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All-In Interview: FDA Commissioner Dr. Marty Makary david friedberg sits down with Dr. Marty Makary for a comprehensive convo on his overhaul of the FDA: -- Safely accelerating clinical trials -- US vs China in biotech -- Fixing the Food Pyramid -- Rethinking vaccines with common sense -- Cutting...

152,456 views • 7 months ago •via X (Twitter)

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NEW episode! Drug development has never been more expensive, in terms of output per dollar spent. This trend, called Eroom’s law, is surprising, considering the incredible technological advances in drug discovery, from genome sequencing to engineering to microscopy. On a new episode of the Works in Progress podcast, Ben Southwood and I talk to Ruxandra Teslo 🧬 about why this has happened and what can be done about it. We discuss how: • AI isn’t a magic bullet for drug discovery. Predictive models lack the physical human data, like individual variation and rare side effects, that can only be generated by actually running real-world clinical trials. • As scientists invent more effective drugs, it becomes harder to discover new treatments that can surpass past successes. This is known as the "Better than the Beatles" problem. • Biotech companies are increasingly moving their "first-in-human" trials to Australia because its simpler regulations allow researchers to test drug safety faster and cheaper than in the US. • Clinical trials can be made more efficient with various reforms including: embracing platform trials, allowing researchers to select from independent ethics boards, expanding the funding and validation of surrogate endpoints, increasing transparency by releasing regulatory correspondence from failed companies, and much more. Timestamps: 00:00:00 Eroom’s law and the paradox of drug development 00:08:03 How clinical trials actually work 00:10:23 The power and controversy of surrogate endpoints 00:14:01 How historical patent laws influenced trial timelines 00:22:46 The Australia advantage and regulatory drag 00:29:08 Institutional review boards (IRBs) and bureaucratic drag 00:32:21 Open science and successful reforms 00:41:49 Our wishlist for clinical trial reforms, and which reforms we *don’t* like 00:53:48 Why AI isn’t a magic bullet for drug discovery

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109,256 views • 4 months ago

🚨 JUST IN: President Trump has nominated Dr. Heidi Overton to be the next FDA Commissioner Dr. Overton stood next to President Trump in the Oval Office just days ago, CELEBRATING Trump’s order reworking the childhood vaccine schedule TRUMP: "Today I am honored to nominate the wonderful Dr. Heidi Overton, MD, PhD, as our next FDA Commissioner. Dr. Heidi has been a ROCKSTAR in my Administration, where she has worked directly with Secretary Kennedy, Dr. Oz, and team, to deliver on the MOST TRANSFORMATIVE Health Agenda in History. She is known to take on the HARDEST issues, and bring me solutions that work best for the Country. Heidi is “ALWAYS RIGHT,” Secretary Kennedy recently said in the Oval Office! We need her leadership at the FDA now to ensure that the U.S. remains the WORLD LEADER for Scientific Discovery and CURES. Dr. Overton was a prestigious White House Fellow in my First Term, is a Board-Certified Physician in Public Health and General Preventive Medicine, and holds a Ph.D. in Clinical Investigations from the Johns Hopkins University. She is SMART and RESPECTED by all! Dr. Heidi will work with Secretary Kennedy and Dr. Oz to RAPIDLY deliver on my priorities of FASTER Cures, INCREASED American Innovation, MAJOR Clinical Trial Reforms, LOWER Drug Prices, and even more MAHA WINS! Dr. Overton will continue putting AMERICA FIRST, and creating a HEALTHY AMERICA. Congratulations to Dr. Heidi Overton! President DONALD J. TRUMP"

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28,607 views • 9 days ago