Dr. Alexander Fleming received his M.D. and internal medicine training from Emory, fellowship training in endocrinology at Vanderbilt and metabolism at National Institutes of Health, where he was a senior fellow. From 1986-98 Dr. Fleming served as reviewer and supervisory medical officer at the US Food and Drug Administration. He acquired 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 analog, metformin, PPAR-agonist, and growth hormone for non-GH deficiency indications. He was responsible for the regulation of the earliest biotech products including human insulin and growth hormone. He helped to shape a number of FDA policies and practices 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 including the Common Technical Document working group.
He was also the founder 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 conceived and led the first FDA pilot project to utilize the internet for regulatory communication. Dr. Fleming is lead author of the book, “Optimizing Development of Therapies for Diabetes.” He has frequently published scientific articles and book chapters, the most recent chapter, Regulatory Considerations for Early Clinical Development, is in Translational Research Methods for Diabetes, Obesity and Cardiometabolic Drug Development, published by Springer in January 2015. He has been a member of number corporate and professional society advisory boards. The most recent is the joint European Association for the Study of Diabetes and American Diabetes Association working group on insulin pump safety. The working group’s statement will be published in March 2015 in Diabetes Care and Diabetologia.
Dr. Fleming founded Kinexum, a strategic advisory firm in 2003 and continues to serve as its chief executive officer.
Dr. Lawrence Steinman is Professor of Neurology, Neurological Sciences and Pediatrics at Stanford University and Chair of the Stanford Program in Immunology from 2001 to 2011. His research focuses on what provokes relapses and remissions in multiple sclerosis (MS) and in neuromyelitis optica (NMO) and the quest for antigen specific therapy. He is developing a small molecule therapeutic in trials for Huntington’s Disease. Steinman identified guardian molecules in brain that have protective properties in a number of inflammatory conditions. These protective molecules activate regulatory B cells.
Steinman was senior author on the 1992 Nature article that led to the drug Tysabri, approved for MS and Crohn’s disease.
Dr. Steinman graduated from Dartmouth College, Magna Cum Laude in Physics. His MD is from Harvard Medical School. He was a post-doctoral fellow in chemical immunology fellow at the Weizmann Institute of Science. After neurology residency he remained on the faculty in 1980.
He has received numerous honors, including the John M. Dystel Prize in 2004, the Javits Neuroscience Investigator Award from the NINDS twice, the Charcot Prize in MS research, and the Cerami Prize in Translational Medicine. Steinman is a member of the National Academy of Sciences, and the National Academy of Medicine.
Dr. Steinman holds 44 patents. He cofounded several biotech companies. He was a Director of
Centocor from 1988 until its sale to Johnson and Johnson.
Julia Manning is a social pioneer, writer, campaigner and commentator. Julia studied visual science at City University, became a member of the College of Optometrists in 1991 and specialised in diabetes.
Her career has included being a visiting lecturer at City University, a visiting clinician at the Royal Free Hospital, working with south London Primary Care Trusts and as a Director of the UK Institute of Optometry.
She formed 2020health in 2006 and left the NHS in 2009. Julia’s research interests are now in harnessing digital to improve well-being. She is an honorary research associate at UCL and a Fellow of the RSA.