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John G. Babish, Ph.D.
Dr. John G. Babish is a molecular biologist with basic research experience in the effects of natural and anthropomorphic compounds on cellular signal transduction pathways. He has published 108 peer-reviewed, scientific papers and is inventor on 15 US patents, 3 foreign patents and 26 patent applications. Dr. Babish has spoken at 38 national conferences on such topics as cytochrome P-450 mediated drug metabolism, molecular markers in cancer epidemiology, nutrition and drug development in AIDS, nutrition in chronic diseases, and risk assessment methodology. He was tenured Associate Professor of Pharmacology and Toxicology at Cornell University, Ithaca, NY for 17 years. Currently, he serves as chairperson of BIOnexus, a Cornell University technology transfer company, Senior Vice President of Ashni, and consultant to the dietary supplement industry for the development of cellular models of chronic diseases. Dr. Babish also serves as the National Coordinator for the USDA Minor Species Drug Program, which provides funding and expertise for the approval of orphan pharmaceuticals in veterinary medicine.
Douglas Flanagan, Ph.D.
Dr. Flanagan is Professor of Pharmaceutics at the University of Iowa. As the Director of Pharmaceutical Services, an FDA approved outsourcing facility at the University of Iowa, Dr. Flanagan was pivotal in the creation of the Center for Advanced Drug Development (CADD). Dr. Flanagan was also the Acting Director of Pharmaceutical Services, a development and GMP manufacturing CRO at the University of Iowa. His wide breadth of experience and knowledge allows him to provide both the academic and the industrial perspective of researchers and drug developers in the Pharmaceutical sciences. Dr. Flanagan is also an elected fellow of the American Association of Pharmaceutical Scientists (AAPS). He holds a Ph.D. in Pharmaceutics from the University of Michigan, Ann Arbor.
Om P. Ganda, M.D
Dr. Ganda is a board certified specialist in internal medicine, endocrinology and metabolism, and clinical nutrition, is an Associate Clinical Professor of Medicine at Harvard Medical School in Boston, Massachusetts. He is also Director of the Lipid Clinic at the Joslin Diabetes Center in Boston and an Attending Physician at the Beth Israel-Deaconess Medical Center, also in Boston. Dr. Ganda received his medical degree from the S.M.S. Medical College of the University of Rajasthan in Jaipur, India. He is a former co-investigator for two National Institutes of Health (NIH) studies, the Diabetes Control and Complications Trial (DCCT) and the Diabetes Prevention Program (DPP). Dr. Ganda is currently a co-investigator for the NIH Epidemiology of Diabetes Interventions and Complications (EDIC) study. He is also participating in clinical trials related to lipid-lowering drugs and diabetes management. Dr. Ganda has authored or coauthored more than 100 publications, including 45 original articles, 30 review articles, and 25 book chapters. He serves on the editorial board of Diabetes Research and Clinical Practice and is a reviewer for such journals as Diabetes, Diabetes Care, Diabetologia, Journal of Clinical Endocrinology and Metabolism, JAMA, and The New England Journal of Medicine. Dr. Ganda is a fellow of the American Association of Clinical Endocrinologists (AACE) and a former member of its Board of Directors (2000-2003); a fellow of the American College of Physicians; and a fellow of the Royal College of Physicians and Surgeons of Canada. He is also a member of the American Diabetes Association and The Endocrine Society. Dr Ganda's awards and honors include Capp's Research Scholar Award from Harvard Medical School, RV Sathe Oration Award at the Golden Jubilee of the Association of Physicians of India (API), and the GP Moses Oration Award by the Research Society for the Study of Diabetes in India (RSSDI).
Mario A. González, Ph.D.
Dr. González is President of P'Kinetics International, Inc. specializing in biopharmaceutics and pharmacokinetics research. Dr. González was previously President of GloboMax Américas and prior to that was Director of Biopharmaceutics and Pharmacokinetics at Schering Research, Miami (formerly Key Pharmaceuticals, Inc). His research has concentrated on the pharmacokinetic and pharmacodynamic evaluation of extended-release oral and transdermal drug delivery systems as well as in vitro/in vivo correlations. Prior to joining the pharmaceutical industry, Dr. González was on the Pharmacy faculty at Purdue University. Currently he is an adjunct Professor in the University Of Florida College Of Pharmacy. Dr. González has been active in AAPS since its inception and was Chair of the Pharmacokinetics Section in 1995. He also served on the organizing committees of the first four AAPS/FDA SUPAC Workshops and was Co-Chair of the Organizing Committee for the first Pharmaceutical Congress of the Americas held in March, 2001. Dr. Gonzalez is also a member of the Controlled-Release Society, the American College of Clinical Pharmacology, and the American Society of Health-System Pharmacists. He serves on the editorial advisory boards of the European Journal of Pharmaceutics and Biopharmaceutics and the International Journal of Clinical Pharmacology and Therapeutics. Dr. Gonzalez was recently appointed to the USP Biopharmaceutics Expert Committee for 2005-2010.
Richard J. Gralla, M.D.
Dr. Gralla was recently named president of the New York Lung Cancer Alliance in New York. Prior to accepting that position, he was professor of medicine, Columbia University, also in New York. He has also been the chief of thoracic oncology at Memorial Sloan-Kettering Cancer Center (New York), and director of the Ochsner Cancer Institute in New Orleans, Louisiana. Dr. Gralla is the author or co-author of over 200 articles and book chapters, and his work has been published in journals such as the New England Journal of Medicine, Annals of Internal Medicine, Journal of Clinical Oncology, Cancer, and Cancer Research. Dr. Gralla serves on the editorial boards of Cancer, Lung Cancer, and Supportive Care in Cancer. He was the president of the Multinational Association of Supportive Care in Cancer (MASCC). Dr. Gralla received his medical degree from the University of Virginia in Charlottesville. He completed a fellowship in medical oncology and was a National Cancer Institute fellow in clinical research at Memorial Sloan-Kettering Cancer Center.
David A.H. Lee, M.D., Ph.D.
Dr. Lee is the Executive Vice President, Research & Development and Chief Scientific Officer, Endo Pharmaceuticals Inc. He joined Endo Pharmaceuticals as Senior Vice President (subsequently Executive Vice President) Research & Development and Regulatory Affairs in December 1997, shortly after the company was created from a management-led buy-out from the DuPont Merck Pharmaceutical Company. He created and leads an R&D organization that has established a substantial track record in the development of both branded and generic products which have helped to establish Endo as a leader in pain management in the US. Dr. Lee was appointed to his current position in April 2004. Prior to joining Endo, Dr. Lee was Executive Vice President, Research and Development from 1992 through 1997, for CoCensys Inc., a biotech company based in Irvine, California focused on the development of CNS drugs. Before joining CoCensys, Dr. Lee held various positions at Solvay Pharmaceuticals in the Netherlands, ranging from head of global clinical development programs to his final position as Vice President, Research and Development. Dr. Lee is a graduate of St. Mary's Hospital Medical School of the University of London and specialized in internal medicine and gastroenterology prior to joining the pharmaceutical industry.
Rajendra Patel, M.D.
Dr. Patel is a practicing cardiologist in New Jersey and is affiliated with the Gardenstate Cardiology Associates. He is a Staff Cardiologist at Our Lady of Lourdes Hospital, the Virtua Health System and the Kennedy Health System. Dr. Patel is a recipient of the Dr. Samuel Epstein award for Outstanding Professional Performance, while serving as a Cardiology Fellow at the Coney Island Hospital. Dr. Patel is a Fellow of the American College of Cardiology and President of the Asian Indian Professional Society. He holds a M.B., B.S. from M.S. University India, and completed his Internal Medicine Residency and Cardiology Fellowship training from Coney Island Hospital, SUNY-Brooklyn, NY.
Robert Pollock, M.S., RPh.
Robert Pollock is Senior Vice President of Lachman Consultant Services, Inc. which provides consulting and regulatory services for the industry. Formerly, Mr. Pollock was the Acting Deputy Director of the Office of Generic Drugs (OGD), Center for Drug Evaluation and Research, Food and Drug Administration. Bob was in the Generic Drugs Program shortly after the passage of the Drug Price Competition and Patent Term Restoration Act (Waxman-Hatch Act). Prior to transferring to the FDA in 1985, he held various field and headquarters assignments with the Health Resources and Services Administration of the Public Health Service. He retired from the PHS in January 1995 with over 20 years of service at the rank of Captain. Mr. Pollock received his B.S. degree in Pharmacy and his M.S. degree in Pharmacy Administration at the University of Rhode Island where he studied as a Fellow of the American Foundation for Pharmaceutical Education. Mr. Pollock has numerous publications and has presented extensively on the drug approval process as well as issues regarding strategic alliances.
Sander J Robins, M.D.
Dr. Robins is a Professor of Medicine at Boston University School of Medicine, Boston, MA. He is currently the Laboratory Director of the Framingham Heart Study. He is a graduate of Dartmouth College and Jefferson Medical College and is certified by the American Boards of Internal Medicine and Gastroenterology. Dr. Robins has had a long-standing interest in lipoprotein metabolism, especially on the role of phospholipids in lipoprotein transport and hepatobiliary cholesterol secretion. He is Co-Principal Investigator of the Veterans Affairs HDL Cholesterol Intervention Trial (VA-HIT). This 7-year trial which was concluded in 1998, has demonstrated for the first time that lipid therapy with a fibrate will significantly reduce the incidence of new coronary events and stroke in patients who have a low HDL-cholesterol but not a high-risk LDL-cholesterol. Dr Robins has authored numerous scientific papers and has presented his research at a number of national and international meetings. He serves on a number of scientific advisory committees ad has served as an Associate Editor of the Journal of Lipid Research. He is a member of the American Federation for Clinical Research, the American Gastroenterological Association, the American Association for the Study of Liver Diseases, and the American Heart Association.