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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, United States
Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching... Read More →

avatar for Richard Forshee

Richard Forshee

Associate Director for Analytics and Benefit-Risk Assessment, CBER, FDA, United States
Richard Forshee is the Acting Deputy Office Director 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... 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... 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, OTAT, CBER, FDA, United States
Zuben E. Sauna is a Principal Investigator and also a CMC Reviewer at the US Food and Drug Administration. His research interests lie in understanding the pharmacogenetic basis of the immune response to proteins used in therapeutic interventions as these affect efficacy and safety... Read More →

Tuesday June 28, 2016 2:00pm - 3:15pm EDT
203AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 18: Global Regulatory, Forum