Chief of Staff, Office of New Drugs, CDER, FDA
Patrick Frey is the Chief of Staff in CDER's Office of New Drugs. He has played leadership roles in the reauthorization of PDUFA V and VI as well as BSUFA II. He was also the CDER lead in developing and implementing CDER's structured framework for benefit-risk assessment. Patrick...
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Senior Vice President, Head of Global Regulatory Affairs and Clinical Safety, Merck Research Laboratories
Sandra Milligan serves as senior vice president and head of Global Regulatory Affairs and Clinical Safety at Merck. She is a graduate of George Washington University School of Medicine and Georgetown University Law Center. Sandy served on DIA’s board from 2011 to 2017, served on...
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Associate Director for Strategic Initiatives, OCD, CDER, FDA
Principal advisor on strategy including CDER international cooperation and harmonization, application of decision science, and other initiatives. Leads FDA Patient Focused Drug Development, and heads the FDA delegation to ICH. Previous work includes leading FDA negotiations for 2002...
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Vice President and Head, Regulatory Policy, North American Regulatory Affairs, Bayer
Kim Quaintance-Lunn serves as Vice President and Head, Regulatory Policy, North American Regulatory Affairs, at Bayer. Kim joined Bayer in February 2014 to establish and lead the US regulatory policy function for the organization. She works with colleagues to analyze regulatory policy...
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Deputy Vice President, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)
Dr. Vereshchagina is a Deputy Vice President at the Pharmaceutical Research and Manufacturers of America or PhRMA. She leads the Regulatory Advocacy team with the focus on the Prescription Drug User Fee Act (PDUFA), the Biosimilar User Fee Act (BsUFA), as well as other regulatory...
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