Hello GCTP Community,
Attached are the minutes from our April Leadership meeting. The Bioanalytical & Biomarker, Clinical Pharm/ADME and CMC subteams also meet monthly. We invite you to get more involved - whether you're interested in short-term collaborations like open scientific discussions, white papers, journal articles, workshop and programming proposals, or if you're looking for a long-term commitment by joining a subteam or a leadership position, we would love to hear from you! Reach out to @Yan Ni to explore the opportunities available and get to know your fellow Community members.
NEWS ALERT Our next virtual Open Scientific Discussion (OSD) is now May 2, 2024, 12 pm – 1 pm EDT.
https://meet.goto.com/505947717
Secondary malignancies post-CART cell therapy: Clinical and Regulatory Perspectives
· Are you aware of the recent FDA requirement of class wide boxed warning on all commercial CAR-T therapies?
· What do we know and not know about second malignancies?
· What's your experience in secondary malignancies and CART cell therapy?
Panelists:
Bruce Levine (Professor, Univ. PENN)
Nicole Verdun (Super Office Director, FDA, CBER)
GCTP Leadership
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Allison Radwick Ph.D.
Sr Regulatory & Policy Comms Mgr
USP
East Fallowfield PA
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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