The past years have seen advancements in remote monitoring and telemedicine. The COVID-19 pandemic has accelerated the movement of healthcare from the hospital and outpatient facilities to the home. This decentralization has also affected the conduct of clinical trials; in July of 2020 FDA issued a final FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. This Guidance suggests that, “Sponsors should determine if in-person visits are necessary to fully assure the safety of trial participants,” and, “in making the decision to continue use or administration of the investigational product, the sponsor should consider whether the safety of trial participants can be assured with the implementation of the altered monitoring approach.”
It is likely that the movement toward remote cardiac monitoring and remote clinical trial visits will continue well past the current public health emergency. As such, it’s essential that clinical trial investigators can confidently monitor patient safety and sponsors have confidence that regulators will accept data that is gathered in a remote format. Therefore, the Cardiovascular Safety Research Consortium (CSRC) has brought together industry experts along with representatives from FDA — from both Centers of Drug and Device Evaluation — in order to explore some best practices for remote cardiac monitoring.
This Cardiac Safety Research Consortium webinar will be moderated by CSRC Executive Director, Jonathan Seltzer, MD, FACC and is sponsored by BioTel Research. The agenda features regulatory and industry experts:
- Use of Remote Captured Data to Assess Cardiac Safety – Fred Senatore, MD, PhD, FACC, Medical Officer/Clinical Team Leader, Division of Cardiology & Nephrology, CDER, FDA
- Cardiac Monitoring Medical Device Landscape— LT Stephen Browning, BS, Assistant Division Director – Blood Pressure and Flow Devices, Division of Cardiac Electrophysiology, Diagnostics and Monitoring, CDRH, FDA
- Practical Aspects of Remote Cardiac Safety Monitoring—Polina Voloshko, MD Chief Medical Officer, BioTel Research
- Case Study: Remote Physiologic Parameters during the COVID-19 Pandemic—Ken Stein, MD, Senior Vice President, Chief Medical Officer for Rhythm Management and Global Health Policy, Boston Scientific
- Regulatory Landscape for Clinical Outcome Assessment— Elektra Papadopoulos, MD, MPH, Acting Director, Division of Clinical Outcome Assessment, Office of New Drugs, CDER, FDA
- Considerations for Remote Capture of Clinical Outcome Assessments – Ken Faulkner, PhD, Vice President, eCOA Scientific Services, ERT
Fred Senatore, MD, PhD, FACC, Medical Officer/Clinical Team Leader, Division of Cardiology & Nephrology, CDER, FDA
Dr. Fred Senatore is a medical officer at the FDA since 2012, having come to the FDA from a varied background: PhD in engineering, professor of engineering, MD internal medicine/cardiology, and the pharmaceutical industry. While at the FDA reviewing NDAs, INDs, and serving as a consultant to other divisions, he availed himself of the opportunities for scientific engagement: Chair of the Enhanced Adherence Strategic Initiative in association with the National Forum for Heart Disease and Stroke Prevention and Association of Black Cardiologists, adjunct assistant professorship at GW School of Medicine, and the Heart Failure Collaboratory with Duke University, lecturing on efficacy review and CFR, and publishing. Prior to joining the FDA, Dr. Senatore worked in the pharmaceutical industry for 17 years. He earned a PhD in chemical engineering from Rutgers University and attended medical school at Texas Tech University. Upon receiving his medical degree, he trained in internal medicine at the Mayo Clinic and in cardiology at Massachusetts General Hospital.
LT Stephen Browning, BS, Assistant Division Director - Blood Pressure and Flow Devices, Division of Cardiac Electrophysiology, Diagnostics and Monitoring, CDRH, FDA
LT Stephen Browning has been with FDA for nearly 8 years with the vast majority of that time spent in review of cardiovascular diagnostic medical devices. LT Browning holds a Bachelor of Science in Biomedical Engineering from Washington University in St. Louis.
Polina Voloshko, MD, Chief Medical Officer, BioTel Research
Dr. Polina Voloshko provides scientific and medical leadership, direction, training and expertise to the BioTelemetry clinical trial staff, cardiologists, medical and scientific consultants, and sponsors. She has over 25 years of experience in clinical cardiology, ECG, ECHO and Holter research. Prior to joining the company, she was VP of Cardiovascular Clinical Services at the Ischemia Research and Education Foundation, Gentiae Clinical Research and Cardiocore. Previously, Dr. Voloshko served as a research fellow at the University of California San Francisco (UCSF) and Chief of Cardiology at Riga City Hospital in Riga, Latvia, an affiliate of the Latvian Medical University. Board-certified in cardiology and internal medicine, Dr. Voloshko received her MD, magna cum laude, at the First St. Petersburg Medical School in Russia.
Kenneth Stein, MD, FACC, FHRS, Senior Vice President & Chief Medical Officer, Cardiac Rhythm Management and Global Health Policy, Boston Scientific
Ken Stein is a graduate of Harvard (in Economics) and earned his MD from New York University School of Medicine. He completed his medical internship and residency at The New York-Presbyterian Hospital/Weill Cornell Medical Center, where he also completed his cardiology and cardiac electrophysiology training.
Prior to joining Boston Scientific in 2009, Dr. Stein held the position of Associate Director of Clinical Cardiac Electrophysiology at Weill Cornell Medical Center and Associate Professor of Medicine at Cornell University. Dr. Stein currently oversees the clinical trials, medical safety, and medical education and clinical communications for Boston Scientific’s Cardiac Rhythm Management, Electrophysiology and Watchman Left Atrial Appendage Closure businesses as well as leading the corporate Global Health Policy team tasked with shaping the company’s policies with respect to global health care delivery and reimbursement. Dr. Stein serves on the board of the Boston Scientific Political Action Committee and on the Scientific Advisory Board of Optum Labs. Since 2013, he has also served on the board of Children’s HeartLink, which currently supports partner hospitals in Brazil, China, India, Malaysia, Ukraine and Vietnam.
Elektra Papadopoulos, MD, MPH, Acting Director, Division of Clinical Outcome Assessment, Office of New Drugs, CDER, FDA
Elektra Papadopoulos, MD, MPH, serves as the Acting Director of the Division of Clinical Outcome Assessment in the Office of New Drugs in the Center for Drug Evaluation and Research (CDER) at the FDA. The Division provides consultation to CDER’s therapeutic area review divisions as well as other FDA Centers on clinical outcome assessments (COAs) including their development and validation for use as study endpoints in medical product development. Papadopoulos has participated in the development of FDA policy related to COAs including multiple methodologic and disease-specific guidance documents. She also leads CDER’s COA Drug Development Tool Qualification Program, which includes innovative assessment methods for use as study endpoints.
Kenneth G. Faulkner, PhD, Vice President, eCOA Scientific Services, ERT
Kenneth G. Faulkner, Ph.D. currently serves as Vice President of eCOA Science and Consulting at ERT. He also serves as an Adjunct Professor in the UNC/NC State Joint Biomedical Engineering program. Prior to joining ERT, Faulkner was the Corporate Vice President for Patient Technology Solutions at Parexel and a co-founder of Synarc, a medical imaging core laboratory started in 1998. In addition to his pharmaceutical development experience, Faulkner worked at GE Healthcare for five years, where he served as the Chief Scientist for the lunar bone densitometry business unit. Faulkner received his PhD from the Joint Bioengineering Program at the University of California Berkeley and San Francisco.
Who Should Attend?
- Clinical Development
- Clinical Research
- Clinical Operations
- Medical Affairs
- Project Management
- Regulatory Affairs
What You Will Learn
In this webinar, participants will learn:
- The impact of COVID-19 on CV trial protocol design and data retrieval accommodations.
- The wide array of regulatory statuses and approval pathways for medical devices.
- How medical devices can be used on label within a clinical trial without any additional FDA review/clearance and which devices/algorithms need to be included for review as part of a trial.
BioTel is a pioneering core lab for clinical trials, an innovative medical device company, and a leading healthcare services organization. With these unique competencies, we have built our research expertise, working with Sponsors, CROs and sites, conducting more than 2,000 clinical trials.
We offer a complete suite of services to support all major areas of drug and device research, and support all major cardiovascular testing modalities for clinical trials, including standard ECG, traditional 24/48/72 Holter, long-term continuous monitoring (ePatch), continuous real-time long-term monitoring, MCOT, ambulatory event monitoring (24/7 TTM), exercise stress tests, CPET, MUGA, and CVMRI. Additionally, we offer advanced imaging analyses in the following therapeutic areas: oncology (including immuno-oncology), liver, cardiovascular, neurology, metabolic, and musculoskeletal, as well as medical devices.