Executive Director, US Regulatory Policy & Global Intelligence
Pfizer
Andrew J. Emmett is Pfizer's FDA Liaison and Executive Director for U.S. Regulatory Policy & Global Intelligence. In his role, Andrew develops and advocates for Pfizer policy positions to enhance the regulatory environment for biomedical innovation. Andrew leads key initiatives on real-world evidence, clinical trial modernization, expedited pathways, FDA user fee legislation, and other areas of regulatory reform. He serves as the primary point-of-contact between Pfizer and FDA on regulatory policy issues and aligns support with trade associations and FDA stakeholder groups in the Washington, D.C. area. Andrew also oversees Pfizer's FDA liaison office in Silver Spring, Maryland and provides strategic counsel to Pfizer drug development teams when meeting with FDA.
Prior to Pfizer, Andrew spent thirteen years with the Biotechnology Industry Organization (BIO) where he served as Managing Director for Science & Regulatory Affairs. Andrew led BIO’s engagement in the 2007 and 2012 reauthorizations of the Prescription Drug User Fee Act (PDUFA) and related FDA modernization legislation. As head of Scientific & Regulatory Affairs for BIO, he coordinated BIO activities regarding drug/biologic R&D, pharmacovigilance and benefit-risk management, regulatory science, pediatrics, manufacturing, biosimilars, anti-counterfeiting, health information technology, and FDA funding.
He attended Cornell University and holds a Master’s of Public Health in healthcare policy from George Washington University.
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Thursday, June 6, 2024
10:45 AM – 11:45 AM EDT