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Challenges in Pre-Clinical & Clinical Development - Top 5 Challenges in Vaccines & Immunotherapeutics


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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.


SELECTING THE BEST PRE-CLINICAL ANIMAL MODELS


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


IDENTIFYING BIOMARKERS FOR IMMUNE RESPONSE


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


STANDARDIZING IMMUNOGENICITY TESTING


Standardization of Immunogenicity Testing Across Species

Travis Harrison, Ph.D., Associate Director, SRI International


Navigating Changing Regulatory Requirements


Talk Title to be Announced

Scott R. Burger, M.D., Principal, Advanced Cell & Gene Therapy


ANALYZING POST-MARKETING SURVEILLANCE AND EPIDEMIOLOGY


Risk Management Strategies for Immunotherapeutics Pre- and Post-Approval

Michael Forstner, Ph.D., Manager, Integrated Safety Risk, PDS, F. Hoffmann-La Roche


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2010 Conference
& Course Catalog

CHI Catalog