Don’t miss this unprecedented opportunity to return to your business with the solutions you need to remain successful in today’s competitive clinical research environment!
Michael J. Koren, MD, FACC, FAPCR, CPI
Founder & CEO
Michael J. Koren, MD, is a practicing cardiologist and Chief Executive Officer at Jacksonville Center for Clinical Research, which conducts clinical trials at 8 locations in Florida. He received his medical degree cum laude at Harvard Medical School, and and completed his residency in internal medicine and fellowship in cardiology at New York Hospital/Memorial Sloan-Kettering Cancer Center/Cornell Medical Center.
Dr Koren is a fellow of the American College of Cardiology. He is also a fellow and president of the Academy of Physicians in Clinical Research and the current president of the regional chapter of the American Heart Association. As a principal investigator, Dr Koren has conducted more than 500 clinical trials on hypercholesterolemia, cardiovascular disease, and heart failure.
Dr Koren’s research has been published in peer-reviewed journals including Journal of the American College of Cardiology, Circulation, New England Journal of Medicine, and The Lancet. He is an editorial board member of Clinical Cardiology. He has lectured nationally and internationally on topics such as lipid-lowering therapy and preventive cardiology.
Susan Greco, MD
Carlos Orantes, MBA
Mr. Carlos Orantes has filled many executive roles in pre-clinical services over the last 20 years. Carlos received his bachelor's from George Washington and MBA from Old Dominion University. As the current CEO of the Accel research sites Carlos has keen insight into the business and financial aspects of clinical trials.
Palaniswamy Vijay, MD
Dr. Palaniswamy Vijay is the Director of the Baptist Health Research Institute (BHRI). Dr. Vijay has a bachelor's and master's degree in Biochemistry and received his Ph.D. and MD Rush Presbyterian St. Luke's Medical Center in Chicago, IL. With over 22 years of research and development experience, Dr. Vijay will bring a wealth of knowledge to the conference.
John M. Isidor, JD
John M Isidor is CEO of Human Subject Protection Consulting, LLC which is based in Cincinnati, Ohio. He was a co-founder of Schulman Associates Institutional Review Board, Inc., an accredited independent IRB located in Cincinnati, Ohio. John served as CEO of Schulman Associates IRB for 16 years. John formerly was a litigation attorney in Cincinnati specializing in civil and criminal law.
Since becoming involved in clinical research through his affiliation with Schulman Associates IRB, John has become a frequent lecturer on how legal and regulatory issues affect the conduct of clinical trials. John has authored many articles regarding legal and ethical issues relating to clinical research. John co-authored four chapters for a textbook entitled Institutional Review Board; Management and Function that was published in 2005. John is a member of the editorial advisory boards of the Guide to Good Clinical Practice and IRB Advisor and Medical Research Law and Policy.
John is licensed to practice law in Ohio as well as before the United States District Court in Ohio, the United States 6th Circuit Court of Appeals and the United States Supreme Court. He is a member of the Cincinnati, Ohio and American Bar Associations.
John received his undergraduate degree from the University of Cincinnati, a Masters degree from Ohio State University and his law degree from Northern Kentucky University.
Robert Hardi, MD
Robert Hardi, MD, AGAF, FAPCR, CPI serves as medical director of Chevy Chase Clinical Research for the Metropolitan Gastroenterology Group division of Capital Digestive Care. He completed his training in Internal Medicine at Semmelweis University Medical School, Hungary, Hannover University Medical School in Germany, and the University of New Mexico Medical School in Albuquerque. He also completed a fellowship in Hematology/Oncology at the University of New Mexico Medical School, and a fellowship in Gastroenterology at Cornell Medical College/The New York Hospital in New York, NY. Dr. Hardi has been in the private practice of Gastroenterology and Internal Medicine since 1984, and is on the Clinical Faculty of George Washington University and Georgetown University. He is Board Certified in both Internal Medicine and Gastroenterology and is a certified physician investigator (CPI). His principal professional interests are inflammatory bowel diseases (he has served on the National Board of the Crohn's and Colitis Foundation of America), clinical research, procedural sedation, colon cancer surveillance, and pancreatic and biliary disorders.