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Session Information
2007 BIO International Convention
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Monoclonal Antibody Safety-Assessment Issues
Track : Drug Discovery and Development
Program Code: DDD080
Date: Wednesday, May 9, 2007
Time: 4:00 PM to 5:30 PM  
Location: 259 AB
CHAIR :
James Green, PhD, Senior Vice President, Biogen Idec, Inc.
SPEAKER (S):
Dr. Christopher Horvath, DVM, MS, Senior Director, Toxicology, Archemix, Inc.
Jennifer Sims, PhD, Director, AstraZeneca, Inc.
Shawn M Heidel, MD, DVM, Department Head, Eli Lilly and Company
Jeanine L Bussiere, PhD, DABT, Executive Director Preclinical, Amgen, Inc.
Laura Andrews, PhD, Vice President, Genzyme Corporation
George Treacy, Vice President, Centocor R&D
Garvin Warner, PhD, Senior Director, Wyeth Research
Description
This session will review current approaches and unique issues that should be considered in the design of biopharmaceutical safety assessment programs. An expert scientific panel will illustrate key points with examples and case studies.



Objectives:
  • Review key components of preclinical safety evaluation programs for biologics.

  • Discuss adequacy of ICH S6 and whether or not "maintenance" or "revision" is required.

  • Discuss impact of TGN1412 incident on preclinical development programs.

    • Streaming Audio with
    PowerPoint Slides
    (Code: DDD080)
      
    This session is a part of:
    Drug Discovery and Development 2-DAY TRACK
    Complete Set of BIO Online / CD-ROM - All 23 Tracks.