September 19 - 21 , 2012

International Workshop on Alternative Methods for Leptospira Vaccine Potency Testing: State of the Science and the Way Forward Final Documents

September 19 - 21 , 2012

• Workshop Proceedings (Biologicals)
• Workshop Summary

Federal Register Notices

September 19 - 21 , 2012

International Workshop on Alternative Methods for Leptospira Vaccine Potency Testing: State of the Science and the Way Forward Meeting Materials

September 19 - 21 , 2012

• Breakout Group Questions
• Poster Session Abstracts
  • Alt DP, et al. Evaluation of Ocular Exposure to Leptospira borgpetersenii Serovar Hardjo in the Golden Syrian Hamster
  • Wilson-Welder J, Alt DP. Evaluation of Bovine Neutrophil Activation by Leptospira

International Workshop on Alternative Methods for Leptospira Vaccine Potency Testing: State of the Science and the Way Forward Presentations

September 19 - 21 , 2012

Opening Session

Welcoming Remarks and Introduction to ICATM Organizations
William Stokes, DVM, RADM, USPHS, NIEHS/NICEATM
Workshop Overview and Objectives
Richard McFarland, PhD, MD, Center for Biologics Evaluation and Research, U.S. FDA
View presentation 

Welcome and Introduction to CVB 
Richard Hill, DVM, MS, Center for Veterinary Biologics, USDA

Session 1: Overview of Public Health Needs, Regulatory Requirements, and Research Initiatives for Leptospira Vaccine Potency Testing

• Leptospirosis: Public Health Perspectives
  Marta A. Guerra, MPH, DVM, PhD, Bacterial Special Pathogens Branch, CDC
• Leptospirosis: Animal Health Perspectives
  Ronald D. Schultz, MS, PhD, University of Wisconsin–Madison, USA
• USDA Regulatory Guidelines and Practices for Veterinary Leptospira Vaccine Potency Testing
  Geetha B. Srinivas, DVM, PhD, Center for Veterinary Biologics, USDA
• European Regulatory Framework and Practices for Veterinary Leptospira Vaccine Potency Testing
  Lukas Bruckner, DVM, Institute of Virology and Immunoprophylaxis, Switzerland
• Next-Generation Human Leptospira Vaccines
  Albert Ko, MD, Yale School of Public Health, USA
• Current NIH Research in Human Leptospira Vaccines
  Joseph J. Breen, PhD, Bacteriology and Mycology Branch, National Institute of Allergy and Infectious Diseases, NIH, USA

Session 2: In Vitro Replacement Alternatives for Potency Testing of Leptospira Vaccines: Development, Validation, and Implementation

• Development of In Vitro Assays for Measuring Relative Potencies of Leptospiral Bacterins Containing Serovars Pomona, Canicola, Grippotyphosa, and Icterohaemorrhagiae
  Kevin W. Ruby, MS, PhD, Center for Veterinary Biologics, USDA
• Validation of Monovalent Leptospira Reference Bacterins for In Vitro Potency Testing: Host Efficacy Trials
  Carole Bolin, DVM, PhD, College of Veterinary Medicine, Michigan State University, USA
• Product-Specific Validation of an In Vitro Assay for Leptospira Potency Testing: An Industry Perspective (1)
  Brett Webster, Boehringer Ingelheim Vetmedica, USA
• Product-Specific Validation of an In Vitro Assay for Leptospira Potency Testing: An Industry Perspective (2)
  Jeffrey Galvin, PhD, Pfizer Animal Health, USA
• Development of Leptospira In Vitro Potency Assays: EU/Industry Experience and Perspectives
  Eric Klaasen, DVM, PhD, MSD Animal Health, The Netherlands
• Expansion of the In Vitro Assay for Leptospira Potency Testing to Other Serovars: Case Study with Leptospira Hardjo
  David P. Alt, DVM, PhD, Infectious Bacterial Diseases Research Unit, ARS, USDA

Session 3: Reduction and Refinement Alternatives for Potency Testing of Leptospira Vaccines: Development, Validation, and Implementation

• Development and Validation of a Serological Potency Test for the Release of Leptospira Vaccines in the European Union
  Elisabeth Balks, DVM, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Germany
• Product-Specific Validation of a Serological Potency Test for Release of Leptospira Vaccines in the European Union
  Catrina Stirling, PhD, Pfizer Animal Health, United Kingdom
• Opportunities and Strategies to Further Reduce Animal Use for Leptospira Vaccine Potency Testing
  Angela Walker, DVM, PhD, Center for Veterinary Biologics, USDA
• Opportunities and Strategies to Further Refine Animal Use for Leptospira Vaccine Potency Testing
  Elsio A. Wunder, Jr., DVM, PhD, Yale School of Public Health, USA
  Karen K. Brown, PhD, Pair O’Docs Consultants, USA