at Precision, I joined in May of
Speaker 6: last year. I was at the FDA for nearly ten years.
Speaker 6: In the latter half I served as a division director
Speaker 6: of one of the solid tumor oncology divisions within THEEDAR.
Speaker 7: I'm Norman Sussman. I'm chief medical Officer at Direct. My
Speaker 7: training is in liver disease and the company is focused
Speaker 7: on an acute form of alcohol liver disease called alcohol
Speaker 7: associated hipatitis.
Speaker 3: That's great, thanks for the introductions.
Speaker 2: We thought the first area that we might focus on
Speaker 2: from a sort of best practice is how best to
Speaker 2: structure your interactions with the FDA. Examples being how to
Speaker 2: prepare who to send and so on. So maybe for
Speaker 2: this first question, I'll hand it to Harpreet first, she's
Speaker 2: had the most hands on experience at the FDA, and
Speaker 2: then we'll get the other panelists to comment to Thanks.
Speaker 6: Peter, Well, we were talking earlier about how much to
Speaker 6: go into the recent events at FDA, and I think
Speaker 6: this panel would be remiss to not, you know, focus
Speaker 6: particularly on Cedar and Seber. So I'm just gonna I
Speaker 6: am going to answer your question, but I just want
Speaker 6: to spend a few moments talking about what has happened
Speaker 6: to my former colleagues at the FDA in the last
Speaker 6: several weeks and months. And we have seen and this
Speaker 6: is two prongs. We'll start with Segur and then moved
Speaker 6: to Sieber. C Derr has seen substantial departures from Peter Stein,
Speaker 6: who headed the Office of New Drugs, so that crosses
Speaker 6: all therapeutic areas. In the oncology group, You've seen the
Speaker 6: departures of key leaders in the Oncology Center of Excellence
Speaker 6: with Mark there, Paul Klutz, the head CEDAR head, Patricia
Speaker 6: Cavezoni now CMO at Pfizer. So that predated some of
Speaker 6: this of what we saw in the last couple of weeks.
Speaker 6: And I think as far as interacting with FDA. What
Speaker 6: you will see there is as far as Sea dur.
Speaker 5: Goes, I think things will be.
Speaker 6: Somewhat routine and normal in terms of I and D reviews, meetings.
Speaker 5: They're continuing to have them.
Speaker 6: What I do think we need to pay special attention
Speaker 6: to is who's showing up at those meetings, who's doing
Speaker 6: the talking, who's noticeably absent, because more departures will come,
Speaker 6: so those noticeably absent leaders may be actually recused because
Speaker 6: they're looking elsewhere. But I think these also present opportunities
Speaker 6: for emerging leaders to come through and take acting positions
Speaker 6: as acting associate directors, deputy directors, and so forth. With Oncology,
Speaker 6: who makes up about forty percent of sedar's work, I
Speaker 6: do think they do have good leadership remaining, and so
Speaker 6: we'll get later into the panel about what I think
Speaker 6: those strategic interactions should look like.
Speaker 5: See Burr.
Speaker 6: On the other hand, I think I saw a very
Speaker 6: substantial loss with Peter Marx, who was really presiding not
Speaker 6: only over all the vaccine work, but this very robust
Speaker 6: cell engene development area, really setting up those regulatory frameworks
Speaker 6: for the first Crisper approval with CASHJEV, the first celling
Speaker 6: gene approval for pediatric form of leukemia and so not
Speaker 6: having him at the HELM I think should cause some
Speaker 6: concern and wanting to understand in the months moving forward,
Speaker 6: who's going to fill that gap and will those policies
Speaker 6: and frameworks that he had been developing to really streamline
Speaker 6: and expedite. You know, there's over two thousand cell e
Speaker 6: gene products in the pipeline, there's over thirty registrational phase
Speaker 6: three trials and cell e gene so Sibur, I think
Speaker 6: is where you're going to see a substantial deficit in leadership,
Speaker 6: and you know, we need to look to see in
Speaker 6: the coming months who's going to step up and fill
Speaker 6: those roles all with the other And I'll talk a
Speaker 6: little more and then we'll come into how I think
Speaker 6: these can be opportunities to enhance our interactions.
Speaker 2: But I think you hit on something it's really critical
Speaker 2: to the discussion this afternoon. I just want to go
Speaker 2: back to, which is I think a lot of us
Speaker 2: have realized along the way that the FDA holds the
Speaker 2: collective knowledge, if they can't talk about it specifically, are
Speaker 2: there any concerns that you have that that collective knowledge
Speaker 2: may be may be affected.
Speaker 6: By this, absolutely, yes, and I think that going to
Speaker 6: the opportunities, I think there are several opportunities for those
Speaker 6: of us in this room, and as we're thinking about
Speaker 6: building our teams and who we send to the FDA meetings.
Speaker 6: You want to as cmos, especially of biotech, you are
Speaker 6: the lateral to the division director.
Speaker 5: The division directors are mds.
Speaker 6: They want to talk to the mds who are developing
Speaker 6: the asset, and you as cmos, if you have a
Speaker 6: robust track record in interacting with the FDA, the newer
Speaker 6: FDA leadership may actually need to hear what the precedent
Speaker 6: has been, or you may need to beef up your.
Speaker 5: Team with some of these FDA folks.
Speaker 6: That are being impacted by the reductions and force to
Speaker 6: kind of turn back around that knowledge to support you. So, yes,
Speaker 6: it's a concern, and also their opportunities to enhance our
Speaker 6: collaborations to bring back some of that knowledge.
Speaker 4: Yeah, I was going to say, we had a discussion
Speaker 4: before and that resonated really well with me. I've worked
Speaker 4: primarily in small biotech and so I don't have the
Speaker 4: big farmer experience, but oftentimes we see those mistakes made
Speaker 4: you see them as regulators and so regular you know,
Speaker 4: maybe your regulatory affairs wants to run the show. I
Speaker 4: have found that basically it's down to it's about patient
Speaker 4: safety and efficacy, and that's a physician the physician discussion oftentimes,
Speaker 4: and you need to present it that way. If there's
Speaker 4: going to be a discussion about pharmakinetics, you should have
Speaker 4: that individual there. You should really plan those meetings that
Speaker 4: you bring your best and brightest and pair them up
Speaker 4: with the agency.
Speaker 1: And I agree.
Speaker 4: I think there's an opportunity now for us to come
Speaker 4: in and basically restate the historical perspective for them because
Speaker 4: we're on the same page about delivering a drug that's
Speaker 4: going to improve the lives of patients, and that's what
Speaker 4: they want to hear from us. And that's oftentimes we
Speaker 4: make it too much about following the guidelines in a
Speaker 4: regulatory procedure, and I think we should. My experience is
Speaker 4: that does not help very much of getting your agenda
Speaker 4: across now.
Speaker 7: And I was very encouraged by what Tuprey said because
Speaker 7: it happens that I'm in a section where a lot
Speaker 7: of my colleagues work. Even though I try not to
Speaker 7: have any x party discussions with them. But I think
Speaker 7: it's a mistake. Companies frequently view FDA as the opponent,
Speaker 7: and it's much better, especially at the medical level, to
Speaker 7: think of them as a collaborator. They first of all,
Speaker 7: they frequently get some of the top people in my
Speaker 7: specialty are on those panels. And number two, they get
Speaker 7: access to data that you will never see. They're reviewing
Speaker 7: protocols and drugs that you're not going to know about.
Speaker 7: And so when they say something, don't get upset about it.
Speaker 7: Think what did they say and how does this apply
Speaker 7: to us, and try to be try to be responsive
Speaker 7: to that. The other thing I would say that I
Speaker 7: see sort of peripherally is people are always trying to
Speaker 7: skirt the rules, pull the wool over their eyes, try
Speaker 7: to get away with something. And I think being honest
Speaker 7: and saying here's what I know, here's what I don't know,
Speaker 7: will really pay dividends. And that's what I would encourage
Speaker 7: any CMO to do.
Speaker 3: I think there's a wise words.
Speaker 2: My interactions have largely been at with siber and I
Speaker 2: entirely concur that there may be a tendency to think
Speaker 2: of the as an adversarial relationship like you've got to
Speaker 2: get this through. Come and get this through the best
Speaker 2: ways to engage positively and very much to read very
Speaker 2: very carefully what the agency is telling you in that feedback,
Speaker 2: and for that reason you need to be transparent too,
Speaker 2: because they will tell you the answer. They want to
Speaker 2: see the drug approved, they want to see the drug progress.
Speaker 2: They're not trying to kill it. But they also have
Speaker 2: all that information, and so engaging as positively as you
Speaker 2: can and working with them. I've got to say that
Speaker 2: in recent past, by experience with siber is that they've
Speaker 2: been very much more interactive than I remember them being
Speaker 2: several years ago. So bear in mind that, particularly at
Speaker 2: the earlier stage, even if you don't have like an
Speaker 2: RMAT or something else, the agency seems very willing at
Speaker 2: the moment to engage semi informally if you have some questions.
Speaker 2: The responses seem to come back. No longer have I
Speaker 2: been experiencing responses which like we'll get to this in
Speaker 2: the I and D process, It's usually you get a
Speaker 2: lot of insight at an early stage.
Speaker 3: I don't know whether others can add to.
Speaker 2: That that approach to navigating the agency.
Speaker 7: So I thought when they were not having live meetings.
Speaker 7: That was a major major step back for us because
Speaker 7: we got a series of letters. I think what Peter
Speaker 7: said is very important. Have other people read the letter
Speaker 7: to you. Don't just take your interpretation. Have an expert,
Speaker 7: have your colleagues, some other people. But the letter we
Speaker 7: got was so concerning, and I knew who the people were,
Speaker 7: and I thought, how did they come with this? You know,
Speaker 7: this was such a such a departure from standard of
Speaker 7: standard of care. But when we had a live meeting,
Speaker 7: literally in five minutes, the whole thing was resolved. And
Speaker 7: so if you have the if you're able to have
Speaker 7: a live meeting, it is so much better. It just
Speaker 7: really smooth everything out and everyone left saying I know exactly.
Speaker 5: What after and FDA is very open for business.
Speaker 6: I mean, part of what will has substantially changed for these,
Speaker 6: you know, for the physicians, for the FDA staff, is
Speaker 6: that they are now required to go in Monday through
Speaker 6: Friday to the campus in Silver Spring, Maryland, and that
Speaker 6: will cause some attrition. At the same time, it will
Speaker 6: open up the door for more in person meetings, and
Speaker 6: I highly recommend going in person.
Speaker 5: There's way more.
Speaker 6: That you can pick up where people are sitting who's
Speaker 6: doing the talking, and you can get way more out
Speaker 6: of those interactions, particularly if you're taking a subject matter
Speaker 6: expert with you. For example, if you're CMO, perhaps you
Speaker 6: know you just need that bolstering of how does this
Speaker 6: struggle look in the clinic, what are investigators saying about it?
Speaker 6: Having that peer to peer interaction in person is substantially
Speaker 6: more valuable than online.
Speaker 7: Yeah, I agree.
Speaker 4: I mean one of the key meetings I remember asking
Speaker 4: for a in person meeting was critical for reading the room,
Speaker 4: understanding what they're nodding, what they're agreeing to. But the
Speaker 4: other interesting part was, are you know you have to
Speaker 4: do your briefing document way in advance? And things evolved
Speaker 4: between that time and between the meeting, and there was
Speaker 4: a feeling in my company is, well, you can't share
Speaker 4: any information that wasn't in your briefing document. And I
Speaker 4: was going to, like, of course i will in the
Speaker 4: in the in the discussion, if they ask for it,
Speaker 4: I'm going to have the piece of paper with me
Speaker 4: with the additional data, because again in that case, it's
Speaker 4: more of a collaboration. It's going to help them understand more. Sure,
Speaker 4: I'm not going to come to the meeting and say
Speaker 4: I blind signed to them, but we're going to have
Speaker 4: a discussion. And as soon as they asked for it,
Speaker 4: I was able to give an additional data that just changed.
Speaker 8: You know.
Speaker 4: Again, alaid some of their concerns which we didn't have
Speaker 4: the time of the briefing book. So again my point
Speaker 4: is not going off script, but being prepared, anticipating where
Speaker 4: your gaps are and trying to fill those. And then
Speaker 4: also I think is really important, particularly if you bring
Speaker 4: in I made this one mistake. I brought an academic
Speaker 4: from Cleveland Clinic and that person kind of went rogue
Speaker 4: on me with and arguing. So that's that's a be
Speaker 4: careful with that.
Speaker 5: Sometimes cavet who you two take it.
Speaker 6: And we all know each other, right, So like the
Speaker 6: division director of the lung cancer division, which was me,
Speaker 6: I know all the lung kol, so I may have
Speaker 6: certain relationships and the division may. So it helps to
Speaker 6: have an insider that you can actually vet which kol
Speaker 6: you know may be better received. I wanted to ask
Speaker 6: you about and so Peter, you talked about c Burr.
Speaker 6: Have you a lot of That's the influence of Peter
Speaker 6: Marx taking a playbook from Rick Pasitor with the Oncology group.
Speaker 6: Have you guys done the interact meetings and are okay?
Speaker 6: Can you talk about that.
Speaker 5: A little bit?
Speaker 3: I can? I can.
Speaker 2: I'll just follow up just with just what you were
Speaker 2: talked about before, which I think is very very important.
Speaker 2: And I've kind of moved to this in my own practice,
Speaker 2: as it were, which is never turned down a face
Speaker 2: to face interaction with the FDA. This is sort of
Speaker 2: a tendency or will go for written responses only and
Speaker 2: it'll it'll be easier, but there's nothing like seeing the
Speaker 2: whites of the eyes. There really isn't. And you actually
Speaker 2: build a bit of rapport and that can go a
Speaker 2: huge way, because you never know when you'll need to
Speaker 2: be interacting again. And if you had a positive you've
Speaker 2: built a bit of a relationship, then you can have
Speaker 2: perhaps more of a difficult yet constructive conversation across the table.
Speaker 3: And so I'm.
Speaker 2: Really glad we all I guess we all lived through
Speaker 2: the COVID era where it was all not but but
Speaker 2: now now we're we're all back.
Speaker 3: I would thoroughly recommend recommend that.
Speaker 2: In terms of the the the interact, which in my
Speaker 2: mind largely.
Speaker 3: Replaced the so called pre pre I n D meeting.
Speaker 2: I think it's a I've actually found I've any I've
Speaker 2: only done one directly. I have done a three Type
Speaker 2: D meetings which are similar sort of set up. I
Speaker 2: think the interact my works pretty well as as a
Speaker 2: as a way to move move your program forward. You
Speaker 2: the pre pre I n D was never minuted formal responses,
Speaker 2: and so.
Speaker 3: You never quite knew what you were taking away.
Speaker 2: Whereas I think the interact adds that level of minuted responses,
Speaker 2: you have a much clearer idea of what's going to
Speaker 2: be going forwards. I would add that the Type D mechanism,
Speaker 2: I know that's been around for a short period. I
Speaker 2: don't know how many people in this room have availed
Speaker 2: themselves of it, but I think it's a really, really
Speaker 2: excellent idea. It's essentially a single topic, but that means
Speaker 2: that you get in the room not just a general cast,
Speaker 2: but you get all of the key people who are reviewing,
Speaker 2: say the clinical section in the case of this particular conference,
Speaker 2: and you can really get some excellent feedback. There's a
Speaker 2: little bit more of an onus on the preparing company
Speaker 2: because you have to submit the questions with the full
Speaker 2: package ahead of time. You don't get to send the
Speaker 2: pre i D. You get to send it in early
Speaker 2: and then the package later. But I've found that the
Speaker 2: interactions have been extremely good and very welcome.
Speaker 3: From the agency. They'd rather have that kind of an
Speaker 3: interaction with you, at least at the SEBA. Does it
Speaker 3: address your question a little bit?
Speaker 6: Yes, I mean I think that we're talking about how
Speaker 6: to how to interact. I think the interact meetings I've
Speaker 6: heard have been successful in that kind of we're going
Speaker 6: to file an ID, but we're trying to figure out
Speaker 6: what may be gating how the FDA may react to
Speaker 6: this somewhat novel trial design or endpoint. And I the
Speaker 6: most commonly used topics for Type D in my experience
Speaker 6: have been around optimus and dose selection. You want that
Speaker 6: dose selection, you want that you want that in writing
Speaker 6: that FDA agrees with your dose is somewhat of a risk,
Speaker 6: in fact, if you're taking somewhat premature data. But and
Speaker 6: on the briefing documents, I think some advice that I
Speaker 6: would give is that you especially now right with a
Speaker 6: constrained volume of staff, these one hundred plus page briefing
Speaker 6: documents are just such a nightmare, and you know it's
Speaker 6: the job of the individual contributor. So I'm telling you,
Speaker 6: as cmos that the division directors your lateral at the FDA,
Speaker 6: but there's two lines of reporting up to them. So
Speaker 6: there's the individual contributor who's as we call medical officers,
Speaker 6: who's getting this briefing document and consolidating it into basically
Speaker 6: an executive summary, which you see in the form of
Speaker 6: the FDA meeting background. They write that, and they have
Speaker 6: to condense those hundred plus pages of this briefing document
Speaker 6: and put the salient parts, and then cascade that up
Speaker 6: to their middle leader, which we call the cross disciplinary
Speaker 6: team leader, who then vets this document and then it
Speaker 6: gets pushed up to the division director. So the division
Speaker 6: director is not seeing your one hundred page plus briefing document.
Speaker 6: So what I think would be wise, especially at this
Speaker 6: critical time, is to basically build that executive.
Speaker 5: Summary at the top of.
Speaker 6: The briefing document so that if it is going to
Speaker 6: be essentially lifted, you've created the salient points, You've put
Speaker 6: it in nice bullet point formats, You've delineated out your
Speaker 6: key topics, you've backed up each of your questions with
Speaker 6: the rationale for what the response you think should be
Speaker 6: is you're basically framing it up because it's going.
Speaker 5: To have to go up two levels to get to
Speaker 5: your lateral.
Speaker 4: Rich Now, well, I think it gets back to trying
Speaker 4: to sit in their seats from where they are and
Speaker 4: they're trying to do their job. And I believe always
Speaker 4: I need to make their job as easy as possible
Speaker 4: so they can go home at night and sleep well
Speaker 4: and not worry about is this somehow two years down
Speaker 4: they missed something. It's my job to make certain that
Speaker 4: all that's in there. And I can give an example
Speaker 4: where sometimes you don't also push the envelope because we're
Speaker 4: all trying to achieve the same goal. We were trying
Speaker 4: to do get a pediatric indication for a pain injection drug,
Speaker 4: and you know, the complicated way to do it was
Speaker 4: do your dose. You know, we didn't know where to
Speaker 4: start with a dose, and we couldn't really do it
Speaker 4: with kids going in the surgery because be on ethical
Speaker 4: not to treat pain. How we're going to find this out, Well,
Speaker 4: what we propose was let's look at real world data
Speaker 4: is being used off label. Let's go to a leading
Speaker 4: institution where they're using it there and mind their data
Speaker 4: and provide all this information to the FDA use claims
Speaker 4: database TOS, saying hey, we're not seeing any toxicity at
Speaker 4: this dose. Let's model that exposure in humans and what
Speaker 4: we think it would be and that's our starting dose.
Speaker 4: And the FDA said, okay, that's reasonable. Second thing, we said, look,
Speaker 4: we can't do it in a setting. We're going to
Speaker 4: have to make certainly these kids are safe. We're going
Speaker 4: to do it in kids that are going to be
Speaker 4: in the ICU for three days because I can't do
Speaker 4: blood draws on these kids all the time. But they're
Speaker 4: already got pickline. I can do this very easily, and
Speaker 4: this is the highest first patient population, so I will
Speaker 4: know if they're in trouble. And I said, that's not
Speaker 4: a good idea. That led to a study that was
Speaker 4: doable in a year's time, led to approval for kids
Speaker 4: down to the age of six years of age, and
Speaker 4: then led to a European acceptance as well. Just because
Speaker 4: we dared to say, what is the best thing to
Speaker 4: do to solve this problem? And the FDA said, let's
Speaker 4: go with that.
Speaker 7: No, I'm going to change the subject. I have nothing
Speaker 7: to add. The one thing I wanted to be aware
Speaker 7: of is that people on the panel read everything. They
Speaker 7: are very familiar with the literature. And we were turned
Speaker 7: down once by a paper that I happened to know
Speaker 7: the first author, and it was just bogus, but it
Speaker 7: was very hard to argue because it was the opposite viewpoint.
Speaker 7: So where you can so we recently had a situation
Speaker 7: where we had a difference on what an end point was.
Speaker 7: So I got some people together and we wrote a
Speaker 7: paper that's accepted because that says it's peer reviewed, and
Speaker 7: this is accepted by a high quality journal, So I
Speaker 7: think that's a CMO. You're in a good position to
Speaker 7: contribute to the literature, even if in the broadest sense,
Speaker 7: is a little bit self serving, but you know, it
Speaker 7: was peer reviewed. The other thing I would say, and
Speaker 7: this was an interesting case, they also read the company literature,
Speaker 7: and I know of a case where they turned down
Speaker 7: an application for orphan status because the company had claimed
Speaker 7: in their commercial literature that this drug would work in
Speaker 7: a whole lot of other things, and then they wanted
Speaker 7: this They wanted approval for this particular indication, and so
Speaker 7: their own hype actually hurt their application, So be aware
Speaker 7: that they read everything, and you should know what your
Speaker 7: company literature says.
Speaker 2: I think some great some great points there as well.
Speaker 3: I love you, I love your example.
Speaker 2: I think, aside from dosetting as well, you know, we
Speaker 2: in my field, we have a lot of unresolved issues
Speaker 2: about approvable endpoints and effect size, and I think the
Speaker 2: mechanisms we've discussed, but also informal discussions with the agency
Speaker 2: embracing that I found, particularly with Receiver, that they want
Speaker 2: to engage, They recognize that we don't know everything, and
Speaker 2: that they're open to open to suggestions. I think normal
Speaker 2: hit on the fact that you need to be comprehensive
Speaker 2: in your review, don't be selective, but once if you
Speaker 2: are comprehensive and you're open to that and you're open
Speaker 2: to their suggestions as well, it can be a very
Speaker 2: constructive relationship.
Speaker 3: And I think we.
Speaker 2: Found we had a very clear example where that didn't
Speaker 2: happen in ophthalmology, and we ended up with an endpoint
Speaker 2: where the bar was Olympic level, and it just meant
Speaker 2: that probably at least one, if not two approvals were
Speaker 2: not granted because that endpoint couldn't be level, couldn't be reached.
Speaker 3: We've now in that era.
Speaker 2: After that, there've been a lot more positive engagements and
Speaker 2: the agency has shown flexibility. And there was a period
Speaker 2: after that where they said, well, the agency is not flexible,
Speaker 2: they'll only allow this. But actually, with constructive engagement and
Speaker 2: comprehensive data reviews and data mining, suddenly the agency is
Speaker 2: much more open into changing that endpoint and making it approvable.
Speaker 2: So that sort of concurs with what you're saying, Hotpread.
Speaker 6: Yeah, I say a lot about endpoint development and validation.
Speaker 6: I mean, no endpoint really has met the Prentice criteria
Speaker 6: and so kind of moving back, which is which is
Speaker 6: basically you know, delineated in the REGs, and so FDA
Speaker 6: has to be at the table when thinking about developing
Speaker 6: new endpoints, and the way to do that is a
Speaker 6: little bit constrained right now because they really should be
Speaker 6: at at the ground level, having meetings, you know, involved
Speaker 6: with the KOLs, with industry on what endpoints are.
Speaker 5: You thinking about.
Speaker 6: I'm sure they're already thinking about them, because certainly other
Speaker 6: sponsors have come to them. MRD is a very classic
Speaker 6: and wonderful example in hematologic milndencies minimal residual disease. And
Speaker 6: you know what the FDA did was work with academic
Speaker 6: collaborators who worked with sponsors, had an Oncologic Drugs Advisory
Speaker 6: Committee and O or an ODAK or an AC. This
Speaker 6: also will be constrained now since that entire department was
Speaker 6: let go, as my understanding, so probably less ad comms
Speaker 6: unless they're reinstated.
Speaker 5: But having FDA kind of walk you.
Speaker 6: There's a playbook to developing novel endpoints and it starts
Speaker 6: with having FDA at the table approving on a novel endpoint.
Speaker 6: It is a monumental task and ask of a regulatory agency,
Speaker 6: and it's all about risk, and so it's in the
Speaker 6: FDA's hands to determine what level of risk may or
Speaker 6: may not be acceptable, and we wanted to do it
Speaker 6: in a collaborative way. So I think today my advice
Speaker 6: would be the moment that we're aware. And by the way,
Speaker 6: FDA is able to join meetings that are local where
Speaker 6: they don't have to be paid to travel, they don't
Speaker 6: have to have travel so if they're in the DMV area,
Speaker 6: they can attend things online right now that aren't necessarily
Speaker 6: politically focused, So one of my colleagues is attending a
Speaker 6: meeting on Saturday about novel endpoints in Saracoma currently at
Speaker 6: the FDA, So being able, so they're not totally closed
Speaker 6: right now, and so bringing them in, giving them some
Speaker 6: grace as you are interacting with them, I think is important,
Speaker 6: especially today, but also you know, involving them in these discussions.
Speaker 4: So if you want to open up.
Speaker 2: For questions or Sidney County's we've we've only got three
Speaker 2: and a half minutes.
Speaker 3: We're going to wrap it up.
Speaker 2: But we thought this, this topic in particular, would would
Speaker 2: benefit from questions from the audience.
Speaker 8: Yes, please, Jeff Oxnard, lung cancer doc, Blossom Health Therapeutics.
Speaker 8: I came to know hartpre at you know, national meetings,
Speaker 8: and I think from your answer, I'm guessing you don't
Speaker 8: expect the directors to be at the national meetings where
Speaker 8: we are used to seeing them, and so access for
Speaker 8: these kind of getting to know your director requires more
Speaker 8: time spent in DC. You're saying.
Speaker 6: Yes, and I mean I do think they'll be to
Speaker 6: join things. But we know, for example that FDA this
Speaker 6: year will not be attending AACR huge loss. FDA will
Speaker 6: likely not be attending ASCO and all your other therapeutic
Speaker 6: conferences for the force, you know, for the next several months.
Speaker 6: We don't know. Marty McCree was at the FDA last week.
Speaker 6: He was there on Wednesday in person. He gave an
Speaker 6: opening speech.
Speaker 5: It didn't really.
Speaker 6: Address many of the hot topics. So we'll just have
Speaker 6: to see how things play out. But Jeff, I don't
Speaker 6: have a great answer for that. I mean, go to
Speaker 6: the meetings, go to Silver Spring, have meetings with them,
Speaker 6: and meet them in person.
Speaker 2: Yeah, I would add that working in the red disease
Speaker 2: space just turn just that question.
Speaker 3: We've had quite a lot of success.
Speaker 2: Engaging the agency through patient advocacy groups and patient advocacy interactions.
Speaker 2: As you're as you're a small bi tech working in
Speaker 2: the space and you're beginning to build those patient advocacy relationships,
Speaker 2: they can be extremely helpful and being able to engage
Speaker 2: the agency, particularly with regard to end points. Any anybody
Speaker 2: else have any other questions?
Speaker 3: Shorter than must be?
Speaker 2: I guess lunch was excellent and so we're all relaxing.
Speaker 2: I think with that, I mean we're pretty much wrapped
Speaker 2: it up. Any last words, normal, no pearls of wisdom.
Speaker 3: When it comes.
Speaker 7: I think I've shared everything I should say.
Speaker 6: Get somebody on your team or that you can tap
Speaker 6: into who has FDA experience and can help you strategize
Speaker 6: ahead of those meetings.
Speaker 5: I spend a lot of my time looking at briefing books.
Speaker 6: Helping make sure the questions are the right questions and
Speaker 6: helping make sure we can lead the FDA at least
Speaker 6: closer to the answer that you're seeking. Get an expert
Speaker 6: on your team, yeah.
Speaker 4: And if you can't within your group. I've often used
Speaker 4: a lot many consultants in different eras, particularly if I'm
Speaker 4: working in multiple disease errors where I'm not engaged with
Speaker 4: that division before myself. I think it's said to have
Speaker 4: someone in there so you get a little bit understanding.
Speaker 4: And if you're working with Europe. The one thing I
Speaker 4: noticed differently from there when I was at my raperture
Speaker 4: at Latvia, I went in with the same as the
Speaker 4: first time I had that interaction, and I felt like
Speaker 4: the same perhaps would be tensioned. At the end of
Speaker 4: the meeting, they said we want to stay for cookies
Speaker 4: and coffee, and I was like, are you kidding me? Yeah, okay, sure,
Speaker 4: so don't treat that we regulated the same particular cross
Speaker 4: the pond sometime too.
Speaker 3: That's a great way to end. Thanks so much, thanks
Speaker 3: to penelists, We.
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