Making his return to the show is the United States current FDA Commissioner Dr. Robert Califf, this time to break down and offer insights into the Administration’s contentious accelerated approval pathway. Dr. Califf expands on the criticisms and concerns surrounding surrogate endpoints and confirmatory trials within the accelerated approval process, shedding light on the ongoing dialogue between the Administration and manufacturers regarding these crucial trials.
He navigates through the intricacies of the Food and Drug Omnibus Reform Act, offering perspectives on the global use of drugs and devices post-negative results in confirmatory trials. Dr.. Califf also emphasizes the imperative need for a revamped post-market evidence generation system while exploring various avenues for achieving this critical transformation.
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Dr. Simrit Parmar, founder of Cellenkos, joins the show to discuss her journey from the lab to the biotech startup world, detailing the inspiration behind launching her company, the challenges of securing funding, and the resilience required to overcome rejections. She shares insights into Cellenkos’ lead product, its progress toward market approval, and the rigorous
Carol Rausch—a healthcare professional, cancer researcher, and former patient with lymphoma—shares how her journey from researcher to patient transformed her understanding of medical language. She discusses the impact of word choice on patients, why certain battle and war metaphors can be harmful, and how language used in clinical settings differs from what resonates with those
Drs. David Braun and Toni Choueiri join to discuss a groundbreaking Nature study on a personalized neoantigen vaccine for adjuvant renal cell carcinoma. They explore the inspiration behind the trial, how the vaccine was developed and administered, and its safety profile. The conversation also covers patient outcomes after 3-4 years, including immune responses and disease
