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Parenteral Drug Association Connecting People, Science and Regulation ®

Science Advisory Board (SAB)

The Science Advisory Board (SAB) is composed of a diverse group of experts drawn from industry, regulatory agencies and academia who provide guidance and set strategic direction for the Parenteral Drug Association (PDA) on technical topics associated with pharmaceutical manufacturing and quality. The SAB guides and supports the development of Technical Reports, Points for Consideration documents, and PDA Journal and PDA Letter articles published by the Association. It further supports the creation and ongoing activities of a range of Interest Groups where members review, discuss and advance industry understanding of numerous technical and quality topics. It contributes to PDA’s educational mission through support of the Training and Research Institute (TRI), assisting with the development of curricula and the identification of instructors. The SAB works closely with the other Advisory Boards (e.g. RAQAB and BioAB) on matters which benefit from the overlapping expertise of these groups such as, when providing a response to proposed regulations and guidance.

For more information about the PDA Science Advisory Board, contact the chair or Janie Miller at [email protected].

PDA Science Advisory Board Members

    Maik W. Jornitz
    G-Con Manufacturing, Inc.
    Phil DeSantis
    Principal Consultant DeSantis Consulting Associates
    Joyce Bloomfield

Advisory Board Members

  • Masahiro Akimoto
    General Manager, Compliance Division Toray Industries
  • John Ayres, MD
    Senior Director Product Safety Assessments
  • Ed Balkovic, Ph.D.
    Microbiologist, Contamination Control Lead
  • Greg Basset
    Executive Director Quality Site Head
    Amgen (EU)
  • Scott Bozzone, Ph.D.
  • Jette Christensen
    Aseptic Scientific Director
    Novo Nordisk A/S
  • Phil DeSantis
    Principal Consultant
    DeSantis Consulting Associates
  • Don Elinski
    Principal Consultant
    Lachman Consultant Services
  • Guenther Gapp
    Consultant, Gapp Quality GmbH
  • Gabriele Gori
    Head of Global Audit and Risk Management, Quality Vaccines | GSK Vaccines
  • Dennis Guilfoyle
    Senior Director, Regulatory Compliance, Johnson & Johnson
  • Ghada Haddad
    Director, Engineering Sterile & Validation CoE
  • Norbert Hentschel
    Director Global Technical QA 
    Boehringer-Ingelheim Pharma GmbH & Co KG
  • Ken Hinds, Ph.D
    Scientific Director, Drug Product Development, Janssen Pharmaceutical Companies of Johnson and Johnson
  • William Miele
    Director Quality Systems and Compliance, Pfizer
  • Rainer Newman
    Independent Expert & Consultant
    Aseptic Process Technology, LLC (APT)
  • Mike Sadowski
    Director Sterile Manufacture Support
    Baxter Healthcare
  • Siegfried Schmitt, Ph.D.
    Principal Consultant
    PAREXEL Consulting (UK)
  • Marsha Stabler-Hardiman
    Senior Consultant
    Concordia Valsource
  • Edward Tidswell, Ph.D.
    Research Director 
  • Wend Zwolnski Lambert
    Global Technology Transfer Lead, Biologics Technical Development and Manufacturing, Novartis AG

PDA Staff Liaisons

Jahanvi (Janie) Miller
Senior Project Manager, Scientific & Regulatory Affairs
PDA Global Headquarters