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New FDA SaMD Guidance Will Bring Monumental Changes to Industry


A discussion of the impact the new FDA SaMD guidance, identifying the differences between companion apps and SaMD, and what to expect from this combination in the future.

David Klein, co founder and CEO of Click Therapeutics, discusses the new FDA SaMD guidance, the clear differences between companion apps and SaMD, and gives insight into what to expect from this combination in the future.

About the speaker

David Benshoof Klein is a healthcare investor and entrepreneur with over 20 years of life science industry experience. Before co-founding Click Therapeutics, David was the former Managing Director at Opus Point Partners which created, financed, and operated 10+ science companies including Cougar Biotechnology (Acquired by J&J), Chelsea Therapeutics (Acquired by Lundbeck), TG Therapeutics (TGTX), Assembly Biosciences (ASMB), Tracon Pharmaceuticals (TCON), Fortress Biotech (FBIO), and Alaunos Therapeutics (TCRT).

David is also a guest faculty member at the Biotechnology Program at Columbia University, NYU Stern School of Business, and Columbia Business School.

In 2012, Mr. Klein co-founded Click Therapeutics, which develops and commercializes software as prescription medical treatments. Mr. Klein holds a bachelor’s degree from Brandeis University, and was recognized by Goldman Sachs in 2019 as one of the 100 most intriguing entrepreneurs at its annual Builders and Innovators conference. A native New Yorker, Mr. Klein is an avid art enthusiast and is co-founder of Eli Klein Gallery, America’s leading Chinese contemporary art gallery.

About the Pharm Exec Podcast

The editors of Pharmaceutical Executivebring you the latest commercial insights to master the science of success. Podcast episodes examine current trends, key conferences, and critical topics in the bio/pharmaceutical industry.

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