Melior Discovery scientific advisors
Christopher Lipinski, Ph.D
Dr. Lipinski is a medicinal chemist with more than 34 years of experience at Pfizer, Inc. In 2002 he retired from the highest scientific position in the worldwide Pfizer research organization (Senior Research Fellow) and now serves as a Drug-Like Properties consultant to Pfizer. Dr. Lipinski is renowned for his "Rule of Five"; an algorithm for predicting drug compounds likely to show oral activity (See Appendix B). His 1997 publication in "Advanced Drug Delivery Reviews", where the "Rule of Five" first appears, is the most frequently cited medicinal chemistry paper in the last decade and is one of the most cited publications in the journal's history. He was recipient of the American Chemical Societies 2004 Medicinal Chemistry award.
Dr Lipinski is a member of the Medicinal Chemistry section of the American Chemical Society, the American Association of Pharmaceutical Sciences, the Society for Biomolecular Screening and the European Federation of Pharmaceutical Sciences. He serves on scientific advisory boards for the Global Alliance for Tuberculosis Drug Development, ASDI Biosciences, Advanced Chemistry Development Labs and the Matrical Company. Dr. Lipinski is a consultant for Symyx and the Hereditary Disease Foundation. He is a member of the editorial board of the journal of Pharmaceutical Sciences, Current Drug Discovery Technology, the highlights advisory board of Nature Reviews Drug Discovery, as well as the advisory boards of several other journals. He serves on the Conference Advisory Board for Cambridge Healthtech Institute. Since 1984, he has been an adjunct faculty member at Connecticut College in New London CT, and has over 180 publications and invited presentations and 17 issued US patents.
Dr. Lipinski received a B.Sc. degree in chemistry from San Francisco State College in 1965 and a Ph.D. in 1968 in physical organic chemistry from the University of California, Berkeley. He joined Pfizer in 1970 following a National Institutes of General Medical Sciences Postdoctoral Fellowship at the California Institute of Technology.
Dr. Ronfeld has 25 year of experience in the pharmaceutical industry working in human and veterinary medicine, in both discovery and development. He spent 20 years at Pfizer in Groton, CT before retiring in 2001. Presently he consults part-time on short-term projects in pharmaceutical research and development, primarily with biotech companies. At Pfizer he had numerous scientific and leadership roles. He led the Drug Metabolism Department (1990-1998) as it grew substantially and increased its discovery involvement, its utilization of in vitro methods and technology, mass spectrometry and the prediction of human pharmacokinetics from preclinical and in vitro data. He also led the development of a Clinical Pharmacokinetics and Pharmacodynamics group within Clinical Research prior to retiring. He has many years of experience in the multi-disciplinary and strategic aspects of drug development and worked on therapeutic, management and process improvement teams. During his time at Pfizer, he was responsible for the pharmacokinetic and drug metabolism sections for several NSA regulatory submissions. He has served on the editorial boards of the journals, Drug Metabolism and Disposition, Current Drug Metabolism, and Journal of Pharmaceutical Sciences. He received his PhD in Pharmacokinetics from the University of California at San Francisco in 1974.
John Amatruda, M.D.
Dr. Amatruda comes to Melior with over 15 years experience in academic medicine and 17 years experience in industry. Most recently, Dr. Amatruda served as Senior Vice President and Franchise Head for Diabetes and obesity at Merck Research Laboratories where he oversaw the development of Januvia™ and Janumet™, breakthrough medicines in thier respective fields. Prior to Merck, Dr. Amatruda was Vice President and Therapeutic Area Head for Metabolic Disorders Research at Bayer, Professor of Medicine Adjunct at Yale Univeristy School of Medicine and Professor of Medicine at hte University of Rochester School of Medicine.
Zan Fleming, Ph.D.
Dr. Alexander "Zan" Fleming is co-founder, president and CEO of Kinexium, LLC, a cardiometabolic strategic consulting organization. He also sits on over a dozen clinical advisory boards for major pharma and biotech companies.
Previously, he served as chief medical officer of Boston Medical Technologies and chief scientific officer of Ingenix Pharmaceutical Services - A UnitedHealth Group Company. For 12 years, he served as reviewer and supervisory medical officer at the FDA, as head of the metabolic group. He has extensive clinical experience and regulatory responsibility in the therapeutic areas of diabetes, other metabolic and endocrine disorders, growth and development, nutrition, lipid-lowering compounds, and reproductive indications. He led reviews of landmark approvals including those of the first statin, insulin analogs, metformin, PPAR-agonist, and growht hormone for non-GH deficiency indications. He was responsible for the regulation of the earliest biotech products including human insulin and growth hormone. He also helped to shape a number of FDA policies and practicies related to therapeutic review and regulatory communication.
His regulatory and technical expertise has been requested in numerous international settings including the World Health Organization, where he was assigned during 1991-92. Dr. Fleming was a member of the expert working groups on Good Clinical practices and General Considerations for Clinical Trials of the International Conference on Harmonization (ICH) and participated on other ICH committees.
Dr. Fleming is the cofounder and editor in chief of the Virtual Journal of Drug Evaluation, of FDA's Center for Drug Evaluation and Research (CDER), a major contributor to FDA's Good Review Practice (GRP) initiative, and chair of the committee responsible for education and training at CDER. He is lead author of the book, "Optimizing Development of Therapies for Diabetes." He serves on numerous scientific advisory boards and expert committees and has served as invited editorialist to The New England Journal of Medicine and as a commentator on National Public Radio.
C. Warren Olanow, M.D.
C. Warren Olanow, M.D., FRCPC is the Henry P. and Georgette Goldschmidt Professor and Chairman Emeritus of the Department of Neurology, and professor in the Department of Neuroscience at the Mount Sinai School of Medicine in New York City. He is also visiting professor in the Department of Neurology at the University of California, San Francisco.
He received his medical degree from the University of Toronto, performed his neurology training at the New York Neurological Institute at Columbia Presbyterian Medical Center at Columbia University, and did post-graduate studies in neuroanatomy at Columbia University. He served on the faculties of McGill University, Duke University, and the University of South Florida prior to joining Mount Sinai.
He is past president of the Movement Disorder Society, past president of the International Society of Motor Disturbances and past treasurer of the American Neurological Association. He has been named an honorary professor at the University of London (Royal Free Hospital), an honorary member of the French Neurological Society, an honorary fellow of the Royal College of Physicians of the United Kingdom, the recipient of the Presidential Award from the Movement Disorder Society, and the 2013 recipient of the Movement Disorder Research Award from the American Academy of Neurology. He serves on the Board of Directors of the National Space Biomedical Research Institute, is a member of the executive committee of The Michael J. Fox Foundation Scientific Advisory Board, is the past chairman of the Scientific Advisory Board of the Bachmann-Strauss Foundation and has served on numerous additional medical and scientific advisory boards. He has served on several editorial boards, and is presently Co-Editor-in-Chief of the journal Movement Disorders.
His clinical and basic science research efforts are directed toward defining more effective therapies for Parkinson’s disease and other neurodegenerative disorders. Dr. Olanow has authored more than 350 publications, and was ranked #1 in the United States in research citations for Parkinson’s disease during the past quarter century. He has lectured on movement disorders at universities and conferences throughout the world.
Karl Kieburtz, M.D.
Dr. Karl Kieburtz MD MPH is the Robert J Joynt Professor in Neurology and the Director of the Clinical & Translational Science Institute and also the Director of the Center for Human Experimental Therapeutics at the University of Rochester Medical Center in Rochester, NY. He also has appointments as Professor of Environmental Medicine and of Public Health Sciences, and serves as Senior Associate Dean for Clinical Research. His research career has focused on developing treatments for diseases with high unmet therapeutic needs, including HIV-related neurologic syndromes and neurodegenerative disorders, such as Alzheimer and Parkinson disease. His research program has had continuous independent funding from the National Institutes of Health for over 20 years and he has served as the principal investigator on over two dozen multi-center clinical trials. His research papers have been cited by others over 10,000 times, according to the Web of Science, and his h-factor is over 50. He has served as a consultant to United States government through the FDA (serving on and chairing the Peripheral and Central Nervous System Advisory Committee), Veterans Administration (chairing the Scientific Evaluation Committee for the Cooperative Studies Program) and the National Institute of Neurologic Disorders and Stroke (serving on the clinical trials study section). He has served as an officer or board member for multiple international professional organizations including the American Neurological Association, the American Society for Experimental Therapeutics and the Movement Disorders Society, and has served as Associate Editor of the journals Neurology and Movement Disorders. As the Director Clinical & Translational Science Institute he helps institutional investigators translate their clinical and bench-based research findings into potential human therapeutic agents. For his roles as an educator he has received the University of Rochester Medical Center’s highest mentoring awards as well as a K24 award from the NIH for mentoring junior faculty. He also maintains an active clinical practice in neurology, primarily seeing patients with neurodegenerative disorders.