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Steve Berman
Vice President, Science and Regulatory Affairs Strategy
Biotechnology Innovation Organization (BIO)
Steve Berman serves as VP of Science and Regulatory Affairs for the Biotechnology Innovation Organization (BIO). Steve joined BIO after serving as a Director, Translational Regulatory Affairs, at AstraZeneca. Steve joined AZ after eight years at FDA, working in both CDER and OC. He began his federal service focusing on regulatory operations, including the stand-up of the Oncology Center of Excellence and the creation and adoption of the 21st Century Cures Workplan, and concluded his time at FDA focused on speeding new therapies to market through drug development tool qualification. Prior to joining FDA, Steve held a leadership role in Medical Affairs at Sucampo Pharmaceuticals.
Sessions
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24-Jun-202629ABWhat We Can Expect from PDUFA VIII
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