Cambridge Healthtech Institute Announces its Third Annual Immunogenicity Summit

July 14, 2011 - PRLog -- Cambridge Healthtech Institute announces details for its third annual Immunogenicity Summit to take place on November 16-18, 2011, DoubleTree Hotel, Bethesda, MD.  A three-day Immunogenicity Summit for innovator biotherapeutics and biosimilars focusing on advances in assays such as neutralizing antibody assays (Nabs), ligand-binding assays, assays in the presence of interfering drug, the benefits of acid dissociation and the application of human mouse models. It also will provide advice on assay selection and means of interpreting the results. The conference will feature case studies on pre-clinical and clinical development with PKPD, safety and efficacy studies and risk assessment. Difficult challenges such as handling pre-existing antibodies and IgE hypersensitivity will be included.

A plenary session will cover clinical strategy and regulatory advice from the FDA and representatives of the European Regulatory Agencies:

Update on US Regulatory Guidance  Susan Kirshner, Ph.D., Associate Chief, Laboratory of Immunology, Therapeutic Proteins, Biotechnology, FDA

European Update on Unwanted Immunogenicity of Biologicals and Biosimilars
Robin Thorpe, Ph.D., FRC Path., Head, Biotherapeutics Group, National Institute for
Biological Standards and Control, UK

Clinical Immunogenicity Strategy: Design and Implementation
Meena Subramanyam, Ph.D., Senior Director, Clinical Science & Technology, Biogen
Idec, Inc.

A second part will examine the roles of T regulatory cells, T cell epitopes, potentially tolerogenic peptides and aggregates in immunogenicity and tolerance. Mechanisms for predicting and controlling immunogenicity will be presented with a wide range of approaches. Sub-visible particles and aggregates are becoming extremely hot, especially from a regulatory perspective and an entire half-day will be devoted to recommended strategies for their assessment and characterization.

For more information and to register, please visit http://www.healthtech.com/imn. Those that register by August 26 will save up to $350.

To inquire about sponsoring and/or exhibiting, contact Katelin Fitzgerald, 781-972-5458, kfitzgerald@healthtech.com.  

Writers and editors are encouraged to attend. To request a press pass, contact Tracey Fielding at tfielding@healthtech.com.

About Cambridge Healthtech Institute (www.chicorporate.com)

Cambridge Healthtech Institute (CHI) is the preeminent life science network for leading researchers and business experts from top pharmaceutical, biotech and academic organizations. CHI’s portfolio of products includes Cambridge Healthtech Institute Conferences, Insight Pharma Reports, Barnett International, Cambridge Marketing Consultants, Cambridge Meeting Planners and Cambridge Healthtech’s Media Group, which includes numerous e-newsletters as well as Bio-IT World magazine.

Founded in 1992, Cambridge Healthtech Institute strives to develop quality information sources that provide valuable new insights and competing points of view while offering balanced coverage of the latest developments. Basic research related to commercial implications is covered, with heavy emphasis placed on end-user insights into new products and technology as well as coverage on the strategy behind the business.

Contact:
James Prudhomme
Cambridge Healthtech Institute
781-972-5400
jprudhomme@healthtech.com