Latest / Making Medicine / FDA Leadership, China & The Future of American Biotech

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FDA Leadership, China & The Future of American Biotech · Making Medicine

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  Speaker 1: At Making Medicine. We're reporting on the headlines, not making
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  Speaker 1: medical recommendations. For personal health questions, always ask your doctor.
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  Speaker 1: Nothing in this episode constitutes investment, financial, or legal advice.
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  Speaker 1: Consult your own advisors before making decisions. But it has
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  Speaker 1: to be crystal clear across all of these hearings, whether
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  Speaker 1: it's IP, FDA or something like our research programs at
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  Speaker 1: the NIH, we have to uplift. We have to have
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  Speaker 1: bipartisan support for this part of the ecosystem that drives
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  Speaker 1: everything forward. Welcome back to the Making Medicine Podcast, where science,
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  Speaker 1: policy and innovation meet. I'm your host John Stanford. This
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  Speaker 1: week we'll cover the latest one who could become the
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  Speaker 1: next leader of the FDA. We'll highlight some key hearings
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  Speaker 1: happening on Capitol Hill, and round out the episode with
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  Speaker 1: our Approvals Corner celebrating new medicines making their way to patience.
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  Speaker 1: And as Grace mentioned last week, we're really excited to
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  Speaker 1: be launching a new series as we celebrate our nation's
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  Speaker 1: two hundred and fiftieth birthday and fifty years of biotech.
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  Speaker 1: That series is called How America Makes Medicine because no
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  Speaker 1: country does drug development just like we do, and this
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  Speaker 1: series will trace the uniquely American relay race from university
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  Speaker 1: lab to startup, to investor, to pharma, to regulator and
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  Speaker 1: eventually to patient that makes us the world's leader in
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  Speaker 1: biotech innovation. We'll be bringing on guests at the heart
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  Speaker 1: of that story, from scientists and founders to investors in policymakers,
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  Speaker 1: and to kick that series off next week, I'm thrilled
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  Speaker 1: to be joined by Kate Hudson of the Association of
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  Speaker 1: American Universities. We'll be highlighting early stage research and the
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  Speaker 1: key role our academic centers play in drug development. You
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  Speaker 1: won't want to miss it, and you won't want to
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  Speaker 1: miss any episodes of this great series. With that, let's
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  Speaker 1: get into the show. Our first story is an update
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  Speaker 1: on the leadership search at the Food and Drug Administration.
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  Speaker 1: News is reporting that we may be nearing the finish
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  Speaker 1: line on non dominating someone for consideration in the Senate.
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  Speaker 1: The three finalists being reported is considered for the position
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  Speaker 1: are Heidi Overton, a White House advisor with ties to
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  Speaker 1: the former Commissioner, Jeffrey Vichirka, an oncologist and CEO of
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  Speaker 1: New York Cancer and Blood Specialists, and Steven Ferrara, a
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  Speaker 1: health affairs official at the Defense Department who previously served
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  Speaker 1: as the CIA's chief medical officer. None of the three
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  Speaker 1: have commented publicly yet about speculation of their naming, and
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  Speaker 1: the timing of a final decision is still unclear, but
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  Speaker 1: the move suggests we could be getting closer after months
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  Speaker 1: of leadership turmoil and frankly absence at the agency. But
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  Speaker 1: whoever gets the nod will still need to clear the
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  Speaker 1: Senate's Health Committee, chaired by Senator Bill Cassidy, who, as
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  Speaker 1: we've talked about on previous episodes, just lost his own
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  Speaker 1: primary to a Trump backed challenger. All three finalists are
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  Speaker 1: medical doctors, so whoever's picked, if it comes out of
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  Speaker 1: this bunch, will likely bring a very different dynamic to
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  Speaker 1: FDA's leader than the current acting Commissioner, Kyle Diamantes, who
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  Speaker 1: came more from the food and A side than from
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  Speaker 1: the scientific background that these three candidates have in Cuba.
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  Speaker 1: It will be watching closely as someone gets nominated, and
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  Speaker 1: of course that they're hearing to see how they might
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  Speaker 1: steer the agency in a new direction at a time
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  Speaker 1: where both stability and modernization are needed. While we wait
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  Speaker 1: for that, FDA nomination. Congress is still hard at work
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  Speaker 1: and biotech is front and center, and several hearings happening
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  Speaker 1: on Capitol Hill this week. Come back next week for
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  Speaker 1: our read on what was covered. But this is what's
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  Speaker 1: on the radar. The Energy and Commerce Health Subcommittee has
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  Speaker 1: a hearing on FDA and biomedical innovation. It's happening literally
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  Speaker 1: as we record this, So a full readout again will
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  Speaker 1: be next week once we've watched and attended the whole thing.
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  Speaker 1: But we pulled the five written testimonies, and here's what
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  Speaker 1: stood out to us, and they're written testimonies. Every witness
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  Speaker 1: pointed to one country, China, and that's no surprise. We've
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  Speaker 1: been talking about it so much on making Medicine, about
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  Speaker 1: the role China's playing in our biomedical ecosystem. One of
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  Speaker 1: the first witnesses, Thomas Bolkei, is that the Council of
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  Speaker 1: Foreign Relations, and he started out by laying out the numbers.
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  Speaker 1: China's share of global clinical trial starts went from one
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  Speaker 1: percent in two thousand and nine to about thirty percent
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  Speaker 1: last year. Early stage trials they were run three to
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  Speaker 1: five times faster at a third to half the cost.
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  Speaker 1: But while there was agreement that China's rise is borne
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  Speaker 1: out by the numbers, there's clearly some difference of opinion
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  Speaker 1: on what the fix for this surging country might be.
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  Speaker 1: Bulky highlighted that just twenty of the more than twenty
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  Speaker 1: seven hundred GCP inspections occurred in China from twenty sixteen
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  Speaker 1: to twenty twenty three. These inspections are on the ground
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  Speaker 1: seeing what's really happening, and it comes down to resources
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  Speaker 1: and bandwidth. But some others argued that the real win
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  Speaker 1: is not focusing on China and what they're doing there,
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  Speaker 1: but making the US faster, not walling China off. That's
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  Speaker 1: certainly something we've heard a lot from guests on the
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  Speaker 1: Making Medicine podcast. Thomas Wang, assistant professor of medicine at
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  Speaker 1: Brigham and Women's Hospital and at Harvard Medical School, even
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  Speaker 1: showed Chinese originated cancer drugs scored substantial clinical benefit twice
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  Speaker 1: as often as everyone else's, so blanket exclusions by country
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  Speaker 1: of origin don't serve patients. Put another way, doctor Hwang
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  Speaker 1: was pointing out that frankly, there is great innovation and
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  Speaker 1: hope for patients in the cancer space in particular that
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  Speaker 1: is coming out of China, and it wouldn't make sense
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  Speaker 1: to prevent US patients from accessing that. But a second
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  Speaker 1: big takeaway is that the bottleneck isn't FDA review times.
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  Speaker 1: Cynthia Verse did Acuvia was crystal clear, it's the time
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  Speaker 1: and resources to assemble the I and D package itself.
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  Speaker 1: Emerging biopharma drive over seventy five percent of new Phase
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  Speaker 1: one starts, and they're going to China or Australia or
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  Speaker 1: others for early speed to signal while they build the
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  Speaker 1: full package for their I and D in the United States.
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  Speaker 1: The fix from a QBUS standpoint is a quote fit
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  Speaker 1: for fih minimum data set to support safe to precede
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  Speaker 1: decisions and more iterative feedback from the FDA earlier on.
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  Speaker 1: I'm sure we'll have other key tidbits, but that's what
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  Speaker 1: stood out from the written testimony we were able to
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  Speaker 1: get our hands on it making medicine. We'll dive in
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  Speaker 1: more next week, but what is clear is this hearing's
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  Speaker 1: happening at the same time that we talk about the
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  Speaker 1: user fee reauthorization of the FDA PADUFA. Check out our
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  Speaker 1: great episode on PADUFA and what it could mean to
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  Speaker 1: the ecosystem. So it makes sense that there's a lot
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  Speaker 1: of focus on FDA reforms. We'll wait to see which
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  Speaker 1: witnesses seem to score the most points with members of Congress.
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  Speaker 1: Can we glean any intel where policymakers on both sides
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  Speaker 1: of the aisle think about going as it relates to China, Australia,
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  Speaker 1: the US and other countries for the future of clinical trials.
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  Speaker 1: But the FDA wasn't the only hearing in town. The
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  Speaker 1: Senate Judiciary Committee met Tuesday for a hearing titled from
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  Speaker 1: Jean's Time Machines the patent eligibility debate, so intellectual property
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  Speaker 1: was very much in vogue this week as well. As
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  Speaker 1: many listeners know, court decisions have left certain innovations, including
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  Speaker 1: a diagnostics, gene based inventions, and now AI driven discoveries,
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  Speaker 1: in a gray zone where innovators can't be sure if
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  Speaker 1: their work's even patentable. For early stage biotech, that uncertainty
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  Speaker 1: is a tax on investment. We'll be watching whether this
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  Speaker 1: hearing builds momentum for legislative reform, namely the Patent Eligibility
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  Speaker 1: Restoration Act or PARA, championed by Friend of the show
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  Speaker 1: Senator Tom Tillis, along with Senators Koons, Herono and Blackburn.
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  Speaker 1: A House version has also been introduced and led by
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  Speaker 1: Representatives Kevin Kylie and Scott Peters. It's something that incubate
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  Speaker 1: the makers of making medicine podcasts. Has also weighed in
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  Speaker 1: on we have to give crystal clear intellectual property protections
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  Speaker 1: for investment to continue. It's a non starter to do otherwise,
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  Speaker 1: and para and legislation like it is needed to move
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  Speaker 1: the conversation forward and modernize an outstanding IP system that
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  Speaker 1: is in need of some reform. Finally, also on Wednesday,
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  Speaker 1: the House Select Committee on China is holding a hearing
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  Speaker 1: protecting American Innovation the Federal Research Security Enterprise with witnesses
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  Speaker 1: from the Department of Energy NIH and the National Science Foundation.
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  Speaker 1: Research Security sits right at the intersection we talk about
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  Speaker 1: constantly on the show, how do we protect American science
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  Speaker 1: from exploitation without choking off the openness that makes it work.
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  Speaker 1: With NIH at the witness table, expect questions about foreign
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  Speaker 1: talent programs, data security, and who gets access to federally
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  Speaker 1: funded research. But it has to be crystal clear across
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  Speaker 1: all of these hearings, whether it's IP FDA or something
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  Speaker 1: like our research programs at the NIH. We have to uplift,
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  Speaker 1: We have to have bipartisan support for this part of
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  Speaker 1: the ecosystem that drives everything forward. I was fortunate to
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  Speaker 1: spend this morning at a roundtable with a number of
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  Speaker 1: leading patient advocates, and one thing was crystal clear. Backing
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  Speaker 1: off the federally funded research, not making it available would
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  Speaker 1: damage the hopes of patients, not just in the US,
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  Speaker 1: but around the world. We are still the beacon of
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  Speaker 1: light to patient communities everywhere, so it is critically important
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  Speaker 1: that we hear in these hearings just how vital that
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  Speaker 1: early stage research funding is. And finally, one of our
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  Speaker 1: favorite parts of the show, getting to the FDA approvals corner.
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  Speaker 1: We missed out on covering what happened in May, so
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  Speaker 1: we have two months worth of good news for patients
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  Speaker 1: and of course for the companies that have invested millions
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  Speaker 1: and billions of dollars in bringing these drugs forward. On
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  Speaker 1: May first, the FDA approved Vipanu from Reigel Pharmaceuticals. It
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  Speaker 1: treats certain advanced or metastatic breast cancers in patients whose
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  Speaker 1: disease progressed after at least one round of endocrine therapy.
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  Speaker 1: Later on May thirteenth, Butclsey from b One Medicines was
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  Speaker 1: approved to treat certain patients with real lapse to refractory
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  Speaker 1: mantle cell lymphoma. On May fifteenth, Backfensdi was approved. It's
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  Speaker 1: astrozenica's drug used alongside other drugs to treat high blood pressure.
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  Speaker 1: Only a week later, on May twenty second, Gilead Sciences
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  Speaker 1: received approval for hepclutics to treat chronic hepatitis delta virus infection.
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  Speaker 1: On May twenty seventh, AVI got approval for a dec
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  Speaker 1: nupaz and stay with me. On this it was approved
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  Speaker 1: for adults with blastic plasma citoid dendritic cell neoplasm, a
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  Speaker 1: rare and aggressive blood cancer. It's great to see a
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  Speaker 1: win for the rare cancer community. On May twenty ninth,
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  Speaker 1: Sipsato from hischopharmaceutical group was approved to induce general anesesia
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  Speaker 1: in adults undergoing surgery. On the same day, Shinogi's Zokova
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  Speaker 1: was cleared as post exposure of prophylaxis for COVID nineteen
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  Speaker 1: for people who've been in contact with someone with the virus.
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  Speaker 1: I should give a shout out to Shinogi's great team.
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  Speaker 1: In Japan, with whom Incubates spend a lot of time
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  Speaker 1: talking about patient axis in that country and how innovation
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  Speaker 1: broad is critically important for American patients. And also on
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  Speaker 1: May twenty ninth, the third drug approval was zanich from Walkhart,
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  Speaker 1: which was approved to treat complicated urinary tract infections. It
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  Speaker 1: was a big month in May, but June had some
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  Speaker 1: great approvals as well. On the twelfth, Behar's m belvist
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  Speaker 1: was approved as an imaging agent to be used with
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  Speaker 1: MRIs to detect and visualize lesions with abnormal blood vessel activity.
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  Speaker 1: On June seventeenth, GSK's Utebzi was approved to treat complicated
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  Speaker 1: urinary tract infections, and finally, on June twenty ninth, Varridian
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  Speaker 1: Therapeutics Lumova was approved to treat thyroid eye disease. That
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  Speaker 1: was a lot and apologies in advance for any mispronunciations
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  Speaker 1: of products or companies, but it's great to see such
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  Speaker 1: a diverse set of products coming forward for patients in
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  Speaker 1: the United States. Credit to the team at the FDA
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  Speaker 1: for working through these incredible data packages bringing hope to
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  Speaker 1: patients and to the entrepreneurs and scientists who made them possible.
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  Speaker 1: As always, we'll keep tracking what's coming down the pipeline,
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  Speaker 1: so stay tuned in future episodes for July's roundup of
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  Speaker 1: FDA approvals That wraps up this episode of the Making
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  Speaker 1: Medicine Podcast. Be sure to subscribe on YouTube and follow
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  Speaker 1: us on other channels so you don't miss upcoming conversations
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  Speaker 1: in our American made series. Do you have thoughts on
• 12:17
  Speaker 1: anything we said on this episode, Let us know and
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  Speaker 1: we might feature your comment next week. Thanks for listening,
• 12:23
  Speaker 1: and as always, keep innovating