Arthur Santora, MD, Ph.D
Dr. Santora joined Kinexum in 2017 after 30-years of experience in clinical pharmaceutical research.
Dr. Santora received his medical education at Emory University in Atlanta, where he also received a PhD in biochemistry. After an Internal Medicine residency, also at Emory, he completed an Endocrinology and Metabolism fellowship at the NIH Clinical Center in Bethesda, MD. His interest in pharmaceutical research was sparked by two-year appointment as a Medical Officer at the US FDA. After his tenure at the FDA, he became an Assistant Professor of Medicine the Division of Endocrinology, Metabolism and Hypertension at Wayne State University Medical School for 3 years before joining Merck Research Laboratories to work on the Fosamax® development program at the start of phase 2. Dr. Santora became the lead Clinical Research physician responsible for many components of Fosamax development. During his work with Fosamax he:
- Designed, monitored and reported the phase 2 and pivotal 3 osteoporosis treatment studies supporting the initial Fosamax NDA
- Monitored phase 2 Paget’s disease study
- Co-authored the NDA for the Paget’s indication
- Co-designed the Fracture Intervention Trial of alendronate, the first long-term study of a drug for osteoporosis to demonstrate both vertebral, hip and non-vertebral fracture outcomes
- Was ”co-inventor” of the once-weekly bisphosphonate regimen for osteoporosis treatment and prevention
- Was the Clinical Research lead for once-weekly Fosamax tablets and oral solution
- Co-designed the clinical development and regulatory strategy for once-weekly Fosamax Plus D (alendronate sodium/ vitamin D3 combination tablets) the first drug/vitamin combination tablet, monitored the pivotal clinical studies and co-authored the NDA
- Participated in numerous FDA and ex-US regulatory authority meetings related to the Fosamax program
- Was the lead physician for the labeling committee from the initial draft through 2016.
- Co-chaired the product’s post-marketing pharmacovigilance team.
- In addition to Fosamax, while he was at Merck, Dr. Santora participated in the development teams of several osteoporosis drug candidates including a DKK-1 antibody, a calcium-sensing receptor antagonist and Cathepsin K inhibitors that did not advance to NDA submission. He was the bone/calcium metabolism “expert” on endocrine and metabolic drug licensing committees and often a “peer reviewer” of both study protocols and development plans endocrine and metabolic drug candidates. He served on the group that managed Merck’s Clinical Research SOPs and was the lead physician for the Study Monitoring and Protocol Deviation SOPs for over 10 years. As a member of many cross-functional teams, he developed a good working knowledge of the contributions colleagues in regulatory affairs liaison, clinical operations, basic research, epidemiology, CMC, medical economics, medical affairs, marketing and patent departments delivered.
Dr. Santora remains active as a physician at Rutgers Robert Wood Johnson Medical School in New Brunswick, NJ, involved in both education and patient care focusing on osteoporosis and other disorders of calcium and mineral metabolism. He is a member of the Endocrine Society, the American Society for Bone and Mineral Research, American Association of Clinical Endocrinologists and a Fellow of the American College of Endocrinology. He is certified in Internal Medicine and Endocrinology & Metabolism.
