Cardiovascular Safety in Biopharmaceutical Product Development – From QT Prolongation and Beyond

Jeff Heilbraun, MS, VP Strategic Development, Cardiovascular Safety Services, Bioclinica

Jeffrey Heilbraun attended Tufts University in Boston, Massachusetts where he completed his Bachelor of Science degree in Biology with a focus on physiology. Jeff continued his studies at The American University in Washington D.C., receiving a fellowship and completing his Masters of Science in Health Promotion and Disease Management. He was employed at The American University as an adjunct professor in the health promotion program. Jeff joined the Bioclinica team in 1993 and has supported activities in data management, operations, and business development. Throughout his career, Jeff has maintained his focus on the science, physiology and regulatory considerations behind cardiac safety within pharmaceutical development. Jeff has presented posters and chaired/participated at the Annual Drug Information Association (DIA) meeting, American Society of Hypertension (ASH), Canadian Clinical Pharmacology Association and at the Cardiac Safety Research Consortium (CSRC). Jeff has been involved in the publication of a number of articles specific to the area of cardiac safety in pharmaceutical development.

Bruce Lloyd, MD, Associate Medical Director and Director of Clinical Cardiology Services, Bioclinica

Bruce K. Lloyd, MD is Bioclinica’s Associate Medical Director and Director of Clinical Cardiology Services. Dr. Lloyd is responsible for the day to day operation of Bioclinica’s cardiovascular services. This involves answering clinical questions, supervising the cardiovascular technicians, and coordinating ECG interpretation services. He also provides clinical review and oversight for Quality Control processes.

Dr. Lloyd received a Doctor of Medicine degree from the Cornell University Medical College in 1972 and his initial training in Internal Medicine was completed at the Johns Hopkins Hospital. He completed his training in both Internal Medicine and Cardiovascular Diseases at the National Naval Medical Center in Bethesda, Maryland. Following completion of his training, Dr. Lloyd remained on the staff at the National Naval Medical Center. In 1984 he became the Chief of Cardiology at the National Naval Medical Center and was appointed as the Senior Cardiovascular Advisor to the Surgeon General. In 1985, Dr. Lloyd was selected as the Consulting Cardiologist for the White House serving under both President Ronald Reagan and President George H.W. Bush and was a consultant for the US Congress.

During his work at the National Naval Medical Center, Dr. Lloyd was the attending physician for one of the landmark cases involving drug interactions and its effect on the QT interval. He is one of the authors of the article ‘Toursade de Pointes Occurring in Association with Terfenadine Use’ reporting this significant drug interaction.

Since moving to Georgetown University, Dr. Lloyd has held multiple positions within the hospital. He has continued to teach and provide clinical care to a wide variety of patients. He has been a visiting professor at numerous locations including four different hospitals in the Russian Federation. He has received multiple awards for his teaching excellence.

Jean T. Barbey, MD, Cardiovascular Safety Expert, American College of Cardiology (FACC)

Dr. Barbey has more than 20 years of experience as a practicing physician, teacher, and clinical researcher in academia and the contract research organization (CRO) industry. He is a fellow of the American College of Cardiology (FACC) and board-certified in internal medicine, clinical pharmacology, cardiovascular disease, and cardiac electrophysiology. He previously served as the medical director at Medifacts International, (now Bioclinica) a global cardiac core laboratory.