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Agenda At A Glance
Untitled Document
| WORKSHOPS • MONDAY, APRIL 26, 2010 | |
| Morning Workshop: Immunogenicity Assessment – Screening and Confirmatory Assays |
|
| 8:00 | Workshop Registration & Morning Coffee |
| 9:00 | Workshop Begins |
| 10:15 | 30-Minute Networking Break |
| 12:15 | Luncheon for Workshop Attendees and Presenters |
| Morning Workshop Leaders Holly W. Smith, Senior Research Scientist, Biomolecular Interactions, ELI LILLY AND COMPANY Robin Marsden, Associate Scientist, AMBRX |
|
| Afternoon Workshop: Bioassays and Cut-Point Determination |
|
| 1:30 | Workshop Begins |
| 3:00 | 30-Minute Networking Break |
| 5:15 | Workshop Concludes |
| Afternoon Workshop Leaders Yao Zhuang, Principal Scientist, AMGEN |
|
| MAIN CONFERENCE: DAY 1 • TUESDAY, APRIL 27, 2010 | |
| 7:15 | Conference Registration and Morning Coffee |
| 8:30 | Chairperson’s Welcome and Opening Remarks Review the history of Immunogenicity studies to understand the evolution of the industry. Michel Awwad, PhD, Director, PFIZER |
| Current Regulatory Landscape | |
| 8:45 | Interactive Review of Regulatory Guidelines and Industry White Papers Panelists: Holly W. Smith, Senior Research Scientist, Biomolecular Interactions, ELI LILLY AND COMPANY Eric Wakshull, PhD, Senior Scientist/Group Leader, Bioanalytical Research & Development Dept, GENENTECH |
| 9:45 | Development of non-neutralizing ADA Associated with Dosing Reactions, Complement Activation and Immune Complex-Mediated Renal Failure Christopher Horvath, DVM MS, DACVP, Vice President, PreClinical Sciences, TALIGEN THERAPEuTICS |
| 10:30 | 30-Minute Morning Networking Break |
| 11:00 | Strategies for the Development and Characterization of Multiplexed Bioassays Laure Moller, PhD, Field Scientific Support Manager, MESO SCALE DISCOVERY |
| 11:30 | Development and Validation of the Immunogenicity Assay for Clinical Studies Hong Lu, MS, R&D Senior Manager, MEDIMMUNE |
| 12:00 | Networking Lunch |
| Effective Management of Drug Interference | |
| 1:00 | A Bioactive Drug Quantitation Based Approach for the Detection of Anti-drug neutralizing Antibodies in Human Serum Yao Zhuang, Principal Scientist, AMGEN |
| 1:30 | Detection of Anti-drug Antibody in Presence of Extreme High Level of Drug Counterpart of Endogenous Protein Sam Song, MD, Senior Scientist, Assay Development, MERRIMACk PHARMACEUTICALS |
| 2:00 | Coping with Seemingly Insurmountable Interference: Back to the Basics Michele Fiscella, Associate Director, Clinical Immunology, HUMAN GENOME SCIENCES |
| 2:30 | 30-Minute Networking Break |
| Data Interpretation/Clinical Relevance | |
| 3:00 | How to Handle Allergenicity Risks in Clinical Development of Biologicals Jorgen Dahlstrom, PhD, Scientific Specialist, Clinical Allergy, PHADIA |
| 3:30 | Applying Pk/PD/ADA/AE to Interpretation of nonclinical Safety Studies Holly Smith, Senior Research Scientist, Investigative Toxicology - Biomolecular Interactions, ELI LILLY AND COMPANY |
| 4:00 | Potential Clinical Impact of Monoclonal Antibody-Induced Immunogenicity in Oncology Sarah Harris, PhD, Senior Scientist, BIOGEN IDEC |
| 4:30 | An Alternate Gamma-Fitting Statistical Method For Anti- Drug Antibody Assays To Establish Assay Cut-Points For Data with non-normal Distribution Brian Schlain, Nonclinical Statistician, BIOGEN IDEC |
| 5:00 | Day One Deep Dive Rehash |
| 5:30 | Day One Concludes |
| 6:00 | Dine-Arounds and the San Francisco Experience |
| MAIN CONFERENCE: DAY 2 • WEDNESDAY, APRIL 28, 2010 | |
| 7:45 | Registration and Morning Coffee |
| 8:15 | Chairperson’s Recap of Day One Michel Awwad, PhD, Director, PFIZER |
| 8:30 | Challenges With Development of Anti-therapeutic Antibody Assays to Detect Antibodies of IgE Isotype Sally Fischer, PhD, Senior Scientist and Group Leader, Bioanalytical Research and Development (BARD), GENENTECH |
| 9:00 | Immunogenicity Assays for a PEGylated Biotherapeutic Bin Zhao, Scientist, BIOMARIN PHARMACEUTICAL |
| 9:30 | Comparability and Immunogenicity: Challenges Faced with Follow-on Biologics Michele Gunsior, PhD, Principal Investigator, COVANCE |
| 10:00 | 30-Minute Morning Networking Break |
| 10:30 | One-Step Quantification of neutralizing Antibodies to Biopharmaceuticals Michael G. Tovey, Laboratory of Viral Oncology, INSTITUT ANDRÉ LWOFF |
| 11:00 | Cell-Based neutralizing Antibody Assay Development Challenges Edwin Golez, Research Associate II, Bioanalytical Chemistry, AMYLIN PHARMACEUTICALS |
| 11:30 | Day Two Morning Deep Dive Rehash |
| 12:00 | Lunch and Learn Roundtables Table A: Regulatory Considerations for Immunogenicity Moderator: Eric Wakshull, PhD, Senior Scientist/Group Leader, Bioanalytical Research & Development Dept, GENENTECHTable B: Strategies to Overcome Soluble Ligand Interference in Clinical Immunogenicity Assessment Moderator: Kate Peng, Associate Scientist at the Bioanalytical Research and Development, GENENTECH Table C: The Critical Reagent Preparation and Characterization For Regulated Immunoassays Moderator: Mark Ma, PhD, Director, Preclinical, Pharmacokinetics and Drug Metabolism, AMGEN Table D: ATA Assay Drug Tolerance Moderator: Kathy Kozak, Scientist, Assay & Automation Technology, GENENTECH Table E: Management of Assay/Sample Interference Moderator: Sam Song, MD, Senior Scientist, Assay Development, MERRIMACK PHARMACEUTICALS |
| 1:15 | Introduction to Tolerance Induction to Therapeutic Proteins Michel Awwad, Director, PFIZER |
| 1:30 | Tolerance Induction In Preclinical and Clinical Studies Richard Garman, Scientific Director, GENZYME |
| 2:00 | Phospahtidylserine Liposomes and Induction of Immune Regulation to Proteins Sathy V. Balu-Iyer, PhD, Associate Professor of Pharmaceutical Sciences, STATE UNIVERSITY OF NEW YORk AT BUFFALO |
| 2:30 | Induction of Peripheral Tolerance (Regulatory Cells) to Proteins David W. Scott, PhD, Professor of Surgery and a Professor of Microbiology & Immunology, UNIVERSITY OF MARYLAnD SCHOOL OF MEDICINE |
| 3:00 | Conference Concludes |