Jennifer Hinkel

Strategic foresight @NASA, evidence-based health DPhil @UniofOxford, biotech AI, skipper @ResilienceRace 🎿🎹🎻🎾🏌🏼‍♀️⛵️

[Jennifer Hinkel @Oncotastic]

As a member of the Sausalito Yacht Club, I am here to take your questions. You're welcome.

[Scott Gottlieb, MD 🇺🇸 @ScottGottliebMD]

My editorial in JAMA Forum: To support the academic research enterprise, we should pursue regulatory reforms that enable institutions to advance more of their discoveries to patients and, in doing so, capture more of the economic value of innovations they achieve. Link in 🧵

[David Dayen @ddayen]

There isn't a bigger nonconformist pursuit than skateboarding. Yet even it has succumbed to private equity, destroying leading brands & structures that kept the scene thriving & local. I look at a new report on this cursed financialization: https://t.co/ULlSkyVBEV

[STAT @statnews]

The FDA has agreed to speed up a review of a rare disease drug developed by Stealth BioTherapeutics, a notable step after the company said it may have to close… https://t.co/BBo4QgBQ2k

[Tatiana Prowell, MD @tmprowell]

#MedTwitter #OncTwitter #regulatory

📢 NEW #FDA Draft Guidance on Overall Survival in #Oncology #ClinicalTrials, covering trial design, #biostats considerations, posthoc & subgroup analyses, &
more. Public comment period open now thru 10/20/2025.

https://t.co/AynF6t23o4

[Nathan A. Pennell MD, PhD, FASCO @n8pennell]

After 17 years at the Cleveland Clinic, I’m starting today as Senior Vice President and Worldwide Head of Hematology Oncology Medical Affairs at Bristol-Myers Squibb. I’m deeply grateful to my colleagues and patients at the Clinic for my experiences there. In my new role, I aim to help bring life-changing drugs to more people affected by cancer worldwide.

[Ruxandra Teslo 🧬 @RuxandraTeslo]

Good article in @WSJ. Why does everyone hate pharma companies? They are literally the most "useful" companies, yet continously vilified. It boggles the mind.

https://t.co/3iO80tbg0v

[Lan @ad0rnai]

we don't talk enough about ski gap relationships

[John Carroll @JohnCendpts]

And just like that, Vinay Prasad is back at the helm of CBER. From the convos I've been having, it's safe to say that no one in biotech understands which end is up at the FDA. The agency included a swipe at "the fake news" in making the announcement. But a simple chronology of events underscores the turmoil at the agency. One exec I talked with in recent weeks likened clinical research these days to traveling a dirt road, with a drunk, gun waving sheriff in charge. Can you imagine what it's like working at the FDA now? Amateurs and antagonists. Absurd.
https://t.co/L68A55XKbz

[UCLA Jonsson Comprehensive Cancer Center @UCLAHealthJCCC]

After being diagnosed with metastatic breast cancer at 34, Elissa Kalver turned hardship into action by creating the first cancer gift registry to support patients in need. With care from @MarlaLipsycMD, she is redefining what it means to thrive.

https://t.co/cKDapzpbVt

[Jennifer Hinkel @Oncotastic]

@AppleHelix I do not believe this article is an accurate representation of events.

[Jing Liang 🇺🇦 @AppleHelix]

FDA INDs being delayed.

[Jing Liang 🇺🇦 @AppleHelix]

In all seriousness, if FDA is going to streamline clinical trials to compete against China, Vinay Prasad would not be the right person to develop the new framework.

[BiotechObserver @BiotechObserver]

From the people who fumed "Marks is so evil for going against his staff!!! "
Cue up the articles criticizing Vinay for this... that will never, ever happen.

[BiotechObserver @BiotechObserver]

The whole idea of this statement is so nuts & shows what a lunatic Vinay Prasad is. Deciding a priori it should NEVER go back on the market? What kind of irresponsible, tyrannical statement is that from a drug regulator? $SRPT
@VPrasadMDMPH

[Gully Foyle @bluejaunt100]

@BiotechObserver @VPrasadMDMPH I’m not a fan of $SRPT, but let’s call out BS here. This is an FDA and HHS telling us to allow chelation, autologous stem cells for longevity, that corn and cane sugars are different- all on the basis of anecdotes. And Prasad is afraid to debate anyone, just blocks them.

[Jennifer Hinkel @Oncotastic]

@BagelC47 @BlaseBio However I think it isn’t right for FDA to drop this at the finish line when previously not voicing concerns about the study design. Moving goalposts after the game has been played.

[Jennifer Hinkel @Oncotastic]

@BagelC47 @BlaseBio Hard to separate tx effect of RP1 from ICI if given in combo w no comparator, & some of study pop were BRAF+ but didn’t get BRAF/MEK inhib first or had not necessarily failed ICI tx. Odd choices on study design and population.

[Jennifer Hinkel @Oncotastic]

@streamtailvents Agree & we will continue to see sing. arm approvals in future despite Prasad skepticism. In RP1 case, (1) pts had not all received SoC (eg BRAF)/weren’t necessarily refrac to ICI alone &,(2) how to separate RP1 tx effect in ICI combo from ICI effect alone with no comparison arm?

[Jing Liang 🇺🇦 @AppleHelix]

Bertrand raises a very good point.

Can one build a large European biotech without US investors?

Argenx and Ablynx come to mind. But they still had some US investors in the syndicate(s)