The cardiac safety ECG environment continues to mature and expand based on scientific advancements and understanding of pathways and systems associated with generating cardiac risk. The most recent ICH-E14 Q&A, and the ensuing cardiac safety conferences and industry meetings, have highlighted the advancements and direction for evaluating the cardiac safety during the drug development process. In addition to the role of ECG data in cardiac safety assessment, there are also considerations related to the “off-target” blood pressure safety signals, which are a consideration from a safety and regulatory perspective.
The objective and learning goals for the webinar will include:
- Provide attendees with the background and perspective on the use of QT prolongation as a cardiac safety endpoint within drug development, and take it forward to the more recent discussions beyond the Through QT (TQT)
- Learning about additional ECG intervals under discussion related to cardiac safety assessment
- An overview of the discussion around the use of long term ECG capture versus the 10 second ECG signal/waveform in clinical trials
- Provide a case study approach looking at therapeutic indications/class of compounds that require specific considerations
- Present background associated with the focus on BP as a cardiovascular safety endpoint in recent years, specific to the off-target blood pressure signal, using a case study review approach for the discussion
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.
Who Should Attend?
- Clinical Project Management
- Clinical Trial Study/Protocol Managers
- Medical Monitors
- Outsourcing and Vendor Management
- Regulatory Groups
- Directors & Associate Directors of Operations
- R&D Directors
- Drug Safety
Bioclinica is a specialty services provider that utilizes expertise and technology to create clarity in the clinical trial process. Bioclinica is organized by three business segments to deliver focused service supporting multifaceted technologies. The Medical Imaging and Biomarkers segment provides medical imaging and cardiac safety services and includes a molecular marker laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, Bioclinica offers a network of research sites, patient recruitment-retention solutions, and a post-approval research division.