Cambridge Healthtech Institute (CHI) has just released the final agenda for its 4th annual Immunogenicity Summit to be held October 10-12, 2012 at the DoubleTree by Hilton Hotel in Bethesda, MD. The event has grown to great heights with over 250 delegates in attendance last year representing over 50 organizations connecting industry, academia, and regulators on immunogenicity testing, immunogenicity avoidance, and regulatory guidance.
“Recent research for the Immunogenicity Summit 2012 revealed an increasing concern about immunogenicity as more innovator and biosimilar products approach the clinic. Current concerns and interests include hypersensitivity and immune complexes, the design of the clinical program, and regulatory authority requirements, particularly the implications of the new biosimilar guidance. There is an increasing interest in predictive tools to support clinical risk assessment. Immunogenicity mitigation is gaining momentum with investigators endeavoring to identify product characteristics that contribute to immunogenicity with a view to engineering and/or selecting non-immunogenic products. Novel tolerance induction approaches are also being investigated,” said Nicole Lyscom, Ph.D., Conference Director, CHI.
This year’s program features a 2-part format covering developments in assay technologies, risk assessment, regulatory guidance and means of predicting and avoiding immunogenicity.
Part One: Immunogenicity Assessment and Clinical Relevance (October 10-11)
Topics covered include: challenges of immunogenicity assays, detection of immune complexes, clinical relevance of anti-drug antibodies, clinical immunogenicity testing strategies, and biosimilars. Part One of the summit highlights three keynote & featured presentations. The first,“Detection of Immune Complex Formation in Non-Clinical Studies and Implications for Clinical Risk Assessment,” will be given by Steve J. Swanson, Ph.D. of Amgen, Inc. The featured presenters are Paul Chamberlain, NDA Advisory Board and Daniela Verthelyi, M.D., Ph.D., Chief, Immunology, Therapeutic Proteins, CDER/FDA.
Part Two: Immunogenicity Prediction and Mitigation (October 11-12)
Part Two begins with a Joint Plenary Session which presents regulatory guidance from the FDA together with a panel discussion, and a background to causes and avoidance of immunogenicity. The keynote presentation titled “Immune Tolerance Induction: Novel Approaches for Novel Clinical Indications” will be delivered by Amy S. Rosenberg, M.D., Director, Division of Therapeutic Proteins, CDER/FDA followed by featured presenters Valerie Quarmby, Ph.D., Director and Principal Scientist, BioAnalytical Sciences, Genentech, Inc., and Jack Ragheb, M.D., Ph.D., Principal Investigator, Immunology, Therapeutic Proteins, CDER/FDA. Other topics covered include: factors contributing to immunogenicity, predictive methods for immunogenicity, and immune tolerance approaches /reducing immunogenicity.
Plus, delegates may attend three pre-conference short courses on binding and neutralizing assays and risk assessment, breakout discussions, networking functions, and an exhibit/poster hall. Delegates attending the Immunogenicity Summit 2012 may track-hop to the sessions at CHI’s concurrent event, PK/PD of Novel Contructs: Bispecific Antibodies, Antibody Fragments, and ADCs.
Complete event details are on-line at ImmunogenicitySummit.com
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
CHI (chicorporate.com) 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.