Translational Pathways for Cardiovascular Devices

INTRODUCTION
Meet The Course Directors
3 Topics
Course Director Spencer B. King, MD
Course Director Anthony N. DeMaria, MD
Course Director Nabil Dib, MD, MSC, FACC
Welcome and Introduction
8 Topics
Fulfill Unmet Educational Need (Knowledge Gap)
Translational Pathway for Trans Aortic Valve Replacement-TAVR
FlowFusion ND Infusion Catheter
U.S. Regulatory Device Evaluation
Translational Pathways for Cardiovascular Devices
Translational Pathway for Cardiovascular Therapy
Who should take this course?
Course Sessions
ISCTR Mission
2 Topics
Learning Objectives
Lecture – Nabil Dib, MD, Msc, President of ISCTR
Translational Pathway to Expedite Scientific Discovery to Patients
2 Topics
Learning Objectives
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
Learning Objectives
Lecture – Todd Brinton, MD, Edward’s Lifesciences
Intellectual Property
3 Topics
Intellectual Property
Learning Objectives
Lecture – James Inskeep, Patent Attorney
Business Plan, Development, and Fundraising
3 Topics
Business Plan, Product Development, and Fundraising
Learning Objectives
Lecture – Stan Rowe, Edward’s Lifesciences
Product Manufacturing
6 Topics
Requirements for Medical Device Manufacturing and Iteration FDA Point of View
Learning Objectives
Lecture – Brad Quinn, FDA
Requirements for Medical Device Manufacturing and Iteration Industry Point of View
Learning Objectives
Lecture – Richard Rapoza, PhD, Abbott Vascular
Preclinical Evaluation
12 Topics
Advanced Cardiac Anatomy – Application in Translational Research Tailored to Current and Future Technology
Learning Objectives
Lecture – Renu Virmani, MD, CV Path Institute
Large Animal Model for Heart Failure, Valvular Disease, Coronary Artery Disease, and Device Testing
Learning Objectives
Lecture – Daniel Burkhoff, MD, Colombia University
Pre-Clinical Study Design and Endpoints for Device Evaluation FDA Point Of View
Learning Objectives
Lecture – Judith Davis, DVM, MS, FDA
Pre-Clinical Study Design and Endpoints for Device Evaluation Investigator Point Of View
Learning Objectives
Lecture – Renu Virmani, MD, CV Path Institute
Early Feasibility Study
6 Topics
Early Feasibility Studies for Device Evaluation
Learning Objectives
Lecture – Andrew Farb, MD, FDA
Current Challenges and Future Direction for Human Early Feasibility Study for Device Evaluation – Industry Point of View
Learning Objectives
Lecture – David Reuter, MD, Seattle Children’s Hospital
Biostatistics
24 Topics
Basic in Statistics
Clinical Study Design for Translational Research – Learning Objectives
Lecture – Chris Mullin, PhD, NAMSA
Basic Statistical Concepts – Learning Objectives
Lecture – Chris Mullin, PhD, NAMSA
Sample Size and Power – Learning Objectives
Lecture – Chris Mullin, PhD, NAMSA
Sensitivity and Specificity – Learning Objectives
Lecture – Chris Mullin, PhD, NAMSA
Common Study Design – Learning Objectives
Lecture – Chris Mullin, PhD, NAMSA
Phases of Translational Research- Learning Objectives
Lecture – Chris Mullin, PhD, NAMSA
Statistics for Evaluation of Cardiovascular Diagnostic Devices – Learning Objectives
Lecture – Chris Mullin, PhD, NAMSA
Pre-Clinical and Clinical Trial Design and Endpoints of Fast Track to Device Approval
Learning Objectives
Lecture – Roseann White, PhD, Duke Research Institute
Advanced Statistical Methods for Translational Research
Learning Objectives
Lecture – Chris Mullin, PhD, NAMSA
Clinical Endpoints/Surrogate Endpoints
Learning Objectives
Lecture – Roseann White, PhD, Duke Research Institute
Regulatory Approval
6 Topics
Regulatory Requirement for Marketing Approval
Learning Objectives
Lecture – Bram Zuckerman, MD, FDA
Regulatory Review of Cardiovascular Devices: European Regulatory Perspective
Learning Objectives
Lecture – Robert Byrne, MD, Heart Centre, Germany
Reimbursement
3 Topics
CMS Criteria for Reimbursement for Cardiovascular Innovation
Learning Objectives
Lecture – Joseph Chin, MD, CMS
Practice Guideline
3 Topics
Practice Guideline Requirement for New Technology
Learning Objectives
Lecture – Alice Jacobs, MD, Boston University
Technology Adoption
6 Topics
Adoption of Technology
Learning Objectives
Lecture – Ian Meredith, MD, Boston Scientific
Global Heart Health, Implications for Translational Research
Learning Objectives
Lecture – Salim Yusuf, D. Phil, World Federation of Cardiology
Patients
3 Topics
The Patients Voice
Learning Objectives
Lecture – Mark Mercola, PhD, Stanford Cardiovascular Institute
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
Learning Objectives
Lecture – Martin Leon, MD, Columbia University
The Methods for Transcatheter Aortic Valve Development
2 Topics
Learning Objectives
Lecture – Stan Rowe, Edwards’s Lifesciences
The Endpoints for Transcatheter Aortic Valve Development
2 Topics
Learning Objectives
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
Learning Objectives
Lecture – Nicole Ibrahim, PhD, FDA
Current Challenges and Future Direction for Aortic Valve Development and Iteration - Industry Point of View
2 Topics
Learning Objectives
Lecture – Stan Rowe, Edward’s Lifesciences
The TAVR Development from Concept to First in Man
2 Topics
Learning Objectives
Lecture – Alain Cribier, MD, University of Rouen, France
The TAVR Development from First in Man to Phase 3 and Beyond
2 Topics
Learning Objectives
Lecture – Martin Leon, MD, Columbia University
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
Learning Objectives
Lecture – Michael Mack, MD, Baylor Scott & White Health
The Methods for Translational Mitral/Tricuspid Valve Device Development
2 Topics
Learning Objectives
Lecture – Michael Mack, MD, Baylor Scott & White Health
The Endpoints for Transcatheter Mitral/Tricuspid Valve Device Development
2 Topics
Learning Objectives
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
Learning Objectives
Lecture – John Laschinger, MD, FDA
Current Challenges and Future Direction for Mitral/Tricuspid Valve Device Development and Iteration - Industry Point of View
2 Topics
Learning Objectives
Lecture – Patricia Todd, Edward’s Lifesciences
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
Learning Objectives
Lecture – Gregg Stone, MD, Columbia University
The Methods for Coronary Stent Development
2 Topics
Learning Objectives
Lecture – Charles Simonton, MD, Abbott Vascular
The Endpoints for Coronary Stent Development
2 Topics
Learning Objectives
Lecture – Donald Cutlip, MD, Beth Israel-Deaconess
Current Challenges and Future Direction for Coronary Stent Development and Iteration - FDA Point of View
2 Topics
Learning Objectives
Lecture – Michael John, MPH, FDA
Current Challenges and Future Direction for Coronary Stent Development and Iteration - Industry Point of View
2 Topics
Learning Objectives
Lecture – Charles Simonton, MD, Abbott Vascular
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
Learning Objectives
Lecture – Douglas Packer, MD, Mayo Clinic
Methods for Catheter Ablation Development
2 Topics
Learning Objectives
Lecture – Douglas Packer, MD, Mayo Clinic
The Endpoints for Catheter Ablation Development
2 Topics
Learning Objectives
Lecture – Marco Cannella, PhD, FDA
Current Challenges and Future Direction for Catheter Ablation Development and Iteration - FDA Point of View  
2 Topics
Learning Objectives
Lecture – Mark Fellman, MS, FDA
Current Challenges and Future Direction for Catheter Ablation Development and Iteration - Industry Point of View  
2 Topics
Learning Objectives
Lecture – Uri Yaron, PhD, Johnson & Johnson
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
Learning Objectives
Lecture – Sr. Magdi Yacoub, MD, Aswan Heart Center, London
The Methods for Left Ventricular Assist Devices Development
2 Topics
Learning Objectives
Lecture – Francis Pagani, MD, University of Michigan
The Endpoints for Left Ventricular Assist Device Evaluation
2 Topics
Learning Objectives
Lecture – Keith Aaronson, MD, University of Michigan
Session VI: Translational Pathway for Ventricular Assist Devices - End
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Translational Pathways for Cardiovascular Devices Translational Pathway to Expedite Scientific Discovery to Patients Lecture – Robert Califf, MD, FDA
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