9th Annual Immunogenicity for Biotherapeutics
Agenda Day One
Tuesday, May 20, 2008
| 7:15 | Conference Registration and Morning Coffee | |
| 8:00 | Chairpersons Welcome and Opening Remarks Shalini Gupta, PhD, Director, Clinical Immunology, AMGEN | |
CURRENT REGULATORY LANDSCAPE | ||
| 8:15 | Panel Discussion Regulatory and White Paper Updates Panelists: Shalini Gupta, PhD, Director, Clinical Immunology, AMGEN Holly W. Smith, Research Scientist, Biomolecular Interactions, ELI LILLY & COMPANY | |
| 9:15 | Panel Discussion New EMEA Guidance: Harmonization of FDA and EMEA Guidelines Panelists: Philippe Stas, Chief Executive Officer, ALGONOMICS | |
ASSAY DEVELOPMENT AND VALIDATION (NAbs) | ||
| 9:45 | Technical Challenges and Regulatory Expectations for Assessing Immunogenicity to a Biotherapeutic Mimetic
Daniel Baltrukonis, Scientist, PFIZER | |
| 10:15 | 30-minute Morning Networking Break | |
| 10:45 |
Pankaj Oberoi, PhD, Director, Scientific Services, MESO SCALE DISCOVERY | |
| 11:15 | The Development and Validation of a Bridging ECL Assay to Detect Antibodies to an Endogenous Protein Therapy
Robin Marsden, Research Associate, AMYLIN PHARMACEUTICALS | |
| 11:45 | General Assay Development and Validation of NAb Assays
Shalini Gupta, PhD, Director, Clinical Immunology, AMGEN | |
| 12:15 | Networking Luncheon | |
| 1:30 | Quantification of Neutralizing Antibodies to Type I Interferons Using A Novel Cell-Based Assay
Michael Tovey, Chief Scientific Officer, NEUTEKBIO | |
| 2:00 | Development and Validation of a NAb Cell Based Assay
Michaela Lerner, MS, Senior Manager, Clinical Science & Technology, BIOGEN IDEC | |
| 2:30 | Neutralizing Antibody Assay Comparisons for ATA Characterization
Kelly Loyet, Associate Scientist, Assay & Automation Technology Department, GENENTECH | |
| 3:00 | 30-Minute Networking Break | |
| 3:30 | Reducing Immunogenicity for Enzyme Replacement Therapy Candidate
Bin Zhao, Scientist, Bioanalytical Sciences, BIOMARIN | |
EXTENDED PANEL DISCUSSION | ||
| 4:00 | Panel Discussion Assay Development and Validation Troubleshooting Session, Ask the Experts! Moderator: Panelists: Mary Saltarelli, Section Manager, Drug Analysis, ABBOTT LAB Darshana Jani, Senior Associate Scientist, BIOGEN IDEC | |
| 5:15 | Day One Concludes | |
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