O’Shaughnessy named acting chief scientist at FDA

Jacqueline O’Shaughnessy has been named acting chief scientist at FDA. She was previously deputy director of the Office of the Chef Scientist. O’Shaughnessy joined the agency in 1996 as a pharmacologist in the Center for Drug Evaluation and Research’s former Division of Scientific Investigations, Office of Compliance. The position is of critical importance to the COVID-19 pandemic response because FDA’s Chief Scientist has authority over the agency’s Office of Counterterrorism and Emerging Threats and is responsible for emergency use authorizations. O’Shaughnessy replaced Denise Hinton, who has been named deputy surgeon general.

Gillian Woollett has joined biosimilars developer Samsung Bioepis Co. Ltd. as VP, head of regulatory strategy and policy for Samsung Bioepis U.S. Prior to joining Samsung, Woollett was SVP at Avalere Health, a consulting company. Her previous positions include VP for scientific and regulatory affairs at BIO and associate VP for biologics & biotechnology at Pharmaceutical Research and Manufacturers of America (PhRMA). In a guest commentary published in BioCentury, Woollett argued that success of the U.S. biosimilars market is essential for securing the future of personalized medicine worldwide...