Determining Release and Throughout-Dating Potency
Specifications: A US Regulatory Policy Workshop

April 21-22, 2015
Ames, Iowa USA

Presentations

Introductory Session

  • Welcome
    • Jim Roth, IICAB (PDF)
  • Introduction to the Workshop
    • Byron Rippke, Director, USDA Center for Veterinary Biologics
  • Overview of Potency Testing Policy Development
    • Dave Siev, USDA Center for Veterinary Biologics
  • Historical Perspective on Regulation of Potency of USDA Regulated Vaccines
    • Dave Dusek, USDA Center for Veterinary Biologics
    • Hans Draayer, EDGE Veterinary Vaccines Consulting Group (PDF)

Issue 1: Product Efficacy and Potency

  • Minimum Protective Dose: How it is Established and What it Indicates
    • Dave Siev, USDA Center for Veterinary Biologics
    • Tom Evans, Zoetis (PDF)

Issue 2: Determining Potency Requirements for Release and Throughout-Dating

  • Potency Specifications for Serial Release and Throughout Dating
    • Monica Reising, USDA Center for Veterinary Biologics
    • Richard Williams, Merial (PDF)
  • Pharmaceutical Shelf-Life Determination – Findings of the PQRI Stability ShelfLife Working Group
    • James Schwenke, Applied Research Consultants (PDF of handout)
  • Minimum Potency Throughout Dating and Lot Release Practices of Other Agencies/Countries
    • Human Vaccines
      • Philip Krause, FDA Center for Biologics Evaluation and Research (PDF)
    • Veterinary Vaccines in European Union (EU) Examples of EU stability assessments and definitions of release and end of shelf-life specifications
      • Jacques Léchenet, International Federation for Animal Health Europe (PDF)

Issue 3: Policy Considerations for Different Product Types

  • Product-Specific Considerations, e.g. Viral Vaccines (live, killed, vectored), Bacterins, Bacterial Extracts, Toxoids
    • Dave Dusek, USDA Center for Veterinary Biologics
    • Mark Zylstra, Boehringer Ingelheim Vetmedica, Inc. (PDF)

Issue 4: Points to Consider When Determining Release and Throughout-Dating Potency Specification

  • Implications of Potency Specifications at Product Release and Through Dating
    • Scott Taylor, USDA Center for Veterinary Biologics
    • Kent McClure, Animal Health Institute (PDF)
  • Assessing and Balancing Risks in the Formulation and Dating Period of Vaccines
    • Francisco Zagmutt, EpiX Analytics (PDF)
  • Veterinary Immunology Insights
    • Christopher Chase, South Dakota State University (PDF)

Issue 5: Views from Users of Veterinary Vaccines

  • Round table discussion including stakeholders of different species groups:
    Performance expectations / prioritization regarding veterinary vaccines (purity, safety, efficacy, availability, affordability, etc.) - 10 minute presentations:
    • Swine, Scott Dee, Pipestone Veterinary Clinic (PDF)
    • Bovine, Kenny Brock, Auburn University
    • Aquaculture, David Starling, Iowa State University (PDF)
    • Companion animals, George Moore, Purdue University (PDF)
    • Equine, Laurel Gershwin, University of California-Davis (PDF)
    • Avian, Steve Roney, University of Georgia (PDF)