Cambridge Healthtech Institute’s 13th Annual
Immunogenicity Case Studies and Clinical Management
Interpretation and Mitigation Strategies in Clinical Settings
May 4 - 5, 2020
As the immunogenicity field is moving forward, closing the gap between clinicians and assay developers is essential in the success of biologic development and accelerating 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, new modalities such as gene and cell therapies, 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.
Case Studies of New Modalities
Immunogenicity Assessments in the Development of AAV Gene Therapies
Mark Milton, PhD, Executive Director, PK Sciences, Global Head Ophthalmology TA, Novartis Institutes for BioMedical Research, Inc.
Early Phase Clinical Immunogenicity of Valoctocogene Roxaparvovec, an AAV5-Mediated Gene Therapy for Hemophilia A
Brian Long, PhD, Associate Director, Immunogenicity Assessment, BioMarin Pharmaceutical, Inc.
Approaches to Reduce Target Interference in the Anti-Drug Antibody Assays, a Case Study
Erik Meyer, PhD, Investigator, Bioanalysis, Immunogenicity and Biomarkers (BIB), IVIVT, R&D, GlaxoSmithKline
Immunogenicity Studies on the Recently Approved Recombinant FVIII Product
Pedro E. Paz, PhD, Director, Principal Scientist, ImmunoProfiling Group in Biologics Research, Bayer Healthcare
Characterization of Immune Response to Bispecific Antibody Therapeutics
Kate Peng, PhD, Group Leader/Senior Scientist, BioAnalytical Sciences, Genentech
IMMUNOGENICITY RISK ASSESSMENT AND MITIGATION
Increased Immunogenicity Associated with Combination Regimens with Immune Modulatory Biologic
Vibha Jawa, PhD, Director and Lead, Predictive and Clinical Immunogenicity, PPDM, Merck & Co., Inc.
Preclinical Immunogenicity Risk Assessment and Lead Optimization for Novel Biological Therapeutic Modalities
Jochem Gokemeijer, PhD, Associate Director, Molecular Discovery Technologies, Bristol-Myers Squibb
Biosimilar ADA Analysis Demonstrates the Potential Impact of Insufficient Drug Tolerance
Heather Myler, PhD, Director, R&D, PPD® Laboratories
CLINICAL STUDIES AND MANAGEMENT
Benefits of Prophylactic Short-Course Immunomodulation in Patients with Infantile Pompe Disease: Demonstration of Long-Term Safety and Efficacy in a Large Cohort
Priya Sunil Kishnani, MBBS, Chen Family Professor of Pediatrics, Chief, Medical Genetics, Molecular Genetics and Microbiology, Duke University
PANEL DISCUSSION: Bridging the Gap between Pharma, Tech Developers and Clinicians: Providing Useful Immunogenicity Data for Actionable Decision in the Clinics
Moderator: Mark Milton, PhD, Executive Director, PK Sciences, Global Head Ophthalmology TA, Novartis Institutes for BioMedical Research, Inc.
* The program is subject to change without notice, due to unforeseen reason.