Dr. Lee S. Simon

Physician and research scientist who has served as the FDA's Division Director of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products

Dr. Lee S. Simon served as the FDA's Division Director of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products (2001-2003). He served in 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. Allan M. Green

Physician, attorney, and research scientist who has represented and consulted with many U.S. and non-U.S. companies with deep experience in the development of medical imaging products, biomarkers and anti-alzheimer's drugs

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.

Dr. Green is Adjunct Professor of Law at Boston College Law School where he teaches Food and Drug Law.

Dr. William Schweiterman

An internist with 10 years at the FDA in the Center for Biologics as Chief of the Medicine Branch

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. Robert Makuch

A professor in the Department of Biostatistics at the Yale School of Public Health

Robert Makuch is a professor in the Department of Biostatistics at the Yale School of Public Health and Director of the Regulatory Affairs Track. A graduate of the University of Connecticut (BA), University of Washington (MA – mathematics), and Yale University (MPhil, PhD), Professor Makuch worked at the National Cancer Institute (NCI) and consulted with the World Health Organization's International Agency for Research on Cancer early in his career.

He also was heavily involved in HIV research from the mid 80s through the early-mid 90s. He participated on the data monitoring committee for the original AZT vs. placebo randomized clinical trial in AIDS patients, and served on numerous committees for the NCI and the National Institute of Allergy and Infectious Diseases. He also worked closely with the Food and Drug Administration (FDA), developing and implementing more than 100 HIV studies. He also served as a Special Government Employee (SGE) to the FDA.

He returned to Yale in 1986, and has worked extensively on methodologic issues in clinical trials and large population-based studies that are aimed to enhance patients' quality of care and insure better health outcomes. In addition, Makuch developed a regulatory affairs track at YSPH for its students, and over the past 11 years has been the leader of numerous training programs for senior delegations of the Chinese Food and Drug Agency. His areas of medical application include improving quality of health care, cancer, HIV, arthritis, and cardiovascular disease.

In 2003, Makuch received the American Statistical Association Fellow Award for his numerous contributions to the field. In 2008, Makuch was received a Distinguished Alumni Award from the University of Connecticut. In 2012, Makuch was nominated to serve on the University of Connecticut Dean's Advisory Board for the College of Liberal Arts and Sciences. He also developed a 5-year biostatistics training program in Japan, in collaboration with the Japanese government.

Steffen Gay

Professor at University Hospital Zurich and Expert in Clinical Study Design and Analysis

Steffen Gay is a graduate of the Medical School at the University in Leipzig. He served since 1976 at the Department of Medicine at the University of Alabama in Birmingham, where he was Professor of Medicine from 1984-1996. Since 1996 he has been Professor of Experimental Rheumatology at the University Hospital of Zurich, Switzerland, which has been recognized as an EULAR Center of Excellence in Rheumatology from 2005-2015.

He has published 64 book chapters and over 360 peer-reviewed scientific papers. He is among the most cited scientists in Clinical Medicine (ISI) with over 19,000 citations and a h-index of 77. He is an Honorary Member of the American Association of Physicians (AAP) and the Alpha Omega Alpha Honor Medical Society. He became the Spinoza Professor for 2002 at University of Amsterdam and a member of the German National Academy of Sciences Leopoldina in 2004. In 2008 he received the Kussmaul-Medal from the German Society of Rheumatology and became Honorary Member of EULAR in 2011.

Since the 1980's he has been involved into the funding of biotechnology companies, serving at the Board of Directors and Scientific Advisors of SME's and the pharmaceutical industry.

His primary expertise is in evaluating the experimental proof of concepts, supervision of clinical trials and the early detection of "off-target" effects in drug development.