Cambridge Healthtech Institute’s Ninth Annual

Immunogenicity Prediction & Control

Regulatory Perspectives, Risk Factors, and Management

October 25-26, 2017 | The Westin Alexandria | Washington, DC

 

This conference will address regulatory and industry perspectives on immunogenicity risk assessment and feature risk assessment for immunotherapy where certain immune responses are stimulated while immunogenicity is of course not desired. We will examine risk factors that contribute to immunogenicity and tools for immunogenicity risk prediction such as in silico and in vitro approaches, and examination of epitopes. In addition, we present experiences with engineering out immunogenicity, and progress in deimmunization and tolerance induction.

IMMUNOGENICITY RISK ASSESSMENT FROM REGULATORY AUTHORITY AND INDUSTRY PERSPECTIVES

FDA Regulatory Perspectives on Immunogenicity Risk Assessment from Phase 1 IND to BLA and Beyond

Joao Pedras-Vasconcelos, Ph.D., Biotech Quality and Immunogenicity Reviewer,Biotechnology Products, CDER-FDA

Determination of the Immunogenicity Risk Challenges of Checkpoint Inhibitors and Combination Therapies

Jochem Goekemeijer, Ph.D., Associate Director, Molecular Discovery Technologies, BMS

RISK FACTORS THAT CONTRIBUTE TO IMMUNOGENICITY

Case Studies on Product Attributes that May Cause Immunogenicity

Marisa Joubert, Senior Scientist, Process & Product Development, Amgen, Inc.

Factors that Stimulate Innate Immunity and Contribute to Immunogenicity Risk

Daniela Verthelyi, Ph.D., CDER/FDA


Monitoring of Immunogenicity for a Therapeutic Protein after Manufacturing Change

Laura I Salazar-Fontana, Ph.D., Associate Director, Biomarkers and Clinical Bioanalysis, Translational Medicine and Early Development, Sanofi

 

TOOLS AND APPROACHES FOR IMMUNOGENICITY RISK PREDICTION

Prediction Strategies for Immune Modulation-Based Therapies

Vibha Jawa, Ph.D., Director, Biologics and Vaccines Bioanalytics, Merck and Co. Inc.

Case Study on Predictive Immunogenicity Studies for Adalimumab: A Systems Pharmacology Approach for Immunogenicity Prediction

Xiaoying Chen, Ph.D., Principal Scientist, PDM, Pfizer, Inc.

MEASURES TO CONTROL IMMUNOGENICITY OF SPECIFIC PRODUCTS

Modificating the Immunogenicity of Blood Coagulation Protein Factor VIII

Kathleeen Pratt, Ph.D., Associate Professor, Medicine, Uniformed Services University of Health Sciences

Presentation and Discussion on New Approaches to Manipulate the Immune Response

Amy S. Rosenberg, M.D., Division Director, Office of Biotechnology Products, CDER/FDA

Domain/Epitope Mapping to Guide Engineering-Out Immunogenicity of Bispecific Antibodies

Priya Sriraman, Ph.D., Principal Investigator, Non-Clinical Development, Celgene Corp.

TOLERANCE INDUCTION

Clinical Development of SEL-212: Use of Tolerogenic Nanoparticles to Mitigate Immunogenicity Against an Enzyme Therapy to Treat Severe Gout

Kei Kishimoto, Ph.D., CSO, Selecta Biosciences

Tolerance-Inducing Programs for Enzyme Replacement Therapies

Priya Kishnani, M.D., C.L., Professor of Pediatrics, Division Chief, Medical Genetics, Pediatrics, Duke University Medical Center



For more details on the conference, please contact:
Nicole Lyscom Ph.D., 
Senior Conference Director
Cambridge Healthtech Institute
Tel: +44 7791 866489
Email: Nlyscom@healthtech.com  
For exhibit & sponsorship opportunities, please contact:
Carolyn Benton
Business Development Manager
Cambridge Healthtech Institute
Tel: 781-972-5412
Email: cbenton@healthtech.com

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Celebrating 25 years