Biotech Advisory Board (BioAB)

The PDA Biotechnology Advisory Board (BioAB) establishes the strategic direction and provides oversight for PDA's biopharmaceutical scientific and technical activities through the development of guidelines, technical reports, and technical bulletins and recommendations of other activities such as conferences or training courses.

Through its sister Advisory Boards, RAQAB and SAB, interacts with regulatory authorities by participating in the development of consensus responses to regulatory draft and final guidance and directives.

For more information about the PDA Biotechnology Advisory Board contact Josh Eaton, Senior Project Manager, S&RA Department at PDA.

PDA Biotechnology Advisory Board Members

CHAIR
E.J. Brandreth
Vice President, Quality and Regulatory Affairs
Althea Technologies

VICE CHAIR
Barbara J. Potts, Ph.D.
Principal Consultant
Potts and Nelson Consultants, LLC

PDA Regulatory Affairs/Quality Advisory Board Liason (RAQAB)

Wendy Zwolenski-Lambert
Divisional Validation Leader, Global MS&T
Novartis

Advisory Board Members

Vince Anicetti
Executive Director of Quality
Boehringer-Ingelheim

Jeffrey C. Baker, Ph.D.
Deputy Director, Office of Biotechnology Products
United States Food and Drug Administration

Michael R. DeFelippis, Ph.D.
Senior Research Fellow, Bioproduct R&D
Eli Lilly and Company, Lilly Research Laboratories

Rebecca A. Devine, Ph.D.
Consultant
Consultant to the Biopharmaceutical Industry

Earl S. Dye, Ph.D.
Director, Technical Regulatory
Genentech, Inc.

John Geigert, Ph.D.
President
BioPharmaceutical Quality Solutions

Frank Hallinan, Ph.D.
Consultant
Consultant to the Biopharmaceutical Industry

Kathryn E. King, Ph.D.
Biologist, CDER, Division of Monoclonal Antibodies
United States Food and Drug Administration

Steven Mendivil
Executive Director, Corporate Quality Company
Amgen

Robert Sitrin
Merck

Rodney E. Thompson, Ph.D.
President
BioPharm Process Associates

Michael E. Wiebe, Ph.D.
President
Quantum Consulting, LLC

Michael S. VanDerWerf
Director - Regulatory CMC
Shire Regenerative Medicine

Hannelore Willkommen, Ph.D.
President
RBS Consulting

PDA Staff Liaison

Joshua E. Eaton
Senior Project Manager,
Scientific & Regulatory Affairs

PDA Global Headquarters

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