Workshop

Under sponsorship by NSF and other Federal agencies, the World Technology Evaluation Center, Inc. (WTEC), the nation's leading organization for conducting international technology assessments, has commissioned a panel of U.S. experts to complete a study started in 2007 on the worldwide advances in Vaccine Development and Production. Previously the United States and Europe were analyzed; now Asia is the focus in this phase.

Results will be presented in a FREE workshop to be held on May 5, 2010, 8:30am - 4:00pm, at the National Science Foundation (NSF), 4201 Wilson Boulevard, Stafford II, Room 555, Arlington, VA, 22230. Although the workshop is free, registration is required.

Register to the workshop

Introduction

The swine flu pandemic of spring 2009 has reminded everyone of the threat of such worldwide disease. Although this pandemic seems to be receding at this writing, it may return in the winter with a vengeance as the Spanish Flu did in 1918. This threat and the continuing danger of greater human transmission of avian influenza has brought to the fore the pressing need for advances in rapidly responsive vaccine development, production, and distribution. According to a National Academy of Sciences Report, identification of a viral strain may take as long as six to eight months with additional months required to produce and distribute effective vaccines. Standard methods for production of vaccines were developed more than 50 years ago. Many modern methods, materials, and processes can enable improvement of the present situation. The solution to providing a rapid response with the production and deployment of therapeutic immunization requires cross-cutting research in manufacturing, biomedical engineering, systems modeling and other disciplines, as well as quality standards, clinical testing, and education of responders and the general public.

Need for an International Study

In 2007 WTEC conducted an assessment in this field. The final report and workshop presentations are posted at wtec/vaccmfg/. However, the available funds limited the scope only to Western Europe with some survey of R&D in North America. The expert panel and several of the sponsors wanted to extend the scope to Asia, where it was known that innovative techniques were being developed to deal with the endemic avian flu. Now that interest has been rekindled in the field, WTEC proposes to conduct the Asian assessment as a follow-on project, with some of the same expert panelists for continuity. Adding the Asian results to the European ones will make for a much more complete picture of R&D status worldwide.

The WTEC assessment will discover future research initiatives that may help address bottlenecks in the R&D and production chain that cause problems for rapid development and large-scale production and distribution of new vaccines. The results will provide guidance to R&D program managers worldwide, including those in the U.S. National Science Foundation and National Institutes of Health, as well as other agencies of the Department of Health and Human Services (e.g., FDA, CDC), the Department of Homeland Security, and the Department of Defense. The information will also be provided to international organizations concerned with public health.

Key questions that will be directly addressed in this evaluation include the following: What is the status of international R&D in rapid vaccine production and the development-deployment systems chain?

How do U.S. activities in this area compare to those of other countries?

What ideas from overseas are worth exploring in U.S. R&D programs, and vice versa?

What technologies will pay off, and what are the needs for government promotion of general progress in vaccine production?

What opportunities exist for international collaboration? Purpose

The goal of this study is to gather information on the worldwide status and trends in vaccine production R&D and to disseminate it to government decision makers and the research community.

The study panelists will gather information on research abroad, which will be useful to the U.S. Government in its own programs. The study will critically analyze and compare the research in the United States with that being pursued in Asia and Europe. This information will serve the following purposes: Identify good ideas overseas worth exploring in U.S. R&D programs

Clarify research opportunities and needs for promoting progress in the field

Identify specific opportunities (persons and institutions) for international collaboration

Evaluate the position of foreign research programs relative to those in the United States Scope

The scope of the study, subject to modification by the sponsors, will focus on the following important topics: Assessment of engineering R&D for flexible, scalable, modular vaccine production that could provide rapid response to the needs of both the general public or to smaller regional outbreaks of disease. Agricultural vaccine will be considered as well because of the demands for massive inoculation of domestic fowl and animals from which applicable lessons may be learned.

Assessment of vaccine production methods for optimum compatibility with flexible, scalable manufacturing. Methods of separation, purification, quality control, etc. will be reviewed. Which technologies can deliver the desired ability to rapidly scale and manufacture?

Assessment of rapid evaluation of vaccine effectiveness. What should be tested? What are possible useful surrogates and models for the population to receive vaccination? Additional Topics and Issues

Other topics may be added to the study scope based on discussion among expert panelists and the sponsors of the study. Some additional topics to be considered could include the following: How can the technology response be matched to the appearance of the threat? A lot might be learned from various countries' responses to local disease threats, e.g., Russia and tick-borne encephalitis disease. What is the interface between local and global vaccine/immunization programs? Rapid spread of disease could be addressed as another aspect of globalization.

How might the deployment/delivery phase for vaccines be improved? Issues of storage, shelf life, stability, and delivery methods should be reviewed. How does the manufacturing decision affect the supply chain?

Level of resources supplied by government and industry on research for vaccine production

Adequacy of existing and planned production facilities The following topics, subtopics, issues, and themes have been suggested for coverage in the study. Experience of Federal research with rotavirus

Manufacturing processes with scalability for large production

Surge capabilities

Production processes for small scale disease prevention

Flexible production capabilities

Storage and extending shelf life

Production problems

Adjuvants

Fill and finish

Intellectual property

Manufacturers' liability problems

Use of microfluidics

Standards and measurement capability: overcome in-process, in situ measurement barriers

Flow fermentation systems

Protein production

Health care modeling, primary healthcare delivery mechanisms

Realistic risk modeling and public education

Modeling of predictive toxicology

Business modeling, public funding, and purchasing

Vaccine distribution and delivery methods

Newer technologies: platforms, recombinant systems, animal testing methods

Nanoscale technologies

Long-term strategies for effective research and development: road mapping Panelists Joseph Bielitzki ,(Panel Chair) , MS, DVM
BS in Biological Sciences, University of Illinois at Chicago
BVS, MS, DVM, University of Illinois at Urbana-Champaign

Joe has a diverse background in science. His early experience is in the infectious agents affecting non human primates, especially the enteric diseases. He worked for 18 years in the National Primate Center System at both the University of Washington and the Yerkes Center of Emory University supporting research across a wide range of biomedicine. In 1996, he became the Chief Veterinary Officer for NASA, where his efforts focused on coordinating the agency wide animal care and use program, compliance issues, hardware design and training. Joe served on the working group for safety issues surrounding sample return missions from Martian environments. In 2000, he served as a government advisor on a task force for a Defense Science Board looking at defense against biological warfare. In 2001, Joe accepted a position as a Program Manager in the Defense Sciences Office at DARPA. At DARPA, he managed an extensive portfolio of life science research including, Long Term Storage of Blood Products, Peak Soldier Performance, Rapid Vaccine Assessment, Surviving Blood Loss, Restorative Injury Repair, Biofilms for Defense, Pathogen Countermeasures and Accelerated Anthrax Therapeutics. During this period, Joe interacted with a variety of federal agencies in the area of biological warfare defense. After DARPA, he relocated to Orlando, where he currently supports the Office of Research and Commercialization at the University of Central Florida and has an appointment in the College of Bimolecular Sciences and Microbiology. He also consults in the area of science and technology development for academia, industry and the government. Immunology, microbiology, pathogen evolution and protective mechanisms of immunity remain a primary interest for him. He is recognized for his expertise in the ethical issues surrounding the use of animals in research.

Professor Biomolecular Science
University of Central Florida
Inventure Holdings

Stephen W. Drew, is a former Distinguished Senior Scientist at Merck & Co., Inc. where his responsibilities encompassed the development of new process technologies for biologics and pharmaceutical manufacturing and technology transfer. Since retirement from Merck, he has founded two new companies (Drew Solutions LLC, a direct consulting firm and Science Partners LLC, an advocacy company for medicines and technologies) that support the biotechnology and pharmaceutical industries. Prior to his retirement, he held vice presidential positions of responsibility at Merck & Co., Inc. as the VP of Vaccine Science and Technology, the VP of Vaccine Operations, and the VP of Technical Operations & Engineering. He joined Merck in 1981 to create the Department of Biochemical Engineering. At Merck, he contributed to the process development and manufacture of several conventional and recombinant microbial products ranging from antibiotics to vaccines. Dr. Drew has expertise in the following areas: manufacturing processes for human and animal vaccines; recombinant biologics; chemical, biological and engineering technology for bulk manufacture of pharmaceuticals and biologics; capital project engineering; process engineering; and fermentation, cell culture, isolation and purification processes for sterile products. Dr. Drew received his B.S. and an M.S. in food science from the University of Illinois, and a Ph.D. in biochemical engineering from the Massachusetts Institute of Technology (MIT). He was elected to the National Academy of Engineering in 1993 and is a member of several professional organizations serving interests in chemical engineering, chemistry and biology. He has held offices in the American Institute of Chemical Engineers, the American Chemical Society, the American Society for Microbiology, and the Society for Industrial Microbiology, and is a Founding Fellow of the American Institute for Medical and Biological Engineering. He has served as Chairman of the advisory committee to the Engineering Directorate of the National Science Foundation. He is a member of two standing committees of the National Research Council (NRC) and has participated in many NRC studies.

Science Partners LLC
126 Mountain Avenue,
Summit, New Jersey 0790l

Cyril Gerard Gay obtained a B.Sc. in Chemistry and a Doctor of Veterinary Medicine from Auburn University, and a Ph.D. in Microbiology from The George Washington University. Dr. Gay has worked in the veterinary vaccine and animal health fields for the last 20 years holding several positions of increasing responsibility in the federal government and the pharmaceutical industry. As Chief, Biotechnology Section, Center for Veterinary Biologics (CVB), United States Department of Agriculture (USDA), Dr. Gay developed the procedures for licensing molecular vaccines that led to the first license for a live recombinant vectored vaccine worldwide. Dr. Gay has led several cross-functional teams in industry that developed veterinary vaccines. As Director, Global Product Development, Pfizer Inc., he developed strategic and tactical plans that interfaced R&D, clinical development, manufacturing, marketing, and product life-cycle management. Dr. Gay is currently the National Program Leader, Animal Health, Agricultural Research Service (ARS), USDA. Dr. Gay provides program direction and national coordination for the department's intramural Animal Health National Research Program, comprised of 124 scientists located in 11 research locations throughout the United States, including: the National Animal Disease Center (NADC), Ames, Iowa, the Avian Diseases and Oncology Laboratory (ADOL), East Lansing, Michigan, the Meat Animal Research Center (MARC), Clay Center, Nebraska, the Southeast Poultry Research Laboratory, Athens, Georgia, the Plum Island Animal Disease Center, Orient Point, New York, the Animal and Natural Resources Institute, Beltsville, Maryland, the Arthropod-Borne Diseases Research Center, Laramie, Wyoming, and the Poultry Research Unit, Mississippi State, Mississippi. Vaccine discovery is a core component of the Animal Health National Research Program.

National Program Leader, Animal Health
Animal Production and Protection
Agriculture Research Service
United States Department of Agriculture
5601 Sunnyside Avenue
Beltsville, MD 20705-5138

Terrance Leighton
Education
Postdoctoral Fellow, Biochemistry, University of California Davis, 1972
Ph. D, Microbiology, University of British Columbia, Vancouver, B.C., 1970
BS, Microbiology, Oregon State University, 1966
Synopsis of Relevant Interests

Molecular evolution of bacterial sporulation; AFM & NanoSIMS single bacterial or viral particle digital imaging under physiological conditions; Pathogen vaccines - Genomics of surface antigens, formulation and delivery technologies; Single antigen:antibody AFM imaging on native pathogen surfaces; Pathogen medical countermeasures - Genomics and structure-based drug design; DNA- and Immuno-based threat agent detection technologies; Broad-band PCR detection of viral and bacterial pathogen signatures by mass spectrometry; Urban surveillance - viral and bacterial pathogen detection systems; Large-area chlorine dioxide pathogen decontamination technologies; Nontoxic personnel pathogen decontamination technologies.

Senior Staff Scientist
Children's Hospital Oakland Research Institute
Children's Hospital Oakland Research Institute, 5700 Martin Luther King Jr. Way, Oakland, California 94609

Sheldon Howard Jacobson, Sheldon H. Jacobson is a Professor, Willett Faculty Scholar and Director of the Simulation and Optimization Laboratory at the University of Illinois at Urbana-Champaign. He has a B.Sc. and M.Sc. (both in Mathematics) from McGill University, and a M.S. and Ph.D. (both in Operations Research and Industrial Engineering) from Cornell University. Since 1996, he has been applying operation research methodologies to address healthcare problems associated with pediatric immunization and vaccination economics, pediatric vaccine pricing, and pediatric vaccine stockpile economics. He has received numerous awards for his research, including a Best Paper Award in IIE Transactions Focused Issue on Operations Engineering and a John Simon Guggenheim Memorial Foundation Fellowship. His healthcare research has been published in a wide spectrum of operations research and medical journals, including Health Care Management Science, Journal of the Operational Research Society, Pediatric Infectious Disease Journal, and Vaccine, among others. He has briefed the Advisory Committee on Immunization Practice (ACIP), the committee that provides guidance to the Secretary of the Department of Health and Human Services on issues related to immunization policy in the United States. He has also worked to transition his research into a publicly available web site,www.vaccineselection, which has been widely used by both government and private sector organization. He has received research funding from several government agencies and industrial partners, including the National Science Foundation and the Air Force Office of Scientific Research.

Professor and Director, Simulation and OptimizationLaboratory
Professor, Willett Faculty Scholar
Director, Simulation & Optimization Lab

Department of Computer Science
University of Illinois
201 N. Goodwin Avenue (MC258)
Urbana, IL 61801-2302

Dr. Mary Ritchey, of Ritchey Associates, Inc., is currently engaged in consulting for the pharmaceutical industry with a focus in the vaccines area.

Prior to taking on consulting assignments she spent 29 years in the pharmaceutical industry working on the development, manufacturing and quality aspects of vaccines and other sterile pharmaceutical products. She joined Lederle Laboratories in 1977 where her initial assignments involved developing processes for manufacturing influenza and poliovirus vaccines. During her tenure at Lederle, and then Wyeth Pharmaceuticals, she held positions of increasing responsibility in the areas of R&D, manufacturing, quality, and technical services. In 1992 she became Vice President of Operations for the Vaccines group and held additional Vice President Positions until her retirement in 2006. Product areas that she was involved in during her years at Lederle and Wyeth included vaccines for viral influenza and polio, including live attenuated and inactivated; diphtheria, tetanus and pertussis, including acellular pertussis; Haemophilus influenzae, meningitis and pneumonia, including polysaccharides and conjugates.

Dr. Ritchey received her BA in Biology from Emmanuel College in Boston, MA, and her PhD in microbiology from Cornell University in Ithaca, NY. Prior to joining industry she completed post-doctoral studies on influenza viruses at Mount Sinai Medical School in New York City.

Ritchey Associates, Inc
206 Somerset Road
Norwood, New Jersey 07648

Narayan Iyer, Ph.D.

Dr. Narayan Iyer is the Acting Chief of the Anthrax Vaccines Section of the Division of CBRN Countermeasures in the Office of the Biomedical Advanced Research and Development Authority (BARDA) within the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response. Dr. Iyer is responsible for the execution and oversight of anthrax vaccines programs authorized under Project BioShield Act of 2004 and the Pandemic and All Hazards Preparedness Act of 2006. At CBRN, Dr. Iyer is responsible for key activities in procurement of current anthrax vaccine countermeasures to the Strategic National Stockpile. He has outlined a clear anthrax vaccine development and procurement strategy for the mid and long-term. Towards these goals and execution of the strategy, his responsibilities include providing technical oversight on advanced development programs as well as ensuring a robust pipeline of candidates mitigate the risks in development for successful execution of strategic vision for countermeasures development. He also leads multiple complementary programs and interagency activities that support advanced product development.

Dr. Iyer has been in the biotech and vaccine industry for over 10 years. He managed both early and advanced product development of two product lines - Anthrax vaccine as part of the Biodefense portfolio and vaccine against Travelers Diarrhea at Iomai Corporation (now Intercell USA). As a Sr. Manager in Technical Operations, has worked in Bioprocess development for drug substance and product manufacturing as well as applications of QbD to late-stage processes, ensuring compliance for licensure requirements. He has received awards and citations for his contributions to advanced product development. Prior to that, at Corning Inc, he managed product development of oligonucleotide-based microarrays for monitoring regulation of gene expression.

Dr. Iyer received his doctorate degree in Molecular Microbiology including his working as a UNESCO fellow at Biological Research Center at Szeged, Hungary, from the Indian Institute of Science (IISc) Bangalore, India. He has numerous publications from his post-doctoral research at UT Southwestern Medical Center and Johns Hopkins School of Medicine.

Acting Chief, Anthrax Vaccines,
Division of Chemical, Biological, Radiological, and Nuclear (CBRN) Countermeasures

Biomedical Advanced Research and Development Authority (BARDA)
Office of the Assistant Secretary for Preparedness and Response
Department of Health and Human Services
330 Independence Avenue, S.W. ,Washington, DC 20201 Source:
Patricia Foland
World Technology Evaluation Center

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