CDER’s Patrick Frey Leaving for Amgen

Office of New Drugs (OND) chief of staff Patrick Frey is leaving the agency 8/24 to join Amgen as Global Regulatory Policy and R&D director. Frey joined the agency in 2008 as an operations research analyst in CDER’s former Office of Planning and Analysis. In 2015, he was detailed to OND to focus on the office’s operational needs. At CDER, Frey played a “critical role in advancing the New Drugs Regulatory Program, including his deep involvement in the user fee reauthorizations,” CDER director Janet Woodcock says in an email to staff. “Most recently, Patrick made significant contributions to our modernization effort of the New Drugs Regulatory Program, particularly with his leadership in designing a new project management structure in OND. Once fully implemented, this new structure, properly matrixed with our scientific review staff, will ensure more consistent processes and approaches to our regulatory work.”