8th Annual Immunogenicity for Biotherapeutics

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Home»Events»8th Annual Immunogenicity...Event Overview»Agenda Day One

8th Annual Immunogenicity for Biotherapeutics

May 08 - 10, 2007 | Hilton San Diego Mission Valley, San Diego, CA

Agenda Day One

Wednesday, May 9, 2007

7:30	Conference Registration and Morning Coffee
8:00	Chairperson's Welcome and Opening Remarks Review the history of Immunogenicity studies to understand the evolution of the industry. Eugen Koren, MD, PhD, Director, Bioanalytical Development SCIOS, A JOHNSON & JOHNSON COMPANY
	INDUSTRY EXPERIENCE & REGULATORY RECOMMENDATIONS FOR ASSAY DEVELOPMENT & VALIDATION
8:15	Case study # 12 Understand Immunogenicity Assessment of Protein Therapeutics Michael Moxness, PhD, DABCC Principal Scientist Clinical Immunology AMGEN
8:45	Case study #13 Technology challenges and risk-based analysis of immunogenicity assessment for new biologic development Patrick Liu, MD, PhD, Director of Bioanalytical Sciences TANOX
9:15	Case study # 14 New Data Generated From The Qualification And Validation Of Two New Assays Thi Mignone, Associate Director HUMAN GENOME SCIENCES
9:45	Morning Networking Break
10:15	Case study # 15 Development and Validation of Drug Tolerant Immunogenicity ECLIA for Therapeutic Antibody Gennady Samokhin, Gerry Kolaitis and Surendra Bansal HOFFMANN-LA ROCHE
10:45	Case study # 16 Case Study: Development And Validation Of Membrane Based Delphia Assay For Determination Of Blocking Antibodies To Fusion Protein X In Human Serum Darshana Jani, Senior Associate Scientist, Research & Development BIOGEN IDEC
11:15	Expert Panel Immunoassay Validation White Paper-Hot off the Presses! Susan Kirshner, PhD, Laboratory of Immunology, Office Therapeutic Proteins FDA Confirmed Holly W. Smith, Research Scientist, Biomolecular Interactions ELI LILLY AND COMPANY Eugen Koren, MD, PhD, Director, Bioanalytical Development SCIOS , A JOHNSON & JOHNSON COMPANY Shalini Gupta, PhD, Director, Clinical Immunology AMGEN Ago B. Ahene, Associate Director, Drug Metabolism and Pharmacokinetics ROCHE
12:00	Networking Luncheon
1:00	Case study # 17 Compare and Contrast White Paper Screening Cut Point Calculations Martin Kane, MS, CRE, Senior Manager, Process Statistics HUMAN GENOME SCIENCES
1:30	Case study # 18 Long-Term Maintenance Of A Calibrator Curve Immunogenicity Assay Used To Support Clinical Trials Michael L. Fox Senior Supervisor, Bioanalytical Assays GENENTECH
2:00	Case study # 19 Designing and Validating an Immunodepletion Assay to Characterize an Immunogenic Response to an Antibody Drug Conjugate Angela Gieber, Senior Research Associate, GENENTECH
2:30	Case study # 20 Use Of A Novel Statistical Approach For Confirmatory Assays Lauri Neyer, PhD, Staff Scientist, Pre-Clinical and Clinical Development Sciences PDL BIOPHARMA
3:00	30- Minute Networking Break
	NEUTRALIZING ASSAYS
3:30	Considerations for the Design and Validation of Neutralizing Antibody Assays Focus on the 2007 White Paper Shalini Gupta, PhD, Director, Clinical Immunology AMGEN
4:00	Case study # 21 A Unique "Interference" Observed Using A Soluble Receptor In A PK And Competitive Binding Nab Assay to a Monoclonal Antibody Deborah Finco-Kent, Scientist PFIZER
4:30	Case study # 22 Comparison Of Neutralizing Antibody Assays For Receptor Binding And Activity of The Enzyme Replacement Therapeutic Naglazyme Erik Foehr, PhD, Associate Director, Pharmacology and Toxicology BIOMARIN PHARMACEUTICALS
5:00	Case study # 23 Case Study: IFN-b Reporter Gene Neutralizing Antibody Assay Michaela Lerner, MS, Senior Manager, Clinical Science & Technology BIOGEN IDEC
5:30	Day One Concludes
5:30 - 7:00	Please Join Us For Reception Hosted by BioVeris