Latest / Making Medicine / Boston Biotech Pulse: Shutdowns, Pfizer Deal, and the Future of Innovation

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Boston Biotech Pulse: Shutdowns, Pfizer Deal, and the Future of Innovation · 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 consult a doctor.
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  Speaker 1: Nothing in this episode constitutes investment, financial, or legal advice,
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  Speaker 1: and please consult your own advisors before making decisions. Hello everyone,
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  Speaker 1: and welcome back to the Making Medicine Podcast or Science
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  Speaker 1: Policy and Innovation Meet. As always, I'm your host, John Stanford.
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  Speaker 1: This week, I'm coming to you from Boston, a hub
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  Speaker 1: of life science innovation that leads the way around the
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  Speaker 1: world in developing new medicines and treatments for disease. I've
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  Speaker 1: been here meeting with leading voices in the investment community
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  Speaker 1: talking about what's next for biotech. Let's get into the show.
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  Speaker 1: Incubate's been spending this week in Boston talking with investors,
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  Speaker 1: biotech executives, and pharmaceutical manufacturers about the state of the
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  Speaker 1: ecosystem at such a critical time, such a critical place.
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  Speaker 1: I'll be talking about some of my key takeaways from
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  Speaker 1: those conversations, but first a few headlines. The top story,
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  Speaker 1: of course, that the federal government remains shut down and
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  Speaker 1: what that could mean for biotech. We did a deep
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  Speaker 1: dive last week, but as this prolongs, we want to
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  Speaker 1: keep on discussing how you may be impacted by a
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  Speaker 1: closure of the federal government that doesn't seem to have
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  Speaker 1: an end in sight. Most notably, at the FDA, business
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  Speaker 1: is continuing. Eighty six percent of staff still remain there
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  Speaker 1: doing the good work of making sure that medicines, food,
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  Speaker 1: and other regulated entities are moving forward. Anything funded with
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  Speaker 1: a user fee has funds still available to it. But
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  Speaker 1: let's talk about what's slowed down or stopped at the FDA.
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  Speaker 1: They will not be able to accept new user fee
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  Speaker 1: funded submissions while there's no congressional funding that includes new
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  Speaker 1: abbreviated drug applications, biologic license applications so NDAs and blas,
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  Speaker 1: as well as five ten PMAs, Denovo's animal drug applications,
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  Speaker 1: and other submissions that require user fee payment. So a
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  Speaker 1: simple way to think about this is if the FDA
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  Speaker 1: activity you're interested in was covered by an already paid
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  Speaker 1: user fee, that work is probably continuing. But if you
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  Speaker 1: needed to file a new application, that's simply not available
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  Speaker 1: to you right now. That's something that the biotech needs
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  Speaker 1: to see addressed right away, as so many new innovations
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  Speaker 1: will require new applications. The other big news is mentioned.
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  Speaker 1: Last week was the announcement of a partnership between the
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  Speaker 1: White House and Pfiser. We covered that in detail, but
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  Speaker 1: got some questions back about what the core tenants of
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  Speaker 1: the deal were. It's important to remember that the actual
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  Speaker 1: deal was not made public and remains confidential, but what
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  Speaker 1: was discussed that day has four key parts. The first
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  Speaker 1: is that Pfizer will provide lowest possible pricing to medicate
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  Speaker 1: programs on their drugs. This is that MFN pricing the
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  Speaker 1: lowest most Favored nation pricing, and so they'll be providing
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  Speaker 1: that to medicaid programs around the country on their products.
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  Speaker 1: The White House also used as an opportunity to announce
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  Speaker 1: their new website platform, trump Rx, where patients can find
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  Speaker 1: direct to consumer or direct to patient pricing on pharmaceuticals,
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  Speaker 1: not just from Pfizer. We'll wait to see when this
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  Speaker 1: comes online in twenty twenty six. As part of the
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  Speaker 1: deal with Peiser, President Trump and Secretary Leutnik are waving
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  Speaker 1: tariffs on Pfeiser's products for three years now. It's important
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  Speaker 1: to remember that the one hundred percent tariff on pharmaceuticals
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  Speaker 1: that Peiser has been waived from has not gone into place,
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  Speaker 1: as the White House pointed to ongoing negotiations before that
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  Speaker 1: gets implemented. But should it be implemented, it seems that
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  Speaker 1: Peiser will be waived three years worth of tariffs on
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  Speaker 1: their products. And finally, along with many other companies and
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  Speaker 1: a total of five hundred billion in announcements about new
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  Speaker 1: onshoring manufacturing, Pizer added seventy billion in their own announcement.
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  Speaker 1: And so we continue to see industry efforts to invest
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  Speaker 1: in the United States. So those are the key tenants
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  Speaker 1: of the Pfizer White House deal as we know them,
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  Speaker 1: and we're waiting to see whether or not other companies
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  Speaker 1: will follow suit. This week, Incubates been in Boston meeting
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  Speaker 1: with investors, biotech executives, and a number of other players
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  Speaker 1: that are so critical to making this city, this state,
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  Speaker 1: and this country a unique leader in the biopharmaceutical ecosystem.
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  Speaker 1: I wanted to share a few key takeaways I had
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  Speaker 1: based on these conversations and where people are. The first
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  Speaker 1: is the noise in Washington. It's beginning to weigh so heavily.
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  Speaker 1: So many executives and investors said what is happening in
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  Speaker 1: Washington makes it very hard to invest and that they
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  Speaker 1: need clarity and certainty. What was once relegated to lawyers
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  Speaker 1: in council and regulatory divisions is now front and center
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  Speaker 1: in the boardroom. What is going to come next out
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  Speaker 1: of Washington and how does it impact the medicine that
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  Speaker 1: we're developing. Investors are struggling to see through the haze
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  Speaker 1: of the announcements coming out of Washington, and a government
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  Speaker 1: shutdown certainly isn't helping. Also interestingly about the role of
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  Speaker 1: Washington is the recent cut to interest rates. We've mentioned
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  Speaker 1: before on the podcast and had other much smarter speakers
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  Speaker 1: talk about this, that the interest rates being so high
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  Speaker 1: have kept people away from risky areas like biotech. So
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  Speaker 1: as we see cuts to the rate by the Fed,
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  Speaker 1: we should be seeing a pickup in interest in the
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  Speaker 1: risky environment of biotech. That's certainly what investors and others
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  Speaker 1: here in Boston are looking for. The second key takeaway
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  Speaker 1: is a growing concern about a threat to a generation
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  Speaker 1: of scientific capabilities. We've covered a lot about proposed cuts
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  Speaker 1: to the NIH, the SBIR program going on pause, and
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  Speaker 1: efforts whether it's through H one B visas or university scrutiny,
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  Speaker 1: that seem to have weakened the ability to bring the
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  Speaker 1: best and brightest to America in order to develop new medicines.
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  Speaker 1: It was a recurring theme in so many conversations that
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  Speaker 1: these are starting to have an effect. One executive from
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  Speaker 1: a school system throughout Massachusetts pointed to already a significant
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  Speaker 1: decrease in foreign applicants that typically fill out masters or
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  Speaker 1: PhD programs, and pointed to a big increase in technical
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  Speaker 1: schools in Europe. They see it as a brain drain
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  Speaker 1: coming out of people who would have otherwise come to
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  Speaker 1: the United States. This is growing into a conversation about
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  Speaker 1: where this state and frankly, the country can be in
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  Speaker 1: five or ten years if we continue to see Masters
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  Speaker 1: in PhD students not finish their studies here. This means
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  Speaker 1: for the pharmaceutical community that developing a workforce and working
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  Speaker 1: on solutions that keep the best and brightest, whether they're
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  Speaker 1: born in the US or otherwise involved in the life
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  Speaker 1: science ecosystem, is critically important because, as another other person
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  Speaker 1: pointed out to me, biotech is hard, and if you're
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  Speaker 1: truly brilliant, you might be choosing to go into the
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  Speaker 1: next tech innovation or AI or another field that doesn't
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  Speaker 1: yield a new medicine to patients in need, and so
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  Speaker 1: it's critically important that we give a signal to those
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  Speaker 1: who are investing their careers and livelihoods in this space
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  Speaker 1: that America will be here for them. There's probably no
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  Speaker 1: place more than Boston that it's so critical that the
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  Speaker 1: life science's ecosystem be championed. Lastly, and closing on a
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  Speaker 1: positive note, I couldn't help but be amazed by the
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  Speaker 1: science and ideas that are going around. We have truly
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  Speaker 1: built in the last decade a whole new toolbox of capabilities,
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  Speaker 1: and I thought it would be worth talking about some
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  Speaker 1: of the more innovative modalities because it's not just that
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  Speaker 1: we're bringing new medicines to market. We're bringing whole new
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  Speaker 1: ways to think about treating the human body. And that
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  Speaker 1: came through that despite the policy uncertainty and despite the
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  Speaker 1: workforce challenges, the scientific case ability seems better than ever.
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  Speaker 1: So here are a few modalities that I found particularly interesting.
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  Speaker 1: Continued gene therapies and genome engineering seems to continue to
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  Speaker 1: be an important place to invest time and energy. A
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  Speaker 1: lot of people were pointing to curative capabilities of changing
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  Speaker 1: a gene, especially in young, young children that have a
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  Speaker 1: lifetime's worth of benefit. It'll be critically important, they said, though,
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  Speaker 1: that these gene therapies find a proper reimbursement path that
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  Speaker 1: makes sense for continued investment. Similarly, efforts around nucleic acids,
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  Speaker 1: whether it's mRNA or RNA interference sRNA or even micro RNA.
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  Speaker 1: There seems to be a whole host of nucleic acid
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  Speaker 1: innovation happening here in Boston, and it will be critically
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  Speaker 1: important that we discover what diseases can be best modified
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  Speaker 1: and treated by this new technology. Similar to gene therapy
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  Speaker 1: is the growing cell and cellular engineering modalities, whether that's
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  Speaker 1: car T or cellular immunotherapies that are of a generation
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  Speaker 1: in situ or scaffold based, and sell reprogramming and transdifferentiation.
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  Speaker 1: All were topics that came up in cellular conversations and
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  Speaker 1: then finally excitement about the development of drugs themselves using
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  Speaker 1: computational systems and modalities, whether that's in silico design or
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  Speaker 1: AI directed. It seems like we're close, but not quite
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  Speaker 1: there yet, and it will be critically important that we
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  Speaker 1: work with the FDA to make sure that the next
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  Speaker 1: generation of innovations are clearly regulated and understood so that
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  Speaker 1: we can bring medicines forward. So those are my three
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  Speaker 1: takeaways from Boston. The policy is playing a bigger and
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  Speaker 1: bigger role than ever now. Most of that policy is
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  Speaker 1: giving people concern that the US might absorb price controls
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  Speaker 1: that frankly have never been in place in the American system,
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  Speaker 1: and that the country might not fairly value innovation if
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  Speaker 1: it's invested in it and brought forward. But also just
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  Speaker 1: basic clarity and certainty about the FDA and I each
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  Speaker 1: and others. The second key takeaway is that we have
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  Speaker 1: to make sure that the next generation of leaders in
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  Speaker 1: biopharmaceuticals is right here in America, and that we are
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  Speaker 1: giving a clear, consistent sign to that workforce that this
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  Speaker 1: is a priority. And finally, that great science is everywhere
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  Speaker 1: around this city and this country. If we invest in it,
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  Speaker 1: if we get the workforce right, we'll continue to be
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  Speaker 1: home to the next generation of drugs. That's certainly what
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  Speaker 1: Boston is focused on. I'm curious what's also happening in
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  Speaker 1: your neck of the woods. Incubat will be out around
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  Speaker 1: the country and hopefully have more episodes like this or
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  Speaker 1: we're hearing from the front lines of the true people
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  Speaker 1: making Medicine. That's all for this week's episode of the
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  Speaker 1: for listening, and, as always from Boston, keep in the
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  Speaker 1: ting bouting, tinggooting, tangooting,