The federal agency known as the FDA, or the Food and Drug Administration, was born over 100 years ago—at the turn of the industrial revolution, in a time of enormous upheaval and change, and rapidly emerging technology. The same could be said to be just as true today. From CRISPR to synthetic biology to using artificial intelligence in medicine, our healthcare system is undergoing massive amounts of innovation and change.
Covering everything from gene-editing your dog to tracking the next foodborne outbreak, this wide-ranging conversation between Principal Commissioner of the FDA Amy Abernethy and Vijay Pande, GP on the Bio Fund at a16z, discusses how the agency is evolving to keep pace with the scientific breakthroughs coming, while staying true to its core mission of assessing safety and effectiveness for consumers in the world of food and medicine.
What the FDA looks like today and the key steps of the FDA process to getting a drug/product to market [2:20]
How to manage a culture when mitigating risk is a top priority while aiming to innovate for the future [5:22]
Creative problem-solving in times of crisis, such as the Opioid crisis [9:58]
Preparing for and preventing drug shortages at scale [13:30]
How advances in bioengineering are transforming healthcare [16:00]
How the FDA is thinking about n=1 therapies and its applications in the future [18:54]
The future of healthcare privacy [26:10]
The ways the clinical trial process are shifting [29:26]
Innovations in Bioengineering as they relate to regulating food in the future [36:02]
How the FDA handles foodborne illnesses and its plans to innovate food safety [39:12]
Discussion about the next 100 years of the FDA [41:25]