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For complete information, including full descriptions of the following sessions, please download the conference brochure.
| 8:30 | Registration and Morning Coffee |
| 9:00 |
Chairperson's Opening Remarks: History and Importance of Immunogenicity Studies
Steven Swanson, PhD, Senior Director, AMGEN
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REGULATORY
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| 9:15 |
Review of Upcoming Recommendations White Paper
Statistical Recommendations on Immunogenicity Method Performance Characteristics
Viswanath Devanarayan, PhD, Associate Director, Experimental Medicine & Biometrics, MERCK & COMPANY
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| 9:45 |
REGULATORY PANEL DISCUSSION
Review and Clarification of Neutralizing Assay White Paper
PANELISTS:
Shalini Gupta, PhD, Associate Director Clinical Immunology, AMGEN
Viswanath Devanarayan, PhD, Associate Director, Experimental Medicine & Biometrics, MERCK & COMPANY
Harald Kropshofer, PhD, Global Coordinator Immunosafety, F. HOFFMANN LA ROCHE SWITZERLAND
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| 10:30 | 30-Minute Morning Break |
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TROUBLESHOOTING ASSAY DEVELOPMENT
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| 11:00 |
Development and Validation of a Drug Tolerant ELISA for Determination of Antibodies to a Human Therapeutic Antibody
Holly Smith, Immunogenicity Group, ELI LILLY AND COMPANY
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| 11:30 |
Techniques to Improve Immunoassay Tolerance to Interfering Substances
Michael Moxness, PhD, DABCC, Principal Scientist, AMGEN
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| 12:15 | Networking Luncheon |
| 1:30 |
Approaches for Pre-Clinical Immunogenicity Risk Assessment: Can We Improve Things for Future Generations?
Theresa J. Goletz, PhD, Principal Research Scientist, Biopharmaceutical Research, CENTOCOR R&D INC.
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| 2:00 |
Clinical Immunogenicity Assay Development and Validation for Therapeutic Antibody/Protein
Larry Lo, Senior Scientist, HUMAN GENOME SCIENCES
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| 2:30 |
Development and Validation of Immunogenicity Assays for A PEGylated Peptide
Peter Schatz, PhD, Senior Director of Biology, AFFYMAX
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| 3:00 |
30- Minute Networking Break
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| 3:30 |
Panel Discussion
Assay Development and Troubleshooting Session
Deborah Finco-Kent, Immunoassay Coordinator, Immunotoxicology Lab, Safety Sciences, PFIZER
An Song, PhD, Senior Scientist, GENENTECH
Holly Smith, Immunogenicity Group, ELI LILLY AND COMPANY
Shalini Gupta, PhD, Associate Director Clinical Immunology, AMGEN
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| 4:00 |
Standardizing Statistics
Applying Statistics to a Confirmatory Assay: Statistical Approach to Setting A Cutpoint For Confirming Positivity
Ingrid W. Caras, PhD, Senior Director, Bioanalytical and Development Sciences, PROTEIN DESIGN LABS
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| 4:30 | TBD GENENCOR |
| 5:00 |
Day One Concludes
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| 5:00 |
Wine and Cheese Reception Hosted by Meso Scale Discovery
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