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
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
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
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
“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
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
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)