Latest / Making Medicine / Trump’s Tariffs, NIH Cuts, FDA Approvals & SBIR Debate | This Week in Making Medicine

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Trump’s Tariffs, NIH Cuts, FDA Approvals & SBIR Debate | This Week in Making Medicine · Making Medicine

• 0:05
  Speaker 1: Hello everyone, and welcome back to the Making Medicine podcast
• 0:08
  Speaker 1: or Science Policy and Innovation Meet. As always, I'm your host,
• 0:12
  Speaker 1: John Stanford. We'll take a quick run through of this
• 0:15
  Speaker 1: week's headlines, looking at items from the FDA andih and
• 0:19
  Speaker 1: an industry, and then in a brand news segment, we'll
• 0:22
  Speaker 1: celebrate the latest FDA approvals, because let's face it, every
• 0:26
  Speaker 1: new therapy deserves a parade. It's a lot of work
• 0:29
  Speaker 1: to get a drug to market and to get it
• 0:31
  Speaker 1: to patients, and we'll take a look at the latest
• 0:33
  Speaker 1: medicines changing lives. With that, let's get into the show.
• 0:38
  Speaker 1: The biggest headline this week comes out of President Trump's
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  Speaker 1: cabinet meeting, where two secretaries, Commerce Secretary Howard Lutnik and
• 0:45
  Speaker 1: HHS Secretary RFK Junior took two seemingly distinct policy ideas
• 0:51
  Speaker 1: and merged them into one. We've talked on earlier episodes
• 0:55
  Speaker 1: about tariffs and Section two thirty two investigations out of
• 0:58
  Speaker 1: the Department of Commerce, and we've talked about this most
• 1:01
  Speaker 1: Favored Nation proposal that the secretary over at HHS or
• 1:05
  Speaker 1: if K Junior, is leading. In the cabinet meeting where
• 1:08
  Speaker 1: President Trump gathers all of his secretaries on a regular basis.
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  Speaker 1: There was discussion that tariffs could some way help get
• 1:15
  Speaker 1: most favored nations over the finish line, and it's something
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  Speaker 1: that we called out on our Tariff's episode. The President
• 1:22
  Speaker 1: Trump seesed tariffs and his authority to use them as
• 1:26
  Speaker 1: being a tool not just in trade policy, but another
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  Speaker 1: policy as well. So the idea of proposed that tariffs
• 1:33
  Speaker 1: could some way help push drug makers to accept most
• 1:36
  Speaker 1: favored nation proposals is certainly one will be watching closely.
• 1:41
  Speaker 1: There's also a lot of discussion about forward progress made
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  Speaker 1: both in conversations with those companies as well as this
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  Speaker 1: broader idea of removing middlemen, something a lot of folks
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  Speaker 1: on both sides of the I'll agree on through more
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  Speaker 1: direct to consumer or direct to patient programs. If coming
• 1:57
  Speaker 1: out of this whole conversation around most faiths nations, we
• 2:01
  Speaker 1: can find a way to get rid of the almost
• 2:03
  Speaker 1: fifty cents on the dollar wasted in the system, then
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  Speaker 1: it could be a positive, although circular conversation we've had
• 2:10
  Speaker 1: about how we make lower prices available to Americans. We'll
• 2:14
  Speaker 1: also be expecting that Section two thirty two report, which
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  Speaker 1: will enable some of this conversation to move forward in
• 2:20
  Speaker 1: the coming days. A second headline this week that may
• 2:24
  Speaker 1: not have made much of the news is the awarding
• 2:26
  Speaker 1: of twenty million dollars by BARTA to Osovax for a
• 2:30
  Speaker 1: universal flu vaccine. Normally, twenty million dollars of investment wouldn't
• 2:35
  Speaker 1: be groundbreaking news, but what's interesting is that this follows
• 2:39
  Speaker 1: right after the cancelation of more than five hundred million
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  Speaker 1: dollars of contracts for mRNA vaccine research. So it's a
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  Speaker 1: clear signal that HHS, BARTA, others will continue to fund
• 2:52
  Speaker 1: vaccine research, but are moving away from mRNA. OSSOVAXOVX eight
• 2:59
  Speaker 1: thirty six targets the highly conserved nucleoprotein of influence at A,
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  Speaker 1: aiming to deliver broad protection against both seasonal and pandemic
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  Speaker 1: flu strains. Early trials and more than fourteen hundred participants
• 3:11
  Speaker 1: have shown encouraging safety and immune responses, leading to the
• 3:14
  Speaker 1: continued investment of BARTA. So again, what does it mean.
• 3:17
  Speaker 1: It means the FDA is still funding vaccine candidates while
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  Speaker 1: they have pulled back from greenlighting other next generation vaccine candidates.
• 3:25
  Speaker 1: Osovac's award does seem like there still remains a regulatory
• 3:29
  Speaker 1: and funding path for vaccine development. In hopefully some positive
• 3:34
  Speaker 1: news for industry, we have our first company in a
• 3:36
  Speaker 1: long time pursuing an IPO and returning to the capital markets.
• 3:41
  Speaker 1: I don't have to remind many that it's been more
• 3:43
  Speaker 1: than six months since the biotech industry has seen its
• 3:46
  Speaker 1: most recent IPO. The company is LB Pharmaceuticals, which filed
• 3:50
  Speaker 1: paperwork earlier this week with the SEC to go public.
• 3:54
  Speaker 1: They're looking for extra cash to get their schizophrenia drug
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  Speaker 1: trials over the finish line. But what was securely notable
• 4:00
  Speaker 1: in their SEC filing, besides the noise about the first IPO,
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  Speaker 1: is just how obvious the policy concerns were. Remember, these
• 4:09
  Speaker 1: SEC documents carry the weight of law, and they can't
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  Speaker 1: just put wild ideas in there, but instead speak to
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  Speaker 1: really legitimate concerns and how business executives are thinking. Uncertain
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  Speaker 1: policy environment was directly added into their SEC filing, and
• 4:24
  Speaker 1: it called out the most favored nation policy as a
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  Speaker 1: possible headwind to the business. This is a clear sign
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  Speaker 1: from the community that what Washington is doing is having
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  Speaker 1: real and substantial impacts on businesses and their ability to
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  Speaker 1: raise investments. And I'll make a plug for Incubates Investment Tracker,
• 4:41
  Speaker 1: which is tracking just that we look at SEC filings
• 4:45
  Speaker 1: and other paperwork that carries the heavy weight of law,
• 4:48
  Speaker 1: where companies are calling out how policy is interfering with
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  Speaker 1: their business and scientific decisions. Zooming out just a little
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  Speaker 1: bit from LB Pharmaceuticals. The idea of this six month
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  Speaker 1: drought in IPO's all also came forward in mass Bio's
• 5:02
  Speaker 1: industry Snapshot, which is out this week. We hope to
• 5:05
  Speaker 1: have a special guest to dive deeper in mass Bio's
• 5:08
  Speaker 1: industry snapshot and the concerning but also optimistic look at
• 5:12
  Speaker 1: Massachusetts ecosystem on a future episode. NIH program reductions remain
• 5:17
  Speaker 1: in the news. This week they decided to end the
• 5:19
  Speaker 1: Minority Biomedical Research Support Program. The NIH has ended it
• 5:24
  Speaker 1: after decades of providing funding, mentorship, and lab experience to
• 5:28
  Speaker 1: underrepresented students. Advocates warned that this could derail the pipeline
• 5:32
  Speaker 1: for the next generation of scientists that were coming from
• 5:35
  Speaker 1: underrepresented communities. Over at the Making Medicine podcast, we really
• 5:40
  Speaker 1: do focus on one thing, making medicine and one of
• 5:43
  Speaker 1: the biggest leaps and moving something forward on a value
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  Speaker 1: chain and development cycle that lasts more than fifteen years.
• 5:49
  Speaker 1: Is the FDA finally giving approval to a drug making
• 5:52
  Speaker 1: it available to patients in the United States. That's why
• 5:56
  Speaker 1: we're launching the FDA Approvals Corner, where we talk about
• 5:59
  Speaker 1: the drugs that are most recently approved by the agency.
• 6:03
  Speaker 1: It's really important that we take time to celebrate that
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  Speaker 1: every month, new medicines to patients who are looking for
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  Speaker 1: hope are becoming made available. I made all the policy noise,
• 6:14
  Speaker 1: and I made all the concern about where the industry
• 6:17
  Speaker 1: stands in capital markets. We should all celebrate as Americans
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  Speaker 1: new medicines being made available. So let's take a look.
• 6:26
  Speaker 1: Here are the latest wins for patients from July. Lino
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  Speaker 1: Zipik from Regeneron was approved with accelerated approval on July
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  Speaker 1: second for relapsed or refractory multiple miloma. Zegfrovi from Diesel.
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  Speaker 1: Also on July second, received accelerated approval for advanced or
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  Speaker 1: metastatic non small cell lung cancer nsclc Ectorle from Calvista,
• 6:49
  Speaker 1: which we've talked about on the program before, received full
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  Speaker 1: approval as the first and only oral on demand treatment
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  Speaker 1: for hereditary angiodema. And zop Go cream from Leo Pharma
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  Speaker 1: was approved on July twenty third and approved from moderate
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  Speaker 1: to severe chronic Handecima Sephians from PTC Therapeutics received approval
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  Speaker 1: for both children and adults for PKU, and finally, Viz
• 7:14
  Speaker 1: from Lens Therapeutics on July thirty first, got approval for presbyopia,
• 7:18
  Speaker 1: the age related difficulty with near vision. July was an
• 7:22
  Speaker 1: exciting month for patients and for companies alike, and it's
• 7:26
  Speaker 1: great to remember that each of these approvals represents a
• 7:29
  Speaker 1: step forward, whether tackling a rare disease, common conditions, or
• 7:33
  Speaker 1: just advancing patient convenience. So it's all take a moment
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  Speaker 1: to be excited for the accomplishments of these companies and
• 7:39
  Speaker 1: the brave patients who went through clinical trials from July
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  Speaker 1: twenty twenty five. Let's turn now to our policy spotlight.
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  Speaker 1: This week, we're taking a look at the SBIR and
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  Speaker 1: STTR programs, the small Business Innovation Research and Small Business
• 7:53
  Speaker 1: Technology Transfer programs that'll be familiar to many in the
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  Speaker 1: industry because they are a lifeline to early stage by
• 8:00
  Speaker 1: tech companies. They provide critical funding for small businesses working
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  Speaker 1: on breakthrough technologies, and importantly, SBIR and STTR doesn't just
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  Speaker 1: benefit the biotech industry. Other technology industries have benefited heavily,
• 8:14
  Speaker 1: and some of the most common and iconic brands actually
• 8:16
  Speaker 1: harken back to SBR investments decades ago. So why are
• 8:21
  Speaker 1: we talking about the SBIR and STTR programs. Well, their
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  Speaker 1: authorization or frankly, their right to exist expires on September thirtieth,
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  Speaker 1: twenty twenty five. Another way to say that, if no
• 8:34
  Speaker 1: action is taken by Congress between now and September thirtieth,
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  Speaker 1: the SBIR program and STTR program will be paused, effectively
• 8:43
  Speaker 1: ended until Congress turns it back on that something Incubate
• 8:47
  Speaker 1: is working alongside many others to avoid. But there's a
• 8:51
  Speaker 1: lot of debate about where SBIR program should go. One
• 8:55
  Speaker 1: possible solution is the Innovate Act, and it's probably got
• 8:58
  Speaker 1: the most attention because it's sponsored by the Senate and
• 9:01
  Speaker 1: House chairs of the Small business committees, Joany Earnst in
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  Speaker 1: the Senate and Roger Williams in the House, and they'll
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  Speaker 1: have a big say because this is under their purview.
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  Speaker 1: One of the key points their bill, the Innovate Act,
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  Speaker 1: makes is the idea of foreign risk. They're really trying
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  Speaker 1: to pay a lot of attention to increased influence of
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  Speaker 1: foreign actors in the development of new technologies. They've put
• 9:23
  Speaker 1: out quite the definition of what's a foreign risk that
• 9:27
  Speaker 1: will throw up on the screen. But in short, any
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  Speaker 1: companies that are taking investment from countries of concern or
• 9:34
  Speaker 1: entities they're in will really have to think about if
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  Speaker 1: they'll continue to be eligible if the Innovate Act is
• 9:40
  Speaker 1: how we move forward. There are other elements to the
• 9:42
  Speaker 1: bill that are very much up for debate, and frankly,
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  Speaker 1: how it would impact certain states remains a key topic
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  Speaker 1: of discussion. What is clear is that something has to
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  Speaker 1: be done, whether that's a short term extension that allows
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  Speaker 1: this debate to continue into the spring, or if we
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  Speaker 1: can find a compromise that allows continuity and certainty to
• 10:03
  Speaker 1: be available for this program for the companies that rely
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  Speaker 1: on it. Again, we can't stress how important this program
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  Speaker 1: is to avoiding the value of death that so many
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  Speaker 1: companies face in their earliest days. The SBIR program is
• 10:17
  Speaker 1: a proven success in the US bioeconomy, and we hope
• 10:21
  Speaker 1: and we'll be fighting for that it is continued and
• 10:24
  Speaker 1: continued with certainty for a long time to come. That's
• 10:27
  Speaker 1: all for this week's episode of the Making Medicine Podcast.
• 10:30
  Speaker 1: Have a thought or question about today's topics, drop a comment,
• 10:34
  Speaker 1: and we'll feature it in next week's episode. Don't forget
• 10:36
  Speaker 1: to subscribe on YouTube and follow us on LinkedIn, X
• 10:39
  Speaker 1: and Instagram using the links in the description. Thanks for listening,
• 10:43
  Speaker 1: and as always, keep innovating.