New drugs, biologics and devices in development today can be very effective at treating the targeted disease or condition. However, many may also have a negative impact on cardiovascular outcomes and therefore the review of clinical events need to be considered. This webinar will provide an overview of the centralized review of cardiovascular safety through implementation of a Clinical Events Committee (CEC) and the importance of collecting and adjudicating events and providing unbiased assessments through electronic expert evaluation. This presentation will highlight the role electronic expert evaluation plays in improving the quality of endpoint assessments for cardiovascular outcomes. A detailed discussion on the Clinical Event adjudication process workflow will be shared.
Attend this webinar to better understand:
- What a Clinical Events Committee (CEC) is and the increasing role they play in streamlining clinical trials
- Improved quality and efficiencies gained through uniform assessments, reduced discrepancies and quicker study endpoint confirmation across complex, global clinical trials
- Other therapeutic areas for consideration to implement adjudication
- Electronic vs traditional event adjudication
Lisa Chwieroth, Director of Clinical Event Committee (CEC) Operations, Bioclinica
With more than 15 years of drug development industry experience, Lisa Chwieroth serves as the Director of Clinical Event Committee (CEC) Operations at Bioclinica. In this role, Ms. Chwieroth holds responsibility for the operational planning process to deliver CEC projects on schedule and on budget while also ensuring quality. Prior to joining Bioclinica, Ms. Chwieroth was with ICON Medical Imaging where she co-founded and led the Electronic Adjudication Services department. Her time at ICON also included roles of increasing responsibility in Clinical Operations and Project Management. Lisa initiated her career as a certified technologist in MRI and CT.
Souhil Zaim MD, Bioclinica
Dr. Zaim is a recognized medical imaging industry senior executive with more than 25 years of medical, scientific and industry experience and was most recently chief medical officer at Median Technologies. He is responsible for ensuring the strategic and long-term medical, scientific and technical development of Bioclinica’s Medical and Science Affairs organization in concert with the Medical Imaging and Biomarkers’ Chief Medical Officer, Dr. Michael O’Neal, and Chief Science Officer, Dr. Thomas Fuerst.
Dr. Zaim was previously with SYNARC (merged with Bioclinica in March 2014) for more than a decade in various leadership roles, including medical director, chief medical officer, vice president of radiology, and director of radiology services, Europe. In these roles, Dr. Zaim established and developed global medical and science affairs teams supporting an array of clinical trial indications. Dr. Zaim is regularly published in peer-reviewed journals, and has extensive central reading and adjudication experience encompassing thousands of patients in hundreds of clinical trials in Oncology, Arthritis, Osteoporosis and other areas.
Prior to this, he was assistant professor of Radiology at the University of California at San Francisco. He earned a medical degree from the University of Algiers and is board certified in Radiology with a certificate in Magnetic Resonance, both from the University of Paris. Dr. Zaim is a member of the Radiological Society of North America, the European Society of Radiology, Osteoarthritis Research Society International, and the American Society of Clinical Oncology.
Stephen D. Wiviott, MD, FACC, Cardiovascular Division, Brigham and Women's Hospital; Associate Professor of Medicine, Harvard Medical School; Senior Investigator, TIMI Study Group
Stephen D. Wiviott, MD, FACC is a graduate of University of Pennsylvania (Mathematics, Magna Cum Laude) and Harvard Medical School (Honors). He served as a Medical House Officer and Chief Medical Resident at Brigham and Women’s Hospital. Following his medical residency training, he served as a Cardiology Fellow at Johns Hopkins Hospital and as a Cardiovascular Research Fellow with the TIMI Study Group with the Cardiovascular Division of Brigham and Women’s Hospital. After completion of his training he has joined the faculty of the Cardiovascular Division of Brigham and Women’s Hospital and serves as Associate Professor of Medicine at Harvard Medical School, as well as a Senior Investigator with the Thrombolysis in Myocardial Infarction (TIMI) Study Group. He attends in the Lown Cardiovascular Intensive Care Unit at BWH.
As a Senior Investigator with the TIMI Study Group, Dr. Wiviott has played important roles in the planning, implementation, and interpretation of several multicenter, national, and international clinical trials in acute coronary syndromes and those studying antiplatelet therapies. He has played leadership roles in the JUMBO-TIMI 26 trial and the TRITON-TIMI 38 trial, the major phase II and III trials which led to the approval of prasugrel. He was the Principal Investigator (PI) of PRINCIPLE-TIMI 44, a study comparing high-dose clopidogrel with prasugrel in patients undergoing PCI, and of the TIMI 38 Coronary Stent Registry. He has also served key roles in trials of secondary prevention of Cardiovascular Disease as an executive committee member of REVEAL, and co-PI of DECLARE – TIMI 58 and CAMELLIA – TIMI 61 assessing Cardiovascular Safety and Efficacy of metabolic therapies. He is the Chairman of the TIMI Clinical Events Committee, and an expert in clinical event definitions and adjudications.
Dr. Wiviott is an author of more than 150 peer-reviewed publications in major medical and cardiovascular journals and of multiple chapters in major cardiovascular textbooks, including Braunwald’s Heart Disease and Cardiovascular Therapeutics, a companion to Braunwald’s Heart Disease. He was named in 2014 by Thomson Reuters as one of “The World’s Most Influential Scientific Minds” and in 2016 as a “Highly Cited Researcher,” inclusive of the top 1% of researchers in Clinical Medicine. He has delivered local, national, and international lectures in the field of acute coronary syndromes, platelet biology, established and novel antiplatelet agents, diabetesand prevention. Areas of clinical and research interest include acute coronary syndromes, platelet inhibitors, cholesterol-lowering therapy, cardiovascular effects of diabetes therapies, and secondary prevention of CAD.
Who Should Attend?
- Clinical Operations
- Cardiac Safety
- Cardiovascular Safety
- Clinical Project Management
- 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.