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Novel Vaccines: Design & Development - Day 1

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Tuesday, August 17

7:20am Registration and Morning Coffee



8:20 Chairperson’s Opening Remarks

Steven Pincus, Ph.D., Executive Director, Analytical Operations, Novavax, Inc.

FDA’s Approach Towards Pandemic Vaccine Preparedness

David ChoDavid S. Cho, Ph.D., M.P.H., Senior Scientist for Emerging and Pandemic Threat Preparedness, Office of the Director, Center for Biologics Evaluation and Research (CBER), FDA

When the 2009 H1N1 influenza virus emerged in the spring of 2009, the Food and Drug Administration (FDA) worked with our sister agencies within the Department of Health and Human Services (HHS), other U.S. government agencies, the World Health Organization (WHO), foreign governments, sister regulatory agencies, and vaccine manufacturers to facilitate the development, production, and availability of safe and effective vaccines against the 2009 H1N1 virus. This combined effort allowed for vaccines to be made, licensed, and delivered to people in record time. This presentation will highlight FDA’s approach towards pandemic vaccine preparedness and the regulatory challenges that the 2009 H1N1 vaccine presented. Biography 

9:15 Influenza Virus-Like Particle Vaccine Produced in Insect Cells Elicits Hemagglutination and Neuraminidase Inhibiting Antibodies in Immunized Healthy Adults

Steven Pincus, Ph.D., Executive Director, Analytical Operations, Novavax, Inc.

Steven PincusHistorically, influenza vaccines have been standardized by their hemagglutinin content and influenza immunity has been measured by determining the level of hemagglutinin inhibiting antibody. To meet the need for improved vaccine with an enhanced immunogenic profile in the elderly, we have developed a technology to produce influenza virus like particles (VLPs) engineered to co-express the HA, NA and M1 proteins. A trivalent vaccine was produced for the 2008-2009 vaccine strains (A/Brisbane/59/2007 H1N1, A/Brisbane 10/2007 H3N2, B/Florida/4/2006). When administered to healthy adults in a Phase II study at 15µg and 60 µg doses, the vaccine was well tolerated and elicited 57-86% 4-fold rise post immunization in HAI titers and 50-73% 4-fold rise post immunization in NAI titers. The VLPs can be used to measure HA and NA immunological responses in a similar manner to live flu virus. Biography 

9:45 New Pneumococcal Vaccines: Protein, Conjugate and Hybrid Vaccine Strategies

Mark AldersonMark Alderson, Ph.D., M.B.A., Director, Pneumococcal Vaccine Project, PATH

The goal of PATH’s pneumococcal vaccine project is to accelerate the development of promising new pneumococcal vaccines that are safe and effective in young children, and to ensure their affordability, availability, and use in developing countries. As part of this project, PATH is developing a portfolio of potential vaccine candidates with a particular emphasis on “common protein” vaccines. Vaccines containing proteins that are common to all pneumococcal serotypes could provide broad and affordable protection to children worldwide. Our current protein vaccine partnerships range from novel methods of antigen discovery to well characterized vaccine candidates that have provided protection in multiple animal models and are currently in early stages of clinical evaluation. A second strategy involves the development of a killed, whole cell vaccine, also designed to offer broad serotype-independent coverage coupled with low manufacturing costs and ease of administration. Biography 

10:15 Networking Coffee Break with Exhibit and Poster Viewing



11:00 Challenges to Develop an HIV Vaccine – The Need for Multiple Approaches

Thomas Hassell, Ph.D., Vice President, Vaccine Development, International AIDS Vaccine Initiative (IAVI)

Epidemiological figures published by UNAIDS in 2009 confirm a stark reality; the number of people living with HIV in 2008 reached 33.4 million, with 7,400 new infections per day.  An AIDS vaccine is believed to be the best hope of ending the pandemic and IAVI (The International Aids Vaccine Initiative) is dedicated to this purpose.  With our partners, we hope to capitalize on a number of recent and exciting scientific advances to overcome the enormous challenges inherent in AIDS vaccine development.  Progress with these multiple approaches will be presented at the conference.  Biography 

11:30 Development of an HIV Vaccine: Challenges and Successes

Indresh Srivastava, Ph.D., Associate Director, Vaccines Research, Protein Biochemistry, Novartis Vaccines & Diagnostics, Inc.

The focus of the HIV project at Novartis is to design and develop a novel Envelope (Env) based HIV vaccine that is able to induce cross-neutralizing antibody responses against diverse primary isolates. We are evaluating several complimentary approaches to enhance the exposure of conserved functional epitopes to improve the ability of Env for inducing potent neutralizing antibodies with special emphasis on two approaches: a) to target conserved functional epitopes involved in co-receptor binding for eliciting cross reactive neutralizing antibody responses; b) evaluate Envs derived from the early primary isolates that may have better exposure of the critical epitopes involved in virus binding and entry compared to the late isolates, which may be better suited for vaccine development. 

12:00pm How to Overcome Cold Chain ChallengesSponsored by
World Courier

Tim Redmond, Director, Regional Accounts, World Courier, Inc.

In the every expanding market of Cold Chain Management, the challenges presented become more complex. In this presentation we will focus on the key factors involved in successful Cold Chain Management. These key factors are, but are not limited to, Planning & Communication, Temperature Profiling, Chain of Custody, Packaging, Temperature Monitoring & Reporting, SOP and Excursions. We will share our experiences and knowledge to offer a practical guide for success in this complex arena. 

Sponsored by
12:15 FluGEM™, A New Intranasal Vaccine to Prevent Influenza
Govert Schouten Govert J. Schouten, Chief Executive Officer, Mucosis B.V. 
Mucosis’s lead program FluGEM™ is aimed at developing a new influenza vaccine that can be administered to humans by a simple spray in the nose. The program is particularly directed at achieving better protection against seasonal influenza in children and elderly. FluGEM™ is a trivalent vaccine based on ordinary split influenza virus antigen formulated with bacteria-like particles derived from Lactococcus lactis. The vaccine raises a potent systemic immune reaction and a superior immune response in the mucosal lining of the nose and lungs, the place on entry of circulating influenza viruses. This provides an additional layer of protection against circulating influenza virus.

12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own 


1:55 Chairperson’s Remarks

Kate Rittenhouse-Olson, Ph.D., Professor, Director, Biotechnology Program, Biotechnical and Clinical Laboratory Sciences, The University at Buffalo

2:00 Live Attenuated Pre-Erythrocytic Malaria Vaccines

Sebastian MikolajczakSebastian A. Mikolajczak, Ph.D., Staff Scientist, Malaria Program, Seattle Biomedical Research Institute

Malaria remains a major public health problem in the developing world.  Eradication of malaria will depend in large part on an effective vaccine that prevents infection. Vaccination with pre-erythrocytic, live-attenuated malaria parasites is capable of inducing sterile immunity and confers long-lasting protection against subsequent Plasmodium infection. The level of protection is currently unmatched and not yet achievable with subunit vaccines. The radiation-attenuated parasite vaccine has been shown to induce lasting sterile protection in humans and in animal models. Here we discuss the development of genetically attenuated parasites (GAPs) as the next generation platform to produce a safe and reproducible, whole-cell malaria vaccine that prevents infection at the pre-erythrocytic stage. Current clinical development of the first generation of GAP vaccines will also be presented.  Biography 

2:30 Development of a Metabolically Active Non-Replicating Sporozoite Vaccine to Prevent Malaria Caused By Plasmodium Falciparum

Peter Billingsley, Ph.D., Senior Director, Entomology and Quality Systems, Sanaria, Inc.

An ideal vaccine for malaria would target all stages of the parasite life cycle, and thereby prevent infection, severe disease and transmission. However, most malariologists agree that if only one stage is to be targeted, it should be the pre-erythrocytic stage, because induction of highly protective immune responses against this stage will prevent blood stage infection and thus disease, and parasite transmission. Our consortium is working to develop such a vaccine. The first-generation vaccine is a metabolically active, non-replicating Plasmodium falciparum sporozoite (PfSPZ) vaccine that is attenuated by irradiation. The first major challenge was to manufacture adequate quantities of such a vaccine that met regulatory standards for initial clinical trials, and demonstrate it was safe, well tolerated and immunogenic in humans.  This has been accomplished. The second major challenge is to determine how to administer for the first time in humans an unprecedented, non-replicating and metabolically active (live) whole-organism vaccine formulation composed of PfSPZ that measure 0.5–1.0 µm x 7–10 µm so as to induce > 85% protection. Volunteers immunized by intradermal (ID) or subcutaneous (SC) routes were protected in the first clinical trial.  However the number of protected subjects was low, and despite a dose response, immunogenicity was sub-optimal.  Animal studies show that intravenous (IV) immunization induces much better immunity and protection than immunization by the SC or ID routes.  These data have been used to inform the design of the next clinical trial.  In parallel efforts are underway to optimize non-IV administration of PfSPZ, and the efficiency and scale-up of manufacture. We are also determining whether genetic targeting techniques can be used to create a parasite clone that will produce attenuated PfSPZ that are not only more potent, but also as safe as radiation-attenuated PfSPZ. Such PfSPZ could be non-replicating (as are radiation-attenuated PfSPZ), replication deficient, or replication competent, but avirulent.  Our goal is to develop, license and deploy a highly effective pre-erythrocytic stage PfSPZ vaccine that prevents blood stage infection, disease, and transmission. Such a vaccine could be used at the community level in Pf elimination campaigns, and at the individual level for prevention of Pf malaria in infants, young children, and pregnant women in endemic areas, as well as individuals of all ages who travel to malaria-endemic areas.  Biography 

3:00 Current Progress & Challenges for Developing a Dengue Vaccine

Beth CollerBeth-Ann Coller, Ph.D., Senior Vice President, Research and Development, Hawaii Biotech, Inc.

The development of dengue vaccines has been ongoing for decades and has proven to be very challenging. A key concern is the perceived need for a balanced tetravalent response in order to minimize the risk of vaccine-induced exacerbated disease. Traditional methods for vaccine development (e.g. live-attenuated viruses) showed early promise with products advancing to Phase 2 clinical development. However, manufacturing issues and the inability to achieve balanced, properly attenuated formulations led to delays or outright termination. Hawaii Biotech, Inc. (HBI) is pursuing the development of a recombinant subunit protein vaccine comprised of antigens that maintain native-like structure. This approach offers potential advantages over live attenuated and chimeric approaches in terms of safety, dosing regimen, and ease of adjusting the tetravalent balance. Progress for the various dengue vaccine development programs will be presented and the challenges remaining for the field discussed. Biography 

3:30 Networking Refreshment Break with Exhibit and Poster Viewing



4:15 TB Vaccine Development

Lew BarkerLewellys F. Barker, M.D., M.P.H., Senior Medical Advisor, Aeras Global TB Vaccine Foundation

Much progress in TB vaccine research and development over the past decade has been accomplished through partnerships between the public, private, and academic sectors via nonprofit organizations like the Aeras Global TB Vaccine Foundation. The main focus is on developing a heterologous prime-boost vaccine regimen that could include a replacement for current BCGs such as a recombinant BCG as the prime, and boosting with one of several novel vaccine candidates, including viral vectored and fusion protein vaccines. A number of vaccine candidates are in clinical trials in the US, Europe and Africa, and several other candidates are in the pipeline. The goals for a new TB vaccine regimen are safety, including in people infected with HIV, and increased efficacy against TB disease. Biography 

4:45 Immunotherapy for Prostate Cancer: Explaining the Conundrum of Improved Survival without Improvement in Time to Progression

Ravi A. Madan, M.D., Assistant Clinical Investigator, Lab of Tumor Immunology & Biology, The Center for Cancer Research (CCR), National Cancer Institute (NCI), NIH

Recent clinical data in prostate cancer suggest significantly improved overall survival without any improvement in time to progression. I will present data from recent clinical trials suggesting that both the kinetics of an anti-tumor immune response and impact of an anti-tumor immune response on subsequent therapies may explain this. I will also explain how these concepts may impact which patient populations should be enrolled in immunotherapy clinical trials and provide data from randomized studies. There is considerable confusion within the medical oncology community about how to interpret the overall survival data for immunotherapy studies and what can explain improvements in overall survival. The simple concepts I will present offer explanations that may help alleviate some of the consternation caused by the available data from randomized studies looking at overall survival.

5:15 Carbohydrate Tumor Antigen Vaccines Using Unique Strategies

Kate OlsonKate Rittenhouse-Olson, Ph.D., Professor, Director, Biotechnology Program, Biotechnical and Clinical Laboratory Sciences, The University at Buffalo

Because the presence of even small amounts of naturally occurring antibody to the Thomsen-Friedenreich cancer antigen TF-Ag is related to improved prognosis, our target Ag is TF-Ag. Our goal is to develop a vaccine that will result in an immune response to TF-Ag in the patient in order to improve prognosis. Several approaches (peptide mimics, constructs with B cell epitopes attached to immune enhancing agents) are being developed. An immune response to TF-Ag could improve the prognosis in breast, colon, bladder, prostate and other carcinomas, thus this vaccine has great clinical potential. Strategies to improve the immune response to carbohydrate antigens also have potential to impact bacterial and viral vaccines. Biography 

5:45 Reception with Exhibit and Poster Viewing

6:45 End of Day

Day 1  |  Day 2 |  Speaker Bios