Applying a Holistic Digital Endpoint Strategy in the Development of Congestive Heart Failure Treatments
This webinar is designed to equip clinical development teams with the scientific rationale and operational insights necessary to elevate the quality and impact of CHF clinical trials.
Register to learn how a digital endpoint strategy can enhance data quality, support regulatory success and improve outcomes in heart failure trials.
Session information:
Time:
- 11:00 a.m. – 12:00 p.m. EDT (NA-East)
- 16:00 – 17:00 BST (UK)
- 17:00 – 18:00 CEST (EU-Central)
As the treatment modalities, scope and complexity of clinical trials for congestive heart failure (CHF) drug development increase, so does the need for precision and accuracy in endpoint definitions and assessments. This webinar will provide a comprehensive exploration of how to integrate cardiac imaging, ECG and arrhythmia assessments, along with a meaningful patient report outcome strategy to optimize study outcomes, ensure data integrity and support regulatory success.
Attendees will gain an in-depth understanding of advanced cardiac monitoring techniques, including continuous arrhythmia assessment, blood pressure tracking and the use of 12-lead ECG to characterize cardiac function. The session will also examine recent professional guidelines and trends regarding patient-reported outcomes in heart failure trials and how these can help us to assess and understand symptom burden and quality of life more accurately.
Experts will present the limitations of relying on site-based echocardiography and discuss the advantages of blinded central review. Advanced modalities such as 3D echocardiography and cardiac MRI will also be reviewed. Finally, the discussion will address the critical role of independent clinical adjudication in major adverse cardiovascular events (MACE) studies, underscoring its value in achieving unbiased, regulator-grade endpoint classification.
This webinar is designed to equip clinical development teams with the scientific rationale and operational insights necessary to elevate the quality and impact of CHF clinical trials.
Register for this webinar to learn how a digital endpoint strategy can enhance data quality, support regulatory success and improve outcomes in heart failure trials.
Speakers
Vic Patel, M.D., Ph.D.
VP and Chief Medical Officer, Cardiology at Clario
Dr. Vic Patel is board-certified in cardiology with a PhD in Biophysics and has done extensive research on mechanisms of cardiac arrhythmias. He was a faculty member at the University of Pennsylvania School of Medicine for 11 years, where he directed molecular arrhythmia research and practiced clinical electrophysiology. Dr. Patel then moved into drug development and cardiac safety as a Clinical Development Leader and Therapy Area Head across all phases.
At Clario, Dr. Patel oversees cardiology science and research, the consulting and ECG/Holter core lab services and he also leads the biostatistics and medical writing groups. He works with our global customers to ensure their needs are met with robust, cost-effective solutions.
Thomas Moll, Ph.D., MBA
Senior Scientific Advisor at Clario
Dr. Thomas Moll has been working in the life sciences industry for more than 20 years and has held various positions both in the CRO space and within big pharma (Eli Lilly). Over the years, one of his areas of focus has been post-marketing projects that require patient experience data for regulatory decision making, be it as a regulatory writer or coordinating large global Phase IV studies. Since joining Clario as a Scientific Advisor eCOA in 2022, he participates in numerous new initiatives aimed at strengthening the role of science throughout the eCOA lifecycle to improve data integrity and ultimately patients’ benefit. In addition, he’s passionate about transmitting his knowledge about the exciting world of drug development to young professionals.
Judith Narisi, BSN, RN
Senior Medical Scientific Affairs Associate at Clario
Judy Narisi is a seasoned healthcare professional with over two decades of experience in clinical research. Trained as a critical care RN, Judy’s research journey began in 2004 as a Study Coordinator, progressing to safety event case management and ultimately event adjudication in 2006. She has held key roles at PharmaNet, Johnson & Johnson and ICON, where her team reviewed 9,000+ cases for a large CV outcomes trial in patients with type II diabetes at high CV risk that compared liraglutide with placebo using a primary composite endpoint of three-point major adverse CV events.
Judy began her tenure at Clario as a Senior Director of Adjudication Services and currently serves as a Senior Medical Affairs Associate for Adjudication. She has successfully managed a team that has been effective in rescuing several large programs and contributed to the approval of several pharmaceutical drugs supported by the adjudication of thousands of events. Judy received her nursing degree from Gwynedd Mercy University in Pennsylvania.
Tonya Varcelli, Ph.D.
Director, Scientific and Medical Affairs, CV Imaging at Clario
Dr. Tonya Varcelli has 20+ years of experience as a subject matter expert supporting clients to ensure comprehensive delivery of services for clinical trials. In her current role, she provides medical and scientific support to Clario study teams and departments to identify new tools and services that improve and expand Cardiovascular Imaging services for clients. She was previously an Imaging Research Scientist responsible for research and development of scientific imaging-related documentation for 80+ clinical trials, including Phase II-IV and pilot studies involving medical devices, pharmaceuticals and combination products (biologics). Tonya began her career as a Ph.D. candidate at the Cleveland Clinic, followed by a role as a Clinical Trial Manager focusing on imaging components within Phase II-IV trials. She earned her Ph.D. from Case Western Reserve University, where she also earned her Master of Science and Bachelor of Engineering, Summa Cum Laude.