CUPA Working Group
@CUPAethics
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We advance research, policy, and education regarding the ethical issues surrounding access to investigational medical products.
New York, NY
Joined October 2020
The combo of diminished staff capacity and immense pressure to use new, but unvalidated, AI tools to replace it “could jeopardize FDA’s gold standard review process, leaving ... further uncertainty about whether FDA-approved drugs work & are effective." https://t.co/yr09MpjFN5
insights.citeline.com
Merck, Lilly, and Johnson & Johnson are some of the pharma companies who have snagged the many staff leaving the FDA’s oncology positions. The Pink Sheet estimates CDER’s oncology division is...
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Today! I’m looking forward to:
Tomorrow, Fri 11/21/25–the final day of PGTME’s annual lecture series-is dedicated to a topic we normally don’t talk about, the economics of gene & cell therapies. MIT professor @AndrewWLo is an engaging speaker who’s thought deeply about the cost of developing new drugs
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Halfway through the week! Tomorrow’s (11/19/25) gene therapy topic is “Communication, Data Sharing, & Reporting”; free registration; submit ?s. Hear from Rachel McMinn (Neurogene), Erin Ward (MTM-CNM Family Connection), Cara Weismann (Orphan Disease Center, UPenn), & Tim Cripe MD
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Tomorrow, Wed, Nov 19, noon-1:15 PM. Free! Register at
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Tomorrow!
Moderated by @steveusdin1; happening Tues 11/18/25. Free! Registration & info at https://t.co/97M1r2mQiZ
#rare #regulation #FDA #geneTherapy #clinicalTrials
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Tomorrow! Featuring @marilynbb_ @lijohnson2000 @isaacfoundation & more. You can still register for free to participate live or submit questions in advance
What are some of the basic ethical concepts & dilemmas concerning gene therapy? How do bioethicists think about them? Come see behind the curtain & ask questions Mon 11/17/25! Free! Register & get more info: https://t.co/97M1r2mQiZ
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#FDA Approves New Safety Warning & Revised Indication that Limits Use for Elevidys Following Reports of Fatal Liver Injury
content.govdelivery.com
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#FDA Approves New Safety Warning & Revised Indication that Limits Use for Elevidys Following Reports of Fatal Liver Injury
content.govdelivery.com
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NHGRI is hiring a new Director, and we’re helping spread the word across the ELSI community. This leadership role oversees NHGRI’s scientific vision, research portfolio, and its long-standing commitment to ELSI. Due Nov 21, 2025 & More info:
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What are some of the basic ethical concepts & dilemmas concerning gene therapy? How do bioethicists think about them? Come see behind the curtain & ask questions Mon 11/17/25! Free! Register & get more info: https://t.co/97M1r2mQiZ
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Featuring Eli Lilly & Company's Peter Marks (former head of the FDA's CBER); Colin Werth (president of the Parent Project Muscular Dystrophy Adult Advisory Committee); and me, and moderated by Steve Usdin, Washington Editor for BioCentury
Moderated by @steveusdin1; happening Tues 11/18/25. Free! Registration & info at https://t.co/97M1r2mQiZ
#rare #regulation #FDA #geneTherapy #clinicalTrials
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Featuring: Emma James, vice president of clinical & medical affairs & head of medical office, Encoded Therapeutics @Johnlantos bioethicist & primary care pediatrician, New York City Rafael Escandon, principal & founder of DGBI Clinical Research & Ethics Consulting (moderator)
11/20/25 Free! Join a moderated dialogue about which ethical principles should be followed (& from whose perspective) during development of genomic medicines. Discussants, drawing on their experience as bioethicists & drug developers, reflect on tensions between theory & practice
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Featuring @AndrewWLo!
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James Watson, dead at 97, was a scientific legend and a pariah among his peers
statnews.com
James Watson, the co-discoverer of the structure of DNA who died Thursday at 97, was a scientific legend and a pariah among his peers.
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Here is how the search for top drug regulator is going: FDA deputy commissioner Sara Brenner sent an email to CDER staff today soliciting applications to lead the center. More here: https://t.co/n2beEMwLRJ
statnews.com
George Tidmarsh left the agency amid accusations of misusing his authority and after clashing with another top official.
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Save the Dates! Register! Share! Whet your appetite by viewing archived sessions: https://t.co/qCPAEhHv3s
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Baby KJ researchers publish FDA interactions/shortcuts as agency eyes new pathway -
endpoints.news
FDA plans to share details on
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I've heard for years that patients/advocates hate the term "false hope". I didn't write this; take it up with the Post. "This mom has 3 children with autism. She’s spent thousands on ‘false hope.’"
washingtonpost.com
With three autistic children, a Michigan mother has been lured into spending thousands on unproven and sometimes risky treatments to ease their symptoms.
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As one agency staffer told me: "In the current FDA environment, it is impossible for dedicated career FDA staff to responsibly regulate new products, conduct groundbreaking research, and manage FDA's resources on behalf of the American public. The situation is not salvageable."
The FDA is a mess. That's probably the nicest way to describe the current, dysfunctional state of a vital regulatory agency. Exhibit 1: Our exclusive reporting tonight on the fall of CDER Director George Tidmarsh Exhibit 2: @LizzyLaw_ exclusive reporting from Friday on a
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