Latest / Making Medicine / Shutdown Fallout, MFN Deals & BIOSECURE Returns

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Shutdown Fallout, MFN Deals & BIOSECURE Returns · Making Medicine

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  Speaker 1: At Making Medicine. We're reporting on the headlines, not making
• 0:03
  Speaker 1: medical recommendations. For personal health questions, always consult a doctor.
• 0:08
  Speaker 1: Nothing in this episode constitutes investment, financial, or legal advice,
• 0:12
  Speaker 1: and please consult your own advisors before making decisions. Hello everyone,
• 0:24
  Speaker 1: and welcome back to the Making Medicine podcast, where 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 we're talking through the latest White House MFN deal,
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  Speaker 1: some shifts in selling gene therapy, biosecure in China, with
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  Speaker 1: special guests John Guy, Incubates Policy director, and more. Let's
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  Speaker 1: get into the show once again. Our top story this
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  Speaker 1: week is day fifteen of the federal government shutdown, and
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  Speaker 1: we're beginning to see more and more impacts for our community.
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  Speaker 1: More specifically, a large number of layoffs at Health and
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  Speaker 1: Human Services, including the Trumpet minute stration issuing a reduction
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  Speaker 1: in force or a riff notices to some thirteen hundred
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  Speaker 1: CDC employees during the government shutdown, labeling them non essential.
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  Speaker 1: Soon after, however, hundreds of those termination notices were rescinded
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  Speaker 1: over half, according to sources, though roughly some six hundred
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  Speaker 1: employees across CDC remain affected. So there's a lot of
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  Speaker 1: confusion at the CDC about who's in and who's out
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  Speaker 1: and how long these rifts will exist. Key units that
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  Speaker 1: were hit but then partially restored included the Morbidity and
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  Speaker 1: Mortality Weekly Report Team, the Epidemic Intelligence Services also known
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  Speaker 1: as OUR Disease Detectives, and the National Center for Immunization
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  Speaker 1: and Respiratory Diseases. The government mentioned that coding errors caused
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  Speaker 1: many of the wrongful notices and that staff were never
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  Speaker 1: actually separated from the agency. But this all comes as
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  Speaker 1: a larger mass firing promised by OMB director Russ Vatt
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  Speaker 1: and the Trump administration, and a broader HHS re organization
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  Speaker 1: plans spearheaded by Secretary RFK Junior that initially proposed cutting
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  Speaker 1: around ten thousand jobs from HHS.
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  Speaker 2: So where these cuts.
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  Speaker 1: Fit in amid a shutdown and all the rhetoric out
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  Speaker 1: of the Trump administration about decreasing the size of the
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  Speaker 1: federal government has a lot of chaos and confusion about
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  Speaker 1: who's reporting to these offices and for companies that work
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  Speaker 1: with them, and for health agencies across the country who
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  Speaker 1: they should be talking to. Then, enter the courts, a
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  Speaker 1: federal judge has already issued a preliminary injunction ruling the
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  Speaker 1: HHS layoffs are unlawful beyond the CDC Earlier rounds of
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  Speaker 1: cuts earlier in the year eliminated thousands of roles at HHS,
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  Speaker 1: FDA and the NIH, which has already caused a lot
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  Speaker 1: of turmoil in the industry.
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  Speaker 2: Some recent announcements.
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  Speaker 1: From large manufacturers departing from self therapy investments also caught
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  Speaker 1: our eye. Mainly Taketa and Novo Nordisk have stepped away
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  Speaker 1: from their self therapy units, and we thought of my
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  Speaker 1: be a moment to think about where cell therapy currently stands.
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  Speaker 1: As many saw earlier this week, Novo announced a restructuring
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  Speaker 1: effort where it will stop working on its self therapies
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  Speaker 1: and cut around two hundred and fifty employees in the
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  Speaker 1: cell therapy space. That follows an announcement earlier this month
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  Speaker 1: by Takeda that it would also exit the cell therapy
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  Speaker 1: development space and let go of about one hundred and
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  Speaker 1: thirty seven employees as part of the restructuring effort. This
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  Speaker 1: follows a string of bad news in the selling gene
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  Speaker 1: therapy space over the year, and even last week on
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  Speaker 1: the show in sharing thoughts about what we heard in Boston.
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  Speaker 1: We know the science and promise here is bringing a
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  Speaker 1: lot of hope to patients, but we haven't seen to
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  Speaker 1: figure out the economics. Take for instance, Bluebird Bio, one
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  Speaker 1: of the true pioneers in the gene therapy space, was
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  Speaker 1: sold earlier this year to a private equity firm for
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  Speaker 1: less than thirty million dollars, despite once being worth nearly
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  Speaker 1: ten billion dollars. Investments across sell in gene therapy space
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  Speaker 1: have been trending down over recent years and eighty three
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  Speaker 1: percent drop since twenty twenty one. In twenty twenty four,
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  Speaker 1: companies developing selling g and editing products raised a little
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  Speaker 1: over a billion across nearly forty venture rounds. In twenty
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  Speaker 1: twenty three, though, they had raised three point five billion,
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  Speaker 1: and in twenty twenty one they had raised eight point
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  Speaker 1: two billion across more than one hundred and twenty deals. Now,
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  Speaker 1: certainly the era of investment right now is hard across
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  Speaker 1: all modalities, and so we can't point to these numbers
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  Speaker 1: in a causal fashion, but it's certainly a tough time
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  Speaker 1: to be investing and to be raising in the selling
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  Speaker 1: gene therapy space. As Peter Marx former FDA SBER director
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  Speaker 1: said there are speed bumps including scientific challenges, manufacturing difficulties,
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  Speaker 1: and real world application of these therapies that need to.
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  Speaker 2: Be worked out.
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  Speaker 1: Selling gene therapies offer incredible potential to treat and even
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  Speaker 1: cure diseases by addressing their roots and that it causes.
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  Speaker 1: So I think we all have to hope that this
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  Speaker 1: pullback and investment is temporary, both for the opportunities it
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  Speaker 1: brings patients and to ensure US leadership in this technology.
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  Speaker 1: We do know that China, for instance, is continuing to
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  Speaker 1: look to develop these new therapies, where some of the
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  Speaker 1: economics and policies remain out of place. I think it's
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  Speaker 1: worth editorializing for a moment that selling gene therapies have
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  Speaker 1: not gotten the broad policy direction out of Washington that
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  Speaker 1: says that they are ready to be invested in, brought
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  Speaker 1: to market, and have a clear path with manufacturing and reimbursement.
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  Speaker 1: It might be worthy for Congress and for the Administration
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  Speaker 1: to invest their energies in that instead of pursuing back
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  Speaker 1: and forth policies around price controls. We're excited that we'll
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  Speaker 1: have a pretty special guest in the selling gene therapy
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  Speaker 1: s based on a future episode where we're going to
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  Speaker 1: dig deeper into these numbers and why there's still cause
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  Speaker 1: for hope for this important part of the industry. The
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  Speaker 1: news this week is that manufacturer Astrosenica entered into a
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  Speaker 1: deal with the White House. This follows on the big
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  Speaker 1: announcement out of Pfeiser that they too had entered into
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  Speaker 1: a deal with the White House. Astrasenica's included a pricing
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  Speaker 1: pledge that will offer medicaid drug prices in the US
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  Speaker 1: that are consistent with prices it offers in other major
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  Speaker 1: developed countries. For new drugs, Astrosenica will launch them at
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  Speaker 1: a quote most Favored Nation price that is no higher
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  Speaker 1: than what it gives to other large markets. Similarly, they
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  Speaker 1: will get a three year reprieve on national security related
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  Speaker 1: pharma tariffs that have been much talked about over the
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  Speaker 1: last couple weeks. Astrosenica says it will give them time
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  Speaker 1: to reconfigure supply chains and manufacture in the US for
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  Speaker 1: products sold domestically. So it sounds and once again we
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  Speaker 1: don't have all the details of these deals. We didn't
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  Speaker 1: see the dotted eyes and cross teas of the Pfiser deal,
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  Speaker 1: and we almost have less information about the Astrosenica deal. Well,
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  Speaker 1: but let's see what we can dig in to say
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  Speaker 1: how it's a little different from what we heard out
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  Speaker 1: of the Peiser deal. First is in product scope. The
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  Speaker 1: specific drugs and discount amounts mentioned vary between the two agreements.
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  Speaker 1: Astrosenica's deal, for instance, mentioned discounts of up to eighty
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  Speaker 1: percent for some of its chronic disease medications, including specific
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  Speaker 1: respiratory drugs. It seems like they were focused more on
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  Speaker 1: specific products than a blanket wide cost cutting that we
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  Speaker 1: saw with Peiser. What's not known necessarily is just how
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  Speaker 1: much of that eighty percent is already built into discounts,
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  Speaker 1: as is providing not just the government but other payers
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  Speaker 1: as well. Similarly, there was a slight different in the
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  Speaker 1: scale of investment the companies both have committed to investing
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  Speaker 1: in the US. Peiser pledged to invest seventy billion dollars,
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  Speaker 1: as Resenica's committed to a smaller but still significant fifty
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  Speaker 1: billion dollar investment. Time will tell if these two deals
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  Speaker 1: are departure from the norm or more to come from
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  Speaker 1: the seventeen companies that received letters from the White House
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  Speaker 1: back in July. Finally, just because the government is shut
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  Speaker 1: down does not mean that Congress isn't continuing to work
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  Speaker 1: through a number of bills. One of the biggest outstanding
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  Speaker 1: ones is the National Defense Authorization Act or NDAA. It
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  Speaker 1: is quote must pass legislation, and it has been passed
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  Speaker 1: almost every year for the past seventy years. It effectively
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  Speaker 1: gives the Pentagon and a few other agencies their marching
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  Speaker 1: orders for the next year.
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  Speaker 2: But it's what's in the bill.
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  Speaker 1: It's a wide ranging piece of legislation that goes far
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  Speaker 1: more than just giving instructions to the Pentagon. If the
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  Speaker 1: term biosecure sounds familiar to you, here's a little bit
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  Speaker 1: of a refresher over the last couple of years, and
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  Speaker 1: John'll get into this in greater detail. A response to
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  Speaker 1: on shoring the US drug development supply chain has been
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  Speaker 1: this idea of bringing more and more cro CDMO and
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  Speaker 1: other drug developments services to the United States. One of
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  Speaker 1: the main targets is certainly China, where a number of
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  Speaker 1: US biotechs and US pharma companies rely on companies over
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  Speaker 1: there to swiftly and cheaply explore the science behind an
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  Speaker 1: asset or a compound. Biosecure went a little dormant after
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  Speaker 1: causing quite a stir in recent years because its implementation
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  Speaker 1: was so challenging. How long and how much would it
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  Speaker 1: cost to onshore this and do we have the workforce? Well,
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  Speaker 1: biosecure didn't die. As all things in Washington, it's been
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  Speaker 1: hanging out and it's found a home in a bill
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  Speaker 1: that's moving in Congress. And with that, let's get into
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  Speaker 1: some greater details with Incubate's policy director, John Guy.
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  Speaker 2: John, thanks for being on.
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  Speaker 1: Before we get into how it ended up in a
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  Speaker 1: defense bill, I want you to kind of maybe bring
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  Speaker 1: people up to speed on biosecure certainly a term we've
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  Speaker 1: thrown around on the podcast before. So let's start with
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  Speaker 1: what is biosecure broadly?
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  Speaker 3: Yeah, thanks for having me, John, So, biosecure is legislation
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  Speaker 3: that implements federal government contracting, loan and grant restrictions to
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  Speaker 3: biotech companies that do business with certain foreign adversaries, particularly
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  Speaker 3: some companies that are based in China.
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  Speaker 1: Before we get into it being the same or different
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  Speaker 1: as the earlier version, is it fair to say that
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  Speaker 1: China hawks that China's the boogeyman here.
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  Speaker 2: That's really the focus of this.
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  Speaker 1: Effort, or is that one of many countries that people
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  Speaker 1: were thinking of when they drafted this.
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  Speaker 3: You know, there are other countries that are considered, but
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  Speaker 3: really China is the main focus of this. And we'll
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  Speaker 3: get into a little bit about, you know, certain provisions
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  Speaker 3: within this and past NDAAs that kind of tackle the
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  Speaker 3: threat of China specifically.
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  Speaker 1: So let's start with how is it the same as
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  Speaker 1: the biosecure we've talked about before in broad strokes.
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  Speaker 3: Yeah, so generally there are a few provisions that carry
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  Speaker 3: over from biosecure one point zero, I guess we can
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  Speaker 3: call it. You know, first, it's banning agencies from buying
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  Speaker 3: or using biotech companies or using biotech from companies of concern.
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  Speaker 3: It's also so banning federal contracts if the contractor or
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  Speaker 3: subcontractors are using that equipment or services on the contract.
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  Speaker 3: It's also blocking grants or loans that would buy or
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  Speaker 3: use those same equipment or services. And it's blocking grantees
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  Speaker 3: or borrowers from spending federal funds with vendors that are
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  Speaker 3: using those same equipment or services on federal work.
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  Speaker 1: So similar to one point zero. It's comprehensive, I would say,
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  Speaker 1: in its reach. I mean what you just laid out
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  Speaker 1: there are they're thinking of all the ways you could
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  Speaker 1: get around it. It's not just the prime, it's the sub.
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  Speaker 1: It's not just grants, its loans, it's not just borrowers,
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  Speaker 1: it's also grantees. So clearly they've drafted it pretty comprehensively.
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  Speaker 1: What stood out to you as different from one point
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  Speaker 1: zero in this second version?
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  Speaker 3: Yeah, so it actually addressed some of the key issues
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  Speaker 3: that were raised in Biosecure one point zero last Congress,
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  Speaker 3: primarily over the naming of specific companies and over opportunities
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  Speaker 3: for companies to address any flags that are raised in
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  Speaker 3: the review process.
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  Speaker 2: Two things there.
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  Speaker 1: So if you're if I'm hearing it right, you know
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  Speaker 1: this was called the Wushi Bill, and there was a
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  Speaker 1: swift reaction to this. You're saying the names of those
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  Speaker 1: companies have been removed. And then did I hear you
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  Speaker 1: right that a company has an opportunity to address some
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  Speaker 1: of this.
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  Speaker 2: Yeah, that's right.
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  Speaker 3: So you know, starting from the top there, so rather
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  Speaker 3: than naming specific companies, it actually established it's two different
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  Speaker 3: procedures for identifying companies of concern. First, it actually uses
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  Speaker 3: the Department of Defense twelve sixty H list to identify
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  Speaker 3: specific companies of concern. And this twelve sixty h list,
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  Speaker 3: I can share a link in the description, it's actually
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  Speaker 3: a roster of Chinese military companies operating directly or indirectly
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  Speaker 3: in the US. Was This list was established in the
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  Speaker 3: twenty twenty one NDAA and it's updated every year. Something
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  Speaker 3: interesting about this twelve sixty h list is they actually
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  Speaker 3: don't receive the due process protections that are available to
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  Speaker 3: companies flagged through the second procedure.
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  Speaker 1: John, I want you to say more about that, because
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  Speaker 1: I don't think this is something that's been picked up
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  Speaker 1: in much media. So, you know, break some news on
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  Speaker 1: the podcast. You're saying that in the bill, there is
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  Speaker 1: an opportunity almost to protest these decisions if you're in
• 13:13
  Speaker 1: sort of this second entity criteria list, and so there
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  Speaker 1: is an avenue to kind of push back I suppose
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  Speaker 1: if the government makes this decision.
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  Speaker 2: Tell us more about that.
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  Speaker 3: Yeah, So this second process for identifying companies, it actually
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  Speaker 3: establishes a formal review process managed by OMB to identify
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  Speaker 3: any companies of concern, and those identification protocols you know,
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  Speaker 3: are focused on any companies that are subject control of
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  Speaker 3: a foreign adversary, whether they involve or are involved in
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  Speaker 3: the manufacturing or distribution of a biotechnology equipment or service,
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  Speaker 3: and if there are a risk to the US national security. However,
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  Speaker 3: you know, those companies that are identified through the second process,
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  Speaker 3: they're actually offered an opportunity to submit information in opposition
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  Speaker 3: to that to the designation, including steps being taken to
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  Speaker 3: mitigate those concerns that are raised. So there's actual chances
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  Speaker 3: here where a company that is initially flagged can address
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  Speaker 3: those concerns and have that flag removed.
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  Speaker 1: Certainly something you don't think of sort of an appellate
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  Speaker 1: process around national security decisions. So I think that's a
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  Speaker 1: great call out and maybe something that will be meaningful.
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  Speaker 1: And as we said, this bill is not moving on
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  Speaker 1: its own, as we would say in DC, it's found
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  Speaker 1: itself a vehicle in this case, the Defense Bill. What
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  Speaker 1: are the next steps for biosecure in in this is
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  Speaker 1: it is this definitely going to become law or are
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  Speaker 1: there are other steps that need to happen.
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  Speaker 3: Yeah, So the House and Senate are going to have
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  Speaker 3: to go to conference over their competing versions of NDAA.
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  Speaker 3: The House version did not include this version of biosecure,
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  Speaker 3: But to be honest, I think given the broad Biparson
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  Speaker 3: support for biosecure, I think it's likely that we'll see
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  Speaker 3: some version of this included in the in the final
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  Speaker 3: legislative text.
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  Speaker 1: That is a big swing and a big announcement of
• 15:04
  Speaker 1: news here on the Making Medicine podcast that biosecure is back.
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  Speaker 1: I think a lot of people, and you know we're
• 15:10
  Speaker 1: focused on tariffs, were focused on MFN. This was something
• 15:14
  Speaker 1: that caused quite a stir and even some divide in
• 15:17
  Speaker 1: the community.
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  Speaker 2: So we'll be watching that.
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  Speaker 1: But as you mentioned to me earlier, that's not all
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  Speaker 1: in the in the NDAA that there is that there's
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  Speaker 1: more here. Can you give us some of the other
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  Speaker 1: big hits that might impact the biotech community.
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  Speaker 2: Yeah, it was really interesting.
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  Speaker 3: So NDAA also included that the establishment of a biotechnology
• 15:35
  Speaker 3: Management Office within the Department of Defense. So DoD must
• 15:39
  Speaker 3: name a senior biotech lead within ninety days and launch
• 15:42
  Speaker 3: a biotechnology management office within one hundred and twenty days
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  Speaker 3: under the Deputy Secretary of Defense.
• 15:49
  Speaker 1: We'd begun through the tariffs conversation. Others to link sort
• 15:54
  Speaker 1: of this concept of biosecurity, and we just talked about biosecure.
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  Speaker 2: What is this Deald's Office going to do?
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  Speaker 3: Yeah, so the office it's charged with executing the defense
• 16:05
  Speaker 3: biotech strategy. It'll update acquisition policies to bring biotech into
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  Speaker 3: DoD programs. It's going to coordinate across government, industry, academia,
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  Speaker 3: and global allies. It's also going to work to streamline
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  Speaker 3: regulations in the biotech space as well as run global
• 16:22
  Speaker 3: tech assessments, seed regional innovation ecosystems. And it's actually going
• 16:26
  Speaker 3: to look to map workforce gaps across the country. So
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  Speaker 3: there's a lot in there.
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  Speaker 2: I know that workforce gap is going to be a
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  Speaker 2: huge one.
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  Speaker 1: I know when we had kendle On from mass Bio,
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  Speaker 1: and it's part of the biosecure conversation is just do
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  Speaker 1: we have the workforce that can allow us to do
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  Speaker 1: all of this here in the US. One of the
• 16:44
  Speaker 1: other things in your note that caught my eye on
• 16:46
  Speaker 1: this just great analysis is there would also be integrating
• 16:50
  Speaker 1: biotech scenarios into war gaming exercises. That's a pretty wide
• 16:55
  Speaker 1: mandate making sure we have the right workforce, but also
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  Speaker 1: all the way up to how biotech could be involved
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  Speaker 1: in much broader global conflict.
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  Speaker 3: Yeah, definitely. It's I think a sign that Congress, DoD
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  Speaker 3: and other agencies are really recognizing the true promise and
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  Speaker 3: threat of biotechnology in the future.
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  Speaker 2: Well, we'll leave it there.
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  Speaker 1: This is not the last time our policy director here
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  Speaker 1: at Incubate, John Guy, will be on the show.
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  Speaker 2: This is his area of expertise.
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  Speaker 1: Thank you, John for pouring through the Senate version of
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  Speaker 1: the NDA to find these two things and give us
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  Speaker 1: an update on them. I'm sure we'll have you back
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  Speaker 1: on to give us an update on biosecure very soon.
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  Speaker 3: Yeah, thanks for having me.
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  Speaker 1: That's all for this week's episode of the Making Medicine Podcast.
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  Speaker 1: Thanks to John Guy, Incubates policy director, for joining and
• 17:42
  Speaker 1: sharing his thoughts on biosecure and more. Do you have
• 17:45
  Speaker 1: a thought or question about today's topics, Drop a comment
• 17:49
  Speaker 1: and we'll feature it in next week's episode. Don't forget
• 17:51
  Speaker 1: to subscribe on YouTube and follow us on LinkedIn, x
• 17:55
  Speaker 1: and Instagram using the links in the description. Thanks for listening,
• 17:58
  Speaker 1: and as always, keep innovating. Thing brooting, thing booting, thing,
• 18:05
  Speaker 1: booting