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Cambridge Healthtech Institute’s Third Annual “Challenges in Pre-Clinical & Clinical Development” conference will focus on the top 5 challenges facing vaccine and immunotherapy developers in 2010. Hear case studies from across a wide range of target areas, both therapeutic and prophylactic, including HIV/AIDS, tuberculosis, RSV, infectious disease, cancer and influenza. Regulatory requirements, advancements in pre-clinical animal models, and biomarkers for determining immune response, including identifying non-responders, will be addressed. Experts in the fields of immunogenicity and biomarkers will describe movements toward standardization to better improve lab-to-lab correlations. Learn new risk management strategies focused on post-market surveillance and epidemiology from industry leaders.
Engineering T cells for Cancer Therapy
Robert Hawkins, Ph.D., Professor, Medical Oncology, University of Manchester, and Coordinator, ATTACK Project
Strategies for the Nonclinical Safety Assessment of Vaccines
Jayanthi Wolf, Ph.D., Associate Director, Safety Assessment, Merck & Co., Inc.
Evaluation of the Safety and Efficacy of a Novel RSV F Particle Vaccine in the Cotton Rat
Ramadevi Raghunandan, Ph.D., Senior Scientist, Immunology, Novavax
An Integrative Paradigm for Biomarker Development in Immunotherapy Clinical Trials-Lessons Learned and Future Directions
Michael Kalos, Ph.D., Director, Translational and Correlative Studies Laboratory, University of Pennsylvania Medical School
Identify Correlates of Protection Biomarker in Vaccine Development
Yiwu He, Ph.D., Senior Program Officer, Global Health, Bill & Melinda Gates Foundation
Talk Title to be Announced
Danilo Casimiro, Ph.D., Director, Vaccine Basic Research, Merck Research Labs
Standardization of Immunogenicity Testing Across Species
Travis Harrison, Ph.D., Associate Director, SRI International
Talk Title to be Announced
Scott R. Burger, M.D., Principal, Advanced Cell & Gene Therapy
Risk Management Strategies for Immunotherapeutics Pre- and Post-Approval
Michael Forstner, Ph.D., Manager, Integrated Safety Risk, PDS, F. Hoffmann-La Roche