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.

Preliminary Agenda

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


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


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.

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