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Biopharmaceutical Advisory Board (BioAB)

The PDA Biopharmaceutical 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, the BioAB interacts with regulatory authorities by participating in the development of consensus responses to regulatory drafts and final guidances and directives.

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

PDA Biopharmaceutical Advisory Board Members

  • CHAIR
    John Geigert, Ph.D.
    President
    BioPharmaceutical Quality Solutions
  • VICE CHAIR
    Michael R. DeFelippis, Ph.D.
    Senior Research Fellow, Bioproduct R&D
    Eli Lilly and Company, Lilly Research Laboratories
  • IMMEDIATE PAST CHAIR
    Michael S. VanDerWerf
    Director, CMC Regulatory Affairs
    Teva Pharmaceuticals

Advisory Board Members

  • Vince Anicetti
    Executive Director of Quality 
    Coherus Biosciences
  • Michael Blackton 
    VP QA CMC
    Adaptimmune LLC
  • E.J. Brandreth
    Vice President, Quality
    Inovio Pharmaceuticals
  • Vijay Chiruvolu
    Senior Director, Product Sciences
    Kite Pharma
  • Rebecca A. Devine, Ph.D.
    Consultant
    Consultant to the Biopharmaceutical Industry
  • Earl S. Dye, Ph.D.
    Director, Technical Regulatory
    Genentech, Inc.
  • Laurie Graham, Ph.D. 
    Biologist, CDER, Division of Monoclonal Antibodies
    United States Food and Drug Administration
  • Olivia Henderson, Ph.D. 
    Principle Engineer
    BIOGEN
  • Christopher Hwang, Ph.D.
    Senior Dir., Commercial Cell Culture Development
    Sanofi
  • Kathryn E. King, Ph.D. 
    Biologist, CDER, Division of Monoclonal Antibodies
    United States Food and Drug Administration
  • Stephan Krause, Ph.D.
    Associate Director QA/QC/Validation
    MedImmune LLC
  • Morten Munk
    Sr. Technology Partner, Global Business Development
    NNE Pharmaplan
  • Nadine Ritter, Ph.D. 
    President and Analytical Advisor
    Global Biotech Experts, LLC
  • Jens Schletter, Ph.D.
    Head Regulatory CMC Group Biopharmaceuticals
    Sandoz
  • Yoshinori Suzuki
    Global Business Development Division
    Three S Japan Co., Ltd.
  • Rodney E. Thompson, Ph.D.
    President
  • Karen Walker
    VP, Global Quality Head, Cell and Gene Therapy
    Novartis
    BioPharm Process Associates
  • Earl Zablackis
    Director-Principal Scientist 
    Sanofi
  • Wendy Zwolenski-Lambert
    Divisional Validation Leader, Global MS&T 
    Novartis

PDA Staff Liaison

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

PDA Global Headquarters