Leadership

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.    

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Leadership List

Officers

G. Alexander Fleming, MD
Founder and Executive Chairman

Thomas Seoh, J.D.
President and Chief Executive Officer

Brian Oscherwitz, MBA, PMP
Chief Operating Officer

 

Clinical Development

G. Alexander Fleming, MD

Arthur Santora, MD, Ph.D

Brian E. Harvey, MD, Ph.D

Charles Alexander, MD

Doug Muchmore, MD

Giora Davidai, MD

Gordon B. Cutler, Jr., M.D.

Grant Williams, MD

Guenther Karmann, Ph.D

John K. Whisnant, Jr, MD

Michael Trautmann, MD

Mustafa A. Noor, MD, FACP

Peter Damsbo, MD

Ramachandra (Ram) G. Naik, M.D.

Simon Bruce, MD

Theo Gana, MD, Ph.D

Todd J. Lorenz, MD

 

Regulatory Strategy and Operations

G. Alexander Fleming, MD

Arthur Santora, MD, Ph.D

Asoke Mukherjee, Ph.D

Brian E. Harvey, MD, Ph.D

Catherine Bernard, Ph.D

David Reinhold Brill, Ph.D

Dia Hill

Frances Mielach, Ph.D, RP.h

Gabrielle Wiederkehr, MSc

Grant Williams, MD

Joshua Sharlin, Ph.D

Michael Sharp, Ph.D

Susan Manley, MS

 

Biostatistics

Alan Fisher, DrPH

 

EU Regulatory

Catherine Bernard, Ph.D

Gabrielle Wiederkehr, MSc

Michael Trautmann, MD

 

Clinical Operations/Project Management

Brian Oscherwitz, MBA, PMP

Chris Yun, B.S.

Gabrielle Wiederkehr, MSc

Julie Waltz Gerlach, B.S.N., M.P.H., R.A.C.

Susan Manley, MS

 

Pre-Clinical

Asoke Mukherjee, Ph.D

Dave Edwards, Ph.D

Frances Mielach, Ph.D, RP.h

Joy Cavagnaro, Ph.D

Michael B. Zemel, Ph.D.

Virgil Whitehurst, Ph.D

 

CMC, Formulation/Process Development & Sourcing

Anand Khedkar, Ph.D

David Bergstrom, Ph.D

Jo Van Betsbrugge, PhD

Knut Zellerhoff, Ph.D

Robert Kaster, RPh., ASQ-CQA

 

Medical Device

Michael Sharp, Ph.D

 

QA/QC

Brian Oscherwitz, MBA, PMP

Jennifer Zhao, B.S.

 

Medical Writing/Electronic Submissions

Jennifer Zhao, B.S.

Kristi Hultberg, B.S.

Sandor Bernath, Ph.D, MBA

 

Botanicals

Jinhui Dou, Ph.D.

 

Government Relations and Public Affairs

Scot Faulkner, MPA

 

Defense & National Security Practice

Dean E.Calcagni, MD

 

Commercialization and Business & Corporate Strategy

Brian Oscherwitz, MBA, PMP

Lisa Jansa, MBA

Martin Lafontaine

Thomas Seoh, J.D.