Dr. Lee S. Simon MD, FACP, FACR
About Lee Simon
Dr. Lee S. Simon is Principal and Managing Director of SDG LLC, a consulting firm in Cambridge, Massachusetts, helping companies create successful drug development programs through good study designs and insightful regulatory strategy (since February 2004). He continues to practice as a Rheumatologist and is licensed in Internal Medicine in Massachusetts. He served as the FDA’s Division Director of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products (DAAODP) within the Center for Drug Evaluation and Research (CDER) from November 2001 to December 2003. He also served as Head Regulatory Consultant to Leerink Swann/Medacorp in Boston, Massachusetts (2004 to 2010). He is a member of the OMERACT Management Group, serving as Chair-Finance and Co-Chair of the Business Advisory Committee. At IAG, Image Analysis Group, he serves as Regulatory Consulting Partner with expertise in clinical rheumatology, drug development, and regulatory affairs.
Dr. Simon’s expertise spans clinical rheumatology, drug development strategy, and regulatory affairs, with particular depth in analgesic and anti-inflammatory drug development, outcome measure development, and pain assessment in clinical trials. His therapeutic area expertise encompasses rheumatoid arthritis, osteoarthritis, spondyloarthritis, gout, SLE, fibromyalgia, bone disease, and pain management. He has extensive experience as a senior investigator and consultant on COX-2 inhibitor development, including celecoxib (Pharmacia/Searle) and as Chair of the International COX-2 Study Group.
His methodological contributions include 12 years of NIH-funded bench research developing in vitro measures of collagen turnover, including a commercial assay for the carboxy-terminal portion of type I procollagen as a marker of new bone synthesis (1981 to 1993). He is an active contributor to OMERACT (Outcome Measures in Rheumatology), contributing to core domain set development for SLE, osteoarthritis, and pain in inflammatory arthropathies. He is on the Steering Committee of IMMPACT developing recommendations for the design and implementation of clinical trials investigating pain, and has contributed to the PROACTIVE public-private FDA partnership on short-term clinical and biomarker changes in knee OA.
Dr. Simon has extensive experience as a senior clinical investigator, FDA reviewer, and regulatory consultant across the full drug development lifecycle. He served as a senior investigator for celecoxib in the US and as senior consultant to Pharmacia/Searle on COX-2 development. He served on the Steering Committee of the NIH Osteoarthritis Initiative (2001 to 2003). He contributed to the SPRINGBOARD Phase 2 randomized double-blind vehicle-controlled trial of EP-104IAR (extended-release intra-articular fluticasone propionate) in knee osteoarthritis, published in The Lancet Rheumatology (2024). He served on the Board of Directors and as a consultant to Savient Pharmaceuticals (2006 to 2012). He has served on consulting advisory boards for numerous pharmaceutical companies across pain, anti-inflammatory, bone turnover, and inflammatory disease modifying agents. He served as Acting Chair of the Arthritis Advisory Committee of the DAAODP (1993 to 2001) and on multiple other FDA advisory committees.
Dr. Simon has 318 publications listed on ResearchGate with 30,069 citations and 117 peer-reviewed publications listed on MediFind. He has authored more than 110 original publications, reviews, and book chapters and has edited several textbooks. He received the 2003 Distinguished Service Award of the American College of Rheumatology and the 2003 Scientific Leadership Award of the Lupus Research Institute. He received several FDA Quality Performance Awards and a Faculty Recognition Award. He is a Fellow of the American College of Physicians (FACP, 1991) and a Fellow/Master of the American College of Rheumatology (FACR/MACR). He was Associate Professor of Medicine at Harvard Medical School (1995 to 2003) and full-time faculty since 1981. He is on the editorial boards of multiple journals.
Dr. Simon obtained his B.S. in Biology from Loyola University Maryland (1969 to 1972) and his MD from the University of Maryland School of Medicine (1972 to 1976). He completed his internship and assistant residency in medicine on the Osler Medical Service at Johns Hopkins Hospital, Baltimore (July 1976 to June 1978), followed by a Clinical and Research Fellowship in Rheumatology (Arthritis Unit) at Massachusetts General Hospital, Boston (July 1978 to June 1981). He joined Beth Israel Deaconess Medical Center (BIDMC) and Harvard Medical School as staff in July 1981, holding progressively senior roles over 20 years including Director of Graduate Medical Education (1989 to 2001), Director of Rheumatology Clinical Research (1995 to 2001), and Associate Chief of Medicine for External Affairs (1999 to 2001). He was appointed Associate Professor of Medicine at Harvard Medical School in 1995. He served as FDA Division Director of DAAODP from November 2001 to December 2003, then returned to clinical practice and founded SDG LLC in February 2004.