Friday, August 24 – Day Three
Production: Heading to Market & to the Patient

7:30am Morning Coffee (Breakfast Workshop Sponsorship Available)

Readying Vaccines for the Clinic

8:30 Chairperson's Remarks

9:05 Accelerating Process Development: Considerations and Challenges
Wei Wei Qi, M.D., Ph.D., Principal Scientist, Process Development, sanofi pasteur

9:35 Adenovirus-Based Vaccines
Joseph Bruder, Ph.D., Director, Vector and Vaccine Programs, GenVec, Inc.
Malaria is one of the most devastating diseases impacting public health. The development of an effective malaria vaccine is a high global priority. We are working towards development of a multi-valent, multi-stage, vaccine for malaria that is based on adenovirus serotype 5 (Ad5). This vaccine is designed to induce protective CD8+ T cell responses against parasite proteins expressed in the liver stage of the parasite life cycle, as well as antibody responses against parasite proteins expressed in the blood-stage. I will discuss our progress on generating multivalent Ad5-based vaccines as well as advances on the generation of Ad5-based vaccines with capsid modifications designed to circumvent pre-existing Ad5 neutralizing antibodies that are prevalent in human populations

10:05 Networking Coffee Break

Readying Vaccines for Market

10:45 Preclinical Development of a Universal Influenza A Vaccine Candidate
Ashley Birkett, Ph.D., Senior Director, Preclinical Research, Acambis Inc.
The highly conserved extracellular domain of the influenza A ion channel protein M2 (M2e) is a target antigen for eliciting broadly protective and long-lasting immunity against influenza A viruses. Since M2e is highly conserved across all influenza A strains previously associated with human-to-human transmission,vaccines based on M2e have the potential to provide universal immunity against strains associated with both seasonal epidemic and pandemic influenza. A clinical candidate M2e-based vaccine (ACAM-FLU-A) has been developed which consists of M2e genetically fused to recombinant hepatitis B core (HBc) virus-like particles (VLPs). The clinical candidate was selected based on preclinical immunogenicity and efficacy data,
as well as production and stability criteria. Preclinical studies have confirmed that ACAM-FLU-A VLPs elicit high titers of anti-M2e antibodies that have high affinity for native M2e protein and are associated with protective immunity in mouse and ferret challenge models. Adjuvants have been shown to serve an important role in enhancing immunogenicity and modulating the anti-M2e IgG subclass distribution such that it most effectively complements our emerging understanding of the mechanism of protection of anti-M2e antibodies. Pre-existing anti-HBc antibodies are not associated with carrier-specific suppression of immune responses to ACAM-FLU-A, which is relevant given the high numbers of anti-HBc seropositive individuals worldwide. The vaccine candidate will enter Phase 1 clinical testing, under a US IND application, in 2007.

11:15 Virus-like Particle (VLP) Vaccines for Seasonal and Pandemic Influenza
Rick A. Bright, Ph.D., Vice President, Global Influenza Programs, Novavax, Inc.
We have developed a novel vaccine platform comprised of Virus-Like Particles (VLPs) made from hemagglutinin, neuraminidase, and matrix proteins of influenza viruses. We have produced a variety of VLP-based vaccines for both human seasonal and avian influenza viruses with potential to evolve into a pandemic threat. In pre-clinical studies our influenza VLP vaccines have been shown to elicit seroprotective immune responses in mice, rat, and ferret models, often with low doses of antigen. In addition, antibodies raised to our VLP vaccines have shown an ability to react with influenza viruses spanning several influenza seasons, leading to a potentially powerful vaccine that may not need to be reformulated on an annual basis.

11:45 A New Influenza Vaccine Based on a Novel Polycationic Sphingolipid - CCS: Immunogenicity and Efficacy in Animal Models
Sarit Samira, Ph.D., Chief Biologist, R&D, NasVax Ltd.
A novel influenza vaccine based on a newly synthetic polycationic sphingolipid which has a dual effect of a carrier and an adjuvant, enables high vaccination efficacy in mice, rats and ferrets when administered mucosally, needle free (intranasally, i.n.), or injected intramuscularly (i.m.). The i.n. administration enables expedient mass vaccination in case of a rapidly expanding epidemic or a bioterror attack. The novel polycationic sphingolipid is D erythro ceramide carbamoyl- spermine = CCS) in which the cationic charges are resulted from one primary and two secondary amines. In mice, i.m or i.n. administration of the standard trivalent influenza vaccine formulated in CCS/cholesterol (CCS/C) liposomes evoked strong immune responses, superior to those achieved upon administration of standard influenza vaccine.

12:15pm Lunch on Your Own (Lunch Workshop Sponsorship Available)

Bringing Needed Vaccines to
Patients Around the World

1:45 Chairperson's Remarks

1:50 Update and Horizons for Transcutaneous Immunization
Gregory M. Glenn, M.D., Chief Scientific Officer, IOMAI Corporation

2:50 Networking Refreshment Break

3:30 Moderated Roundtable Discussions
Topics for Discussion:
(1) Vaccine Economics
(2) PR & Public Perceptions of Vaccines
(3) Ensuring Adequate Supply of Flu Vaccines

5:00 End of Conference