CUPA Working Group

Join us this Friday @ noon ET to talk about the ethics of intentionally infecting humans with pathogens Tinyurl.com/seema-k-shah Password: 2468

Reason shyly shows herself… yahoo.com/news/articles/…

This would be great reading for @DrMakaryFDA: Rare disease advocates fume over FDA’s mixed signals statnews.com/2026/02/26/rar… By @Jasonmmast

ICYMI: Wyoming stem cell bill is latest risky, anti-FDA state legislation ipscell.com/2026/02/wyomin… #stemcells #stemcell #FDA

Brendan Parent, JD, is visiting from NYU for his lecture, "Respecting and Learning from the Dead: Ethical Research Involving the Physiologically Maintained Deceased." Register here for lunch: events.ticketleap.com/tickets/maclea…

Important read for those in drug development, especially those siting #clinicaltrials. And OPEN ACCESS, so no excuse not to read 😊

Pharma CEOs should demand Prasad’s departure FDA’s CBER director is endangering patients, damaging FDA, and destabilizing drug companies — and Moderna’s flu vaccine won’t be his last target. Comment from @steveusdin1 biocentury.com/article/658404

A followup from @ZacharyBrennan on the fundamental breakdown going on at the FDA over the $MRNA decision. Regulatory chaos as the leadership at the FDA breaks with staff to enforce an anti-vaccine agenda is lethal for biotech. It's hard enough developing drugs without an anti-science political crusade interfering in the process. endpoints.news/prasad-overrul…

CMS’ new MAHA ELEVATE innovation model has a fundamental flaw––no definition of what is a "medicine", opening the door for quackery statnews.com/2026/01/16/cms… via @statnews

Controversial CDC hep B vaccine study in Guinea-Bissau may be canceled cidrap.umn.edu/childhood-vacc…

COMMENTARY: When confusion replaces clarity about vaccines, children pay the price cidrap.umn.edu/childhood-vacc…

Is ‘shared decision-making’ being hijacked by U.S. health officials to sow doubt about vaccines? statnews.com/2026/01/20/sha… via @statnews

“Who should pay for expanded access?” panel, Pamela Gavin (NORD), Andrew Lo (MIT Sloan), Sabrina Paganoni (Harvard Med School), David Scheer (Scheer & Co), moderated by Christopher Robertson (BU School of Law) #cupacon26

Preapproval Access to Pyschedelics panel moderated by ⁦@HollyLynchez⁩ #CUPACon26

The final #CUPACON26 session: “Is There a Role for Expanded Access in the New FDA?” @BioCentury’s @steveusdin1 moderates an expert panel made up of @realrickpazdur (former FDA), Thos Cochrane (Harvard Med School), & Jean Swidler (Genetic ALS & FTD)

Predictions of snowmageddon notwithstanding, #CUPACon26 carries on! Today started with workshops on preparing clinicians to navigate expanded access, embedding ethical principles in early access programs, & what’s special about expanded access for gene & cell therapies

Thx #CUPACon26 workshop facilitators (presenting & planning): @JinsyMd & Lisa Kearns from @nyulangone; Emma James from @EncodedTx; Catherine Lawrence from @bionicalemas; Christine MacCracken from @JNJNews; Carolyn Chapman from @MRCTCenter & @lindsaymcnairmd, Equipose Consulting