Science and Regulatory Affairs

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 Iris Rice, Manager, S&RA Department at PDA.

PDA Biotechnology Advisory Board Members

CHAIR
Mr. 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 and Quality Control Liaison

Mr. Michael S. VanDerWerf
Associate Director, US Regulatory Affairs, Vaccines
GlaxoSmithKline Biologicals

Advisory Board Members

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

Stephen W. Brown, Ph.D.
Manager, CTO BioManufacturing
Vivalis

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

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

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

Frank Hallinan, Ph.D.
Senior Director, Quality Strategy
Pfizer

Mr. Norbert Hentschel
Director, Technical QA and Compliance

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

Annemarie Möritz, Ph.D.
Quality Expert
Novartis Pharma AG, Werk, Klybeck

Mr. Søren Theusen Pedersen
Director, External Affairs
Novo Nordisk A/S

Robert Sitrin, Ph.D.
Executive Director, VMSC-Bioanalytics
Merck & Company, Inc.

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

Mrs. Gail Sofer
Director, Regulatory Compliance
Sofeware Associates

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

Hannelore Willkommen, Ph.D.
Directorate
RBS Consulting

Ms. Wendy Zwolenski-Lambert
Director, Pharma Business Support
Abbott Laboratories
PDA Staff Liaison

Mr. Vince R. Anicetti
Fellow, Scientific and Regulatory Affairs
Genentech, Inc.

Mr. James C. Lyda
Senior Regulatory Advisor, Scientific & Regulatory Affairs
PDA Global Headquarters

Ms. Iris D. Rice
Manager, Scientific & Regulatory Affairs

 

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