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, MD, JD, is Senior Vice President ande Head of Global Regulatory Affairs and Clinical Safety, consisting of the global regulatory, safety and CMC functions of Merck Research Laboratories. In addition to serving on the board of directors and past president of the D...
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Director, Office of Strategic Programs, CDER, FDA
Dr. Theresa Mullin plays a lead role in a number of CDER’s strategic initiatives including the human drugs international program, drug user fee negotiation and implementation, regulatory informatics, and major program evaluations and other initiatives. She is currently serving...
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Vice President and Head, US Regulatory Policy, Bayer
Kim Quaintance-Lunn serves as the Vice President and Head, US Regulatory Policy at Bayer. She works with colleagues to analyze regulatory policy and advocate for changes in the regulatory environment, serves on global and US Regulatory Leadership teams, and assists in the develop...
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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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