Cambridge Healthtech Institute’s 12th Annual
Immunogenicity Case Studies and Clinical Management
Interpretation and Understanding of Immunogenicity Data in Clinical Settings
April 8-9, 2019
As the immunogenicity field is moving forward, closing the gap between clinicians and assay developers is essential in the success of biologic development and accelerates the adoption of new biologic therapies in patient treatments. This year, CHI’s Immunogenicity Case Studies and Clinical Management conference will focus on new case studies of novel biologics and emphasize on closing this gap by providing multiple viewpoints from clinicians, technology developers and regulators on how to use immunogenicity data in clinical settings.
THE IMPACT OF IMMUNOGENICITY ON SAFETY
How to Characterize ADA Responses and Assess their Clinical Impact to Better Inform the Clinical Relevance of ADA Using a Risk-Based Approach
Sandra Garces, MD, PhD, Senior Medical Advisor for Immunogenicity, GPS Medical and Benefit-Risk Management, Eli Lilly and Company
RISK ASSESSMENT AND WORK FLOW PROCEDURE FOR CLINICAL OUTCOME PREDICTION
Utilizing Risk Assessment Approach to Decide Clinical Approaches and Validate Data Set
Vibha Jawa, PhD, Director, Biologics & Vaccines Bioanalytics, Merck & Co, Inc.
Relationship Between ADA and PK Assays: Is There an Impact?
Marcela M. Araya, PhD, Principal Scientist, Group Leader, BioMedicine Design, Pfizer
New Updates on the Use of Low Dose Transient Methotrexate
Ankit Desai, PhD, Research Fellow, Duke University Medical Center
Applying Modeling Methodologies to Analyze the Impact of Immunogenicity on Exposure and Efficacy
Josiah Thomas Ryman, PhD, Senior Scientist, Predictive and Clinical Immunogenicity, Merck & Co, Inc.
Detection of Drug Specific IgE Antibodies to Therapeutic Proteins
Susan Richards, PhD, Presidential Scientific Fellow, Translational Medicine Early Development, Sanofi R&D
POST MARKETING COMMITMENTS
Strategies of Conducting Post Marketing Commitment Studies to Support the Safety and Effectiveness of Biologics
Darshana Jani, PhD, Associate Director & Global Lead Biologics, Pfizer, Inc.
PANEL DISCUSSION: Characterization and Impact of Post Marketing Commitment Requirements for New Biologics Approved by the FDA
Moderator: Susan Richards, PhD, Presidential Scientific Fellow, Translational Medicine Early Development, Sanofi R&D
CASE STUDIES OF BIOLOGICS
Nonclinical and Clinical Immunogenicity Assessment of Bispecific Protein Therapeutics
Eric A. Wakshull, PhD, Principal Scientist, Group Leader, Genentech, Inc.
Lessons Learned from Biologic Agents in Rheumatology – Immunogenicity
Vibeke Strand, MD, MACR, FACP, Adjunct Clinical Professor, Immunology/Rheumatology, Stanford University
* The program is subject to change without notice, due to unforeseen reason.