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Challenges in Pre-Clinical & Clinical Development - Top 5 Challenges in Vaccines & Immunotherapeutics - Day 1

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Welcome Letter | Day 1  |  Day 2 

Wednesday, August 18

12:15pm Registration

1:45 Opening Remarks

Bruce L. Levine, Ph.D., Director, Clinical Cell & Vaccine Production Facility, University of Pennsylvania

1:50 Keynote Presentation: Challenges of Developing Novel Vaccines: The Best of Times and the Worst of Times

George SiberGeorge Siber, M.D., Executive Chairman, Genocea Bioscience, Director, Selecta Bioscience





Danilo Casimiro, Ph.D., Director, Vaccine Basic Research, Merck Research Labs

2:30 Development of Biomarkers of Vaccine Efficacy Against Chronic Viral Infections

Danilo Casimiro, Ph.D., Director, Vaccine Basic Research, Merck Research Labs

3:00 Rational Vaccine Design and the Search for Correlates of Protection: Which one Comes First

Geert Vanden Bossche, D.V.M., Ph.D., Senior Program Officer, Global Health Vaccine Discovery, Bill & Melinda Gates Foundation 

A thorough understanding of disease pathogenesis and the immunological consequences of natural infection is fundamental to developing more rationally designed vaccines and to establishing meaningful immune markers of protection against infection. Since the mechanisms of immunity involved in establishing protection against extracellular pathogens profoundly differ from those involved in preventing, limiting, and clearing intracellular infections, radically different vaccination paradigms are required. This implies the design of ‘smarter’ vaccines capable of educating and priming the host immune system for a defense strategy that enables the host to overturn rather than to mimic  the pathogen’s natural invasion strategy.

3:30 Ice Cream Bar Refreshment Break with Exhibit and Poster Viewing

4:15 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 School of Medicine

Biomarkers are defined as any biochemical feature that can be used to measure the effects of treatment on patients or on the progress of disease.  In this presentation, we will discuss the increased relevance and integration of biomarker studies with emerging and changing paradigms in clinical trial research, and drawing from past experiences and recent technological advances, focus specifically on two critical elements for biomarker development- comprehensiveness in approach and quality in laboratory operations.

4:45 High Resolution Immunomonitoring to Identify Correlates to Clinical Outcome

Charles A. Nicolette, Ph.D., Chief Scientific Officer, Vice President, Research and Development, Argos Therapeutics

A greater understanding of the complex responses to experimental immunotherapeutics will facilitate the identification of biomarkers that predict clinical outcome. We have developed a broad-based immunomonitoring platform based on 14-color multiparametric flow cytometry for high resolution analysis of induced immune responses to our RNA-loaded DC immunotherapy.  Interim conclusions from clinical immunomonitoring data using this method and techniques for analyzing these large data sets will be discussed.  



5:15 Cohort Event Monitoring – A Description of Methodology and Tools

Magnus Wallberg, M.Sc., Head, Systems Development Strategies, Production, Development and Quality, the Uppsala Monitoring Centre

The growing use of vaccines in public health programs in both developed and developing countries has increased the need to identify any safety issues as soon as possible – so that actions can be taken. The WHO and the Uppsala Monitoring Centre (UMC) have proposed a methodology called Cohort Event Monitoring that can be used to monitor safety in vaccination programs and also developed CemFlow which is a web-based tool that is perfectly suited to gather relevant information in a format that is optimized for analysis and signal detection. Use of CemFlow will add ´real life´ information to the limited data obtained in clinical trials and give insight in the profile of events that occur following administration of the vaccine(s) in the population that was monitored. The presentation will give insight in the potential benefits of Cohort Event Monitoring and a brief introduction to CemFlow.

5:45 End of Day

Day 1  |  Day 2