Our distinguished Senior Advisory Board consists of members with expertise in research, development, toxicology, regulatory, clinical and product approval.
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James Paulson, Ph.D.
Dr. Paulson is a world renowned glycobiologist and an expert on influenza viral receptor biology. He is a Professor, Dept. of Chemical Physiology, at The Scripps Research Institute. Dr. Paulson served as the President of The Society for Glycobiology. He is a member of the editorial board for the Journal Glycobiology, and a Honorary Member of the American Society of Clinical Investigation. He is currently the Principal Investigator on a $34 million NIGMS grant to fund the Consortium for Functional Glycomics and is co-chair of the Human Glycomics/Proteomics Initiative. Since 1990, he served as the Vice President of Research, Chief Scientific Officer and Board Member of Cytel Corporation, a publically traded biopharmaceutical company, until its merger with Epimmune in 1999. Previously, Dr. Paulson was a Professor and Vice-Chair of the Department of Biological Chemistry of the University of California, Los Angeles, School of Medicine. Dr. Paulson holds a Ph.D. degree in Biochemistry from the University of Illinois at Champaign-Urbana.
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Robert Webster, Ph.D.
Dr. Webster is Professor at St. Jude Children’s Research Hospital and holds the Rose Marie Thomas Chair. Since 1975, he has been Director of the World Health Organization (WHO) Collaborating Center for Studies on interests include the emergence and control of influenza viruses, viral immunology, the structure and function of influenza virus proteins and the development of new vaccines and antivirals. The major focus of his research is the importance of influenza viruses in wild aquatic birds as a major reservoir of influenza viruses and their role in the evolution of new pandemic strains for humans and lower animals. His curriculum vitae contain over 500 original articles and reviews on influenza viruses. He has trained many scientists who now contribute to our understanding of the evolution and pathogenesis of influenza. Dr. Webster is a member of National Academy of Sciences and a Fellow of the Royal Society, London. He earned his Ph.D. from the Australian National University.
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Howard Levine, Ph.D.
Dr. Levine has over 25 years of experience in process development, manufacturing and operations in the biopharmaceutical industry. He is the Founder and President of BioProcess Technology Consultants, Inc., a leading biopharmaceutical CMC consulting firm which provides assistance with all aspects of process development, manufacturing, quality control, quality assurance, and validation of biopharmaceutical manufacturing processes and facilities. Dr. Levine is currently a member of the Editorial Advisory Boards of International BioPharm Report, and is also co-editor of a directory of biologics contract manufacturers. He is a member of the Scientific Advisory Board of Acretia, Inc., and serves as acting Chief Technology Officer for Triton BioSystems, Inc. Prior to founding BioProcess Technology Consultants, Dr. Levine was Vice President of Manufacturing Operations at Repligen Corporation for all process development and manufacturing activities. He previously held positions of increasing responsibility in process development and manufacturing at Genentech, Amgen, and Xoma. Dr. Levine holds a Ph.D. degree in Biochemistry from the University of Chicago.
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Joy Cavagnaro, Ph.D., DABT, RAC
Dr. Cavagnaro is an expert toxicologist, and founder & president of Access BIO L.C., a consultancy specializing in regulatory strategies and product development. She has over 25 years of industry and government experience including over 8 years with the FDA. During her tenure at CBER, was appointed to the SBRS, served as FDA’s topic lead for safety for the ICH initiative for 7 years and lead for safety for the ICH initiative for 7 years and rapporteur for the ICH S6 Preclinical Safety Evaluation of Biotechnology Products. She also chaired the working group responsible for the 1996 FDA Guidance Concerning Demonstration of Comparability of Human Biological Products including Therapeutic Biotechnology-derived Products. Prior to joining the FDA, Dr. Cavagnaro was a principal study director for biotechnology products at Covance. Dr. Cavanaro is the past chair of the Regulatory Affairs Professional Society, and currently serves as chair of BioSafe a Biotechnology Industry Organization (BIO), which identifies key regulatory issues related to the preclinical safety evaluation of biopharmaceutical products. Dr. Cavagnaro holds a PhD degree in Biochemistry form the University of North Carolina, Chapel Hill.
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Frederick Hayden, Ph.D.
Dr. Hayden is an internationally recognized expert on respiratory viral infections and a leading clinical investigator on influenza antiviral agents. He is currently an advisor to WHO for its global effort to fight influenza pandemics. He is a Stuart S. Richardson Professor of Clinical Virology and Professor of Internal Medicine at the University of Virginia School of Medicine. He has served as the editor for Antimicrobial Agents and Chemotherapy. He has also served on editorial boards for Antiviral Research, Antiviral Therapy, and the Journal of Antimicrobial Chemotherapy. Dr. Hayden is a member of the Executive Committee for the NIAID - University of Alabama Collaborative Antiviral Study Group and the Board of Directors for the International Society for Antiviral Research. Dr. Hayden has performed extensive research into infections and the application of antiviral agents for their prevention and treatment. The scope of his studies has ranged from antiviral mechanisms of action to clinical trials involving experimentally induced and naturally occurring infections. Dr. Hayden holds a M.D. degree from Stanford University and is board-certified in internal medicine and infectious diseases.
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Andrew T. Pavia, M.D., FIDSA, FAAP (Chair, Clinical Advisory Board)
Dr. Pavia is the George and Esther Gross Presidential Professor and Chief of the Division of Pediatric Infectious Diseases at the University of Utah Health Sciences Center. He is very active as an infectious disease investigator and in policy. Dr. Pavia serves on several advisory committees for federal and state government on vaccine policy, biodefense, and pandemic influenza preparedness. He leads several committees of the Infectious Diseases Society of America and has been a member of the Institute of Medicine Committee on “Antivirals for Pandemic Influenza: Guidance on Developing and Distribution and Dispensing System.” Dr. Pavia’s research interests include the epidemiology of influenza and other emerging infections; he has published more than 100 scientific articles and chapters. He also has significant experience in the clinical development of antiviral compounds. Dr. Pavia earned his M.D. degree from Brown University, served at the Centers for Disease Control as an Epidemic Intelligence Service Officer and a Preventive Medicine Resident, and is board certified in Internal Medicine and Infectious Diseases.
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