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  /  2016 Translational Pathways For Cardiovascular Devices
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