Lecture &#8211; Robert Califf, MD, FDA

Lecture – Nabil Dib, MD, Msc, President of ISCTR

Translational Pathway to Expedite Scientific Discovery to Patients

2 Topics

Lecture – Robert Califf, MD, FDA

SESSION I: BASIC KNOWLEDGE FOR CV DEVICES DEVELOPMENT

Session I

Session I: Basic Knowledge for CV Devices Development

Concept/Innovation

3 Topics

Choosing an Innovative Concept

Lecture – Todd Brinton, MD, Edward’s Lifesciences

Intellectual Property

3 Topics

Intellectual Property

Lecture – James Inskeep, Patent Attorney

Business Plan, Development, and Fundraising

3 Topics

Business Plan, Product Development, and Fundraising

Lecture – Stan Rowe, Edward’s Lifesciences

Product Manufacturing

6 Topics

Requirements for Medical Device Manufacturing and Iteration FDA Point of View

Lecture – Brad Quinn, FDA

Requirements for Medical Device Manufacturing and Iteration Industry Point of View

Lecture – Richard Rapoza, PhD, Abbott Vascular

Preclinical Evaluation

12 Topics

Advanced Cardiac Anatomy – Application in Translational Research Tailored to Current and Future Technology

Lecture – Renu Virmani, MD, CV Path Institute

Large Animal Model for Heart Failure, Valvular Disease, Coronary Artery Disease, and Device Testing

Lecture – Daniel Burkhoff, MD, Colombia University

Pre-Clinical Study Design and Endpoints for Device Evaluation FDA Point Of View

Lecture – Judith Davis, DVM, MS, FDA

Pre-Clinical Study Design and Endpoints for Device Evaluation Investigator Point Of View

Lecture – Renu Virmani, MD, CV Path Institute

Early Feasibility Study

6 Topics

Early Feasibility Studies for Device Evaluation

Lecture – Andrew Farb, MD, FDA

Current Challenges and Future Direction for Human Early Feasibility Study for Device Evaluation – Industry Point of View

Lecture – David Reuter, MD, Seattle Children’s Hospital

Biostatistics

24 Topics

Basic in Statistics

Clinical Study Design for Translational Research – Learning Objectives

Basic Statistical Concepts – Learning Objectives

Sample Size and Power – Learning Objectives

Sensitivity and Specificity – Learning Objectives

Common Study Design – Learning Objectives

Phases of Translational Research- Learning Objectives

Statistics for Evaluation of Cardiovascular Diagnostic Devices – Learning Objectives

Pre-Clinical and Clinical Trial Design and Endpoints of Fast Track to Device Approval

Lecture – Roseann White, PhD, Duke Research Institute

Advanced Statistical Methods for Translational Research

Clinical Endpoints/Surrogate Endpoints

Lecture – Roseann White, PhD, Duke Research Institute

Regulatory Approval

6 Topics

Regulatory Requirement for Marketing Approval

Lecture – Bram Zuckerman, MD, FDA

Regulatory Review of Cardiovascular Devices: European Regulatory Perspective

Lecture – Robert Byrne, MD, Heart Centre, Germany

Reimbursement

3 Topics

CMS Criteria for Reimbursement for Cardiovascular Innovation

Lecture – Joseph Chin, MD, CMS

Practice Guideline

3 Topics

Practice Guideline Requirement for New Technology

Lecture – Alice Jacobs, MD, Boston University

Technology Adoption

6 Topics

Adoption of Technology

Lecture – Ian Meredith, MD, Boston Scientific

Global Heart Health, Implications for Translational Research

Lecture – Salim Yusuf, D. Phil, World Federation of Cardiology

Patients

3 Topics

The Patients Voice

Lecture – Mark Mercola, PhD, Stanford Cardiovascular Institute

2019 Diagnostic Devices Development

5 Topics

2019 Device Development: Essential Concepts

2018 Requirements for CV Devices Approval

2017 Clinical Endpoints & Biostatistics

2016 Preclinical, Early Feasibility, and Safety Study for Device Development

Session I: Basic Knowledge for CV Devices Development - End

SESSION II: TRANSLATIONAL PATHWAY FOR TRANSCATHETER AORTIC VALVE

Session II

Session II: Translational Pathway for Transcatheter Aortic Valve

1 Topic

Session II Topics

The Clinical Need for Innovative Treatment for Aortic Valve Disease

2 Topics

Lecture – Martin Leon, MD, Columbia University

The Methods for Transcatheter Aortic Valve Development

2 Topics

Lecture – Stan Rowe, Edwards’s Lifesciences

The Endpoints for Transcatheter Aortic Valve Development

2 Topics

Lecture – Ori Ben-Yehuda, MD, Cardiovascular Research Foundation

Current Challenges and Future Direction for Aortic Valve Development and Iteration - FDA Point of View

2 Topics

Lecture – Nicole Ibrahim, PhD, FDA

Current Challenges and Future Direction for Aortic Valve Development and Iteration - Industry Point of View

2 Topics

Lecture – Stan Rowe, Edward’s Lifesciences

The TAVR Development from Concept to First in Man

2 Topics

Lecture – Alain Cribier, MD, University of Rouen, France

The TAVR Development from First in Man to Phase 3 and Beyond

2 Topics

Lecture – Martin Leon, MD, Columbia University

2016 Aortic Valve Development

2 Topics

2017 Valve Disease/TAVR

Session II: Translational Pathway for Transcatheter Aortic Valve - End

SESSION III: TRANSLATIONAL PATHWAY FOR TRANSCATHETER MITRAL/TRICUSPID VALVE DEVICES

Session III

Session III: Translational Pathway for Transcatheter Mitral/Tricuspid Valve Devices

1 Topic

Session III Topics

The Clinical Need for Innovative Treatment for Mitral/Tricuspid Valve Disease

2 Topics

Lecture – Michael Mack, MD, Baylor Scott & White Health

The Methods for Translational Mitral/Tricuspid Valve Device Development

2 Topics

Lecture – Michael Mack, MD, Baylor Scott & White Health

The Endpoints for Transcatheter Mitral/Tricuspid Valve Device Development

2 Topics

Lecture – Blasé Carabello, MD, East Carolina University

Current Challenges and Future Direction for Mitral/Tricuspid Valve Device Development and Iteration - FDA Point of View

2 Topics

Lecture – John Laschinger, MD, FDA

Current Challenges and Future Direction for Mitral/Tricuspid Valve Device Development and Iteration - Industry Point of View

2 Topics

Lecture – Patricia Todd, Edward’s Lifesciences

2019 Structural Heart Intervention Imaging

3 Topics

2017 MV/TV Transcatheter Repair/Replacement

2016 MV/TV Development

Session III: Translational Pathway for Transcatheter Mitral/Tricuspid Valve Devices - End

SESSION IV: TRANSLATIONAL PATHWAY FOR CORONARY STENT

Session IV

Session IV: Translational Pathway for Coronary Stent

1 Topic

Session IV Topics

The Clinical Need for Innovative Coronary Stent

2 Topics

Lecture – Gregg Stone, MD, Columbia University

The Methods for Coronary Stent Development

2 Topics

Lecture – Charles Simonton, MD, Abbott Vascular

The Endpoints for Coronary Stent Development

2 Topics

Lecture – Donald Cutlip, MD, Beth Israel-Deaconess

Current Challenges and Future Direction for Coronary Stent Development and Iteration - FDA Point of View

2 Topics

Lecture – Michael John, MPH, FDA

Current Challenges and Future Direction for Coronary Stent Development and Iteration - Industry Point of View

2 Topics

Lecture – Charles Simonton, MD, Abbott Vascular

2019 Devices for Complex Coronary Lesions

4 Topics

2019 Advances in the Assessment of High Risk Coronary Lesions

2017 CAD/Coronary Stent

2016 Coronary Stent Development

Session IV: Translational Pathway for Coronary Stent - End

SESSION V: TRANSLATIONAL PATHWAY FOR CATHETER ABLATION

Session V

Session V: Translational Pathway for Catheter Ablation

1 Topic

Session V Topics

The Clinical Need for the Treatment of Arrhythmia Innovative Catheter Ablation

2 Topics

Lecture – Douglas Packer, MD, Mayo Clinic

Methods for Catheter Ablation Development

2 Topics

Lecture – Douglas Packer, MD, Mayo Clinic

The Endpoints for Catheter Ablation Development

2 Topics

Lecture – Marco Cannella, PhD, FDA

Current Challenges and Future Direction for Catheter Ablation Development and Iteration - FDA Point of View

2 Topics

Lecture – Mark Fellman, MS, FDA

Current Challenges and Future Direction for Catheter Ablation Development and Iteration - Industry Point of View

2 Topics

Lecture – Uri Yaron, PhD, Johnson & Johnson

2017 Arrhythmia/Catheter Ablation

2 Topics

2016 Catheter Ablation Development

Session V: Translational Pathway for Catheter Ablation - End

SESSION VI: TRANSLATIONAL PATHWAY FOR VENTRICULAR ASSIST DEVICES

Session VI

Session VI: Translational Pathway for Ventricular Assist Devices

1 Topic

Session VI Topics

Ventricular Assist Devices, The Windy Road to Recovery

2 Topics

Lecture – Sr. Magdi Yacoub, MD, Aswan Heart Center, London

The Methods for Left Ventricular Assist Devices Development

2 Topics

Lecture – Francis Pagani, MD, University of Michigan

The Endpoints for Left Ventricular Assist Device Evaluation

2 Topics

Lecture – Keith Aaronson, MD, University of Michigan