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Speakers 
Dr Else Marie Agger, Project manager, Adjuvant Research, Statens Serum Institut
Dr. Else Marie Agger is project manager of Adjuvant Research in the Department of Infectious Disease Immunology, Statens Serum Institut (SSI). She has worked with pre-clinical assessment of subunit vaccines with a special emphasis on the adjuvant component and has extensive experience within a number of adjuvants, in particularly with adjuvants based on cationic liposomes being developed by SSI. Currently, she is involved in the coordination of a workpackage within an EU-funded project dealing with vaccine optimisation for a subunit vaccine against tuberculosis. In addition, as work-package leader within an EU-funded project focused on improved vaccination strategy against influenza she has experience with adjuvantation of influenza vaccines.
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Colonel Randall Anderson, Director, Military Vaccine Agency, US Department of Defense
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Dr Jon Andrus, Chief, Immunisation Programme, Pan American Health Organisation
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Dr KV Balasubramaniam, Managing Director, Indian Immunologicals
Shri K V Balasubramaniam, Managing Director, Indian Immunologicals Ltd holds a graduate degree in Mechanical Engineering from Madras University (1979) and a masters degree in management from the Indian Institute of Management, Ahmedabad ( 1981).
He has over 25 years experience in managing industrial enterprises, with nearly 20 years in the pharmaceutical industry. He joined Indian Immunologicals in 1996 as Chief executive and has been instrumental in reviving the fledgling unit of the National Dairy Development Board and making it a professionally managed, performance driven and result oriented vaccine player. He was inducted into the Board as Managing Director in 1999. Indian Immunologicals is today the No 1 animal vaccine player , the 4th largest animal health company and the 10th largest biotech company in India.
Shri Balasubramaniam’s key area of expertise has been in general management, starting new businesses, turn around management and project management.
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Dr Harvey Bale Jr., Director General, International Federation of Pharmaceutical Manufacturers and Associations
Dr. Bale is Director-General of the International Federation of Pharmaceutical Manufacturers Associations, IFPMA. Created in 1968 as an non-profit, non-governmental organization (NGO), the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) represents the research-based pharmaceutical industry and other manufacturers of prescription medicines, through over 55 industry member associations worldwide. IFPMA is the main channel of communication between this sector of the industry and the World Health Organization (WHO), the World Trade Organization (WTO) as well as other international organizations that are concerned with health and trade-related issues. Since Dr. Bale's arrival, IFPMA has engaged in developing new private-public partnerships, including the Global Alliance for Vaccines (GAVI), the Medicines for Malaria Venture (MMV) and the WHO Industry Roundtable process which is looking at joint actions in the areas of drug access, drug development and drug quality and counterfeiting. As Director-General, he also serves as President of the Pharmaceutical Security Institute an organization dedicated to combating counterfeiting.
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Dr Eliav Barr, Head of Biological Clinical Research, Merck & Co
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Dr Julia Barrett, Senior Clinical Consultant, Biologicals Consulting Group
Julia Barrett, MD, MPH - Senior Clinical Consultant Dr. Barrett joined BCG as a senior consultant in December 2004 after working as an affiliate with the company for several years. She worked from 1992-1997 as a senior clinical reviewer at CBER and is currently a consultant and practicing clinician in Internal Medicine in Colorado. Her regulatory expertise, coupled with her ongoing clinical experience, provides her with a unique perspective on CBER requirements for the design, preparation and implementation of Phase 1, 2, & 3 clinical protocols.
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Ms Amie Batson, Senior Health Specialist, World Bank
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Dr Vera Byrnes, Vice President, Synergee LLC
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Dr Max Ciarlet, Associate Director, Vaccine & Biologics - Clinical Research Department, Merck Research Laboratories
Dr. Ciarlet is a French citizen born in Caracas, Venezuela. He earned his BS in Biological Sciences at Florida Atlantic University (Boca Raton, Florida) in 1987 and his PhD in Microbiology/Virology at the Instituto Venezolano de Investigaciones Científicas (IVIC, Caracas, Venezuela) in 1992. Dr. Ciarlet is an experienced virologist with more than 17 years of rotavirus research, and is currently engaged in vaccine clinical trials with Merck & Co., Inc.
At IVIC, Dr. Ciarlet studied the antigenic and molecular divergence of animal rotaviruses, and his academic achievements were publicly recognized in 1993 when he was bestowed by the president of Venezuela. Dr. Ciarlet completed his post-doctoral research training at Baylor College of Medicine in Houston, Texas, where he evaluated the immune response and protective efficacy of different formulations of candidate virus-like particles (VLP) subunit vaccines against rotavirus. Dr. Ciarlet subsequently became an Assistant Professor at Baylor College of Medicine and his work focused on the initial virus-cell interactions and rotavirus pathogenesis, including the development of a new animal model of age-dependent rotavirus-induced diarrheal disease in rats.
In 2002, Dr. Ciarlet joined Merck Research Laboratories (MRL) and was responsible for generating the analytical data for the critical characterization activities of Merck’s candidate rotavirus vaccine, RotaTeq®. His efforts included complete physical, biochemical, antigenic, and molecular characterization of RotaTeq® and the characterization of all process-related impurities. Since late 2004, Dr. Ciarlet has joined the Department of Clinical Research at MRL as a Clinical Monitor, carefully designing and implementing clinical trials in support of the rotavirus vaccine program. Dr. Ciarlet is currently the Lead Clinical Monitor overseeing the Phase III and Phase IV activities for the RotaTeq® franchise.
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Dr Kathleen Coelingh, Senior Director, Scientific Affairs, MedImmune Vaccines
Dr. Kathleen L. Coelingh is senior director, scientific affairs for MedImmune Vaccines, Inc. She develops scientific strategies for MedImmune’s influenza, respiratory syncytial virus, parainfluenza and human metapneumovirus vaccines.
Dr. Coelingh joined Aviron (now MedImmune Vaccines, Inc.) in 1993 as a senior scientist. She previously held a number of increasingly responsible positions at Aviron as a scientist and director.
Prior to joining Aviron, Dr. Coelingh was a staff scientist at Protein Design Labs in Mountain View, California. Previously, she had served for ten years as a senior staff fellow in the Respiratory Viruses Section of the Laboratory of Infectious Diseases at the National Institute of Allergy and Infectious Disease, a division of the National Institutes of Health. Dr. Coelingh began her career as a post-doctoral fellow and later a research associate in the Division of Virology at St. Jude Childrens’ Research Hospital.
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Dr Oren Cohen, Chief Medical and Scientific Officer, Quintiles Transnational Corp.
Oren J. Cohen, MD, is Chief Medical and Scientific Officer for Quintiles Transnational. Concomitantly, he holds an appointment as clinical associate professor of medicine on the infectious diseases faculty of George Washington University Medical Center.
Joining Quintiles in 2001, Dr. Cohen served on the company’s bioterrorism preparedness committee. His industry experience is concentrated in antiviral drug development, with particular emphasis in HIV, hepatitis B and hepatitis C. Completing a fellowship at the National Institute of Allergy and Infectious Diseases, he conducted clinical HIV/AIDS research at NIAID’s Laboratory of Immunoregulation for several years. At NIAID, he served on a clinical practices panel that formulates national guidelines for the use of antiretroviral agents.
Dr. Cohen was elected to Phi Beta Kappa at Brandeis University, where he received a bachelor’s degree in biochemistry. He earned a medical degree from Duke University and completed his residency at New York Hospital/Cornell University Medical Center, where he was assistant chief resident. He is board certified in internal medicine and infectious diseases. He has written more than 50 scientific articles and book chapters. A fellow of the Infectious Diseases Society of America, he also serves as a reviewer for such highly respected medical journals as The Lancet and AIDS, among others. He has won numerous awards for his professional achievements and has presented his work at dozens of conferences around the world.
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Dr Annie De Groot, Chief Executive Officer and Chief Scientific Officer, Epivax
De Groot earned degrees from Smith College (BA, 1978) and the Pritzker School of Medicine at the University of Chicago (MD, 1983). She was trained in internal medicine at Tufts New England Medical Center (1986), and then went on to complete additional training in immunoinformatics and vaccine research under Jay Berzofsky at the National Institutes of Health (1989). Following her fellowship at the NIH, she returned to Tufts NEMC for clinical training in infectious disease (1991). She became board certified in Internal Medicine in 1986 and in Infectious Disease in 1992. In 1992, she joined the faculty of the Brown University Medical School, where she opened the TB/HIV Research Laboratory. De Groot licensed the EpiMatrix vaccine design technology from her laboratory at Brown and established EpiVax, a bioinformatics and vaccine design company in 1998. She teaches undergraduate students vaccinology at Brown University and provides clinical care to patients at the Rhode Island TB clinic and the Rhode Island Free Clinic. She is founder and Co-Chief editor of Infectious Diseases in Corrections report (an on-line electronic journal, established 1998) and founder and Scientific Director of the GAIA Vaccine Foundation (501c3, 2002). De Groot has received uninterrupted federal funding for her research activities through multiple NIH (K08, R21, R01, SBIR) and foundation grants since 1989. She has published more than 60 articles and chapters describing the development of epitope-driven vaccines and the application of immunoinformatics tools. In addition to her active research on vaccines for HIV, TB, Tularemia, Smallpox and EBV, she is a pioneer in the field of deimmunizing protein therapeutics. She was the recipient of a National Foundation for Infectious Diseases-Eli Lilly Award, two Rhode Island Foundation awards and a Commercial Innovation Award (from the Rhode Island Center for Cellular Medicine). More recently, she was recognized as one of the “Best and the Brightest” in Science and Technology by Esquire Magazine (2003) and Rhode Island Woman Physician of the Year (2006) for her work on the GAIA HIV vaccine.
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Dr Béatrice De Vos, Head Global Medical Affairs, GlaxoSmithKline Biologicals
Beatrice De Vos is a medical doctor trained at the Catholic University of Leuven in Belgium and at the Erasme University in Brussels. She is a member of the Belgian College of Pharmaceutical Medicine. In the early 90s, she started the medical department of Menarini in Belgium and then moved to clinical research with Wyeth-Ayerst Research and Development. In 1999, she joined GSK Biologicals vaccine headquarters at Rixensart, Belgium, to lead the worldwide clinical development of a new rotavirus vaccine. Supported by a global team of GSK collaborators, she has been responsible for the delivery of an extensive global clinical file leading to the registration of the GSK rotavirus vaccine. Currently, she is head of the Worldwide Medical Affairs Department and is responsible for the global medical and scientific communication support for the entire range of GSK Bio marketed vaccines.
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Dr Ronald Ellis, Senior Vice President, Research and Development, Avant Immunotherapeutics
Dr. Ronald Ellis has 25 years of industry experience in research and development of vaccines and biologics. He has championed or led R&D efforts on a wide range of viral and bacterial vaccines from discovery or in-licensure through early and advanced development as well as to product licensure and launch – including several vaccines on the market – those for human papilloma virus, rotavirus, varicella, hepatitis B, and Haemophilus influenzae type b. He is Editor-in-Chief of the peer-reviewed journal Human Vaccines, launched in 2005.
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Dr Renata Engler, Colonel, Director, Vaccine Healthcare Centers Network, Walter Reed Army Medical Center
*Laboratory of Allergic Diseases, NIAID, NIH, Bethesda, MD: Clinical Instructor, Consultant: 1996-present. *Associate Professor, Department of Medicine (primary), Department of Pediatrics (secondary), Uniformed Services University of the Health Sciences (USUHS), Bethesda, Maryland 20814 : 1996-present *National Institute of Allergic & Immunologic Diseases (NIAID), National Institute of Health (NIH), Bethesda, MD; Clinical Instructor, Consultant: 1985-1996. *Asst. Professor, Department of Pediatrics, USUHS: 1983-present *Instructor, Department of Medicine, USUHS: 1980-1982 *Teaching Fellow, Department of Medicine, 1978-1980
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Dr Elaine Esber, Executive Director, Medical Affairs International, Merck Vaccine Division, Merck & Co.
Elaine C. Esber, M.D., is a pediatrician with a subspecialty in Pediatric Hematology and Oncology. She joined Merck & Co., Inc., in April 2001, as Executive Director, Medical Affairs International in the Merck Vaccine Division (MVD). In this capacity, she represents MVD with international organizations, including the World Health Organization (WHO), the Global Alliance for Vaccines and Immunization (GAVI), the Pan American Health Organization (PAHO), the International Association for Biologics (IABs), as well as numerous other international organizations. She represents Merck &Co, Inc. on the Ad Hoc Industry Group that discusses GAVI policy and activities, serves in support of the GAVI Board member (a position currently held by the Merck Vaccine President) , as well as on the IFFIm Task Team, among others. She Chairs the International Federation of Pharmaceutical Manufacturers Association’s (IFPMA) Biologics and Vaccines’ Committee and serves as the industry member of the Strategic Advisory Group of Experts (SAGE) of the WHO as well as representing the biologics industry on behalf of IFPMA. Dr. Esber also directs the Merck Vaccine Network – Africa Program (MVN-A) for the Merck Company Foundation. The project is aimed at developing training centers in Africa in support of immunization efforts of GAVI. In addition, she is frequently called upon to make presentations on vaccines, immunization, regulatory and other related topics.
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Jean-Louis Excler, Senior Medical Director, The International AIDS Vaccine Initiative
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Dr Patricia Fast, Executive Director, Medical Affairs, Research and Development, The International AIDS Vaccine Initiative
As Director, Medical Affairs, Dr. Fast directs the human trials of IAVI-sponsored vaccine candidates. Dr. Fast joined IAVI from Aviron, a biopharmaceutical firm, where as Director, Clinical Research, she oversaw studies of vaccines for influenza and cytomegalovirus. She received her MD at Michigan State University, is board certified in pediatrics and also holds a PhD in immunology from the University of California at Los Angeles (UCLA). At the Division of AIDS at the US National Institute of Allergy and Infectious Diseases (NIAID), Dr. Fast led HIV vaccine clinical research as Associate Director for Vaccines and Prevention. In addition, she has worked at The Upjohn Company, Wellcome Research Laboratories and UCLA. Dr. Fast has served on several national and international vaccine advisory committees, including the UNAIDS Vaccine Steering Committee, the NIAID AIDS Vaccine Working Group, the Scientific Advisory Committee for the American Foundation for AIDS Research and the U.S. National Vaccine Advisory Committee. She currently serves on the UNAIDS/WHO Vaccine Advisory Committee.
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Dr Leonard Friedland, Senior Director, Vaccines, Clinical R&D and Medical Affairs, GlaxoSmithKline Biologicals
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Ms Gargee Ghosh, Senior Program Officer, Global Health Policy and Finance, Bill and Melinda Gates Foundation
Gargee Ghosh is a Senior Program Officer in Global Health Policy and Finance at the Bill & Melinda Gates Foundation. She works on building access to new health technologies in the developing world, in particular on the Foundation’s portfolio of work in innovative financing – partnering to create new funding mechanisms for donors to give more and more efficiently, and also partnering to mobilize new sources of funding (e.g., from the private sector). In that capacity, she has been involved in establishing GAVI’s International Finance Facility for Immunization, discussions on Advance Market Commitments, the pilot of a Global Fund Debt Conversion initiative, and more recently, in discussions on the pilot airline tax and drug purchase facility sponsored by the French government. Prior to joining the Foundation, Gargee was a manager with McKinsey & Company in New York and London working on healthcare and financial services projects, and was one of the first employees of the Center for Global Development’s Global Health Policy Research Network where she managed a portfolio of work on incentive mechanisms to stimulate product development. Gargee has a masters degree in economics from the University of Oxford. a masters in international relations from the Georgetown School of Foreign Service, and an undergraduate degree from the University of Victoria in Canada. She lives in Seattle, WA.
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Dr Doug Given, Partner, Bay City Capital
Douglass Given, MD, PhD, MBA, is a Partner at Bay City Capital and has been with the firm since October 2000. He was formerly Chief Executive Officer and a director of NeoRx, and Corporate Sr. Vice President and Chief Technical Officer of Mallinckrodt. Prior to Mallinckrodt, Dr. Given served as Chief Executive Officer and a director of Progenitor and Mercator Genetics. He held positions as Vice President at Schering Plough Research Institute, Vice President at Monsanto/G.D. Searle Research Laboratories, and Medical Advisor at Lilly Research Laboratories. Dr. Given is the Chairman of VIA Pharmaceuticals and a member of the board of directors of SemBioSys Genetics and Aksys, Ltd. He is also a member of the Visiting Committee to the Division of Biological Sciences and the Pritzker School of Medicine at the University of Chicago and the Johns Hopkins Bloomberg School of Public Health Advisory Board. Dr. Given holds an MD with honors and a PhD from the University of Chicago, and an MBA from the Wharton School, University of Pennsylvania. He was a fellow in Internal Medicine and Infectious Diseases at Harvard Medical School and Massachusetts General Hospital.
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Dr Lance Gordon, Former President and CEO Vaxgen, Independent Advisor
Dr Lance Gordon has more than 20 years of experience in the vaccine industry, developing both vaccine products and companies. Prior to joining VaxGen, Dr Gordon served as founding CEO and a member of the Board of Directors of two vaccine companies, OraVax and North American Vaccines. He was also the CEO of North American’s predecessors, American Vaccine Corp and Selcore, Inc. During the 1980’s, Dr. Gordon served a seven-year tenure at Connaught where he was Director of Viral and Bacterial vaccines research and the inventor of ProHibit® a vaccine for infant meningitis, the first bacterial conjugate vaccine to receive FDA approval. After leaving Connaught, he served as a medical director at E.R. Squibb where he designed and implemented clinical pharmacology programs for infectious and inflammatory disease products and candidates.
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Mr Michel Greco, Independent Vaccine Expert, Independant Vaccine Expert
Michel Greco has had a long and successful career in the industry, both in pharmaceuticals first, with the former Rhone-Poulenc Group, and in the vaccine area for the last 15 years. From 1988 to 1993, through successive mergers and acquisitions, he had senior management responsibilities at Institut Mérieux, then Pasteur Mérieux Connaught. From 1994 to 1998, he was President and CEO of Pasteur Mérieux MSD (a European joint venture between Pasteur Mérieux and Merck). Since 1998 and until the beginning of 2003, he was President and COO, then Deputy CEO and member of the Board of Aventis Pasteur. Michel Greco is presently member of the Board of a number of biotechnology companies and of non-profit international institutions.
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Dr Martin Green, Lead Toxicologist, Office of Vaccines Research and Review, FDA
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Dr Robert Hecht, Senior Vice President for Public Policy, The International AIDS Vaccine Initiative
Robert Hecht is the Senior Vice President for Public Policy at the International AIDS Vaccine Initiative. Previously, he served at the World Bank as Director and Manager of the Bank’s central unit for Health, Nutrition, and Population, and before that as Chief of Operations for the World Bank's Human Development Network. Dr. Hecht is one of the authors of the 1993 World Development Report, "Investing in Health" and numerous other publications on the economics and anthropology of development. From 1998 to 2001, he was an Associate Director in the Joint United Nations Programme on HIV/AIDS (UNAIDS). He holds a BA degree from Yale University and a PhD. from Cambridge University.
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Dr Luc Hessel, Executive Director, Medical and Public Affairs, Europe, Sanofi pasteur MSD
Dr Luc Hessel is Executive Director, Medical and Public Affairs, Europe, at Sanofi Pasteur MSD, the European Joint Venture between Sanofi Pasteur and Merck & Co., leading companies in vaccines and biotechnology products. He graduated in medicine from the University of Bordeaux in 1976. His professional background includes 13 years of clinical and academic activities in Internal Medicine and Public Health at the University Hospital in Limoges, France. Since 1986, he worked at Sanofi Pasteur in clinical research and development of new vaccines and other biopharmaceuticals. At Sanofi Pasteur, he then served as Director of Medical Affairs and Head of the Pharmacovigilance Department between 1992 and 1996. From 1997 to 2001, Dr. Hessel had responsibility for managing the medical function at Sanofi Pasteur MSD, and coordinating the company’s medical and clinical activities. Since April 2002 he is in charge of medical and public affairs, covering a broad range of activities, including medical expertise for online and new vaccines, relationship with governments and international institutions, pharmacovigilance and risk management. Dr. Hessel is currently chairman of the Influenza Pandemic Working Group of the European Vaccine Manufacturers (EVM) a specialised group within the European Federation of Pharmaceutical Industry Associations (EFPIA), and is member of the Biologicals and Vaccines Committee of the International Federation of Pharmaceutical Manufacturers Associations (IFPMA), where he chairs the Influenza Vaccine Supply International Task Force.
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Professor Peter Hotez, Professor and Chairman, Department Microbiology and Tropical Medicine, The George Washington University
Peter Hotez is Professor and Chair of the Department of Microbiology and Tropical Medicine at The George Washington University, where his major research and academic interest is in the area of vaccine development for parasitic and tropical diseases, and the role of vaccines in international diplomacy.
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Dr Suresh Jadhav, Executive Director, Serum Institute of India
Dr. Suresh S. Jadhav, Executive Director (Q.A.), Serum Institute of India Ltd. Dr. Jadhav has served since 1992 as Executive Director of Serum Institute of India Ltd., Pune, which he joined as a manager, quality control (QC) in 1979. He has been instrumental in the development and adoption of the latest QC techniques and in elevating the Institute to standards on par with Western manufacturing facilities. He played a vital role in securing accreditation from World Health Organization (WHO) for Serum Institute, helping to put the Serum Institute on the global map as a supplier to U.N. agencies. Dr. Jadhav’s 34 years of technical expertise covers areas including biologicals quality control and assurance and good manufacturing practice techniques, pharmacology, standardization of biochemical methods, inspections of laboratories, and pharmacological and toxicological screening of various drugs, toxins and venoms. His expertise in the field of biologicals has been recognized in requests since 1988 as a WHO advisor on vaccine policy, newer vaccines, vaccine testing, and international standard. He has also been appointed by WHO’s Global Programme for Vaccines and Immunization as a member of their Expert Review Committee on Animal Husbandry. He served on the Sabin Vaccine Institute Task Force on Harmonization for Vaccine Supply, 2003. Dr. Jadhav holds a MPharm from Nagpur University and a Ph.D. from the Haffkine Institute, Mumbai.
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Dr Allan Jarvis, Senior Vice President, Corporate Development, sanofi pasteur
Allan Jarvis is currently Senior Vice President, Corporate Development at Aventis Pasteur, a Division of Aventis Pharmaceuticals. In that capacity he is responsible for the Business Development, Strategic Planning and Process Efficiency and Cost Effectiveness functions. He oversees AvP’s worldwide Corporate Development function and is responsible for managing the company’s growth through alliances, joint-ventures, partnerships, mergers, acquisitions, and the licensing of products and technology. Prior to this, he was Vice President, Business Development and Strategy for the Vaccine Business Unit of Wyeth Pharmaceuticals. Allan received his PhD in Molecular Genetics from the University of California and held NIH Post-Doctoral Fellowships from 1976-1980 at Sloan Kettering Cancer Institute and the Worcester Foundation for Experimental Biology. In 1980, he co-founded Damon Biotech, Inc. where he held diverse positions of increasing responsibility from Manager, Molecular Biology to Vice President, Research and Vice President Business Development. From 1990 to 1992, he worked at Abbott Laboratories, Inc., as Director, Business Development. In 1992 he joined Repligen Corp. in the dual role of Vice President, Business Planning for the parent company and Sr. Vice President, Commercial Development for its wholly owned subsidiary, Amira, Inc. His primary areas of business focus include: strategic planning, valuing products and technology, negotiations and partnership management.
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Ms Fran Lessans, President and Chief Executive Officer, Passport Health
As founder, president and CEO of PASSPORT HEALTH?, Fran brings over 29 years of medical and management experience to her clients. Before founding PASSPORT HEALTH?, Fran worked in a variety of clinical settings as a registered nurse, educator and health care administrator. Fran’s business acumen is known in the community, as she has successfully turned multiple troubled organizations into profitable ventures. In 2005 she was awarded the Innovator of the Year award by the Maryland Department of Business & Economic Development and in 2006 won the Ernst & Young Entrepreneur of the Year award for the Maryland region.
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Dr Ruth Levine, Director of Programmes and Senior Fellow, Center for Global Development
Ms. Levine is a Senior Fellow and Director of Programs at the Center for Global Development (CGD) and head of CGD’s Global Health Policy Research Network. An expert on health and education, she was previously a Senior Economist at the World Bank and Social Sectors Advisor at the Inter-American Development Bank. She has worked in 14 developing countries and on global programs such as the Global Alliance on Vaccines and Immunization. Ms. Levine holds a doctoral degree in economics and public health from Johns Hopkins University and is co-author of The Health of Women in Latin America and the Caribbean (World Bank) and the forthcoming Millions Saved: Proven Successes in Global Health (CGD).
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Mr Clement Lewin, Vice President, Biodefense and Policy, Acambis
Clement Lewin is Vice President of Government Affairs and Strategy at Acambis. Prior to taking up his position, Clem was at Chiron Vaccines as Vice President Government Affairs & Immunization Policy for the US and Vice President, Strategic Planning & Business Intelligence for the business unit based at global headquarters in the United Kingdom. Clem obtained his BSc and PhD from the University of London. After 5 years as a Research Fellow at the Universities of London and Edinburgh focusing on mechanisms of action and resistance to antibiotics he obtained an MBA with distinction from Cornell University. He then joined the life sciences practice of Pittiglio Rabin Todd & McGrath specializing in product development issues. Prior to joining Chiron, Clem was with Merck Vaccines Division in a variety of domestic and international marketing positions and with Bayer Pharmaceuticals as Director of Global Scientific Affairs for their anti-infective franchise. He currently serves as the BIO liaison representative to the Advisory Committee on Immunization Practices and on the advisory boards of Bio Ventures for Global Health and the Alliance for Biosecurity.
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Mr Andy Lewin, Business Development Director, SynCo Bio Partners
Andy Lewin currently heads the Business Development and Project Management functions at SynCo Bio Partners and has more than ten years experience in biotechnology and pharmaceutical development especially within the context of contract research and contract manufacturing organisations.
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Dr Karen Lingnau, Head of Pharmacology and Toxicology, Intercell AG
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Dr Christian Loucq, Director, The PATH Malaria Vaccine Initiative
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Mr Jacques-Francois Martin, President and CEO, Parteurop
Jacques-François Martin has spent the essence of his career in the pharmaceutical, biological and life sciences industries.
From 1970 until 1976, he was the Chief Executive Officer of Rhône-Poulenc Pharma in Hamburg, Germany. Martin then returned to France to join the Institut Mérieux as Vice President of sales and marketing, where he largely contributed to the international expansion of Mérieux. He was named the company’s Chief Executive Officer in 1988, and successfully negotiated with the government of Canada to acquire Connaught Laboratories.
In 1991, Martin set up Parteurop S.A, a biotech consulting company based in Lyon, France. At Parteurop, Martin as Chairman and CEO, helps establish start-up companies by leveraging innovation from French and foreign institutions.
From 1996 to 1998, Martin was the Chief Executive Officer of the Fondation Jean Dausset – Centre d’Etudes du Polymorphisme Humain, a private foundation dedicated to genomics research.
From September 1996 to September 1999, he was a member of the Board of INSERM (Institut National de la Santé et de la Recherche Médicale, the French National Institute of Health).
From 1994 to 1997, Martin served as the Chairman of the Biologicals Committee of the International Federation of Pharmaceutical Manufacturers Associations. As such, he was a member of the Scientific Advisory Group of Experts of WHO (SAGE).
From November 1997 to June 2003 he was a member of the Board of the International AIDS Vaccine Initiative (IAVI).
From 2000 to January 2005, Martin held the position of President of The Vaccine Fund. He lead the Fund’s efforts to provide lifesaving vaccines and other immunization program support to low-income countries. In this capacity, he was also a member of the Board of GAVI (Global Alliance for Vaccines and Immunization).
He is member of the Board of several life sciences companies. Martin holds a Master’s in Business Administration from the Ecole des Hautes Etudes Commerciales.
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Dr Julie McMurray, Project Manager, Epivax
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Dr Karen Midthun, Deputy Director, Vaccines and Immunisation, CBER, FDA
Dr. Midthun is the Deputy Director of Medicine in the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration. CBER regulates vaccines, blood and blood products, and cellular, tissue, and gene therapies. Its responsibilities include oversight of the investigational phases of product development, decisions regarding licensure, and post-licensure surveillance activities. Immediately prior to her current position within FDA, she served as Director of the Office of Vaccines Research and Review within CBER. She has published many articles in peer-reviewed journals, and has represented the FDA at many public meetings and interacted with Congress, both at hearings and briefings. Before joining the FDA in 1993, Dr. Midthun was an assistant professor in the Department of International Health at the Johns Hopkins Bloomberg School of Public Health, where she was involved in the clinical development of several investigational vaccines at the Center for Immunization Research. She also was a faculty member of the Division of Infectious Diseases, Johns Hopkins School of Medicine.
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Dr Melinda Moree, Director, The PATH Malaria Vaccine Initiative
Dr. Moree develops and directs the overall strategy and implementation of the PATH Malaria Vaccine Initiative. Leading the team, she ensures adequate funding to fulfill MVI’s mission, the highest quality for all program activities, continued commitment to existing relationships, and the forging of new, focused partnerships. Dr. Moree previously led business development for MVI. Prior to joining PATH, she was Manager of Advanced Research at EKOS Corporation. She received her Ph.D. in medical microbiology from the University of Maryland at Baltimore.
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Dr Michael Nelson, Assistant Chief of Allergy/Immunology Department, Director Clinical Laboratory Immunology Research, Vaccine Healthcare Centers Network, Walter Reed Army Medical Center
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Dr Sergio Nishioka, Chairman, DCVR Network
Sérgio Nishioka, Brazilian, born in April 22, 1956, is a physician graduated from the Faculty of Medicine, University of São Paulo, in Brazil, in 1979. He did his residency training in Infectious Diseases (1982) and obtained a Masters degree, also in Infectious Diseases (1993), from the same institution. He has also obtained a Master of Sciences degree in Epidemiology from the London School of Hygiene and Tropical Medicine, in London, U.K. (1990), and a PhD in Epidemiology from McGill University, in Montreal, Canada (2001). He worked as a university teacher from 1985 to 2003, at Universidade Federal de Uberlândia, in Brazil, and has worked as temporary adviser to the World Health Organization (WHO), Pan American Health Organization (PAHO) and to the Brazilian national regulatory agency, ANVISA. Since July 2003 he has been manager of the Office of New Drugs, Research and Clinical Trials at ANVISA, where clinical trial protocols and new drug applications are analyzed. Dr. Nishioka has over 100 publications, mostly in international journals, including original articles, short communications, case reports, and letters to the editor, and has also authored book chapters and book reviews. Most of his publications are on tropical medicine, clinical toxicology, research methods, and epidemiology/pharmacoepidemiology.
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Dr Derek O'Hagan, Head of Vaccine Delivery Research and Vice President, Novartis Vaccines and Diagnostics
Dr Derek O’Hagan is Head of Vaccine Delivery Research and Vice President Novartis Vaccines and Diagnostics, now based in Siena. He previously spent 10 years at Chiron, Emeryville. Past positions that he has held include a lecturer in Drug Delivery, School of Pharmaceutical Sciences, University of Nottingham.
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Ms Ann O'Hara, General Manager, Bioprocess, GE healthcare
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Walter Orenstein, Professor, Emory Univ School of Public Health, former head, National Immunization Program, CDC
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Dr Bram Palache, Global Medical Affairs Director, Influenza Vaccine, Solvay Pharmaceuticals
1973-1980: University of Amsterdam, Biochemistry (MSc degree) 1980-1984: Clinical Research Associate. Clinical Research Department Duphar B.V., Weesp, The Netherlands 1984-1987: European Clinical Projectleader, Gastroenterology group. Clinical Research Department Duphar B.V., Weesp, The Netherlands 1984: International Clinical Projectleader, Influenza vaccine. Clinical Research Department Duphar B.V., Weesp, The Netherlands 1990-1991: Influenza Research Fellow at Erasmus University and the WHO Dutch National Influenza Centre, Rotterdam, The Netherlands (Prof N. Masurel) 1991: Thesis and PhD degree, Erasmus University, Rotterdam, The Netherlands (Prof N. Masurel) 1990: Global Medical Affairs Director Influenza Vaccines. Solvay Pharmaceuticals B.V., Weesp, The Netherlands 1990: Board Member of "Foundation of Respiratory Virology, in particular Influenza (SRVI)", Erasmus University and WHO Dutch National Influenza Centre, Rotterdam, The Netherlands (Chairman: Prof. A.D.M.E. Osterhaus) Since 1992: Executive Board member, European Scientific Working group on Influenza (ESWI) Since 1993: Editorial Board member, "Influeza", Bulletin of European Scientific Working group on Influenza (ESWI) Since: 2000Member of the Organising Committee Options IV Meeting Crete, Greece. Since 2001: Members of the Clinical Working Group EVM (European Vaccine Manufacturers) Since 2001: Member of the Public Health Working Group EVM (European Vaccine Manufacturers) Since 2002: Member of the Organising Committee First European Influenza Conference, Malta
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Dr Peter Paradiso, Vice President, New Business and Scientific Affairs, Wyeth Vaccines
Peter R. Paradiso, Ph.D. is Vice President, New Business and Scientific Affairs for Wyeth Vaccines, a Division of Wyeth Pharmaceuticals in Collegeville, PA. In this position, Dr. Paradiso is responsible for global scientific affairs and strategic planning within the vaccine research and development group and for commercial oversight of products in development. He has worked in the field of vaccine development at Wyeth for the past 22 years. Dr. Paradiso has published broadly in the field of pediatric vaccines, especially in the areas of glycoconjugates, combination vaccines and respiratory viral vaccines. He has been involved in the development and the global registration of vaccines for H. influenzae type b, DTaP, rotavirus, N. meningitidis group C, streptococcus pneumoniae and influenza.
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Dr Peter Patriarca, Senior Consultant, Biologics Consulting Group
Peter Patriarca is presently Senior Consultant at the Biologics Consulting Group, Inc., headquartered in Alexandria, Virginia, USA. Dr Patriarca provides advice to pharmaceutical companies and other organizations in reference to drug development and regulatory approval, focusing primarily on vaccines and other biological products. Previously, Dr Patriarca served as a Medical Officer in the United States Public Health Service from 1980-2001, where he was appointed to various positions at the U.S. Centers for Disease Control and Prevention (CDC), the National Vaccine Program Office (NVPO), and the U.S. Food and Drug Administration (FDA). While with the FDA, Dr. Patriarca served as the Director of Viral Products in the Office of Vaccines Research and Review, CBER. From 2001-2005, Dr Patriarca served as Vice President and Head, Worldwide Regulatory Affairs and Pharmacovigilance at MedImmune, Inc., a biotechnology firm located in Gaithersburg, Maryland, and was the regulatory lead for the FluMist and CAIV-T programs as well as three investigational vaccines.
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David Pepperl, Senior Consultant, Biologics Consulting Group, Inc.
David J. Pepperl, Ph.D. - Senior Consultant. Dr. Pepperl joined the BCG team in January of 2004. As a toxicologist and preclinical development manager, David has managed numerous development projects ranging from small peptides, small molecules, monoclonal antibodies, cell and gene therapy products, adenoviral therapies, bacterial based oncology therapies and hormonal therapies. At BCG, David will provide services including development and review of preclinical product development programs, strategic planning of program implementation capabilities, review and preparation of nonclinical study reports and regulatory submissions, and GLP auditing and study monitoring services for both emerging and established biopharmaceutical companies. Prior to joining BCG, David served as toxicologist and Manager of Preclinical Development at TherImmune where he drafted preclincial development strategies, authored nonclinical sections of regulatory submissions and managed preclinical development programs for clients. In this capacity, he designed and managed nonclinical pharmacology and toxicology studies, performed GLP and scientific audits and reviewed study data on behalf of clients.
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Dr Helene Pora, Vaccine Application Development Director, Pall Life Sciences
Dr Hélène Pora is Vaccine Application Development director with Pall LIfe Sciences , where she has the worldwide responsibility for the development of improved separation and purification solutions for the vaccine and gene therapy market. She is also heavily involved in the development of improved single use technologies and related scale-up aspects. Hélène has more than 20 years of experience working for the pharmaceutical and the separation industries, the last 15 years with Pall Corporation. She holds an Engineering Degree in Biochemistry (with Molecular Biology) from the Institut National Agronomique (France) and a PhD in Biochemistry ( on protein engineering and purification) from the University of Orsay (France). Hélène Speaks regularly at conferences about improved separation technologies for the biotechnology and biopharmaceutical industry.
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Dr Douglas Powell, Director of Immunology, Antigen Express
As an H5N1 virologist and immunologist, Antigen Express Director of Immunobiology Doug Powell studies the immune response H5N1 influenza vaccines and infection. The antibody response in humans vaccinated with inactivated H5N1 virus produced in chicken eggs or by recombinant H5 is relatively weak to when compared to seasonal H1N1 and H3N1 vaccines. This suggests that the H5 hemagglutinin molecule is poorly immunogenic. It is generally accepted that egg-based or recombinant H5 vaccines will play little role during the first wave of a pandemic, therefore it is essential to develop novel vaccination strategies for H5N1. The virus-specific CD4+ T cell response is critical in providing help to B cells for optimal generation of neutralizing antibodies. We have mapped several MHC Class II epitopes in H5 and have demonstrated that immunization with defined epitopes greatly enhances the CD4+ T cell responses to recombinant H5 protein.
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Dr Nadine Ritter, Senior Consultant, Biologics Consulting Group, Inc.
Nadine M. Ritter, Ph.D. - Senior Consultant Nadine has over 12 years of industry experience in the technical, quality and regulatory requirements of biopharmaceutical product development and commercialization. She is an analytical biochemist with expertise in R&D, GLP and cGMP activities from startup organizations to multinational pharmaceutical corporations. Her specialties include biotechnology product characterization, release and stability testing, analytical test method development and validation, product and process comparability studies, biotechnology transfer projects, laboratory quality and compliance, and the effective management of outsourced biopharmaceutical testing and manufacturing.
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Dr Una Ryan, President and CEO, Avant Immunotherapeutics
Una S. Ryan, Ph.D., O.B.E. is President and CEO of AVANT Immunotherapeutics, Inc., a publicly traded biopharmaceutical company developing vaccines and immunotherapeutics for cardiac surgery, cholesterol management, biodefense, travelers, food safety, and global health. AVANT is developing a portfolio of oral vaccines designed to provide rapid protection following a single dose. AVANT’s rotavirus vaccine is marketed by GlaxoSmithKline Biologicals as Rotarix® in the European Union and over 65 countries. Dr. Ryan has led the expansion of AVANT’s vectored bacterial vaccines programs, completed three company acquisitions, and established the company’s new manufacturing facility in Fall River, Massachusetts. She is also Research Professor of Medicine at the Boston University School of Medicine and serves on its Board of Visitors. She is immediate past Chair of the Massachusetts Biotechnology Council, serves on its Board, as well as the Boards of the Biotechnology Industry Organization, the New England Healthcare Institute, the Board of Associates of the Whitehead Institute, and the Board of Directors of IQuum, Inc. Dr. Ryan is a member of the Strategy & Policy Council of the MIT Center for Biomedical Innovation and serves as a member of the Business Advisory Board of BIO Ventures for Global Health. In 2002 Her Majesty Queen Elizabeth II awarded Dr. Ryan the Order of the British Empire (OBE) for her services to the research, development and promotion of biotechnology.
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Dr Patrick Squiban, Chief Medical Officer and Vice President Medical and Regulatory Affairs, Innate Pharma
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Dr Indresh Srivastava, Associate Director, Immunology and Cell Biology, Novartis Vaccines and Diagnostics
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Dr Erich Tauber, Vice President, Product Development and Medical Affairs, Intercell
Erich Tauber is responsible for Product Development and Medical Affairs for Intercell. In his role he oversees functions including Clinical Development, Project Management and Regulatory Affairs.
Before joining Intercell, he had various responsibilities with Baxter and AstraZeneca. Erich Tauber has been trained as paediatrician at the Universities of Vienna and Southampton.
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Ms Wendy Taylor, Founder, Vice President of Strategy and Operations, BIO Ventures for Global Health
Wendy Taylor is the Founder and Vice President of Strategy and Operations of BIO Ventures for Global Health (BVGH). She founded and raised initial funding for BVGH and led the organization’s initial strategy and implementation as its Executive Director. Previously, she served as Director of Regulatory Affairs and Bioethics for the Biotechnology Industry Organization (BIO) where she negotiated the third reauthorization of the Prescription Drug User Fee Act (PDUFA) and developed the organization's global health initiatives. Ms. Taylor has extensive experience in the executive and legislative branches of the US government, including the Office of Management and Budget where she oversaw FDA regulatory activities, the Department of Health and Human Services and the US House Committee on Ways and Means. Ms. Taylor received a Master of Public Policy from the Kennedy School of Government at Harvard University and a B.A. from Duke University.
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Dr Jeffrey Ulmer, Head, Immunology and Cell Biology, Novartis Vaccines and Diagnostics
Dr. Jeffrey Ulmer received his B.Sc. with honors from the Department of Chemistry at the University of Regina in 1978 and was the recipient of the Merit Award of the Society of Chemical Industry. He received his Ph.D. in biochemistry from McGill University in 1985 and completed his postdoctoral training in the laboratory of Nobel laureate Dr. George Palade in the Department of Cell Biology at Yale University School of Medicine. At Merck Research Laboratories he conducted seminal studies on DNA vaccines, and is currently Head, Immunology & Cell Biology at Novartis Vaccines and Diagnostics. His group is responsible for discovery and technology development of vaccines and adjuvants; and production, purification, and characterization of recombinant protein-based vaccines. He has published over 150 scientific articles, is on the editorial boards of Expert Opinion on Biological Therapy and Human Vaccines, and is on the Scientific Advisory Committee of the Duke University Multiscale Integrative Immunology for Adjuvant Development program.
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Dr Keith Wells, Head, Masechusetts Office, Biologics Consulting Group, Inc.
Dr. Wells is a Virologist (Ph.D., State University of New York Health Science Center at Syracuse) who brings to the firm over thirteen years of experience in the biopharmaceutical industry, principally in the areas of process development, process validation and manufacturing. Keith has moved into the position of Massachusetts Office Head with the development of this office in January 2005.
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Dr Roy Widdus, Consultant, Global Health Futures Network
Dr Widdus has experience in a variety of work settings including: academic research; teaching; the biotechnology and pharmaceutical industries; and policy development for science and health in government and international agencies. Presently he undertakes selected consulting assignments and other activities in international health.
From January 2000 through December 2004, Dr Widdus served as Project Manager of the Initiative on Public-Private Partnership for Health, at the Global Forum for Health Research, an independent, international foundation, based in Geneva. The Initiative monitored, analysed and supported partnerships addressing development of and access to drugs, vaccines and other products for alleviating neglected diseases and other health conditions in developing countries.
From 1995 to January 2000 Dr Widdus was Co-ordinator of the Secretariat to the Children’s Vaccine Initiative, a multi-agency, cross-sector effort to accelerate vaccine development and introduction for poorer countries
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Ms Sandra Wrobel, President and Chief Executive Officer, Applied Strategies
Sandy Wrobel leads Applied Strategies’ extensive work with companies in the pharmaceutical and biotechnology industries and with global and public health organizations. She has over 20 years of experience in strategy development, R&D portfolio management, business process design and implementation, and organizational design and development. Sandy is frequently called on to address an organization’s most complex problems, typically resulting in a clear framework for identifying, analyzing, and selecting a productive and value-adding path forward. She is a valued and trusted advisor to private industry executives and to key public sector organizations such as the World Bank, the Bill & Melinda Gates Foundation, Johns Hopkins School of Public Health, and numerous vaccine public-private partnership teams.
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Michel Zaffran, Deputy Executive Secretary and Chief Technical and Policy Officer, GAVI Alliance
Michel Zaffran is a French National , Born in Algeria in 1956. He is an engineer from Ecole Centrale, France and TH, Darmstadt, Germany with subsequent training in Tropical Epidemiology at the Heidelberg University.
After 2 years in Morocco, with the French Government, he joined GRET, a French NGO for which he worked in Burkina Faso and the Democratic Republic of Congo (formerly called Zaire)
Michel Zaffran then spent 18 years with WHO Vaccines and Immunization Department, in cold chain and logistics, overseeing the work on quality of immunization services and as Programme Manager in charge of the departmental strategic planning. His last assignment with WHO was as Coordinator of the Access to Technologies team where he was leading efforts in Vaccine Quality, Vaccine Management, Vaccine Supply and Immunization Financing. From 1998 to 2003 he was the WHO representative on the Working Group which helped design and launch GAVI.
Since February 2006 Michel Zaffran is Deputy Executive Secretary of the GAVI alliance, with responsibility over the Technical/Policy areas
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Dr Rinaldo Zurbriggen, Chief Executive Officer, Pevion Biotech
1991 - Diploma in Biochemistry from the University of Freiburg, Switzerland 1991-1995 Research Teaching Assistant at the same institute 1995 - PhD degree in Biochemistry 1996 - Scientist at Berna Biotech Ldt., Berne (Switzerland) 2000 - 2001 Head Virus Research at Berna Biotech Ldt. 2002 - Chief Scientific Officer at Pevion Biotech Ldt.
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