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.

Preliminary Agenda

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.

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