November 8-10, 2021 | Virtual Conference

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SPEAKERS

Donald Ashley, JD

Director
Office of Compliance (OC), CDER, FDA

Lisa Bercu, JD

Regulatory Counsel, Division of Policy Development (DPD), OGDP, OGD, CDER
FDA

John Brooks, JD

Partner
South Capitol

Sally Choe, PhD

Director
Office of Generic Drugs (OGD), CDER, FDA

Jacqueline Corrigan-Curay, JD, M.D.

Principal Deputy Center Director
Center for Drug Evaluation and Research (CDER), FDA

Gerald Dal Pan, M.D., MHS

Director
Office of Surveillance and Epidemiology (OSE), CDER, FDA

LCDR David Eng, PharmD

Team Leader, Division of Project Management, ORO, OGD, CDER
FDA

Robert Dorsam, PhD

Director, Division of Pharm Tox Review, Office of Safety & Clinical Evaluation, OGD, CDER
FDA

Dhaval Gaglani, MS

Branch Chief, Division of Immediate and Modified Release Products III, Office of Lifecycle Drug Products, OPQ, CDER
FDA

Sarah Ibrahim, PhD

Associate Director for Global Regulatory Affairs, Immediate Office, OGD, CDER
FDA

Michael Kopcha, PhD, RPh

Director
Office of Pharmaceutical Quality (OPQ), CDER, FDA

Darby Kozak, PhD

Deputy Director, Division of Therapeutic Performance I, Office of Research and Standards (ORS), OGD, CDER
FDA

Dan Leonard

President and Chief Executive Officer
AAM

Robert Lionberger, PhD

Director, ORS, OGD, CDER
FDA

Markham Luke, M.D., PhD

Director
DTP, ORS, OGD, CDER, FDA

Elizabeth Miller, PharmD

Assistant Commissioner for Medical Products and Tobacco Operations
Office of Regulatory Affairs (ORA), FDA

Thomas O’Connor, PhD

Division Director, Division of Product Quality Research, Office of Testing and Research, OPQ, CDER
FDA

Ronald Piervincenzi, PhD

Chief Executive Officer
United States Pharmacopeia

Andre Raw, PhD

Senior Science and Policy Advisor, Office of Lifecycle Drug Products, OPQ, CDER
FDA

Eva Temkin, JD

Partner, FDA and Life Sciences
King & Spalding LLP

Eric Tichy, PharmD, MBA

Vice Chair, Pharmacy Supply Solutions
Mayo Clinic

Rachel Turow, J.D.

Associate General Counsel, Regulatory Law & Policy
Teva Pharmaceuticals

Daniela Verthelyi, M.D., PhD

Chief, Laboratory of Immunology, Division of Biotechnology Review and Research III, Office of Biotechnology Products (OBP), OPQ, CDER
FDA

Janet Woodcock, M.D.

Acting Commissioner
FDA

Sarah Yim, M.D.

Director
Office of Therapeutic Biologics and Biosimilars, CDER’s Office of New Drugs (OND), FDA

Lei Zhang, PhD

Deputy Director, ORS, OGD, CDER
FDA

Liang Zhao, PhD

Director, Division of Quantitative Methods & Modeling, ORS, OGD, CDER
FDA
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