ISCTR Consensus Summit Saturday, October 29, 2016 Walter E. Washington Convention Center, Room 146A Washington, DC 7:00 am - 5:00 pm
2016 Translational Pathways For Cardiovascular Devices
Objective
To Develop a Consensus Document for Translational Pathway for Future Cardiovascular Device Development and Iteration for Cardiovascular Diseases (Valvular, Coronary Artery, and Arrhythmia) That Incorporates Input from Industry, FDA, and CMS.
Introduction
7:00 – 7:05
Welcome Statement
– Nabil Dib, Spencer King View Presentation
7:05 – 7:20
ISCTR Mission And Statement of Meeting Purpose
– Nabil Dib View Presentation
Session I – Basic Process for Device Development
Moderators: Bram Zuckerman, Jack Lewin View Presentation
7:20 – 7:35
Requirement for New Technology to be Included in thenGuidelines, “The Ultimate Goal”
– Alice Jacobs View Presentation
7:35 – 7:50
CMS Criteria For Reimbursement of Cardiovascular Innovation
– Joseph Chin View Presentation
7:50 – 8:05
Regulatory Requirement for Marketing Approval
– Deborah Castillo View Presentation
8:05 – 8:20
Pre-Clinical and Clinical Trial Design and Endpoints of Fast Track to Device Approval
– Roseann White View Presentation
8:20 – 8:35
A Unified Approach for Clinical Trial Design That Meets The Requirement of Regulatory Approval, Reimbursement And The Clinical Practice Guideline
– Mitchell Krucoff View Presentation
8:35 – 9:00
Panel Discussion:
Bram Zuckerman, Jack Lewin, Nabil Dib, Alice Jacobs, Joseph Chin, Deborah Castillo, Roseann White, Mitchell Krucoff, Robert Roberts, Anthony DeMaria, Stan Rowe, Charles Simonton, Spencer King, Ron Waksman
9:00 – 9:15
Break
Session II – Pre-Clinical, Early Feasibility, and Safety Study for Device Development
Moderators: Andrew Farb, David Reuter View Presentation
9:15 – 9:30
Current Challenges and Future Direction for Feasibility and Early Human Study for Device Evaluation; FDA Point of View
– Andrew Farb View Presentation
9:30 – 9:45
Current Challenges and Future Direction for Feasibility and Early Human Study for Device Evaluation; Industry Point of View
– David Reuter View Presentation
9:45 – 10:00
Requirements for Medical Device Manufacturing And Iteration; Industry Point of View
– Richard Rapoza View Presentation
10:00 – 10:15
Requirements for Medical Device Manufacturing And Iteration; FDA Point of View
– Brad Quinn View Presentation
10:15 – 10:30
Optimal Pre-Clinical Study Design and Endpoints for Device Evaluation; Investigator Point Of View
– Renu Virmani View Presentation
10:30 – 10:45
Optimal Pre-Clinical Study Design and Endpoints for Device Evaluation; FDA Point Of View
– Judith Davis View Presentation
10:45 – 11:00
Panel Discussion:
Andrew Farb, David Reuter, Michael Minogue, Richard Rapoza, Brad Quinn, Renu Virmani, Judith Davis, Laura Perkins, Roseann White, James Muller, Patricia Todd, Robert Kohler
11:00 – 11:20
Lunch
11:20 – 11:30
Presentation of the Glen and Marilyn Nelson Award for Innovation and Translation in Cardiovascular Medicine to Robert Califf
– Anthony DeMaria and Marilyn Nelson
Keynote Address:
11:30 – 12:00
The Translational Pathway to Expedite Scientific Discovery to Patients
– Robert Califf View Presentation
Session III – Aortic Valve Development
Moderators: Spencer King, Stan Rowe View Presentation
12:00 – 12:15
The Clinical Need for Innovative Treatment for Aortic Valve Disease
– Martin Leon View Presentation
12:15 – 12:30
Current Challenges and Future Direction for Aortic Valve Development and Iteration; Industry Point of View
– Stan Rowe View Presentation
12:30 – 12:45
Current Challenges and Future Direction for Aortic Valve Development and Iteration; FDA Point Of View
– Nicole Ibraham View Presentation
12:45 – 1:00
Panel Discussion:
Stan Rowe, Nicole Ibraham, Michael Mack, Renu Virmani, Patricia Todd, Bram Zuckerman, Spencer King
Session IV – Mitral/Tricuspid Valve Development
Moderators: Gregg Stone, Changfu Wu View Presentation
1:00 – 1:15
The Clinical Need for Innovative Treatment for Mitral/Tricuspid Valve Disease
– Michael Mack View Presentation
1:15 – 1:30
Current Challenges and Future Direction for Mitral/Tricuspid Valve Development And Iteration; Industry Point of View
– Patricia Todd View Presentation
1:30 – 1:45
Current Challenges and Future Direction for Mitral/Tricuspid Valve Development and Iteration; FDA Point of View
– John Laschinger View Presentation
1:45 – 2:00
Panel Discussion:
Gregg Stone, Changfu Wu,Patricia Todd, John Laschinger, Renu Virmani, Michael Mack
Session V – Coronary Stent Development
– Moderators: Neal Fearnot, Spencer King View Presentation
2:00 – 2:15
The Clinical Need for Innovative Coronary Stent
– Gregg Stone View Presentation
2:15 – 2:30
Current Challenges and Future Direction for Coronary Stent Development and Iteration; FDA Point of View
– Michael John View Presentation
2:45 – 3:00
Panel Discussion:
Spencer King, Michael John, Charles Simonton, Neal Fearnot, Mark Toland, Gregg Stone, Craig Thompson
3:00 – 3:10
Break
Session VI – Catheter Ablation Development
Moderators: Douglas Packer, Mark Fellman View Presentation
3:10 – 3:25
The Clinical Need for the Treatment of Arrhythmia, Innovative Catheter Ablation
– Douglas Packer View Presentation
3:25 – 3:40
Current Challenges and Future Direction for Catheter Ablation Development and Iteration; Industry Point of View
– Uri Yaron View Presentation
3:40 – 3:55
Current Challenges and Future Direction for Catheter Ablation Development and Iteration; FDA Point of View
– Mark Fellman View Presentation
3:55 – 4:15
Panel Discussion:
Douglas Packer, Uri Yaron, Jun Dong, Mark Fellman, Anthony DeMaria, Timothy Laske, Win-Kuang Shen, Mark Carlson
Session VII – Consensus Document
4:15 – 4:30
Writing Consensus Document
– Anthony DeMaria View Presentation
4:15 – 4:30
Writing Consensus Document
– Anthony DeMaria View Presentation
4:30 – 5:00
Panel Discussion:
Anthony DeMaria, Spencer King, Bram Zuckerman, Jack Lewin, Robert Roberts, Andrew Farb, Stan Rowe, Charles Simonton, Rick McGuire, Roseann White, Nabil Dib, James Muller
ISCTR Consensus Meeting Speakers
Alice Jacobs, MD
Vice Chair, Clinical Affairs at The Cardiovascular Center, Boston University
Andrew Farb, MD
Medical Officer, Interventional Cardiology Devices Branch, FDA
Anthony DeMaria, MD
Former ACC President, and Director of the Sulpizio Cardiovascular Center at UCSD
Brad Quinn
Acting Branch Chief, Cardiac Diagnostics Devices Branch, FDA
Bram Zuckerman, MD
Director, FDA Division of Cardiovascular Devices, FDA
Charles Simonton, MD
Chief Scientific Officer, Cardiac Therapies, Abbott Vascular
Changfu Wu, PhD
Mechanical Engineer, Structural Heart Device Branch, FDA
Craig Thompson, MD
CMO, Boston Scientific
David Reuter, MD
Director, Cardiac Innovation, Seattle Children’s Hospital
Douglas Packer, MD
Mayo Clinic
Gregg Stone, MD
Director of Cardiovascular Research and Education
Columbia University Medical Center/New York Presbyterian Hospital
Jack Lewin, MD
CEO of CRF and Chairman, National Coalition on Health Care
James Muller, MD
Brigham and Women’s Hospital
John Laschinger, MD
Medical Officer, Structural Heart Device Branch, FDA
Joseph Chin, MD, MS
Deputy Director, Coverage and Analysis Group, Center for Clinical Standards and Quality, CMS
Judith Davis, DVM, MS
Senior Veterinary Medicine Reviewer, Cardiac Electrophysiology Devices Branch, FDA
Jun Dong, MD, PhD
Medical Officer, Cardiac Electrophysiology Devices Branch, FDA
Laura Perkins, DVM, PhD
Abbott Vascular
Martin Leon, MD
Professor of Medicine at Columbia University Medical Center
Mark Fellman, MS
Acting Deputy Director I, Division of Cardiovascular Devices, FDA
Mark Toland
Chief Executive Officer, Corindus
Michael John, MPH
Branch Chief, Circulatory Support Devices Branch, FDA
Michael Mack, MD
Chair of the Cardiovascular Governance Council at Baylor Scott & White Health
Mitchell Krucoff, MD
Professor of Medicine, Duke Clinical Research Institute
Nabil Dib, MD
President, ISCTR
Neal Fearnot, PhD
Vice President, Cook Group, Inc.
Nicole Ibraham, PhD
Branch Chief, Structural Heart Device Branch, FDA
Patricia Todd
Senior Director, Marketing, Edwards Lifesciences
Renu Virmani, MD
President, CV Path
Richard Rapoza, PhD
Division VP of Research & Development, Abbott Vascular
Rick McGuire
Medical Writer
Robert Bonow, MD
Northwestern University
Robert Califf, MD
Commissioner of Food and Drugs, FDA
Robert Roberts, MD
Professor of Cardiology, University of Arizona College of Medicine
Roseann White, PhD
Director of Pragmatic Clinical Trials, Duke Clinical Research Institute
Spencer King, MD
Fuqua Chair of Interventional Cardiology at the Fuqua Heart Center of Piedmont Hospital and Clinical Professor of Medicine at Emory University
Stanton Rowe
Chief Medical Officer, Edwards Lifesciences
Timothy Laske, PhD
Vice President of Research and Business Development – Medtronic AF Solutions
Uri Yaron, PhD
VP, WW R&D Cardiovascular & Specialty Solutions, Johnson & Johnson
Win-Kuang Shen, MD
Mayo Clinic