HHS | FDA Town Hall [Non-CME]

Tuesday, March 12, 2024

8:00 AM – 12:30 PM ET

Program Director(s)

Andrew Farb, MD

Chief Medical Officer, Office of Cardiovascular Devices
U.S. Food and Drug Administration
Silver Spring, Maryland, United States
Nicole Ibrahim, PhD

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

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

SBRBPAS Expert
Food and Drug Administration
Silver Spring, Maryland, United States
Bram Zuckerman, MD

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

Disclosure(s):

Andrew Farb, MD: No relationships to disclose

Nicole Ibrahim, PhD: No financial relationships to disclose

Changfu Wu, PhD: No financial relationships to disclose

Bram Zuckerman, MD: No relationships to disclose

Presentations:

8:00 AM – 8:08 AM ET

Early Feasibility Study and Breakthrough Devices Programs: FDA Update
Speaker: Andrew Farb, MD – U.S. Food and Drug Administration
8:00 AM – 9:30 AM ET

THE MEDICAL DEVICE INNOVATION LANDSCAPE: NAVIGATING NOVEL DEVICES THROUGH THE PROCESS
Moderator: Dorothy B. Abel, BSBME – Abel and Wolf Consulting
Moderator: Andrew Farb, MD – U.S. Food and Drug Administration
Moderator: Aaron V. Kaplan, MD, FSCAI, FACC, FNAI – Dartmouth Health Geisel School of Medicine at Dartmouth
Moderator: Mitchell Krucoff, MD, FACC – Duke University Medical Center/Duke Clinical Research Institute
8:08 AM – 8:16 AM ET

From US EFS to Pivotal Study: Industry Perspective and Case Example ECP Device
Speaker: Charles A. Simonton, MD, FACC, FSCAI – Abiomed Inc
8:16 AM – 8:24 AM ET

Total Product lifecycle the FDA Advisory Program (FDA-TAP)
Speaker: April Marrone – FDA/CDRH
8:24 AM – 8:32 AM ET

CMS Perspectives on Breakthrough Innovative Technologies
Speaker: Steven Farmer, MD, PhD – CMS
8:32 AM – 8:40 AM ET

Labeling Expansion Opportunities Through NEST with Aggregated Real-World Data | The MDIC Experience
Speaker: Chip Hance, BS, MBA – Regatta Medical
8:40 AM – 8:55 AM ET

Keynote Lecture: FDA's Office of Cardiovascular Devices: Current Status and Priorities
Speaker: Bram Zuckerman, MD – U.S. Food and Drug Administration
8:55 AM – 9:30 AM ET

Panel Discussion: Innovative Technology Headwinds and Tailwinds
Panel Moderator: Andrew Farb, MD – U.S. Food and Drug Administration
Panel Moderator: Aaron V. Kaplan, MD, FSCAI, FACC, FNAI – Dartmouth Health Geisel School of Medicine at Dartmouth
Panel Moderator: Mitchell Krucoff, MD, FACC – Duke University Medical Center/Duke Clinical Research Institute
Panel Discussant: Dorothy B. Abel, BSBME – Abel and Wolf Consulting
Panel Discussant: Steven Farmer, MD, PhD – CMS
Panel Discussant: Chip Hance, BS, MBA – Regatta Medical
Panel Discussant: Katherine Kumar, PhD, RAC – 4C Medical Technologies, Inc.
Panel Discussant: April Marrone – FDA/CDRH
Panel Discussant: Charles A. Simonton, MD, FACC, FSCAI – Abiomed Inc
Panel Discussant: Changfu Wu, PhD – Food and Drug Administration
9:30 AM – 9:38 AM ET

Real-World Data to Evaluate Medical Devices - Promise and Peril
Speaker: Robert W. Yeh, MD, MSc – Beth Israel Deaconess Medical Center
9:30 AM – 10:30 AM ET

INCORPORATING REAL-WORLD DATA INTO REGULATORY AND CLINICAL DECISION MAKING: CHALLENGES AND OPPORTUNITIES
Moderator: Wayne Batchelor, MD, MHS – Inova Heart & Vascular Institute
Moderator: Mitchell Krucoff, MD, FACC – Duke University Medical Center/Duke Clinical Research Institute
Moderator: Bram Zuckerman, MD – U.S. Food and Drug Administration
9:38 AM – 9:46 AM ET

How to Minimize Disparity in Clinical Trials
Speaker: Roxana Mehran, MD, FACC, FACP, FCCP, FESC, FAHA, MSCAI – Icahn School of Medicine at Mount Sinai, New York
9:46 AM – 9:54 AM ET

The Public Health Need for and the Challenges of Clinical Trial Enrollment | Follow-Up From 5 - 10 Years Effectiveness
Speaker: Roseann M. White, MA – Edwards Lifesciences
9:54 AM – 10:02 AM ET

Global Collaborative Structured Evidence Collection | The European Experience
Speaker: David Erlinge, MD, PhD – Lund University
10:02 AM – 10:30 AM ET

Panel Discussion: Leveraging Real-World Evidence: Where Are We Now and What Lies Ahead?
Panel Moderator: Wayne Batchelor, MD, MHS – Inova Heart & Vascular Institute
Panel Moderator: Mitchell Krucoff, MD, FACC – Duke University Medical Center/Duke Clinical Research Institute
Panel Moderator: Bram Zuckerman, MD – U.S. Food and Drug Administration
Panel Discussant: David Erlinge, MD, PhD – Lund University
Panel Discussant: Nicole Ibrahim, PhD – U.S. Food and Drug Administration
Panel Discussant: Roxana Mehran, MD, FACC, FACP, FCCP, FESC, FAHA, MSCAI – Icahn School of Medicine at Mount Sinai, New York
Panel Discussant: Rebecca Torguson, MPH – FDA
Panel Discussant: Roseann M. White, MA – Edwards Lifesciences
Panel Discussant: Robert W. Yeh, MD, MSc – Beth Israel Deaconess Medical Center
10:30 AM – 10:38 AM ET

The Digital Health Revolution and Its Clinical Trial Impact
Speaker: C. Michael Gibson, MD – Beth Israel Deaconess Medical Center
10:30 AM – 11:32 AM ET

CLINICAL TRIAL TRANSFORMATION IN THE DIGITAL HEALTH ERA
Moderator: Jodi J. Akin, MS – Hawthorne Effect, Inc.
Moderator: Joaquin E. Cigarroa, MD – OHSU Knight Cardiovascular Institute
10:38 AM – 10:46 AM ET

Summary from the Digital Health CRT 2024 Session
Speaker: Mona Advani, M.Sc., MBA – CardioMed Device Consultants
10:46 AM – 10:54 AM ET

FDA Perspectives on Digital Health Apps in Cardiovascular Trials
Speaker: Aneesh Deoras, MSE – U.S. Food and Drug Administration
10:54 AM – 11:32 AM ET

Panel Discussion: Digital Heath Apps in Clinical Trials: Ready for Prime Time?
Panel Moderator: Jodi J. Akin, MS – Hawthorne Effect, Inc.
Panel Moderator: Joaquin E. Cigarroa, MD – OHSU Knight Cardiovascular Institute
Panel Discussant: Stephen Browning, BSE – FDA/CDRH
Panel Discussant: Mona Advani, M.Sc., MBA – CardioMed Device Consultants
Panel Discussant: C. Michael Gibson, MD – Beth Israel Deaconess Medical Center
11:32 AM – 11:40 AM ET

Updates on Defining Periprocedural MI in US Clinical Trials
Speaker: Hector M. Garcia-Garcia, MD, PhD – MedStar Washington Hospital Center
11:32 AM – 12:30 PM ET

REDEFINING PERI PROCEDURAL MI IN CLINICAL TRIALS
Moderator: Donald E. Cutlip, MD, FACC – Beth Israel Deaconess Medical Center
Moderator: P F Adrian Magee, MD – FDA
Moderator: Ernest Spitzer, MD – Cardialysis B.V.
11:40 AM – 11:48 AM ET

Periprocedural MI: A European Society View
Speaker: Ernest Spitzer, MD – Cardialysis B.V.
11:48 AM – 11:56 AM ET

FDA Perspectives on Periprocedural MI in Trials Intended for Regulatory Review: What Has Changed?
Speaker: Lydia Glaw, PhD – US FDA
11:56 AM – 12:30 PM ET

Panel Discussion: Defining Periprocedural MI in Clinical Trials
Panel Moderator: Donald E. Cutlip, MD, FACC – Beth Israel Deaconess Medical Center
Panel Moderator: P F Adrian Magee, MD – FDA
Panel Moderator: Ernest Spitzer, MD – Cardialysis B.V.
Panel Discussant: Rafael Cavalcante, MD, PhD – Boston Scientific
Panel Discussant: Hector M. Garcia-Garcia, MD, PhD – MedStar Washington Hospital Center
Panel Discussant: Lydia Glaw, PhD – US FDA
12:30 PM ET

Adjourn