Immunogenicity Summit
Immunogenicity and Bioassay Summit


Cambridge Healthtech Institute’s Eighth Annual
Immunogenicity Prediction & Control
Identifying Causes, Pre-empting, and Management

   October 27-28, 2016 | Hyatt Regency Baltimore | Baltimore, Maryland
Part of CHI's Immunogenicity and Bioassay Summit 2016

Considerable progress is being made in predicting and controlling immunogenicity. At CHI's Eighth Annual Immunogenicity Prediction & Control conference, industry, academic and FDA experts will examine the causes of immunogenicity such as aggregates and impurities, the significance of epitopes and HLA-binding, and the importance of Quality by Design principles and of having manufacturing control systems in place. It will also focus on the benefits of working with protein engineers to pre-empt immunogenicity and on how humanized mouse models and in silico, in vitro and ex vivo tools can contribute to a risk assessment and mitigation strategy. The disparity often seen between predictive data and the outcome in the clinic will be highlighted and solutions for increasing predictive accuracy will be offered together with recommendations for the clinical trial design for this kind of study. Case studies on controlling immunogenicity will focus on gene therapy, ophthalmology, treatment for multiple myeloma, and on immunotherapy with the exciting new promising CAR-T cells. Finally, we present successful tolerance induction methods for Pompe disease, Factor VIII, and refractory gout.

Preliminary Agenda


RISK FACTORS THAT CONTRIBUTE TO IMMUNOGENICITY

Understanding the Impact of Immunogenicity on Quality by Design

Valerie Quarmby, Ph.D., Staff Scientist, BioAnalytical Sciences, Genentech, Inc.

Impact of Aggregates on Immunogenicity

Will Hallett, Ph.D., Product Quality and Immunogenicity Reviewer, CDER/FDA

Robust Immune Response to a Product-Related Impurity and Impact on Immunogenicity Rate of an Antibody Therapeutic

Sally Fischer, Ph.D., Principal Scientist/Group Leader, Assay Development and Technology (ADT), Genentech/Roche


IMMUNOGENICITY PREDICTIVE STUDIES

Benefits of Humanized Mouse Models for the Study of Immunogenicity

Michael Brehm, Ph.D., Associate Professor, Molecular Medicine, University of Massachusetts Medical School

Working with Protein Engineers to Predict and Pre-Empt Immunogenicity of Biotherapeutics

Tim Hickling, Ph.D., Associate Research Fellow, Pharmacokinetics, Dynamics and Metabolism, Pfizer, Inc.

Immunogenicity Risk-Assessment Based on Computer Algorithms in Conjunction with in vitro and ex vivo Assays

Zuben Sauna, Ph.D., Principal Investigator, Division of Hematology Research and Review, FDA/CBER


CORRELATION BETWEEN PREDICTIVE IMMUNOGENICITY AND THE CLINICAL OUTCOME

Determination of Clinical Relevance of Predictive Immunogenicity

Vibha Jawa, Ph.D., Principal Scientist, Clinical Immunology, Amgen, Inc.


MEASURES TO CONTROL IMMUNOGENICITY

Immunogenicity Safety and Efficacy Concerns for Immunotherapy Products

J. Joseph (Jos) Melenhorst, Ph.D., Director, Product Development & Correlative Sciences, Center for Cellular Immunotherapies, University of Pennsylvania


MEANS OF OVERCOMING IMMUNOGENICITY / DEIMMUNIZATION APPROACHES / TOLERANCE

Measures to Avoid Immunogenicity for a Gene Therapy Product

Harald Petry, CSO, uniQure

Induction of Tolerance in Pompe Disease

Susan Richards, Ph.D., Global Deputy, Immunology & Biomarkers, and Vice President, Clinical Laboratory Sciences, DSAR, Sanofi

Strategy for Inducing Tolerance using Drug-Laden Nanospheres

Ira Pastan, M.D., Co-Chief, Molecular Biology, National Cancer Institute, National Institutes of Health and
Ronit Mazor, Ph.D., Post-Doctoral Fellow, Laboratory of Molecular Biology, National Cancer Institute, NIH

Tolerogenic Immunotherapy for Pegsiticase, a Pegylated Uricase for the Treatment of Refractory Gout

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




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 and sponsorship opportunities, please contact:
Carolyn Benton
Business Development Manager
Cambridge Healthtech Institute
Tel: 1 781-972-5412
Email: cbenton@healthtech.com

For media and association partnerships, please contact:
James Prudhomme
Senior Marketing Manager
Cambridge Healthtech Institute
Tel: 781-972-5472
Email: jprudhomme@healthtech.com

Register Today!


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