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.
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
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
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.
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.
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
For exhibit & sponsorship opportunities, please contact:
Business Development Manager
Cambridge Healthtech Institute