Recurring guest Mikkael A. Sekeres, MD, Professor of Medicine and Chief of the Division of Hematology, Sylvester Comprehensive Cancer Center, is today’s guest of honor to discuss and spotlight his just-published book: Drugs and the FDA: Safety, Efficacy, and the Public’s Trust. Dr. Sekeres begins by sharing an anecdote of his experience on the FDA Oncologic Drugs Advisory Committee (ODAC) for Avastin as an inspiration to write the book. Then, he delves into the detailed process of becoming an ODAC member and how conflicts of interest are handled in the screening process, how personal experience bias (rather than data) may influence ODAC members to vote to approve a drug, financial compensation allotted to ODAC members, and how ODAC members balance science with humanity when considering drugs for approval. The conversation ends with a commentary on the good and bad of DTC advertising, the future of clinical trial phasing and designing, and a few other interesting discussion points.
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
