Dr. G. Alexander “Zan” Fleming
On April 14, 2012, we appointed Dr. G. Alexander Fleming to our Board of Advisors. Dr. Fleming is a board certified endocrinologist with medical and research training at Emory, Vanderbilt, and National Institutes of Health. He served as reviewer and supervisory medical officer for 12 years at the FDA and brings extensive clinical experience and regulatory responsibility in the therapeutic area of diabetes and other general metabolic, bone, and endocrine disorders, growth and development, nutrition, lipidlowering compounds, and reproductive indications. He led reviews of landmark approvals including those of the first statin, insulin analog, metformin, PPARagonist, and growth hormone for nonGH deficiency indications. He was responsible for the regulation of the earliest biotech products including human insulin and growth hormone. Dr. Fleming helped to shape a number of FDA policies and practices related to therapeutic review and regulatory communication and represented the FDA at the International Conference on Harmonisation (ICH) and the World Health Organization. Dr. Fleming serves on numerous scientific advisory boards, expert committees, and corporate boards. He has continued to promote dialogue and creativity within the community of therapeutic developers. Dr. Fleming has authored the book, "Optimizing Development of Therapies for Diabetes" and a wide variety of scientific and policy publications. He has served as an invited editorialist to The New England Journal of Medicine and as a commentator on National Public Radio.
Dr. Jay S. Skyler
On April 9, 2013, we appointed Dr. Jay Skyler to our Board of Advisors. Dr. Skyler's career in diabetes spans five decades, where his research interests have concentrated in clinical aspects of diabetes, particularly improving the care of Type 1 diabetes. Dr. Skyler is a Professor of Medicine, Pediatrics and Psychology at the University of Miami Miller School of Medicine and Deputy Director for Clinical Research and Academic Programs at the Diabetes Research Institute. He also is an Adjunct Professor of Pediatrics at the Barbara Davis Center for Childhood Diabetes, University of Colorado at Denver. He is a past President of the American Diabetes Association, the International Diabetes Immunotherapy Group, and the Southern Society for Clinical Investigation, and was a Vice-President of the International Diabetes Federation. He served as a member of the Endocrinology, Diabetes, and Metabolism Subspecialty Examining Board of the American Board of Internal Medicine, as Chairman of the Council of Subspecialty Societies of the American College of Physicians (ACP) and a member of the ACP Board of Regents. A frequent national and international lecturer, Dr. Skyler has been an author, editor and co-editor of numerous books, monographs, chapters and articles. Dr. Skyler was founding Editor-in-Chief of Diabetes Care.
Dr. Lorenzo Piemonti
Lorenzo Piemonti, MD, was born in Carate Brianza, Italy, and graduated Summa cum Laude from the University of Milan in 1994, and specialized with Summa Cum Laude in Endocrinology and Metabolic Diseases and in Micro and Experimental surgery at the University of Milan in 2000 and 2004, respectively. At IRCCS Ospedale San Raffaele (OSR), he serves as Director of the Diabetes Research Institute and as Director of Human Islet Transplantation Program. He also serves as Chief of the Beta Cell Biology Unit within the Diabetes Research Institute, Director of the Human Islet Processing Facility, and as Coordinator of the European Consortium for Islet Transplantation that has been providing human beta cell products for research and clinical applications at OSR, in Italy and across state barriers in Europe since 2000. He also serves as Professor in Endocrinology at Università Vita-Salute San Raffaele of Milan and as Honorary Visiting Professor at Vrije Universiteit of Brussels.
Dr. Piemonti currently also serves as section Editor of Cell Transplantation: the Regenerative Medicine Journal and of Current Diabetes Reports, and is on the editorial board of Acta Diabetologica. Dr. Piemonti is also a council member of the International Pancreas and Islet Transplantation Association (IPITA) of The Transplantation Society (TTS) and previously (2011-2017) served as member of the European Pancreas and Islet Transplantation Association (EPITA) committee of the European Society for Organ Transplantation (ESOT).
Prof. Heiko von der Leyen, MD
Dr. Heiko von der Leyen is the head of the coordination center for clinical studies at Hannover Medical School (HCTC-KKS). He was co-founder and managing director of Hannover Clinical Trial Center GmbH (HCTC), which was founded in 2005 as an academic Contract Research Organization (CRO) dedicated to clinical trial management services and early product development support, before its incorporation into Hannover Medical School as an executive division.
Prof. von der Leyen was trained in Pharmacology, Internal Medicine, and Cardiology at University of Hamburg and Hannover Medical School. From 1995-1996 he served as junior faculty member at the Division of Cardiovascular Medicine of Stanford University. Since 2001 he has been an extraordinary Professor of Internal Medicine at Hannover Medical School.
Prof. von der Leyen has served in several executive management positions in the biotechnology industry, with a focus on the clinical development of advanced therapy medicinal products (tissue engineering, gene therapy, DNA medicine). He is currently the speaker of the board of the network of academic clinical research organizations in Germany (KKS-Network) and a member of the network committee of ECRIN-ERIC, a European clinical trial infrastructure organization.
Dr. Stephen Minger
Dr Stephen Minger is a pioneering researcher in human stem cell biology, particularly in the area of cellular transplantation and regenerative medicine. Stephen is the Director of SLM Blue Skies Innovations Ltd, and he was previously the Chief Scientist for GE Healthcare Life Sciences and the Senior Consultant in Cellular Sciences and Regenerative for GE Healthcare Life Sciences. He was the Stem Cell Expert and a Member of the UK Gene Therapy Advisory Committee (GTAC) at the Department of Health; is a consultant and reviewer to the European Commission Framework Programs to promote European-wide biomedical research; a member of the Grants Working Group of the California Institute of Regenerative Medicine; and was a founding member of the Board of Directors of the Canadian Centre for the Commercialization of Regenerative Medicine (CCRM). Minger was also a Lecturer and then Director of the Stem Cell Biology Laboratory at King’s College.
Dr. Minger holds a PhD in Pathology (Neurosciences) from the Albert Einstein College of Medicine and completed post-doctoral work in central nervous system gene therapy, neural transplantation, and neural stem cell biology at UCSD.
Dr. Bala Manian
Dr. Bala Manian has over 35 years of experience in the biomedical sciences and brings extensive executive and oversight experience to Orgenesis. Dr Manian has served as chairman of the board of directors of ReaMetrix Inc. since founding the company in 2004. He serves as a director of Syngene International Limited, a publicly traded Indian biotechnology company, and previously as a director of Biocon Ltd., a publicly traded Indian biopharmaceutical company. Dr. Manian is a co-founder and director of Quantum Dot Corporation and a co-founder of SurroMed, Inc. He was the founder and chairman of the board of directors of Lumisys Incorporated, a medical imaging company acquired by Eastment Kodak Co.; the founder and chairman of the board of directors of Molecular Dynamics Incorporated, a life science instrumentation company acquired by Amersham BioSciences; and the founder and chairman of the board of directors of Biometric Imaging Inc, acquired by Becton Dickinson.
Dr. Manian received a B.S. in Physics from the University of Madras, an M.S. in Applied Optics from the University of Rochester, and a Ph.D. in Mechanical Engineering from Purdue University.