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

Sunday, August 16, 2009 Pre-Conference Short Courses 2:00-5:00pm – Separate Registration Required  Short Course #1:    Vaccine Business Opportunities: Collaborations, Mergers and Acquisitions Successful Strategies for your Product and Technology For full programming, please click here  Short Course #2: Managing Process Change in Vaccine Manufacturing Successful regulatory submissions throughout the product life-cycle For full programming, please click here

Tuesday, August 18, 2009

 

ADJUVANT BREAKTHROUGHS & SUCCESSES

12:30pm Registration

1:40 Chairperson’s Opening Remarks

1:45   Opening Keynote Presentation: Development of Human Cell-Based Assays for Early Evaluation of Adjuvant Safety   Hana Golding, Ph.D., Chief, Laboratory of Retrovirus Research, Division of Viral Products, Office of Vaccine Research and Review (OVRR), CBER, FDA Many new vaccine adjuvants are under development. Some of the new adjuvants are well defined synthetic products, with known mechanism of action, but many are being identified through high-throughput screening of small molecules or compounds derived from biological cell extracts. Early screening of candidate adjuvants for potential in vivo toxicities could enhance product development. We have initiated a program for pre-clinical evaluation of novel adjuvants and delivery systems based on Human Detector Cell Lines. The assays are designed to measure PGE2 and pro-inflammatory cytokines known to be associated with systemic toxicities in vivo. Both in vitro and in vivo studies will be described.

2:15  Keynote Presentation:  GSK Adjuvant Experience: Value, Successes and Challenges  Nathalie Garçon, Ph.D., Vice President & Head, Research & N. American R&D, GlaxoSmithKline Biologicals Adjuvants and Adjuvant Systems constitute one approach to induce the immune response & ensure the protection against challenging pathogens in the context of specific target populations. This has been made possible by the improved understanding of the immune mechanisms and molecules involved in the induction and maintenance of adequate immune responses. This has lead to the successful development of new adjuvanted vaccines with clear clinical benefits. Those will be discussed in light of the success and remaining challenges.

2:45 Featured Presentation:
MF59: A Safe and Potent Vaccine Adjuvant for Use in Influenza Vaccines

Derek O’Hagan, Ph.D., Director, Vaccine Delivery Research, Novartis Vaccines & Diagnostics, Inc.

MF59 is a safe and potent emulsion based vaccine adjuvant that has been licensed in more than 20 countries (Fluad®), for more than 10 years, for use in an influenza vaccine focused on elderly subjects. The addition of MF59 to the vaccine allows for more broad cross reactivity against viral strains not actually included in the vaccine. Hence MF59 has broad potential to be used as a safe and effective vaccine adjuvant for a broad range of vaccines.

 3:15 Ice Cream Bar Refreshment Break with Exhibit and Poster Viewing

TOLL-LIKE RECEPTORS (TLRs)

4:00 Adjuvant Properties of CpG Oligonucleotides

Dennis M. Klinman, Ph.D., Senior Investigator & Head, Lab of Experimental Immunology, NIH NCI

Synthetic oligodeoxynucleotides (ODN) expressing unmethylated CpG motifs mimic the ability of bacterial DNA to trigger the mammalian immune system through Toll-like receptor 9. This ability can be harnessed therapeutically by employing CpG ODN as vaccine adjuvants. The effect of CpG ODN on humoral and cellular immunity will be discussed, with specific focus on their ability to accelerate, magnify and prolong the generation of protective humoral immune responses.

 4:30 Enhancing Vaccine Immunogenicity Through Use of TLR9 Agonists

Risini D. Weeratna, Ph.D., Senior Research Scientist, Vaccine Research, Ottawa Laboratories, Pfizer Global R&D

A number of different Toll-like receptors (TLR) have been shown to have potent vaccine adjuvant activity. Synthetic oligodeoxynucleotides containing CpG motifs (CpG ODN) are immune stimulatory agonists for TLR9 that is found in the endosomal compartment of human B cells and plasmacytoid dendritic (pDC) cells, initiating and enhancing Th1-biased innate and adaptive immune responses. I will focus my talk on use of CpG ODN as vaccine adjuvants in both prophylactic and therapeutic vaccines and share pre clinical and clinical data that has been generated up-to-date showing potent adjuvant activity of this class of molecules.

5:00 Agonists of Pattern Recognition Receptors, including TLRs and NLRs, as Vaccine Adjuvants: Current Practice and Translational Development

Ofer Levy, M.D., Ph.D., Staff Physician & Principal Investigator, Infectious Diseases, Harvard Medical School/Children’s Hospital Boston

Molecular characterization of mechanisms by which human pattern recognition receptors (PRRs) detect endogenous danger signals and microbial infection has greatly expanded our understanding of the innate immune system. PRRs include Toll-like receptors (TLRs), nucleotide oligomerization domain-like receptors (NLRs), retinoic acid inducible gene-like receptors (RLRs) and C-type lectin receptors (CLRs). Research on the developmental expression of these systems in the fetus, newborn and infant is incomplete but has already yielded important insights into the susceptibility of newborns to infection. Progress in characterizing PRRs is thus informing and expanding the design of improved adjuvants. This review summarizes recent developments in the field of innate immunity with special emphasis on developmental expression in the fetus, newborn and infant and its implications for the design of more effective neonatal and infant vaccines.

5:30 End of Day