Latest / Making Medicine / Why FDA Instability is Driving Biotech Capital Abroad — What Investors Are Saying
Transcript
- 0:00Speaker 1: At Making Medicine. We're reporting on the headlines, not making
- 0:03Speaker 1: medical recommendations. For personal health questions, always consult a doctor.
- 0:08Speaker 1: Nothing in this episode constitutes investment, financial, or legal advice,
- 0:12Speaker 1: and please consult your own advisors before making decisions.
- 0:16Speaker 2: The vast majority of agreed that the changes at FDA
- 0:20Speaker 2: had in some way prompted some degree of change in
- 0:24Speaker 2: their thinking and their approaches to their investment.
- 0:34Speaker 1: Welcome back to the Making Medicine podcast for science, policy
- 0:38Speaker 1: and innovation. Meet I'm your host, John Stanford. We've all
- 0:42Speaker 1: seen the headlines about leadership changes, in staffing uncertainty at
- 0:46Speaker 1: the FDA. But rather than speculate, we decided to go
- 0:49Speaker 1: straight to the source and partnered with menat Health to
- 0:52Speaker 1: conduct original research and ask investors directly how FDA stability
- 0:57Speaker 1: is shaping their decision making. Today, I'm joined by Life
- 1:01Speaker 1: Sciences and FDA partner Rachel Share from Manette to walk
- 1:05Speaker 1: us through what they found. Let's get into the show. Rachel,
- 1:09Speaker 1: Welcome to the show.
- 1:10Speaker 2: Thanks John, thanks for having me.
- 1:12Speaker 1: Well, it's great to have you on and it was
- 1:14Speaker 1: great to partner with Manette on this incredible piece of
- 1:17Speaker 1: research that just came out and We're going to dig
- 1:19Speaker 1: into it in a second. But for our listeners who
- 1:22Speaker 1: don't know Manat and the incredible resource and firm that
- 1:26Speaker 1: it is, can you tell us a little bit about
- 1:28Speaker 1: Manett Sure.
- 1:29Speaker 2: Manette is bipartisan law and consulting firm that really sits
- 1:35Speaker 2: at the intersection of healthcare policy regulation. We do a
- 1:41Speaker 2: lot of work with industries of all sorts. So we've
- 1:46Speaker 2: been around for many decades now, and our role here
- 1:50Speaker 2: was really to be an independent and objective convener of
- 1:57Speaker 2: the research that we'll be talking about here today.
- 2:00Speaker 3: Terrific and we got the right person on.
- 2:02Speaker 1: As mentioned in the intro, you're a partner at the
- 2:04Speaker 1: firm exclusively focused on FDA and life sciences. Can you
- 2:08Speaker 1: give a little bit of your background that led you.
- 2:11Speaker 3: To this role.
- 2:12Speaker 2: Yeah, So I've been in sort of the FDA space
- 2:15Speaker 2: for over two decades now. I worked on Capitol Hill
- 2:19Speaker 2: for over ten years as FDA Council for the Energy
- 2:23Speaker 2: and Commerce Committee, and then also worked at FDA, and
- 2:28Speaker 2: I have been sort of in the FDA orbit for
- 2:32Speaker 2: many years since. Well.
- 2:33Speaker 1: One of the reasons Incubate was so compelled to work
- 2:36Speaker 1: with Manette was sort of the rigor and structure that
- 2:39Speaker 1: you put into these projects. I commend you in the
- 2:43Speaker 1: firm for finding a way to put out something that's
- 2:45Speaker 1: respected on both sides of the aisle. And so you know,
- 2:50Speaker 1: we have been talking all year. It was hard to
- 2:54Speaker 1: pick up the editorial piece of the Wall Street Journal
- 2:56Speaker 1: any week and not see something about instability at the FDA.
- 3:00Speaker 1: And that's something certainly Incubate and the Making Medicine team
- 3:04Speaker 1: have talked to policymakers about on the hill. But we
- 3:07Speaker 1: wanted to bolster that case, and that's what led to
- 3:09Speaker 1: this great project with you. We wanted to get that
- 3:14Speaker 1: perspective from the investor and do it in a rigorous
- 3:17Speaker 1: and methodical way that policymakers can listen to. So, when
- 3:21Speaker 1: approached with a project like that, can you walk us
- 3:25Speaker 1: through the research design? What were you actually trying to
- 3:29Speaker 1: find out and how did you approach it? How did
- 3:31Speaker 1: you structure this for a productive conversation with these investors?
- 3:35Speaker 2: Yeah, great question. So we really set out to understand
- 3:41Speaker 2: whether and how the recent leadership and staffing changes, the
- 3:47Speaker 2: staffing cuts and other changes that have occurred with respect
- 3:51Speaker 2: to regulatory decision making and FDA since early twenty twenty
- 3:55Speaker 2: five have impacted the investor can be unity. The work
- 4:02Speaker 2: was qualitative. We conducted in depth interviews with senior investors
- 4:08Speaker 2: spanning the really the full drug development life cycle, from
- 4:12Speaker 2: pre clinical through commercial stage assets. We asked only open
- 4:19Speaker 2: ended questions. We really made it clear that we wanted
- 4:23Speaker 2: to understand again whether and how all of the changes
- 4:29Speaker 2: that you just mentioned, John, are impacting investor behaviors. We
- 4:34Speaker 2: told the interviewees that all the interviews would be anonymous.
- 4:40Speaker 2: The goal of the project was really to get the
- 4:43Speaker 2: honest and frank views of what's really going on in
- 4:46Speaker 2: the minds of these investors, and so to get that,
- 4:50Speaker 2: we really felt it was important to make sure they
- 4:52Speaker 2: knew the conversations would be kept anonymous.
- 4:56Speaker 1: Well, and something I really liked in the findings, which
- 5:00Speaker 1: folks can find on Incubate's website Incubatecoalition dot org, was
- 5:05Speaker 1: to think of that old movie with Tom Cruise. The
- 5:08Speaker 1: Minority Report was in there in a couple places. I
- 5:11Speaker 1: like that you captured, you know, in in some of
- 5:14Speaker 1: these quotes, that it's not a one size fits all answer.
- 5:17Speaker 1: It's not FDA good, FDA bad, it's the really nuanced
- 5:22Speaker 1: perspectives and I think that's the reality of investing. And
- 5:25Speaker 1: I'm just impressed that you were able to draw those answers.
- 5:29Speaker 1: And from your perspective, you know, you mentioned who you
- 5:32Speaker 1: talked to and that you drew from early early all
- 5:36Speaker 1: the way up to clinical.
- 5:38Speaker 3: How important was it.
- 5:39Speaker 1: Do you feel like that you captured not just one
- 5:41Speaker 1: piece of the value chain, but really the entire investor ecosystem.
- 5:45Speaker 2: Yeah, again, that was something that was really important to
- 5:48Speaker 2: us to make sure we were talking to folks sort
- 5:52Speaker 2: of across all phases of product development and all types
- 5:56Speaker 2: of investors. We spoke to a total of sixteen investors,
- 6:01Speaker 2: and I'll just quickly walk through the type so you
- 6:04Speaker 2: get a sense of really the diversity of views that
- 6:07Speaker 2: we think we captured here. Five were venture capital investors,
- 6:12Speaker 2: four were multi stage investors, three were industry investors, two
- 6:19Speaker 2: public equity investors, one private equity investor, and one Series
- 6:25Speaker 2: A and seed capital investor. So I think through that again,
- 6:30Speaker 2: these were folks who were involved at everything from very
- 6:35Speaker 2: early stage through to late stage development. We think we
- 6:40Speaker 2: got a good array of views here.
- 6:43Speaker 1: Well, I don't want to bury the lead any further
- 6:45Speaker 1: and stand between you listeners and what you heard, So
- 6:50Speaker 1: let's dive in the incredible reports out there.
- 6:53Speaker 3: What did you hear from the investors?
- 6:55Speaker 2: Yeah, well, first of all, before we get into sort
- 6:58Speaker 2: of what we heard, I think it's important to sort
- 7:01Speaker 2: of frame up what they told us specifically was on
- 7:05Speaker 2: their minds in terms of the changes at FDA, and
- 7:09Speaker 2: again in the questions that we asked them, we were
- 7:12Speaker 2: very careful to not characterize what those changes were, and
- 7:18Speaker 2: we were careful to not characterize exactly the nature of it.
- 7:23Speaker 2: What we heard though from these investors was frequently words
- 7:29Speaker 2: like turmoil and uncertainty at FDA, and these are their words,
- 7:33Speaker 2: not ours. The investors were very familiar with sort of
- 7:37Speaker 2: the nature and extent of the changes that has occurred
- 7:40Speaker 2: since early twenty twenty five, including the various types of
- 7:45Speaker 2: staffing cuts that occurred under sort of the dramatic restructuring
- 7:50Speaker 2: as it was called at the time within HHS, very
- 7:55Speaker 2: aware of the leadership changes at FDA, including the departures
- 8:00Speaker 2: of several very long standing leaders who had literally decades
- 8:06Speaker 2: of experience in some cases per person, and really what
- 8:11Speaker 2: that meant in terms of the institutional knowledge that was
- 8:15Speaker 2: leaving the agency. There were also a lot of concerns
- 8:19Speaker 2: about the ways in which this administration had gone about
- 8:24Speaker 2: implementing policy changes with things like publishing articles and medical journals,
- 8:31Speaker 2: or posting policies on SBA's website, and whether or not
- 8:37Speaker 2: you could rely on those as policy proclamations. So just
- 8:43Speaker 2: to put that out there again, these were the themes
- 8:46Speaker 2: and statements that we heard from the investors when we
- 8:49Speaker 2: simply asked about what the changes were at FDA. So
- 8:53Speaker 2: the community is very well aware of all of these
- 9:00Speaker 2: that are going on at FDA and tracking it really
- 9:02Speaker 2: on a daily basis. We didn't need to tell them
- 9:05Speaker 2: anything about those changes.
- 9:07Speaker 1: Yeah, it's really interesting. I'm thinking back to Incubate's first
- 9:10Speaker 1: event at JP Morgan Gosh four or five years ago,
- 9:14Speaker 1: and you know, we really had to push people to
- 9:20Speaker 1: know that things were even happening in Washington, and they
- 9:24Speaker 1: weren't tracking this, and if you ask them about staffing
- 9:27Speaker 1: changes at FDA, none of this was getting through. And
- 9:30Speaker 1: it sounds like we are in a completely different moment
- 9:32Speaker 1: where this community is watching Washington with a laser like focus,
- 9:39Speaker 1: maybe trying to read tea leaves, maybe not. So I
- 9:42Speaker 1: think that that's really interesting. The report had four specific themes,
- 9:49Speaker 1: and I was wondering if you might walk us through
- 9:52Speaker 1: sort of each of those and then would love to
- 9:55Speaker 1: dive into a few more specifics.
- 9:57Speaker 2: Yeah, definitely, and yes, we arranged the report into, as
- 10:03Speaker 2: you said, four themes, and we thought that was important because,
- 10:06Speaker 2: as you can imagine, when we had sixteen in depth
- 10:10Speaker 2: conversations with these investors, we needed to sort of bring
- 10:14Speaker 2: some kind of structure to the report. So we did
- 10:20Speaker 2: that through sort of collating the views that we heard
- 10:24Speaker 2: along these four themes. So the first theme that we
- 10:27Speaker 2: talk about in the report is that the investors really
- 10:32Speaker 2: view the current environment as unstable in ways that directly
- 10:38Speaker 2: undermine the confidence in the regulatory predictability, the scientific consistency,
- 10:45Speaker 2: and institutional continuity at the FDA. The part of that
- 10:51Speaker 2: theme is that there is a sense that the leadership
- 10:56Speaker 2: changes that we mentioned and staffing cunts have we can
- 11:00Speaker 2: trust in FDA guidance, expanded perceived downside risk, and complicated
- 11:07Speaker 2: efforts to articulate clear regulatory pathways to those capital providers.
- 11:14Speaker 2: The sort of upshot of this first theme that we
- 11:17Speaker 2: heard is that the investors are really recalibrating their risk tolerance,
- 11:24Speaker 2: their restructuring portfolios in some cases and in many cases
- 11:29Speaker 2: simply reassessing the attractiveness of US based drug development. Now
- 11:35Speaker 2: to your point, originally, John, that's not what we heard
- 11:38Speaker 2: in every case, and there were some other views that
- 11:41Speaker 2: we occard that we can mention here, But that's the
- 11:45Speaker 2: sort of overarching theme. I thought I would just share
- 11:49Speaker 2: one quote, and our report lays out the quotes themselves
- 11:54Speaker 2: throughout again to sort of our research methodology, we wanted
- 11:59Speaker 2: to let the quote that we heard speak for themselves,
- 12:02Speaker 2: so there are more quotes like this throughout our report,
- 12:06Speaker 2: but to sort of capture some of this theme, one
- 12:09Speaker 2: of the quotes from a private equity investor we spoke
- 12:12Speaker 2: with said quote, I don't think science is ruling the
- 12:16Speaker 2: day they are at all, and I don't think much
- 12:19Speaker 2: of what they say matters. They are going to do things,
- 12:22Speaker 2: but the words they utter on a daily or weekly
- 12:26Speaker 2: basis have nothing to do with it. Chaos is the
- 12:29Speaker 2: only thing they can use. They will say one thing
- 12:32Speaker 2: and then twenty four hours do something completely inconsistent with
- 12:37Speaker 2: it and do not care. So that was just one
- 12:39Speaker 2: quote from one investor, but I think that's the kind
- 12:43Speaker 2: of thing that we heard a lot that sort of
- 12:45Speaker 2: illustrate this first theme.
- 12:48Speaker 1: Yeah, I mean it's a pretty stunning quote, and I
- 12:50Speaker 1: do appreciate Manett putting those quotes into the report itself
- 12:55Speaker 1: so that we can see these investors represented by their
- 12:58Speaker 1: own words. How about the second theme.
- 13:00Speaker 2: The second theme was around the ways in which the
- 13:04Speaker 2: changes that we've talked about are disproportionately impacting certain product
- 13:10Speaker 2: categories in areas more than others. And if you follow
- 13:15Speaker 2: the news, this isn't going to be surprising necessarily, but
- 13:19Speaker 2: a lot of investors we spoke with described growing reluctance
- 13:23Speaker 2: to invest in vaccines, selling gene therapies, certain oncology approaches
- 13:31Speaker 2: in the midst of what they view to be uncertainty
- 13:35Speaker 2: over evidentiary standards and political influence on the FDA's decision making.
- 13:42Speaker 2: And again, to you know, to illustrate this with one
- 13:45Speaker 2: of the quotes that we heard, one was from a
- 13:50Speaker 2: public equity investor saying, right now, the untouchables are gene
- 13:56Speaker 2: therapy to some degree, and self therape be and vaccines.
- 14:01Speaker 2: So that was just one of the quotes we heard
- 14:03Speaker 2: there on that theme.
- 14:04Speaker 1: Yeah, and I think that aligns with some not just
- 14:07Speaker 1: investor and biotech conversations we've had on the podcast, but
- 14:10Speaker 1: also patient communities as well that really their therapeutic area
- 14:16Speaker 1: are desperate for innovation in that space, and so that's
- 14:18Speaker 1: particularly concerning from our point.
- 14:22Speaker 3: How about the third theme.
- 14:23Speaker 2: The third theme was around China, and really the theme
- 14:29Speaker 2: was that China is increasingly perceived to be a rising powerhouse.
- 14:36Speaker 2: And again this is something that I think is very
- 14:38Speaker 2: much in the press these days. It's something that Congress
- 14:42Speaker 2: has been focused on. What we heard was that interviewees
- 14:48Speaker 2: acknowledged a degree of risk with investments in China. And
- 14:52Speaker 2: I should say it's not only China that was mentioned.
- 14:54Speaker 2: There are other countries abroad that we're mentioned to. But
- 15:00Speaker 2: the investors we spoke was said that this focusing on China,
- 15:06Speaker 2: for instance, the speed, the efficiency, and the cost advantages
- 15:11Speaker 2: of the Chinese ecosystem are increasingly difficult to overlook. And
- 15:18Speaker 2: the investors, many of them, noted that this was not
- 15:22Speaker 2: necessarily a trend that started with the last year and
- 15:27Speaker 2: with the new administration. It's something that started well before
- 15:31Speaker 2: this current administration. But the general sentiment was that the
- 15:38Speaker 2: changes and the perceived instability at FDA are exacerbating and
- 15:44Speaker 2: having the effect of redirecting the capital to China and
- 15:50Speaker 2: other areas abroad. And again, to just use one of
- 15:53Speaker 2: the quotes that we heard one venture capital investor said,
- 15:58Speaker 2: we just can't ignore nor Chinese innovation. Pharma focus shifted there.
- 16:05Speaker 2: Everybody's eyes shifted to risk off assets. Will it shift
- 16:10Speaker 2: back maybe?
- 16:11Speaker 1: Yeah, it's a question we deal with every day. We're
- 16:15Speaker 1: just coming off the heels of a day spent with
- 16:17Speaker 1: the National Security Commission on Emerging Biotech, which was all
- 16:22Speaker 1: things China. I'm curious was Australia one of those other
- 16:25Speaker 1: countries that we keep hearing that. I don't know if
- 16:28Speaker 1: you heard that as well, but there's China in one bucket,
- 16:31Speaker 1: but Australia is this other one that people keep on referencing.
- 16:34Speaker 2: We did have a couple of investors mentioned interest in Australia.
- 16:40Speaker 2: One maybe two mentioned ongoing clinical trials that they were
- 16:44Speaker 2: involved in Australia. So yes, we did hear that, But
- 16:48Speaker 2: the vast majority of interviewees focused on China. I don't
- 16:54Speaker 2: think that we had an interview where China didn't come up.
- 16:58Speaker 1: Yeah, and how about the final theme.
- 17:02Speaker 2: The final theme was around the kind of interconnectedness of
- 17:07Speaker 2: FDA with other entities in the federal government. NIH was
- 17:13Speaker 2: the agency or institution we heard the most about, and
- 17:19Speaker 2: the theme is that the sort of sense of instability
- 17:23Speaker 2: that folks were mentioning at FDA was not unique to FDA,
- 17:28Speaker 2: that they were noticing it at other agencies like NIHCDC
- 17:33Speaker 2: was mentioned, and the sort of general ecosystem the changes
- 17:39Speaker 2: across the board were really amplifying the risks associated with
- 17:44Speaker 2: biomedical investing because of that interconnectedness of NIH and other
- 17:51Speaker 2: federal agencies to this sort of biomedical investment enterprise. Lots
- 17:58Speaker 2: of the investors that met this did note that these
- 18:01Speaker 2: changes may become more prevalent in the longer term, and
- 18:08Speaker 2: that reduced and less predictable support for early stage research
- 18:13Speaker 2: is what's at stake here, that that's sort of undermining
- 18:17Speaker 2: the future innovation and future investments. Again, to just use
- 18:23Speaker 2: one of the quotes we heard to sort of illustrate
- 18:27Speaker 2: this is a venture capital investor said, I think cutting
- 18:33Speaker 2: NIH funding the effect might be seen four to five
- 18:37Speaker 2: years from now. Lots of professors can't pay PhD students
- 18:42Speaker 2: and postdocs. Postdocs aren't coming to the US, and a
- 18:46Speaker 2: lot go back to their home countries. It's cutting off
- 18:50Speaker 2: a lifeline to professionals who are going to take biotech
- 18:54Speaker 2: industry jobs.
- 18:55Speaker 1: Yeah, that workforce concern another one that we're hearing as
- 18:59Speaker 1: you you add those all up, I mean, four distinct themes,
- 19:03Speaker 1: but as you pointed with that last one, that there's
- 19:06Speaker 1: an intersection almost between all of them that doesn't craft
- 19:11Speaker 1: a great outlook. Was there anything that surprised you as
- 19:15Speaker 1: you listen to how the investors described this.
- 19:17Speaker 3: Was there anything maybe you didn't expect but that you.
- 19:20Speaker 2: Heard, and I'm going to say it was necessarily a surprise.
- 19:24Speaker 2: I would say it was pretty striking to hear the
- 19:29Speaker 2: sort of strong agreement across all the different types of
- 19:33Speaker 2: investors that we talked with, the vast majority of them
- 19:38Speaker 2: agreed that the changes at FBA had in some way
- 19:43Speaker 2: prompted some degree of change in their thinking and their
- 19:47Speaker 2: approaches to their investments. And again the sort of array
- 19:53Speaker 2: of views that we heard. Some were more exaggerated in
- 19:58Speaker 2: terms of what the extent of that impact was. Some
- 20:02Speaker 2: said they flat out walked away from investments they were considering.
- 20:08Speaker 2: Others said it just gave them more pause, it made
- 20:11Speaker 2: them think more carefully. So, but the sort of striking
- 20:16Speaker 2: thing was the sort of agreement across the board from
- 20:20Speaker 2: all sixteen of the investors we spoke with.
- 20:23Speaker 1: Well, I think it's really telling because I think one
- 20:25Speaker 1: of the one of the questions we had if we
- 20:27Speaker 1: had you on six months ago or eight months ago,
- 20:30Speaker 1: it could be fifty to fifty to talk to a
- 20:33Speaker 1: biotech investor of have you had an issue with instability?
- 20:37Speaker 1: And some of them would say yes, I was a
- 20:39Speaker 1: part of Unicuro, as part of Replemune.
- 20:42Speaker 3: Those are two recent examples.
- 20:44Speaker 1: And some people said, you know, I hear about it,
- 20:46Speaker 1: but it hasn't affected me personally. And it seems like
- 20:50Speaker 1: maybe the toll has added up that while it's all
- 20:54Speaker 1: to a varying degree across these sixteen investors, there are
- 20:57Speaker 1: some central themes that are on their mind. And if
- 21:00Speaker 1: it was a binary question of has it made you
- 21:03Speaker 1: change your behavior? The answer seems like a resounding yes.
- 21:06Speaker 3: Does that sound right?
- 21:08Speaker 2: Yes? And I think it is right, but again to
- 21:12Speaker 2: what degree? And I think that's where we heard a
- 21:14Speaker 2: lot of you know, variability with some again sort of
- 21:19Speaker 2: stating what I mentioned that in many cases it's making
- 21:23Speaker 2: them walk away from certain investments, whereas before they would
- 21:27Speaker 2: have stuck with them. Others say, this is something we
- 21:31Speaker 2: might be able to ride out, but we are approaching
- 21:35Speaker 2: this with more caution, asking more questions, taking longer to
- 21:39Speaker 2: come to these decisions than we otherwise.
- 21:41Speaker 3: Would given that nuance.
- 21:42Speaker 1: Putting on your methodology hat, you know, retrospectively was sort
- 21:47Speaker 1: of that qualitative conversation the right take for this. Would
- 21:52Speaker 1: you still structure it this way or if you were
- 21:53Speaker 1: to do it again, I think we would.
- 21:56Speaker 2: And you know again, I think the reason we were
- 21:58Speaker 2: able to get such frank and honest feedback was because
- 22:03Speaker 2: we assured that these conversations would be kept confidential. So
- 22:09Speaker 2: I think sort of taking the approach that we did
- 22:12Speaker 2: in the report, which was basically letting those honest assessments,
- 22:17Speaker 2: letting those honest views come out, was the right approach.
- 22:23Speaker 2: And you know, again, for anyone who's been tracking this,
- 22:26Speaker 2: a lot of this has been appearing in the press
- 22:31Speaker 2: in one way or another, from one to you know,
- 22:35Speaker 2: investors who are willing to go on the record. Some
- 22:39Speaker 2: have kept their identities confidential that I've seen in the press,
- 22:43Speaker 2: But this was really an effort to catalog and collect
- 22:47Speaker 2: a lot of those views across the investment landscape and
- 22:53Speaker 2: really let their words speak for themselves.
- 22:57Speaker 1: I mean those words I want to I want to
- 23:00Speaker 1: pay the mind. Is there anything that you heard that
- 23:04Speaker 1: was reassuring or conversely something that we as an ecosystem
- 23:09Speaker 1: really need to sit and think about. Any any words
- 23:12Speaker 1: stand out to in particular.
- 23:13Speaker 2: I think the one of the takeaways from this is that,
- 23:19Speaker 2: you know, there is a widespread recognition that investing in
- 23:24Speaker 2: the US being able to bring innovation to the US
- 23:28Speaker 2: remains a very strong goal for everyone we spoke with,
- 23:33Speaker 2: and that to the extent investors are sort of thinking
- 23:37Speaker 2: about investing elsewhere that's not necessarily their first choice. It's
- 23:42Speaker 2: sort of a bigger force at play here, and they're being,
- 23:48Speaker 2: you know, looking at these other markets out of necessity.
- 23:53Speaker 2: I think there is a strong sense that at the
- 23:57Speaker 2: end of the day, things will right themselves here in
- 24:00Speaker 2: the US, and I think that's where the sense that
- 24:05Speaker 2: we heard was. As I think I mentioned and one
- 24:08Speaker 2: of the quotes was that at some point, hopefully these
- 24:12Speaker 2: trends will reverse, that they will sort of return to
- 24:16Speaker 2: a place where the US FDA is predictable and stable
- 24:23Speaker 2: in their words, and that that's something that together we
- 24:27Speaker 2: will work to achieve again.
- 24:29Speaker 1: Well, maybe we attribute that to a career spent trying
- 24:33Speaker 1: ninety nine molecules, watching them all fail and waiting for
- 24:37Speaker 1: one to work. That actually makes day. You have to
- 24:40Speaker 1: be a persistent optimist. And so I'm glad that you
- 24:43Speaker 1: called out that there's a belief that we can get
- 24:47Speaker 1: back to the gold standard, to the stability and to
- 24:51Speaker 1: focusing on what we do well from a perspective of
- 24:55Speaker 1: biotech entrepreneurship as we wrap up, and I'm is so
- 25:00Speaker 1: grateful that you not just for the report, but that
- 25:02Speaker 1: you would take the time to sit with us after
- 25:04Speaker 1: the report's publication. For a listener today or to someone
- 25:08Speaker 1: who only has a couple of minutes to scan through
- 25:12Speaker 1: the report, what's one thing you would want them to
- 25:15Speaker 1: take away?
- 25:16Speaker 2: I mean, you know, I think the one thing is
- 25:20Speaker 2: that across the board, what we heard is how critical
- 25:26Speaker 2: it is for investors to have that regulatory predictability. That
- 25:33Speaker 2: there is this belief in the importance and the critical
- 25:38Speaker 2: role that FBA plays not only in the United States
- 25:42Speaker 2: but worldwide, and so to ensure that we've got stability
- 25:46Speaker 2: and predictability is just critically important. I can't overstate it.
- 25:53Speaker 2: The other thing that I think we heard that we
- 25:58Speaker 2: hope will sort of come from all of this that
- 26:01Speaker 2: the investors focused on over and over again is that
- 26:05Speaker 2: need for institutional knowledge, for institutional stability, and that policy
- 26:14Speaker 2: clarity and predictability are so critical to the entire biomedical ecosystem,
- 26:21Speaker 2: but particularly the investors, And so that with that effort
- 26:27Speaker 2: to ensure that we've got that predictability and stability at FDA,
- 26:33Speaker 2: we will continue to sort of play the role in
- 26:36Speaker 2: the global ecosystem that we have for so long.
- 26:41Speaker 1: Well, I think that is the perfect takeaway that this
- 26:45Speaker 1: couldn't matter more. We have to get this right. Investors
- 26:49Speaker 1: watch so closely. As you said earlier, you didn't have
- 26:52Speaker 1: to push them to get answers out or to catch
- 26:55Speaker 1: them up on the news. It is top of mind
- 26:58Speaker 1: to everyone, which makes this report, our partnership with Manat
- 27:01Speaker 1: and this podcast so timely. So, Rachel, I'm incredibly grateful.
- 27:05Speaker 1: The report will be available on Incubate's website and we'll
- 27:09Speaker 1: put links in the description below so that everyone can
- 27:13Speaker 1: take a look at the incredible work Rachel and her
- 27:15Speaker 1: team did.
- 27:16Speaker 3: Rachel any closing thoughts.
- 27:18Speaker 2: No, thank you for having us, and we appreciate the
- 27:21Speaker 2: opportunity to have been able to do this sort of
- 27:25Speaker 2: qualitative research for Incubate, So thanks for having us.
- 27:31Speaker 1: That wraps up this episode of the Making Medicine podcast.
- 27:34Speaker 1: A huge thank you to Manat and Rachel for joining us.
- 27:37Speaker 1: You can find the complete breakdown of the findings at
- 27:40Speaker 1: the link in the description of this episode. Be sure
- 27:42Speaker 1: to subscribe on YouTube and follow us on our other
- 27:44Speaker 1: channels so you don't miss upcoming conversations. Do you have
- 27:47Speaker 1: thoughts on anything FDA and how it might impact you
- 27:51Speaker 1: or your company. Let us know and we might feature
- 27:54Speaker 1: your comment in next week's episode. Thanks for listening and
- 27:58Speaker 1: as always, keep innovating.
- 28:00Speaker 3: Thing Thing Good Thing, The Thing Good Thing,