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  • Tuesday, Mar 12th
    8:00 AM – 12:30 PM ET
    HHS | FDA Town Hall [Non-CME]
    Location: International Ballroom East
    Program Director: Andrew Farb, MD – U.S. Food and Drug Administration
    Program Director: Nicole Ibrahim, PhD – U.S. Food and Drug Administration
    Program Director: Mitchell Krucoff, MD, FACC – Duke University Medical Center/Duke Clinical Research Institute
    Program Director: Changfu Wu, PhD – Food and Drug Administration
    Program Director: Bram Zuckerman, MD – U.S. Food and Drug Administration
    InnovationHHS | FDA Town Hall [Non-CME]
  • Tuesday, Mar 12th
    8:00 AM – 8:08 AM ET
    Early Feasibility Study and Breakthrough Devices Programs: FDA Update
    Location: International Ballroom East
    Speaker: Andrew Farb, MD – U.S. Food and Drug Administration
    InnovationHHS | FDA Town Hall [Non-CME]
  • Tuesday, Mar 12th
    8:00 AM – 9:30 AM ET
    THE MEDICAL DEVICE INNOVATION LANDSCAPE: NAVIGATING NOVEL DEVICES THROUGH THE PROCESS
    Location: International Ballroom East
    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
    InnovationHHS | FDA Town Hall [Non-CME]
  • Tuesday, Mar 12th
    8:08 AM – 8:16 AM ET
    From US EFS to Pivotal Study: Industry Perspective and Case Example ECP Device
    Location: International Ballroom East
    Speaker: Charles A. Simonton, MD, FACC, FSCAI – Abiomed Inc
    InnovationHHS | FDA Town Hall [Non-CME]
  • Tuesday, Mar 12th
    8:16 AM – 8:24 AM ET
    Total Product lifecycle the FDA Advisory Program (FDA-TAP)
    Location: International Ballroom East
    Speaker: April Marrone – FDA/CDRH
    InnovationHHS | FDA Town Hall [Non-CME]
  • Tuesday, Mar 12th
    8:24 AM – 8:32 AM ET
    CMS Perspectives on Breakthrough Innovative Technologies
    Location: International Ballroom East
    Speaker: Steven Farmer, MD, PhD – CMS
    InnovationHHS | FDA Town Hall [Non-CME]
  • Tuesday, Mar 12th
    8:32 AM – 8:40 AM ET
    Labeling Expansion Opportunities Through NEST with Aggregated Real-World Data | The MDIC Experience
    Location: International Ballroom East
    Speaker: Chip Hance, BS, MBA – Regatta Medical
    InnovationHHS | FDA Town Hall [Non-CME]
  • Tuesday, Mar 12th
    8:40 AM – 8:55 AM ET
    Keynote Lecture: FDA's Office of Cardiovascular Devices: Current Status and Priorities
    Location: International Ballroom East
    Speaker: Bram Zuckerman, MD – U.S. Food and Drug Administration
    InnovationHHS | FDA Town Hall [Non-CME]
  • Tuesday, Mar 12th
    8:55 AM – 9:30 AM ET
    Panel Discussion: Innovative Technology Headwinds and Tailwinds
    Location: International Ballroom East
    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
    InnovationHHS | FDA Town Hall [Non-CME]
  • Tuesday, Mar 12th
    9:30 AM – 9:38 AM ET
    Real-World Data to Evaluate Medical Devices - Promise and Peril
    Location: International Ballroom East
    Speaker: Robert W. Yeh, MD, MSc – Beth Israel Deaconess Medical Center
    InnovationHHS | FDA Town Hall [Non-CME]
  • Tuesday, Mar 12th
    9:30 AM – 10:30 AM ET
    INCORPORATING REAL-WORLD DATA INTO REGULATORY AND CLINICAL DECISION MAKING: CHALLENGES AND OPPORTUNITIES
    Location: International Ballroom East
    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
    InnovationHHS | FDA Town Hall [Non-CME]
  • Tuesday, Mar 12th
    9:38 AM – 9:46 AM ET
    How to Minimize Disparity in Clinical Trials
    Location: International Ballroom East
    Speaker: Roxana Mehran, MD, FACC, FACP, FCCP, FESC, FAHA, MSCAI – Icahn School of Medicine at Mount Sinai, New York
    InnovationHHS | FDA Town Hall [Non-CME]
  • Tuesday, Mar 12th
    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
    Location: International Ballroom East
    Speaker: Roseann M. White, MA – Edwards Lifesciences
    InnovationHHS | FDA Town Hall [Non-CME]
  • Tuesday, Mar 12th
    9:54 AM – 10:02 AM ET
    Global Collaborative Structured Evidence Collection | The European Experience
    Location: International Ballroom East
    Speaker: David Erlinge, MD, PhD – Lund University
    InnovationHHS | FDA Town Hall [Non-CME]
  • Tuesday, Mar 12th
    10:02 AM – 10:30 AM ET
    Panel Discussion: Leveraging Real-World Evidence: Where Are We Now and What Lies Ahead?
    Location: International Ballroom East
    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
    InnovationHHS | FDA Town Hall [Non-CME]
  • Tuesday, Mar 12th
    10:30 AM – 10:38 AM ET
    The Digital Health Revolution and Its Clinical Trial Impact
    Location: International Ballroom East
    Speaker: C. Michael Gibson, MD – Beth Israel Deaconess Medical Center
    InnovationHHS | FDA Town Hall [Non-CME]
  • Tuesday, Mar 12th
    10:30 AM – 11:32 AM ET
    CLINICAL TRIAL TRANSFORMATION IN THE DIGITAL HEALTH ERA
    Location: International Ballroom East
    Moderator: Jodi J. Akin, MS – Hawthorne Effect, Inc.
    Moderator: Joaquin E. Cigarroa, MD – OHSU Knight Cardiovascular Institute
    InnovationHHS | FDA Town Hall [Non-CME]
  • Tuesday, Mar 12th
    10:38 AM – 10:46 AM ET
    Summary from the Digital Health CRT 2024 Session
    Location: International Ballroom East
    Speaker: Mona Advani, M.Sc., MBA – CardioMed Device Consultants
    InnovationHHS | FDA Town Hall [Non-CME]
  • Tuesday, Mar 12th
    10:46 AM – 10:54 AM ET
    FDA Perspectives on Digital Health Apps in Cardiovascular Trials
    Location: International Ballroom East
    Speaker: Aneesh Deoras, MSE – U.S. Food and Drug Administration
    InnovationHHS | FDA Town Hall [Non-CME]
  • Tuesday, Mar 12th
    10:54 AM – 11:32 AM ET
    Panel Discussion: Digital Heath Apps in Clinical Trials: Ready for Prime Time?
    Location: International Ballroom East
    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
    InnovationHHS | FDA Town Hall [Non-CME]
  • Tuesday, Mar 12th
    11:32 AM – 11:40 AM ET
    Updates on Defining Periprocedural MI in US Clinical Trials
    Location: International Ballroom East
    Speaker: Hector M. Garcia-Garcia, MD, PhD – MedStar Washington Hospital Center
    InnovationHHS | FDA Town Hall [Non-CME]
  • Tuesday, Mar 12th
    11:32 AM – 12:30 PM ET
    REDEFINING PERI PROCEDURAL MI IN CLINICAL TRIALS
    Location: International Ballroom East
    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.
    InnovationHHS | FDA Town Hall [Non-CME]
  • Tuesday, Mar 12th
    11:40 AM – 11:48 AM ET
    Periprocedural MI: A European Society View
    Location: International Ballroom East
    Speaker: Ernest Spitzer, MD – Cardialysis B.V.
    InnovationHHS | FDA Town Hall [Non-CME]
  • Tuesday, Mar 12th
    11:48 AM – 11:56 AM ET
    FDA Perspectives on Periprocedural MI in Trials Intended for Regulatory Review: What Has Changed?
    Location: International Ballroom East
    Speaker: Lydia Glaw, PhD – US FDA
    InnovationHHS | FDA Town Hall [Non-CME]
  • Tuesday, Mar 12th
    11:56 AM – 12:30 PM ET
    Panel Discussion: Defining Periprocedural MI in Clinical Trials
    Location: International Ballroom East
    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
    InnovationHHS | FDA Town Hall [Non-CME]
  • Tuesday, Mar 12th
    12:30 PM ET
    Adjourn
    Location: International Ballroom East
    InnovationHHS | FDA Town Hall [Non-CME]