Chadi welcomes back Bishal Gyawali, MD, PhD, Queen’s University Cancer Research Institute (Canada), to the show to discuss the history of the FDA’s accelerated approval regulatory pathway, how it is sometimes abused, how low-level surrogate endpoints are being used for approval, what happens (and what should happen) when confirmatory trials do not confirm clinical benefit for drugs approved through this pathway, how conflicts of interest may impact some regulatory decisions, and so much more. Dr. Gyawali raises some thought-provoking questions and critical points in this deep, nuanced discussion.
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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
