Overview | Day 2 | Download Clinical Risk Management Brochure
12:15pm Networking Luncheon (Riverfront Room)
1:40 Chairperson’s Remarks
Hideki Garren, M.D., Ph.D., Co-founder & Vice President of Research, Bayhill Therapeutics, Inc.
1:45 Clinical and Regulatory Considerations for the Development of VaccinesJulia Barrett, M.D., M.P.H., Senior Clinical Consultant, Biologics Consulting Group, Inc.The development of a vaccine for the prevention of an infectious disease involves unique scientific, clinical and regulatory issues. This presentation will review the clinical development of vaccines from the pre-IND phase through licensure. Particular focus will be given to: study design; the selection of an optimal dose and schedule; the role of immunogenicity data in vaccine development; collection of safety data; duration of vaccine protection; concurrently administered vaccines; clinical bridging studies; and the
2:15 Clinical Development of Cancer ImmunotherapeuticsRemi Palmantier, Ph.D., Director and Head, Cancer Immunotherapy N American Program, GlaxoSmithKline Biologicals
2:45 HIV Vaccines: Measuring Safety and Efficacy in a Global Clinical Trials NetworkJames Kublin, M.D., M.P.H., Director, HIV Vaccine Trials Network, Fred Hutchinson Cancer Research CenterFormed in 1999 by the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) and headquartered in Seattle, Washington, the HIV Vaccine Trials Network (HVTN) is an international collaboration of scientists, community educators, research institutions and commercial drug companies whose goal is to accelerate the search for an HIV vaccine by sharing trialresults and facilitating parallel, concurrent testing. With 25 research institutions on four continents (Africa, Asia, North America and South America) and a closely involved network of Community and Global Advisory Committees, the HVTN has both the technical ability and the community relationships to conduct trials across the globe and to test vaccine on geographically diverse strains of HIV. The HVTN conducts all phases of clinical trials. In all, the HVTN has enrolled over 7000 participants worldwide in its 9 years of operation. (HVTN/UCSF Pipeline Project). Recent HIV vaccine clinical trials conducted over the last year have presented many challenges, especially in regards to safety and immunogenicity. The STEP study is one such high‐profile example of challenges faced. On‐going results and evaluation of the recent STEP study and implications for future HIV vaccine trials will be discussed.
3:15 Networking Refreshment Break in the Exhibit Hall (Sponsorship Available)
4:00 Clinical Trial Results with a DNA Vaccine for Autoimmune Disease: How to Safely Treat MS and Type 1 Diabetic PatientsHideki Garren, M.D., Ph.D., Co-founder & Vice President of Research, Bayhill Therapeutics, Inc.DNA vaccines are a promising method of antigen-specific treatment for autoimmune diseases. We have conducted clinical trials with two DNA vaccines for autoimmune diseases: BHT-3009 for multiple sclerosis and BHT-3021 for type 1 diabetes. The results of these clinical trials will be described, with particular focus on how patients are being monitored to ensure that any potential exacerbation of the autoimmune response is caught early.
4:30 Developing Vaccine Recruitment Strategies: One Size Does Not Fit AllRobert F. Betts, M.D., Professor of Medicine in Infectious Diseases, University of Rochester Medical CenterRecruitment strategies for vaccine studies present a challenge. Typically, volunteers are enticed by (1) remuneration as compensation for time spent, (2) a good track record in the community, and (3) vaccine safety in that order. Recruiting volunteers from at-risk populations requires interacting with the medical-care providers of the at-risk who have a vested interest in the vaccine benefit. Thus, the care providers support the recruitment and their enthusiasm is both "infectious" and critical. However, for small-scale studies, presence at the point of care delivery by the vaccine team is essential. For large-scale studies, a different strategy is required.
5:00 End of Day One
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