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ICCVAM/NICEATM/ECVAM
Scientific Workshop on Alternative Methods to Refine, Reduce and Replace the Mouse LD50 Assay For Botulinum Toxin Testing
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Agenda and Additional Meeting Materials Workshop Presentations Regulatory Information


Poster for November 2006 Scientific Workshop on Alternative Methods for Botulinum Toxin Testing
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Session #1: Overview of Public Health Needs for Botulinum Toxin Testing and Regulatory Requirements

Session #2: Current Understanding and Knowledge Gaps for Botulinum Toxin

Session #3: Potential Replacement of Animal Use for Botulinum Toxin Potency Testing

Session #4: Refinement (Less Pain and Distress) of Animal Use for Botulinum Toxin Potency Testing

Session #5: Reduction of Animal Use for In Vivo Botulinum Testing

Session #6: Wrap-up of Panel Discussions


Welcome and Introduction To Presentations
  • William Stokes, Director, NICEATM [PDF]
  • Len Schechtman, Chair, ICCVAM [PDF]
  • Marlies Halder, ECVAM [PDF]
Session #1: Overview of Public Health Needs for Botulinum Toxin Testing and Regulatory Requirements
Co-Chairs: Abby Jacobs and Jodie Kulpa-Eddy

Food Safety
  • Overview of Botulinum Toxin and the Incidence and Severity of Botulism [PDF]
    Susan Maslanka (Centers for Disease Control and Prevention, US)

  • Current Testing and Practices for Botulinum Prevention in Foods [PDF]
    Shashi Sharma (U.S. Food and Drug Administration, CFSAN)
Drug Safety
  • Medical Conditions Treated with Botulinum Toxin [PDF]
    Mark Hallett (National Institutes of Health, National Institute of Neurological Disorders and Stroke, US)

  • Current Potency Testing Requirements and Practices for Botulinum Toxin Products [PDF]
    Elizabeth Shores (U.S. Food and Drug Administration, CDER)
Vaccine Potency Testing
  • Current Testing Requirements and Practices for Botulinum Toxin for Vaccine Potency Testing [PDF]
    Jodie Kulpa-Eddy (U.S. Department of Agriculture)
Diagnostic Needs
  • Current Animal Diagnostic Testing Requirements and Practices for Botulinum Toxin Potency and Detection [PDF]
    Tonie Rocke (U.S. Geological Survey, National Wildlife Health Center)

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Session #2: Current Understanding and Knowledge Gaps for Botulinum Toxin
Co-Chairs: James Keller and Ram Ramabhadran
  • Overview of the Modes and Mechanisms of Action of Botulinum Toxin [PDF]
    Dirk Dressler (Rostock University, Germany)

    Note: Dr. Dressler's presentation has been edited for posting on this webpage. Some of the decorative graphics have been removed to reduce file size and facilitate viewing. No scientific content has been altered. If you would like to obtain a copy of the presentation as it was shown at the workshop, please contact Dr. Dressler.

  • Pharmacokinetics of Botulinum Toxin [PDF]
    Lance Simpson (Thomas Jefferson University, US)

  • Essential Characteristics of Potential Test Methods to Replace the Mouse LD50 for Botulinum Toxin Potency Testing [PDF]
    Eric Johnson (University of Wisconsin, US)

  • Overview of U.S. and European Research Initiatives on Botulinum Toxin
    Lillian Van De Verg (National Institutes of Health, National Institute of Allergy and Infectious Diseases, US) [PDF]
    Andreas Rummel (Medical School of Hannover, Germany) [PDF]

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Session #3: Potential Replacement of Animal Use for Botulinum Toxin Potency Testing
Co-Chairs: Susan Maslanka and Shashi Sharma

Potential Replacement: Endopeptidase Assays
  • Overview of Endopeptidase Assays [PDF]
    Dorothea Sesardic (National Institute for Biological Standards and Control, UK)
Potential Replacement: Cell-Based Assays
  • Overview of Cell-Based Assays [PDF]
    K. Roger Aoki (Allergan, Inc., US)

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Session #4: Refinement (Less Pain and Distress) of Animal Use for Botulinum Toxin Potency Testing
Co-Chairs: Elizabeth Shores, Leonard Smith, and William Stokes

Refinement: Using Ex Vivo Assays to Avoid Pain and Distress in Botulinum Testing
  • Mouse Phrenic Nerve-Hemidiaphragm Assay [PDF]
    Andreas Rummel (Medical School of Hannover, Germany)
Refinement: Alternative In Vivo Botulinum Assays that Do Not Require Death as an Endpoint
  • Mouse Hind Limb Assay [PDF]
    K. Roger Aoki (Allergan, Inc., US)

  • Mouse Abdominal Ptosis Assay [PDF]
    Dorothea Sesardic (National Institute for Biological Standards and Control, UK)
Refinement: Potential Use of Non-Lethal Endpoints in Botulinum LD50 Testing to Minimize Pain and Distress
  • Overview of the Physiological Progression of Botulism in Mice [PDF]
    Eric Johnson (University of Wisconsin, US)

  • Potential Behavioral and Pharmacological Endpoints Predictive of Mouse Lethality [PDF]
    Jerry Calver (Calver Biologics Consulting, Canada)

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Session #5: Reduction of Animal Use for In Vivo Botulinum Testing
Co-Chairs: Marlies Halder and Richard McFarland
  • Impact of Sample Size and Toxin Reference Standards on LD50 Results [PDF]
    Rose Gaines Das (National Institute for Biological Standards and Control, UK)

  • Proposed Testing Strategies that Would Reduce Animal Use in Botulinum Toxin Testing [PDF]
    Kenneth Clarke (Allergan, Inc., US)

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Session #6: Wrap-up of Panel Discussions
The presentations provided below are summaries of the panel discussions at the workshop. Additional information and details about the items noted in each of the presentations will be further discussed in an upcoming workshop report.
  • Summary of Session 2 Discussions: Knowledge Gaps and Research Needs [PDF]
    James Keller and Ram Ramabhadran

  • Summary of Session 3 Discussions: Replacement Alternatives [PDF]
    Susan Maslanka and Shashi Sharma

  • Summary of Session 4 Discussions: Refinement Alternatives [PDF]
    Elizabeth Shores, Leonard Smith and William Stokes

  • Summary of Session 5 Discussions: Reduction Alternatives [PDF]
    Marlies Halder and Richard McFarland
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