Not too often you see HRQoL data in drug commercials. Via Ari Gnanasakthy youtu.be/VDFF6MCFzKM?...

Former FDA Commissioner:

Nice paper outlining how RWE can be applied in IRA evaluation of drugs academic.oup.com/healthaffair...

Glad to see GLP-1s continue to push expanded direct offerings: www.prnewswire.com/news-release...

Reports and documentation are a low-hanging fruit for biopharma and can help reduce OpEx, especially that which is currently outsourced to vendors. CSRs, other study reports, payer dossiers, briefing book docs etc etc. Big potential for short to medium-term savings

Short-termism driven by personal timelines rule the day. Greater purpose be damned. Would a Vagelos or Termeer have done the same? I would think not, and hopefully history judges the two archetypes accordingly.

Was really expecting more of these people.

I am grieving for the many talented & dedicated FDA employees who have been mistreated & those left to do the work of protecting public health. Also for those who will be harmed by this among patients and the public. Those who are complicit in their silence will be judged harshly by history.

I am going to be so pissed if--after everything--I do, in fact, die of dysentery.

Defend the NIH. timmermanreport.com/2025/02/defe...

Biopharma companies and CEOs are keeping their heads down at their own peril. They should speak up about what’s happening to the NIH and other science agencies before it’s too late. Silence gives consent. And no one should consent to this.

Of course not reflective of many (most?) of us working in the industry. Unfortunately, anything at NIH today that will lead to a new drug is way too long a time horizon for leadership to worry about personally (chances are they'll be long gone by the time it comes to fruition).

BREAKING: In response to doctors' lawsuit, Judge John Bates, a George W. Bush appointee, orders CDC, NIH, and FDA to put back up websites and datasets cited by the doctors in their lawsuit as having been relied upon and pulled down without notice. storage.courtlistener.com/recap/gov.us...

This is the most relevant article to NIH and research cuts I’ve seen. Imagine if this was today , how many people would be saying “Why are we studying Gila Monsters and their impact on diabetes ? That’s wasted money !” globalnews.ca/news/9793403...

Pharma bet that Trump>Biden may be tested sooner than I thought w the news of FDA cuts. Especially if review timelines / meeting timelines start getting impacted

Some interesting parallels re Deepseek: US-based LLMs and the bio explosion in China:US biotech Still feel it'll be net positive for the industries and consumers at large in both cases

I shouldn't try to apply logic here and apologies for the rare political post but if NIH is developing all of the drugs then why are we freezing all of the funding again?

Excellent piece and nicely balanced on the "China asset farm" issue. While others' concerns on impact to the US bio ecosystem are understandable I think it's also important to consider the macro impact re impact on overall discovery/development economics.

Re-upping this reply thread from last night. Drugs don't come from nowhere, folks. And we're not ripping off the NIH, either.

Interesting that Leerink now has a team doing independent cost effectiveness analyses. Seems to be taking more of a GCEA approach. An alternative to ICER? www.leerink.com/article/a-cp...

He also misunderstands (although not the first time) how drug pricing works. Demand is not perfectly inelastic.

Fantastic overview of methods to quantify the various components of the ISPOR value flower in GCEA #HEOR #biosky pmc.ncbi.nlm.nih.gov/articles/PMC...

Did not realize this. Alex Azar-Pence connection too potentially with Lilly HQ in Indianapolis

Nice to see more focus on the "lost" voice in the US access landscape. Arguably the most powerful group that is the least called on. Suspect $LLY $NVO can do it because of the cash boon but if successful perhaps we see more of it more broadly down the road

I'm re-upping this drug development "starter pack" of some Bluesky accounts organized by Greg Medlock—senior director of R&D at Cambridge, MA-based biotech Vedanta Biosciences. See below: #biosky

Nice to start seeing some #HEOR posts around here especially as #ISPOREurope kicks off

I wonder what GLP-1 patient vote breakdown was the election. “They’re counting on selling it to Americans because we’re so stupid and so addicted to drugs” -RFK on Ozempic www.cnn.com/2024/11/17/h...

Miss Tweetdeck? Try Deck.Blue - thar's the website to access it

One thing pharma understands very well as evidenced by the distinct functions of clinical science, TA clinical, stats. Another area where FDA deserves credit via its role in ensuring adequate trial design/ analysis plans at least when it comes to making approval decisions

Probably giving too much credit re strategy here, but it's possible Trump knows RFK won't get confirmed. Gives him an "out" on all the pharma and ACA stuff.

A perhaps overlooked cost of poorly designed clinical trials: Current trial participation is typically an exclusion criteria for enrollment onto other, perhaps better, clinical trials.

RFK to be nominated for HHS

Merck going to China for PD1xVEGF is interesting but not surprising. Another in the ongoing wave as the science has caught up with much better economics vs the US.

Nina Kjellson, Canaan Partners talking about how IRA has shifted big pharma view and pushed initial indication revenue expectation higher given IRA, making it harder to take the more traditional approach of starting in smaller maybe quicker indications and then expanding. Via Biopharma Dive Live

Interesting post by Ronny Gal on ex-US blockbusters. While they certainly exist, how many cos (aside from Novartis apparently) are thinking this way? And margins / FCF certainly lower in these markets. www.linkedin.com/posts/ronny-...

Why I believe human causal biology, rigorously applied, combined w good org structure/strong sci leadership/right size, can improve R&D PoS, eg $VRTX, $REGN. Also: emerging tech incl AI can/should/will contribute to next iteration of R&D elevation. In TR: timmermanreport.com/2024/10/yes-... #biosky

Well balanced piece on an issue that is still too black and white in commentary. One impact I think we'll see more of is same-class follow-on small molecules for future / earlier settings in oncology. Use the lead asset as part of POC to justify starting pivotal for follow on in earlier settings.

Glad to see some nice #biosky discussions lately. Place seems to be picking up and maybe even starting to feel like the good days of the other place

I do wonder how much this has to do with where big pharmas sit in major investors' portfolios - ie more stable, cash-generating side v growth portfolio. Would drug dev be better off if companies viewed more as growth vehicles a la Silicon Valley? Then again small bios fill that space in biopharma

Some insights and advice from consultants who participated in first round of IRA negotiations. Some nice actionable tidbits including potential role of comparative evidence and RWE in populations of interest : pink.citeline.com/PS155353/Per...

No surprise CBO does not expect GLP-1s to be cost-saving because it is highly unlikely; but important to remember this isn't an est of value, just a financial analysis which is CBO's job. Value includes improvement and extension of people's lives. www.cbo.gov/publication/...

Commercialization risk is very real and often underdiscussed outside investment circles imo including in general pharma pricing/value discussions #biosky

Evolving models for innovative drugs; on direct-to-consumer offerings by pharma #biosky open.substack.com/pub/refining...

Amazing patient perspective from John Carroll of Endpoints. Plenty of gaps remain in incentivizing development in high unmet need diseases endpts.com/after-i-was-...

Watching this I think Matt Gline would make a great elevator speech on "why doesn't pharma spend more on R&D / spend so much on marketing etc etc". Hope he gets more involved in the policy discussion side of things www.biotechtv.com/post/roivant...

ICYMI: Reference Collection to push back against “Common Statistical Myths (cc @f2harrell.bsky.social) discourse.datamethods.org/t/reference-...

Not sure I agree with this take. Who will forego the top/bottomline potential even if short-lived? Incentives would heavily prefer it over not and if anything these cases suggest maybe run up is smaller next time but more sustained (if market learns from the exp).

Sanofi's gap between avg US list and net prices was 19+ percentage points in 2023 - largest since before 2016. Also largest gap ever for insulins? #grosstonetbubble

Finally watched Breakthrough, the documentary about Jim Allison and the birth of IO. Highly recommend.

Recent HTA transparency rules could add to the PR crisis for the industry re difference in US v ex-US prices (likelihood of back-calculation/estimation of post-discount price higher, while post rebate price still relatively opaque in US)