Vivek Subbiah, MD, executive director of medical oncology research, MD Anderson Cancer Network, makes his triumphant return to the show to break down designing clinical trials for investigative therapies and the regulatory maze that follows before these therapies can find their way to the market. Dr. Subbiah begins by using precision medicine advances in lung cancer as a backdrop for the discussion on histology agnostic drug approvals. Then, he moves into the full regulatory flow map of how drugs make their way from phase I trials through FDA approval. The accelerated approval pathway, post-approval trials, synthetic control arms, off-label data, real-world data, and assessment bias are all discussion points given ample attention in this truly informative interview.
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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
