8th Annual Immunogenicity for Biotherapeutics
Agenda Day Two
Thursday, May 10, 2007
| 8:15 |
Chairperson's Recap of Day One Holly W. Smith, Research Scientist, Biomolecular Interactions |
| 8:30 |
Case study # 24 Cledwyn L Davies, PhD, Qualified Person, Manager, Product Quality & Regulatory Affairs, Health Protection Agency |
| 9:00 |
Case study # 25 For more information on speaking opportunities, please contact Andrew Sinetar, Sponsorships Manager, at (800) 345-8016, ext. 3246 or email: asinetar@iirusa.com. |
| 9:30 |
Overcoming Obstacles in Outsourcing Immunogenicity Studies
Moderator:
Panelists: |
| 10:15 | 30-minute Morning Networking Break |
|
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PRECLINICAL |
| 10:45 | Case study # 26 Real-life Challenges in the Development of Immunogenicity assays and discuss approaches to address these successfully to derive meaningful results from the Clinical/Pre-clinical Studies Lakshmi Amaravadi, PhD, Principal Scientist, Clinical Science & Technology |
| 11:15 |
Case study # 27 Harald Kropshofer, PhD, Head & Global Coordinator, Immunosafety of Biotherapeutics |
| 11:45 |
OPEN SESSION For more information on speaking opportunities, please contact Andrew Sinetar, Sponsorships Manager, at (800) 345-8016, ext. 3246 or email: asinetar@iirusa.com. |
| 12:15 | Networking Luncheon |
| 1:15 |
Preclinical Strategies for Immunogenic Biotherapeutics Holly W. Smith, Research Scientist, Biomolecular Interactions Lakshmi Amaravadi, PhD, Principal Scientist, Clinical Science & Technology Thi Mignone, Associate Director |
| 1:45 |
Case study # 28 Ingrid Caras, PhD, Senior Director, Pre-clinical and Clinical Development Sciences |
| 2:15 |
Case study # 29 & 30 New Phase 3 Data Bin Zhao, Scientist II, BioAnalytical Research & Development Joleen White, PhD, Scientist II, BioAnalytical Sciences |
| 2:45 |
Case study # 31 Linda Zuckerman, PhD, Director, PreClinical Development |
| 3:15 |
Conference Concludes |
| 3:30 - 5:00 | T cell dependent immunity "White Paper" group meeting
Open meeting - All conference participants are invited to attend. Methods for Pre-Screening and Reengineering Protein Therapeutics for Potential Immunogenicity: Review of Available Tools and Techniques, and Development of a Standard for Comparison Organizers: Annie De Groot (Brown University and EpiVax) and the TCWP Group* This is one of a series of four scheduled open "consensus building" meetings between experts and drug developers whose goal is to formulate a white paper on the role of cellular immunity in the development of anti-drug antibodies to biologics. Methods for predicting and confirming T cell immunogenicity (in silico, in vitro and in vivo) will be compared and contrasted. New theories about immunogenicity and standards for the determination of immunogenicity will be discussed. An attempt will be made to clarify "what is known" about the contribution of cellular immune response to protein therapeutics and 'what is not known" including such topics as the role of T regulatory cells and cytotoxic T cells. An outline of the proposed discussion will be distributed to interested participants in advance upon request (AnnieD@EpiVax.com). * David W. Scott, Ph.D., Gene Koren, Ph.D., Geoff Hale Ph.D., C, Andrew Glasebrook, Ph.D., Eric Wakshull, Ph.D., Herman Waldmann, Ph.D., Matthew Baker, Ph.D., Harald Kropshofer, Ph.D., Steve Swanson Ph.D., William W Kwok, PhD. and others. For more information Contact: Annie De Groot at AnnieD@EpiVax.com |
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