CUPA Working Group

We advance research, policy, and education regarding the ethical issues surrounding access to investigational medical products.

[Dr. Alison Bateman-House @ABatemanHouse]

Join us this Friday @ noon ET to talk about the ethics of intentionally infecting humans with pathogens
https://t.co/UytFYK42jn
Password: 2468

[CUPA Working Group @CUPAethics]

Reason shyly shows herself… https://t.co/rzYO3IDxmL

[Dr. Alison Bateman-House @ABatemanHouse]

https://t.co/NaJjxorMNw

[Matthew Herper @matthewherper]

This would be great reading for @DrMakaryFDA:

Rare disease advocates fume over FDA’s mixed signals https://t.co/lh7JfuFPNC

By @Jasonmmast

[Paul Knoepfler @pknoepfler]

ICYMI: Wyoming stem cell bill is latest risky, anti-FDA state legislation https://t.co/AVSyw2VQHU #stemcells #stemcell #FDA

[The MacLean Center @MacLeanEthics]

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: https://t.co/IWs43GGLxm

[Dr. Alison Bateman-House @ABatemanHouse]

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

[steve usdin @steveusdin1]

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 https://t.co/nqH8dr2Gxf

[John Carroll @JohnCendpts]

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.
https://t.co/q6Qm3IjiSv

[Dr. Alison Bateman-House @ABatemanHouse]

CMS’ new MAHA ELEVATE innovation model has a fundamental flaw––no definition of what is a "medicine", opening the door for quackery https://t.co/oVSizL1fOp via @statnews

[Dr. Alison Bateman-House @ABatemanHouse]

Controversial CDC hep B vaccine study in Guinea-Bissau may be canceled https://t.co/oLfsT3vXta

[Dr. Alison Bateman-House @ABatemanHouse]

https://t.co/dwYTUW5ML4

[Dr. Alison Bateman-House @ABatemanHouse]

COMMENTARY: When confusion replaces clarity about vaccines, children pay the price https://t.co/PyJmGiDNMm

[Dr. Alison Bateman-House @ABatemanHouse]

Is ‘shared decision-making’ being hijacked by U.S. health officials to sow doubt about vaccines? https://t.co/nlA4jmuUGV via @statnews

[Dr. Alison Bateman-House @ABatemanHouse]

“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

[Dr. Alison Bateman-House @ABatemanHouse]

Preapproval Access to Pyschedelics panel moderated by ⁦@HollyLynchez⁩ #CUPACon26

[CUPA Working Group @CUPAethics]

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)

[CUPA Working Group @CUPAethics]

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

[Dr. Alison Bateman-House @ABatemanHouse]

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

[CUPA Working Group @CUPAethics]

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)