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Friday, June 26, 2015 | 1:00 – 4:00 pm 


The need for the rapid formulation of novel vaccines in response to emerging pathogens is critical to public health and safety. The vaccines developed should elicit protective immune responses and be unaffected by pre-existing immunity to vaccine components. In addition, these treatments should be amenable to combination and multi-agent formulation, and should be safe for all populations and the environment.

Topics to be covered include:

  • Status of Vaccines for Ebola
  • Vaccines for Bacterial Pathogens
  • Advances in Rational Vaccine Design and Development Role of Adjuvants in Developing More Effective Vaccines
  • Veterinary Vaccines and New Generation of the DIVA-concept
  • Advances in Vaccine Manufacturing
  • Strategies for Vaccine Licensing
  • FDA’s Regulatory Policy
  • Initiatives for Funding Vaccine Development Government Vaccine Portfolio

Presentation Summaries 

Rational Combinatorial Vaccine Development for Known and Unknown Pathogens: Universal vs. Regional  

Willy Valdivia-Granda, Ph.D., CEO, Orion Integrated Biosciences  

Of the thousands of peptides encoded by a pathogen proteome, only a small fraction induces protective immunity and identifying such regions have proved challenging. While in vitro and in vivo immunogenic evaluation of individual peptides led to the implementation of several immunogenicity prediction algorithms, the accuracy of these bioinformatic applications range from 15 to 80% and some methods are simply unusable for vaccine development. Here we introduce a new approach for vaccine design and development using our motif fingerprint technology. Our experience in the generation of targets for Ebola, MERS, SARS, Influenza and Dengue will be discussed. The presentation will summarize the need for a new generation of universal and regional vaccines.

Evaluating Effective Immunity Against Filoviruses for Production of Better Vaccines  

Leslie Lobel, M.D., Ph.D., Department of Microbiology, Immunology and Genetics Faculty of Health Sciences, Ben Gurion University of the Negev, Israel  

We will explore the merits of studying long term immunity in filovirus survivors for development of vaccines and therapeutics in addition to the current status of the field. Recovery from ebolavirus infection in humans is associated with the development of both cell-mediated and humoral immune responses. According to recent studies, individuals that did not survive infection with ebolavirus appear to have lacked a robust adaptive immune response and the expression of several early innate response markers. However, a comprehensive protective immune profile has yet to be described. We examined cellular and humoral memory immune responses among survivors of filovirus outbreaks in Uganda from 2000 to 2012. Cytokine responses between groups were similar but had distinct differences. Neutralizing, filovirus-specific IgG activity against irradiated virus and filovirus specific recombinant proteins were detected in survivor cohorts. Additionally, humoral and cell-mediated crossreactivity was identified in these cohorts. The immune responses in survivors groups demonstrate persistent recognition of filovirus specific antigens. Different cytokine responses were observed between different outbreak survivors, suggesting that each outbreak may not yield identical memory responses and promotes the merits of studying the immune responses among outbreaks of the same virus for optimal vaccine design. Finally, our demonstration of cross-reactive immune recognition suggests that there is potential for developing cross-protective vaccines for filoviruses.

Novel Immunization Strategies for Biodefense Applications  

Darrell R. Galloway, Ph.D., Adjunct Professor of Pharmaceutical Chemistry, Department of Pharmaceutical Chemistry, University of Utah  

The presentation will feature an overview of three different technology strategies with direct application to immunization against biodefense agents. First, a discussion of a novel cytokine depot formulation which has demonstrated the ability to immediately enhance the immunological efficacy against numerous protein antigens from viral or bacterial sources. Data will be presented comparing the efficacy of immunization with adjuvant formulated anthrax PA and LF antigens versus the current anthrax vaccine. In addition, enhanced efficacy of immunization against hepatitis B will be provided. The second technology to be presented will be an overview of a strategy used to rapidly induce an immune response against any number of antigens. This strategy has been used to induce chemically programmed antibodies and has been applied to studies in cancer and HIV infection. Finally, a novel approach to the induction and selection of therapeutic human monoclonal antibodies will be presented. An overview of a technology to rapidly induce the production of intracellular combinatorial libraries of antibodies with applications to biodefense will be discussed.

New Paradigm and Rational Strategies Needs for Protective Immunizations  

Francisco Veas, Ph.D., Senior Leading Researcher, French Institute of Research for Development (IRD), France  

Despite that Pasteur’s like fashioned vaccines have shown great successes against multiple pathogens, including bacteria and viruses even those able to induce highly severe pathologies such as small pox virus, yellow fever virus, polio, rabies virus as well as measles, a long list of infectious diseases remain without any prophylactic (1st option) or even therapeutic solution (2nd option). Therefore, a new paradigm of vaccination is more than needed. This new paradigm of vaccination must include: (i) the exposure of highly conserved unmasked epitopes of the targeted pathogen, (ii) additional new-generation adjuvants as well as an improved understanding of the modulation of the host immune response. Respectively, these unmet needs will require high sequence quality and updated data that must be a combination of high quality structural data and high quality metagenomic data, to indeed complete the knowledge on the human immune response during and after immunization.

Instructor Biographies 

Willy Valdivia-Granda, Ph.D., CEO, Orion Integrated Biosciences  

In 2005, Willy Valdivia funded Orion Integrated Biosciences, Inc. to develop a new generation of diagnostics, prophylactic and therapeutic solutions for know and unknown infectious pathogens of biodefense relevance. With his background in molecular genetics, bioinformatics and business development, Willy serves as CEO of the corporation and oversees Orion’s research in decoding genomic signatures associated with source of origin, virulence and possible genomic manipulation. Willy is published in the areas of infectious diseases, genetics, bioinformatics and biodefense. He serves as a subject matter expert for the U.S. government in areas spanning computational biology, solutions for diseases of military relevance, genomic and metagenomic data generation and alaysis, biotechnology, nanotechnology and nanofabrication.

Leslie Lobel, M.D., Ph.D., Department of Microbiology, Immunology and Genetics Faculty of Health Sciences, Ben Gurion University of the Negev, Israel  

Dr. Leslie Lobel, M.D., Ph.D., is a senior lecturer and a leading researcher at the Ben Gurion University of the Negev, Israel and is the chair of the Department of Microbiology, Immunology and Genetics Faculty of Health Sciences. Dr. Lobel received her M.D., Ph.D. in 1988 from Columbia University. Dr. Lobel’s research interests include such areas as replication competent retroviral vector, filamentous phage display libraries, immunoprospecting and human monoclonal antibodies, lymphoma specific monoclonal immunoglobulins, immunoglobulin profiling and combinatorial biology.

Darrell R. Galloway, Ph.D., Adjunct Professor of Pharmaceutical Chemistry, Department of Pharmaceutical Chemistry, University of Utah  

Dr. Galloway obtained a baccalaureate degree in microbiology from the California State University in Los Angeles in 1973 and completed a doctoral degree in biochemistry in 1978 from the University of California, followed by two years of postgraduate training in immunochemistry as a Fellow of the National Cancer Institute at the Scripps Clinic and Research Foundation in La Jolla, CA. Dr. Galloway was commissioned as a Lieutenant in the U.S. Navy in 1978 and entered active service in 1980. Dr. Galloway worked at the Naval Medical Research Institute in Bethesda, MD where he served as a research scientist from 1980-1984 working on vaccine development. Captain Galloway has been a member of the American Society for Microbiology since 1980 and has served as past President of the Ohio Branch of that organization. Dr. Galloway is currently President and Founder of Galloway & Associates and is an Adjunct Professor of Pharmaceutical Chemistry at the University of Utah.

Francisco Veas, Ph.D., Senior Leading Researcher, French Institute of Research for Development (IRD), France 

Dr. Veas is a senior leading researcher at the French Institute of Research for Development (IRD), Montpellier France, head of the LIPMC and deputy director of the UMR-Ministry of Defense3; He coordinates the European IF-EBOLA action. He is also lecturer of epistemology and history of medical sciences at the Ecole Pratique de Hautes Etudes and Montpellier University. Dr. Veas received his PhD in 1986 from Montpellier University.  Dr Veas is co-founder and CSO of the ApoH-Technologies Co., which is dedicated to pre-analytical preparation of any kind of sample (human or animal fluids or tissues, environment, food, etc) for ultrasensitive diagnosis of pathogens from any origin (Clinic, veterinary, industry, environment). His research is mainly scoped on conservative host-pathogen interactions, including innate immunity players and conserved structures and functions of the pathogen.

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