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System Reboot Needed! FDA Approval Process

Show Floor, Sky Stage
October 9, 2023
Bill Geary
Flare Capital Partners
Dr. Amy Abernethy
Dr. Scott Gottlieb
New Enterprise Associates (NEA)
Susan Coller Monarez, Ph.D.
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The panel, including former FDA commissioner Scott Gottlieb, touched upon various aspects of healthcare including the use of AI, regulatory policy, medical supplies, and the challenges of the medical therapeutic supply chain. The discussion highlighted that the use of AI in healthcare is essential but its full potential hasn't been fully utilized, largely due to outdated regulatory frameworks. The panel suggested that the FDA need to create regulatory frameworks appropriate for AI. This includes ensuring transparency in AI tools and data sets used to train AI models. The discussion also advocated for greater collaboration between the industry and regulators to define the parameters for data sets that can reliably train large AI models. The speakers further addressed the issue of drug shortages, attributing it to the unattractive nature of the drug manufacturing sector due to lack of investment and older manufacturing facilities. The panel agreed that the only long-term solution would be to adjust the reimbursement process under Medicare.

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