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Dr. Lee S. Simon has served as the FDA’s Division Director of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products (2001-2003). He has also served multiple FDA advisory committees and has extensive experience in drug development as a senior investigator for celecoxib in the US. Dr. Simon was a senior consultant to Pharmacia/Searle on COX-2 development has served on consulting advisory boards for numerous other pharmaceutical companies. For 12 years, he worked as a NIH funded investigator and he has served two terms on the Board of Directors of the American College of Rheumatology (ACR). Dr. Simon has also served as Chair of the International COX-2 Study Group as well as Chair of Education for the ACR and the National Arthritis Foundation. He served on the Steering Committee of the NIH Osteoarthritis Initiative and has been Chair of the biannual “Innovative Therapies in Autoimmune Disease” conference sponsored by the ACR, FDA, NIH and Arthritis Foundation. Dr. Simon is on the editorial boards of multiple journals and has authored more than 110 original publications, reviews and book chapters, and has edited several text books.

Dr. Simon can be reached by email at leesimon@sdgltd.com

Dr. Allan Green is a physician, attorney, and research scientist who has significant operating management experience with a number of successful biomedical companies. Dr. Green holds several US Patents, has served as a technical consultant to a variety of government committees. He has held several medical school appointments and is the author of numerous peer-reviewed scientific papers on biochemistry and drug development. Dr. Green is well known for his Issues and Commentary series that analyzes competitive commercial aspects and potential markets for emerging pharmaceutical technologies. He has successfully represented many American and non-U.S. clients in their relationships with the FDA and has organized a number of multi-disciplinary conferences on healthcare, pharmaceutical and funding issues. He was formerly Medical Director of New England Nuclear Corporation, a Founder of Neurochem, Inc., and Of Counsel to the law firm of Mintz, Levin, Cohn, Ferris,Glovsky and Popeo, P.C. He is Adjunct Professor of Law at Boston College Law School where he teaches Food and Drug Law.

Dr. Green can be reached by email at amgreen@sdgltd.com

Dr. Robert Makuch is Professor of Biostatistics at the Yale School of Medicine where he created the Biostatistics Consulting Unit to provide data management and biostatistics collaborative support to medical researchers in 1986. Dr. Makuch has been a major collaborator with and statistical consultant to many US and international governmental agencies, universities and life sciences companies. He has served on numerous data and safety monitoring committees covering a broad range of therapeutic indications including arthritis, cancer, cardiovascular, migraine and HIV. As special advisor to the Senior Management Board of GD Searle, Dr. Makuch reviewed all pre-clinical and clinical development plans and participated in resource allocation decisions to select and speed development of the most promising compounds.

Dr. William D. Schwieterman is an independent consultant for biotech and pharmaceutical companies who specializes in clinical development. Dr. Schwieterman is a board-certified internist and rheumatologist who spent 10 years at the FDA in the Center for Biologics overseeing a wide range of clinical development plans for a large number of different types of molecules. First as Chief of the Medicine Branch, and then as Chief of the Immunology and Infectious Disease Branch in the Division of Clinical Trials in CBER, he worked with sponsors for the development of new agents for pulmonary medicine, neurology, sepsis, hepatitis, rheumatology, infectious disease, solid organ transplantation and wound-healing, among other areas, and also worked closely with reviewers of vaccines, devices (CDRH) and oncologic products. Dr. Schwieterman also helped author the Agency’s “Good Review Practices” for investigational products and was instrumental in the development of several guidance documents.

Dr. Vibeke Strand is Adjunct Clinical Professor of Medicine, Division of Immunology at Stanford University and a leading consultant in clinical trial methodology, regulatory strategy and clinical studies involving autoimmune diseases. She has been a clinical research investigator, member of IRBs and worked internally at 3 pharmaceutical and biotech companies directing clinical research. Since 1991, Dr. Strand has led a consulting practice offering clinical research and regulatory strategy expertise. She has assisted in preparation of applications, briefing documents and data presentation for successful defense of NDA and BLA applications, including: Ganciclovir™ in CMV Retinitis; CD5 Plus in GvHD; Neoral™ in RA; Ontak™ in CTCL, Arava™ in RA; Celebrex™ in RA and OA; Remicade™ in RA x-ray; Kineret™ in RA; Humira™ in RA, Supartz™ in OA as well as additional labeling claims for the above products. In addition to her consulting activities, Dr. Strand continues to serve patients, supervise Rheumatology Fellows at Stanford, serves on the editorial board for several journals, has published over 90 articles and 25 chapters and has co-edited 2 books.