Panel Discussion: Leveraging Real World Evidence: Where Are We Now and What Lies Ahead?

Tuesday, February 28, 2023

10:07 AM – 10:30 AM ET

Panel Moderator(s)

Mitchell Krucoff, MD, FACC (he/him/his)

Professor Medicine/Cardiology
Duke University Medical Center/Duke Clinical Research Institute
Durham, North Carolina, United States

Disclosure(s): Abbott Vascular: Consultant/Advisory Board (Ongoing), Consulting Fees (e.g., advisory boards) (Ongoing), Other Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); Boston Scientific: Consultant (Ongoing), Other Research Support (Ongoing); Cook medical: Consultant (Ongoing), Other Research Support (Ongoing); Getinge: Consultant (Ongoing), Other Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); InfraRedx: Clinical Trial Support (Ongoing), Consultant (Ongoing), Research Grant (includes principal investigator, collaborator or consultant and pending grants as well as grants already received) (Ongoing); Johnson & Johnson: Consultant (Ongoing), Other Research Support (Ongoing), Research Grant (includes principal investigator, collaborator or consultant and pending grants as well as grants already received) (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); Medtronic: Clinical Trial Support (Ongoing), Consultant (Ongoing), Grant Recipient (Ongoing), Other Research Support (Ongoing), Research Grant (includes principal investigator, collaborator or consultant and pending grants as well as grants already received) (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); Nipon: Consultant (Ongoing); OrbusNeich Medical Inc.: Clinical Trial Support (Ongoing), Consultant (Ongoing), Grant/Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); SMT: Consultant (Ongoing), Research Grant (includes principal investigator, collaborator or consultant and pending grants as well as grants already received) (Ongoing); Terumo Corporation: Other Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing)
Bram Zuckerman, MD

Director Office of CV Devices
U.S. Food and Drug Administration
Silver Spring, Maryland, United States

Disclosure(s): No financial relationships to disclose

Panel Discussant(s)

Dominic Allocco, MD, MS

Vice President, Clinical
Boston Scientific, Minnesota, United States

Disclosure(s): Boston Scientific: Employee (Ongoing), Shareholder (Ongoing)
Ori Ben-Yehuda, MD (he/him/his)

Professor of Medicine
University of California, San Diego
La Jolla, California, United States

Disclosure(s): Bioventrix, Inc: Ownership Interest (stocks, stock options, patent or other intellectual property or other ownership interest excluding diversified mutual funds) (Ongoing), Salary (Ongoing); Cardiovalve: Consultant (Ongoing)
Keith D. Dawkins, MD, FACC, FSCAI, FRCP

Chief Medical Officer
Shockwave Medical Inc
Santa Clara, California, United States

Disclosure(s): Shockwave Medical, Inc.: Employee (Ongoing), Shareholder (Ongoing)
Neal E. Fearnot, PhD

Vice President
Cook Group Incorporated
West Lafayette, Indiana, United States

Disclosure(s): Cook Medical: Employee (Ongoing)
Gerardine Finn, BS

VP Structural Heart and Aortic Regulatory Affairs
Medtronic Inc.
Santa Rosa, California, United States

Disclosure information not submitted.
Nicole Ibrahim, PhD

Deputy Office Director, OCVD
U.S. Food and Drug Administration
Silver Spring, Maryland, United States

Disclosure(s): No financial relationships to disclose
William H. Maisel, MD, MPH (he/him/his)

CDRH Chief Medical Officer
U.S. Food and Drug Administration
Silver Spring, Maryland, United States

Disclosure(s): No financial relationships to disclose
Misti Malone, PhD (she/her/hers)

Asst Director, PIDT
FDA
Silver Spring, Maryland, United States

No relationships to disclose
Rebecca Torguson, MPH

Deputy Division Director
FDA
Washington, District of Columbia, United States

No relationships to disclose
Roseann M. White, MA

Senior Director of Biostatistics
Edwards Lifesciences
Chapel Hill, North Carolina, United States

Disclosure(s): Edwards Lifesciences: Employee (Ongoing)
Robert W. Yeh, MD, MSc

Associate Professor of Medicine
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States

Disclosure(s): Abbott Vasular, Boston Scientific, MEdtronic: Consultant (Ongoing), Consultant/Advisory Board (Ongoing), Industry Grant Support (Ongoing); Bard, Cook, Philips: Grant/Research Support (Ongoing); Elixir Medical, Shockwave, Zoll, Cathworkd: Consultant (Ongoing)

Disclosure(s):

Mitchell Krucoff, MD, FACC: Abbott Vascular: Consultant/Advisory Board (Ongoing), Consulting Fees (e.g., advisory boards) (Ongoing), Other Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); Boston Scientific: Consultant (Ongoing), Other Research Support (Ongoing); Cook medical: Consultant (Ongoing), Other Research Support (Ongoing); Getinge: Consultant (Ongoing), Other Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); InfraRedx: Clinical Trial Support (Ongoing), Consultant (Ongoing), Research Grant (includes principal investigator, collaborator or consultant and pending grants as well as grants already received) (Ongoing); Johnson & Johnson: Consultant (Ongoing), Other Research Support (Ongoing), Research Grant (includes principal investigator, collaborator or consultant and pending grants as well as grants already received) (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); Medtronic: Clinical Trial Support (Ongoing), Consultant (Ongoing), Grant Recipient (Ongoing), Other Research Support (Ongoing), Research Grant (includes principal investigator, collaborator or consultant and pending grants as well as grants already received) (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); Nipon: Consultant (Ongoing); OrbusNeich Medical Inc.: Clinical Trial Support (Ongoing), Consultant (Ongoing), Grant/Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); SMT: Consultant (Ongoing), Research Grant (includes principal investigator, collaborator or consultant and pending grants as well as grants already received) (Ongoing); Terumo Corporation: Other Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing)

Bram Zuckerman, MD: No financial relationships to disclose

Dominic Allocco, MD, MS: Boston Scientific: Employee (Ongoing), Shareholder (Ongoing)

Ori Ben-Yehuda, MD: Bioventrix, Inc: Ownership Interest (stocks, stock options, patent or other intellectual property or other ownership interest excluding diversified mutual funds) (Ongoing), Salary (Ongoing); Cardiovalve: Consultant (Ongoing)

Keith D. Dawkins, MD, FACC, FSCAI, FRCP: Shockwave Medical, Inc.: Employee (Ongoing), Shareholder (Ongoing)

Neal E. Fearnot, PhD: Cook Medical: Employee (Ongoing)

Nicole Ibrahim, PhD: No financial relationships to disclose

William H. Maisel, MD, MPH: No financial relationships to disclose

Roseann M. White, MA: Edwards Lifesciences: Employee (Ongoing)

Robert W. Yeh, MD, MSc: Abbott Vasular, Boston Scientific, MEdtronic: Consultant (Ongoing), Consultant/Advisory Board (Ongoing), Industry Grant Support (Ongoing); Bard, Cook, Philips: Grant/Research Support (Ongoing); Elixir Medical, Shockwave, Zoll, Cathworkd: Consultant (Ongoing)