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Craig B. Bleifer

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Craig is a seasoned healthcare executive, previously serving as general counsel for two major pharmaceutical companies, Novo Nordisk and Daiichi Sankyo. With over 30 years as a corporate and life sciences lawyer, he provides counsel on legal, compliance, policy, and regulatory issues related to healthcare products and businesses. He provides strategic advice based on his practical real-world experiences, spanning discovery to commercialization.

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On Jan. 14, 2026, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) jointly released the “Guiding Principles of Good AI Practice in Drug Development,” a set of 10 high-level principles intended to steer the safe and responsible use of AI across the product lifecycle. While not formal industry guidance, the…