Immunogenicity Assessment and Clinical Relevance Conference, Part One at Immunogenicity Summit

July 3, 2012 - PRLog -- This conference focuses on different types of immunogenicity assay, on evaluation of the results in terms of screening and confirmatory cut points, on handling drug interference and pre-existing antibody, and the impact of anti-drug immune complexes, and non-IgE hypersensitivity. It will include case studies on the relationship of anti-drug antibodies to PK, PD, safety and efficacy, including a case study for a novel biotherapeutic, and look at the impact of immunogenicity on clinical risk assessment.

Featured Presenters:

Detection of Immune Complex Formation in Non-Clinical Studies and Implications for Clinical Risk Assessment
Steve J. Swanson, Ph.D., Executive Director, Medical Sciences, Clinical Immunology,
Amgen, Inc.

Fundamental Considerations for Defining “Comparable” Immunogenicity of Biosimilar
Therapeutic Monoclonal Antibodies
Paul Chamberlain, NDA Advisory Board

Immunogenicity Considerations in the Approval of Generic Enoxaparin in the US
Daniela Verthelyi, M.D., Ph.D., Chief, Immunology, Therapeutic Proteins, CDER/FDA

Register and view full details at: http://www.ImmunogenicitySummit.com

Stay on for Part Two: Immunogenicity Prediction and Mitigation (Oct. 11-12).

To inquire about sponsoring and/or exhibiting, contact Tim McLucas, 781-972-1342, tmclucas@healthtech.com.

Writers and editors are encouraged to attend. To request a press pass, contact Lisa Scimemi at lscimemi@healthtech.com.

About Cambridge Healthtech Institute (www.chicorporate.com)

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, Cambridge Marketing Consultants, Barnett Educational Services, Cambridge Meeting Planners and CHI’s Media Group, which includes news websites and e-newsletters including Bio-IT World and eCliniqua. Founded in 1992, CHI strives to develop quality information sources that provide valuable new insights and competing points of view while offering balanced coverage of the latest developments.

Contact:

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