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Tuesday, June 28 • 2:00pm - 3:15pm
#254: CBER Town Hall: State of the Center and Plans for the Future

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Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-595-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will provide an overview of CBER's current work on ongoing initiatives and will summarize its priorities moving forward. This forum will consist of five brief presentations followed by a question and answer session with the speakers.

Learning Objectives

Identify regulatory work recently completed or in progress and communicate Center priorities for the coming years.


Peter W. Marks


Zuben Sauna, PhD

Victor Lu, PhD

Sara Gagneten, PhD

Richard Forshee, PhD

avatar for Peter Marks

Peter Marks

Director, Center for Biologics Evaluation and Research, FDA
Served as Clinical Director of Hematology at Brigham and Women's Hospital, worked in the pharmaceutical industry on the clinical development of hematology and oncology products, led the Adult Leukemia Service and served as Chief Clinical Officer of Smilow Cancer Hospital. He joined the FDA in 2012 and became Center Director in 2016. Dr. Marks is board certified in internal medicine, hematology and medical oncology, and is a Fellow of the American... Read More →


Richard Forshee

Associate Director for Research, Office of Biostatistics and Epidemiology, CBER, FDA
Richard Forshee is the Associate Director for Research for the Office of Biostatistics and Epidemiology in the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration. He works on a wide range of issues related to the risks and benefits of blood and blood products, vaccines, and human cell and tissue products. Before joining the FDA, he was the Director of the Center for Food, Nutrition, and Agriculture Policy at the... Read More →
avatar for Sara Gagneten

Sara Gagneten

Associate Div Director, Policy, Office of Vaccines Research and Review, CBER, FDA
Dr. Gagneten completed her graduate studies at the Uniformed Services University for the Health Sciences (USUHS) in Maryland and conducted research in virology and genetic recombination before joining the Office of Vaccines Research and Review (OVRR) at CBER, FDA. Currently she is the Associate Division Director for Policy in the Division of Viral Products. She has extensive experience in the regulatory aspects of vaccine development and... Read More →
avatar for Victor Lu

Victor Lu

Biologist, Office of Cellular, Tissue and Gene Therapies, CBER, FDA
avatar for Zuben Sauna

Zuben Sauna

Principal Investigator, Office of Blood Research and Review, CBER, FDA

Tuesday June 28, 2016 2:00pm - 3:15pm
203AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA