Pre-Conference Workshop |  Day 1  |  Day 2  |  Download Brochure 


Tuesday, August 18, 2009


7:30am Morning Coffee (Breakfast Sponsored Presentation Opportunity Available)


VACCINE PLATFORM INNOVATIONS

8:25 Chairperson’s Remarks

Zelig Eshhar, Ph.D., Professor of Immunology, Weizmann Institute

8:30 Development of a Novel Baculovirus-Insect Cell System to Assess the Impact of Protein Glycosylation on Influenza Virus Subunit Vaccines

Donald Jarvis, Ph.D., Professor, Department of Molecular Biology, University of Wyoming

The baculovirus-insect cell system has been used to produce subunit and VLP HA vaccine candidate against influenza viruses, which have been evaluated in human clinical trials. However, the recombinant HAs comprising these vaccine candiDate have N-glycosylation patterns derived from insect cells, which are not necessarily identical to those found on the native HA products. In this presentation, I will discuss our efforts to produce insect cell lines designed to provide more natural HA N-glycosylation patterns and to use these cell lines to evaluate the impact of insect versus higher eukaryotic N-glycoslation patterns on the efficacy of rHA subunit vaccine candidate.

9:00 Chimigen Platform Technology: A Platform of the Future for Immunotherapeutic Vaccine Development

Rajan George, Ph.D., Executive Vice President & Chief Technology Officer, Biotechnology Division, Paladin Labs, Inc.

Chimigen® Platform is a versatile, highly adaptable platform for the development of immunotherapeutic agents for the treatment of chronic viral infections and for certain types of cancer. Chimigen® Vaccines are recombinant fusion proteins of antigen(s) and specific regions of a xenotypic antibody which target specific receptors on antigen presenting cells, especially dendritic cells, for binding, internalization and processing. Antigen presentation occurs via both Class I and Class II pathways which results in both cellular and humoral immune responses. The platform can be used for the production of prophylactic as well as therapeutic vaccines. Current applications include therapeutic vaccines against chronic HBV and HCV infections, prophylactic vaccines against avian influenza, HCV and Biodefense applications. The platform also has use in cell-specific delivery of siRNA for gene silencing and as antivirals.

9:30 ApoVax104 as a Novel Therapeutic Vaccine

Haval Shirwan, Ph.D., Founder and Chief Scientific Officer, ApoImmune; Professor, Department of Microbiology and Immunology, Director, Molecular Immunomodulation Program, Institute for Cellular Therapeutics, and Hamilton Chair in Autoimmune Disease and University Scholar, School of Medicine, University of Louisville

ApoVax104 is a novel, flexible vaccine platform technology being applied to cancer and infectious disease. ApoVax104 is a recombinant chimeric protein consisting of streptavidin and the costimulatory protein 4-1BB ligand (4-1BBL). ApoVax104 can be combined with any antigen to create a potent and efficient disease-specific vaccine. In preclinical studies, ApoVax104 has proven to be much more effective and less toxic than two other benchmark vaccine components currently being tested in late stage clinical trials.

10:00 Networking Coffee Break with Exhibit and Poster Viewing


VACCINE DEVELOPMENT PATHWAY—
STEPS ALONG THE WAY

10:45 Vaccines: WIIFM (or I): An Industry Perspective on Vaccine Investment Decision Making

Frank J. Malinoski, M.D., Ph.D., President, TD Consultancy

Historically, investment in vaccine development has carried a high probability of success. With more difficult targets, new and untested technologies, expanded regulatory hurdles, and competition for limited resources, the decision making process now must balance multiple factors including the medical need, time to market, and return on investment. In this discussion, we will explore recent successes and failures that have shaped the current investment environment.

11:15 Interactive Panel Discussion
How to Fund Vaccine Research & Development in Today’s Economy

This panel discussion will address the steps necessary to develop a vaccine product, and the data sought by funding sources that lead to approval. Representatives from the major sources of vaccine funding will share their insight, advice, and guidelines addressing how to obtain the funds needed to progress a vaccine candidate, whatever an organization’s structure and size.

Moderator:   Rick Bright, Ph.D., Scientific Director, Influenza Vaccine Project, PATH

Panelists:

  • Michael Callahan, M.D., Program Director, Defense Sciences Office, DARPA
  • Catherine Hennings, M.S., M.B.A., Senior Commercialization Advisor, Vaccine Development Global Program, PATH
  • Gregory Milman, Ph.D., Director, Office for Innovation and Special Programs, Division of Extramural Activities, NIAID, National Institutes of Health
  • Thomas P. Monath, Ph.D., Team Member, Kleiner Perkins Caufield & Byers
  • Robin A. Robinson, Ph.D., Director, Biomedical Advanced R&D Authority (BARDA), US Department of Health & Human Services

12:15pm   End of “Novel Vaccines: Design & Development”  meeting