APPI Leadership

President, Chairman of the Board

Peter Rheinstein MD, JD, MS, consults and speaks on drug issues. Previously, he was senior vice president for medical and clinical matters at a Johns Hopkins spinoff firm developing cancer diagnostics and therapeutics, publisher of the journal Discovery Medicine, and director of several offices for the U.S. Food and Drug Administration.

Rheinstein also has been a practicing physician, medical school faculty member, medical director for a national chain of extended care facilities, and president of the Drug Information Association (DIA). He has served APPI as its vice president for American Medical Association (AMA) Relations and delegate to the AMA House of Delegates, vice chair of the Policy Committee (and of ACRP’s Government Affairs Committee), and president of the Baltimore-Washington Chapter. He received the APPI President’s Outstanding Service Award in 2003.

President Elect

Jonathan Seltzer, MD, MBA, MA, FACC, is President of Applied Clinical Intelligence, LLC in Bala Cynwyd, Pa., and director of clinical research at Main Line Health Heart Center in suburban Philadelphia. He has worked on numerous data monitoring committees in multiple therapeutic areas, served as an institutional review board member, and co-chaired federally sponsored meetings focused on human subject protection. For APPI, he has served on the Executive Committee, as treasurer and chair of the academy’s annual meeting, and as APPI’s liaison to the Clinical Trials Transformation Initiative. A Fellow of the American College of Cardiology, he also holds an appointment as a clinical assistant professor at Jefferson Medical College.

Trustees Secretary-Treasurer

Michael J. Koren, MD, FACC, directs activities at the Jacksonville Center for Clinical Research (JCCR), a multispecialty research organization with seven locations that has conducted more than 1,000 trials involving more than 100 investigators. JCCR has spawned several initiatives through its Encore Research Group subsidiary. These initiatives include Ask 100 Doctors, a national online consulting and consensus-building tool for physicians, e-Trialdoc, a software system to help research sites conduct studies, and various training initiatives. Dr. Koren is an honors graduate of both Brandeis University and Harvard Medical School. He received his postdoctoral training at Cornell Medical Center in internal medicine and cardiology, and is board-certified in Internal Medicine and Cardiology. He also is the director of noninvasive cardiology at Memorial Hospital Jacksonville and maintains a private cardiology practice.

Immediate Past President

Charles M. Alexander, MD, FACP, FACE, CPI (Hon), is Senior Medical Director in Global Medical Affairs at Merck. Dr. Alexander began working for Merck in 1992 and was in Outcomes Research 1996-2008 when he assumed his current position. Previously he co-chaired the APPI Academic Medicine Taskforce, served on the ACRP Board of Trustees as Ex-Officio, the Joint Task Force for the Affiliation Agreement and the APPI Negotiating Committee which successfully concluded in the affiliation agreement which was signed in 2005. He has served leadership roles in AAPP, APPI, and ACRP since 1998, has been a member of the AAPP/APPI Board of Trustees since 2001. In 2008, he received an honorary certified physician investigator designation in recognition of his work helping to create the physician investigator certification program.

Dr. Alexander received his medical degree and did postgraduate training from the University of Southern California and LAC/USC Medical Center, Los Angeles. Prior to joining Merck, he practiced diabetes, endocrinology and internal medicine in Los Angeles for ten years where he was also Clinical Professor of Medicine of the USC School of Medicine. Dr. Alexander is board certified in Internal Medicine and Endocrinology-Metabolism and is a Fellow of both the American College of Physicians and the American College of Endocrinology. He is the author of numerous scientific articles and presentations.

Trustees

Chris Allen, MD, FRCA, FFPM, leads Global Medical Information at Merck. He previously headed International Phase IV Clinical Research and Investigator initiated studies. Prior to this he was responsible for International Medical Affairs and Clinical Research activities for cholesterol lowering with ezetimibe and ezetimibe-simyastatin.  Allen trained at Kings College London and qualified as an anesthesiologist.  Chris is a past President of the International Federation of Pharmaceutical Physicians.

Robert Dracker, MD, MHA, MBA, CPI, is president of the Onondaga County Medical Society in Syracuse, N.Y., and has been medical director of Summerwood Pediatrics in Liverpool and Camillus, N.Y., since 1993. He earlier served as medical director for the Transfusion Medicine Service at University Hospital in Syracuse, for the Biocyte Corp., and for ViaCord, and founded Infusacare Medical Services. Dr. Dracker received his bachelor’s degree in biology from New York University and his MD from SUNY Health Science Center at Syracuse, followed by a residency in pediatrics and fellowships in pediatric hematology/oncology and in blood banking/transfusion medicine, all at University Hospital, a masters in health services management from the New School for Social Research, and an MBA from Columbia College. He is currently enrolled in the Central New York Masters in Public Health Program.

Amirtha (Amy) Naadimuthu, MD, CPI, is vice president of clinical research and head of the Clinical Research Unit of sanofi-aventis U.S., based in Bridgewater, N.J. She has been in the pharmaceutical industry for more than 28 years, during which she has managed the development of various drugs in Phase I–III clinical trials and through New Drug Applications. Dr. Naadimuthu’s medical background is in pediatric hematology and oncology, and her areas of interest include personalized medicine, biomarkers, site partnership, investigator training, patient recruitment and retention, and efficiency of monitoring and data quality. She served as president the Greater Philadelphia Chapter of ACRP in 2007, and more recently as APPI’s liaison to the Clinical Leadership Committee and to the Clinical Research Technical Group of the Pharmaceutical Research and Manufacturers of America.

Samuel Simha, MD, FACOG, CPI, is an Ob/Gyn in private practice in Memphis, Tenn., and has been practicing for more than 25 years in Canada and in the United States. A graduate of the University of Chile Medical School, he interned and completed his residency at the University of Toronto. Dr. Simha began to develop a more formal interest in clinical research in 2001, and obtained his investigator’s certification in 2004. He is currently the medical director of Research Memphis Associates, a company dedicated to women’s health research, which he founded five years ago. He also volunteers his time in the Latino community, serving on various committees and acting as a regular guest speaker on Radio Ambiente, where he answers questions on women’s reproductive health.

Jay Udani, MD, CPI, is the founder, CEO and Medical Director of Medicus Research. He is a board-certified Internist who served as Chief Resident at Cedars-Sinai Medical Center before completing two fellowships in Health-Services Research and Integrative Medicine at Cedars-Sinai/UCLA. He is currently the Medical Director of the Northridge Hospital Integrative Medicine Program and on the clinical faculty of the UCLA School of Medicine. He was one of the first physicians to become a Certified Principal Investigator (CPI) through the APPI/ACRP and as a Key Opinion Leader in the field of Integrative Medicine