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.