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Vaccine leaders from around the world will come together to discuss critical issues surrounding the development of effective – and affordable – vaccines at the 6th annual Novel Vaccines meeting. We will examine the most promising vaccines against the most pernicious diseases threatening humanity. The Novel Vaccines meeting not only provides a snapshot of where vaccine innovations stand today, but also gives vaccine professionals the opportunity to network, establish collaborations, and learn from leaders in the field.
Tuesday, August 16
7:20 am Registration & Morning Coffee
8:20 Chairperson's Opening Remarks
Alan Liss, Ph.D., Director, MCMi PHSAT, FDA, Office of the Commissioner, Office of Counterterrorism and Emerging Threats
Opening Keynote Presentation
8:30 Vaccines for the 21st Century
 Peter Mason, Ph.D., Head, Microbial Molecular Biology, Novartis Vaccines and Diagnostics - Biography
The vision for modern vaccines is to protect people of all ages as a safe and friendly "life insurance" from a multitude of diseases reaching far beyond classic childhood vaccines. The development of new and effective vaccines against bacterial meningitis represents a current and convincing argument of the positive impact of new vaccine technologies. The elucidation of molecular structures, the detailed understanding of immunological mechanisms, novel adjuvants, synthetic vaccines or the generation of new vectored delivery methods provide good examples for the exciting technological revolution that we are witnessing and which will open up new avenues to address specific needs during various stages of life.
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Featured Presentation
9:15 Innovative Approaches to Accelerate Vaccine Development for Low-Resource Countries
John W. Boslego, M.D., Director, Vaccine Development Program, PATH - Biography
Vaccine development is expensive and manufacturers often focus on products for wealthy countries. Recent increases in global health resources have prompted new models for solving global health problems. Creative partnerships between the public and private sectors have been one successful approach. Because many of these partnerships receive support from public or philanthropic sources, it is important to ensure that the resulting products are available, accessible, and affordable to everyone as a means to improve health.
9:45 Vaccines: Challenges & Knowledge Gaps
Amy J. Weiner, Ph.D., Senior Program Officer, Bill & Melinda Gates Foundation - Biography
Vaccines are the highest priority at the Bill and Melinda Gates Foundation because they clearly provide long-term solutions for the greatest impact in global disease prevention. We focus our efforts on developing vaccines for especially challenging diseases, such as HIV/AIDS, TB, malaria and enteric diseases that cause significant mortality in low income countries. Making vaccines is hindered by our limited understanding of critical immune parameters, such as correlates of immune protection, and technologies needed to control the immune response in ways that result in efficacious vaccines. I will discuss the challenges, knowledge gaps that confront us and technologies that may accelerate making prophylactic vaccines.
10:15 Networking Coffee Break with Exhibit and Poster Viewing
11:00 Progress In Developing Whole Sporozoite-Based Malaria Vaccines
Peter Billingsley, Ph.D., Senior Director, Entomology & Quality Systems, Sanaria, Inc.
Sanaria has successfully manufactured and released the world's first metabolically active, non-replicating, radiation-attenuated Plasmodium falciparum (Pf) sporozoite (SPZ) vaccine, the PfSPZ Vaccine, and has used the experience and expertise to develop new PfSPZ products based on the same platform. The first-in-humans PfSPZ Vaccine clinical trial and non-human primate studies conducted in parallel have provided a clear pathway for the next clinical trials, in which the vaccine will be administered intravenously.
11:30 POSTER HIGHLIGHT
Design of a "Universal Influenza Vaccine" Using a De Novo Designed Conformationally Constrained, Two-Stranded Alpha-Helical Coiled-Coil Template as an Immunogen to Display Conserved Alpha-Helical Epitopes from the Stem of Influenza Hemagglutinin
Robert S. Hodges, Ph.D., Professor & Director, Biochemistry & Molecular Genetics, University of Colorado Denver Health Sciences Center
12:00 Lunch on Your Own
1:55 Chairperson's Remarks
Lewellys F. Barker, M.D., M.P.H., Senior Medical Advisor, Aeras Global TB Vaccine Foundation
2:00 Innovating Influenza Vaccines
Frank J. Arnold, Ph.D., Senior Program Manager (Tunnell Consultant), Vaccine Advanced Development, Influenza Division, Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), US Department of Health and Human Services, Office of the Secretary - Biography
The influenza vaccine landscape contains a rich variety of products both licensed and under various stages of development. The technologies vary from conventional egg based applications to cell culture based to various recombinant targets and are as diverse as the biotech industry itself. This presentation will discuss the influenza vaccine landscape in detail and the status of the technologies under development across the broad view of the development strategies. Each of the technologies has their own set of challenges and advantages of which will be discussed as it relates to the overall landscape of products available. The overall impact of the landscape will show that there are a number of exciting technologies under development to further the rich technology base for future influenza vaccine development.
2:30 Universal Influenza Vaccine: Research & Results from Clinical Testing
Teresa Lambe, Ph.D., James Martin Fellow, The Jenner Institute, University of Oxford - Biography
Influenza A viruses cause occasional pandemics and frequent epidemics. Licensed influenza vaccines that induce high antibody titers to the polymorphic viral surface antigen hemagglutinin must be re-formulated and readministered annually. A vaccine providing protective immunity to the highly conserved internal antigens could provide longer-lasting protection against multiple influenza subtypes. We discuss here our findings with a novel, influenza vaccine (MVA-NP+M1) designed to rationally augment T cell responses to the internal nucleoprotein (NP) and matrix protein 1 (M1) proteins.
3:00 Talk Title to be Announced
Daniel Adams, J.D., Executive Chairman, Protein Sciences Corporation
3:30 Networking Refreshment Break with Exhibit and Poster Viewing
4:15 In vitro Modeling of Pediatric Vaccine Responses
Ofer Levy, M.D., Ph.D., Principal Investigator, Medicine/Infectious Diseases, Children's Hospital Boston - Biography
Despite the fact that pediatric vaccines comprise over 50% of the global market, pediatric vaccine development has typically not taken into account the distinct immune system of newborns and infants. Over the past few years there has been important characterization of age-dependent maturation of innate and adaptive immune responses that will inform future pediatric vaccine development.
4:45 Progress in Developing a Recombinant Attenuated Salmonella Vaccine Against Pneumococcal Diseases
Roy Curtiss, III, Ph.D., Director, Center for Infectious Diseases and Vaccinology, The Biodesign Institute, Arizona State University - Biography
Our goal is to construct a novel low-cost recombinant attenuated Salmonella vaccine delivering multiple protective Streptococcus pneumoniae protein antigens that is safe for newborns and will induce after oral needle-free immunization protective immunity. The prototype first-generation attenuated S. Typhimurium strain and three S. Typhi strains all have the same genotype. Each strain possesses mutations conferring a regulated delayed attenuation and antigen synthesis in vivo phenotypes, that enhance immunogenicity while minimizing fluid secretion associated with gastroenteritis, and preclude biofilm formation. The final-generation S. Typhi strains possess improved first-generation vaccine attributes and additional mutations to further enhance immunogenicity to five pneumococcal antigens.
5:15 A New Approach to Mucosal Pathogen Vaccine Design: Proteomic Screening for TH17 Antigens that Protect from Streptococcus Pneumoniae Colonization
Kristin Moffitt, M.D., Assistant in Medicine, Children's Hospital Boston; Instructor, Pediatrics, Harvard Medical School - Biography
IL-17A-secreting CD4+ T cells (TH17 cells) have been shown to mediate resistance to mucosal colonization by multiple pathogens including S. pneumoniae. Immunization with several candidate antigens induced protection from colonization in two strains of mice. This immunity was abrogated when immunized mice were CD4+ T cell depleted or treated with an IL-17A neutralizing antibody at time of challenge. This work establishes proof of concept that proteomic screening for TH17 antigens successfully identifies immunogenic targets that elicit TH17 immunity thereby preventing colonization by S. pneumoniae. This method may represent a new paradigm for the design of vaccines against mucosally colonizing pathogens.
5:45 MCM/Regulatory Science Initiative -FDA's Response to the Need for Accelerating Medical Countermeasure Development
Alan Liss, Ph.D., Director, MCMi PHSAT, FDA, Office of the Commissioner, Office of Counterterrorism and Emerging Threats - Biography
The events of 9/11 and the subsequent mailings of anthrax-laden envelopes forever changed the way Americans view public health and their personal security. Despite considerable financial and human resource investments since 2001, the United States does not yet have the range of medical countermeasures (MCMs) it requires to rapidly and effectively respond to a deliberate chemical, biological, radiological or nuclear event or to a naturally occurring infectious disease outbreak. To enhance the probability of success, FDA has launched (8/2010) a Medical Countermeasures Initiative to facilitate FDA being engaged from the earliest steps of MCM development. FDA also intends to better define clear, scientifically-supported development pathways, and identify and help fill important scientific and regulatory gaps that often derail MCM development. This talk is a program update noting current progress and continuing opportunities for FDA's active engagement with industry and academic experts to assist advancements in regulatory science that will enable the Nation to successfully develop the next generation of MCMs needed to protect the American people.
6:00 Reception with Exhibit and Poster Viewing
7:00 Close of Day
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