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.
Highlights:
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]
Read more
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.
Highlights:
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]
Read less