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Table of Contents


Part I: Key Topics for Product Development: Devices, Biologics and Drugs

I.1 A Needs-Based Approach to Health Technology Innovation: The Stanford Biodesign Process
  Jonathan G Schwartz MD, Paul G Yock MD,
Uday N Kumar MD, and Todd J Brinton, MD
I.2 Intellectual Property and Strategy Development
  Neil K Nydegger Esq
I.3 Investigational and New Cardiovascular Devices: Strategy and Decision-Making for Reimbursement in the Post-Reform Era
  John C Lewin MD, Janna Crittendon,
Louis Garrison PhD and Larry McNeely
I.4 Sources of Funding for Early Stage Ventures
  Ron King PhD MBA and MaryAnn Guerra MBA
I.5 Anesthesia and Care of the Large Animal for Survival Studies: Sheep
  Cheryl Blaze BVSc PhD MBA
I.6 Anesthesia and Care of the Large Animal for Survival Studies: Pig
  Cheryl Blaze BVSc PhD MBA
I.7 Echocardiography in Translational Research
  Pierre Monney MD, Xavier Jeanrenaud MD,
Hendrick Tevaearai MD EMBA and Didier Locca MD
I.8 MRI in Translational Research
  Andrew J Ludman MD, Stéphanie M Perruchoud Fluri MD, Juan F Iglesias MD,
Anthony Mathur PhD and Didier Locca MD
I.9 Biomarkers in Cardiovascular Medicine
  Christiane Chène PhD, Sarah Longnus PhD
and Hendrik Tevaearai MD EMBP
I.10 Clinical Study Design for Translational Research
  Christopher M Mullin MS and Scott Brown PhD

Part II: Device Translational Pathway

II.1 Regulatory Pathway for 510k, IDE, and PMA
  Deborah G Castillo, Bram D Zuckerman MD and Felipe Aguel PhD
II.2 EU Regulatory Frameworks for Medicines and Medical Devices for Cardiovascular Disease
  Peter Feldschreiber LLB and Alasdair Breckenridge MD
II.3 Product Development of Devices
  Robert E Kohler MS
II.4 Large Animal Models for Cardiovascular Device Development
  Yanping Cheng MD, Daniel Burkhoff MD PhD
and Juan Granada MD
II.5 Translational Platform for Aortic Valve Replacement
  Alain Cribier MD
II.6 Translational Pathway for Tissue Engineered Aortic Valves
  Jerome Sohier PhD, Adrian H Chester BSC PhD and Sir Magi H Yacoub MD
II.7 Translational Platform for Mitral Valve Repair and Replacement
  David G Reuter MD PhD and Patrick M Sullivan MD
II.8 Electrophysiology: Translational Research Platforms
  Fu Siong Ng PhD, Michael T Debney and Nicholas S Peters MD
II.9 The Translational Pathway for Mechanical Circulatory Support
  Toshinobu Kazui MD PhD, Tia Pilikian MS, Destiny Lagrand BA,
Richard G Smith MSEE CCE, Sir Magdi Yacoub MD and Zain Khalpey MD PhD

Part III: Biologics Translational Pathway

III.1 Cellular and Gene Therapy for Cardiac Disease: FDA Product and Pre-Clinical Regulatory Considerations
  Wei Liang PhD and Brent McCright PhD
III.2 Cellular Therapy Product Development for Cardiac Repair and cGMP Manufacturing
  Todd R Flower PhD
III.3 Autologous Myocardial Repair and Regeneration through Intracoronary Administration of Allogeneic Cardiac Stem Cells and/or Growth Factors
  Bernardo Nadal-Ginard MD PhD, Georgina M Ellison PhD
and Daniele Torella MD PhD
III.4 Tissue Engineering and Applications for Treatment of Myocardial Infarction
  Aboli A Rane PhD, John Watson PhD and Karen L Christman PhD
III.5 Mouse, Rat, Sheep and Pig as Functional Models for Cell Therapy
  Jonathan Dinsmore PhD
III.6 Pathology Assessment for Regenerative Therapy
  Stefanie Dimmeler PhD, Annarosa Leri MD, Marcello Rota PhD,
Marion Muhly-Reinholz MTA, Andreas M Zeiher MD and Piero Anversa MD
III.7 Cellular and molecular imaging in translational cardiovascular research
  Johannes Riegler PhD and Joseph C Wu MD PhD
III.8 Methods of Stem Cell Delivery
  Nabil Dib MD MSc
III.9 Clinical Trial Design and Endpoints for Cardiovascular Stem Cell Therapies
  Marko Banovic MD PhD, Atta Behfar MD PhD, Marc Vanderheyden MD PhD,
Branko Beleslin MD PhD, Andreas M Zeiher MD, Andre Terzic MD PhD
and Jozef Bartunek MD PhD

Part IV: Drug Translational Pathway

IV.1 Regulatory Considerations for Drug Development
  Christiane Chène PhD and Hendrik T Tevaearai MD EMBA
IV.2 Translational Pathway for Drug Development
  Hendrik T Tevaearai MD EMBA, Sarah L Longnus PhD, André Roland MSc, Florian Dick MD, Olaf Stanger MD, Didier Locca MD and Christiane Chène PhD
IV.3 Personalized Medicine and Translational Genomics
  Robert Roberts MD

List of Authors


Felipe Aguel PhD

Deputy Director

Divisino of Neurologicl and Physical Medicine Devices

FDA/CDRH/ODE

Silver Spring MD USA

Piero Anversa MD

Professor of Anesthesia and Medicine

Center for Regenerative Medicine

Brigham and Women’s Hospital

Harvard Medical School

Boston MA USA

Marko Banovic MD PhD FESC

Cardiology Clinic

Clinical Centre of Serbia

-and-

Medical Faculty

University of Belgrade Serbia

Belgrade Serbia

Jozef Bartunek MD PhD

Associate Director

Cardiovascular Center

OLV Hospital

Aalst Belgium

Atta Behfar MD PhD

Assistant Professor of Medicine

Senior Associate Consultant

Division of Cardiovascular Diseases

Mayo Clinic College of Medicine

Rochester Minnesota USA

Branko Beleslin MD PhD FESC FACC

Assistant Professor

Clinic of Cardiology

Clinical Center of Serbia

-and-

Medical Faculty

University of Belgrade Serbia

Belgrade Serbia

Cheryl A Blaze BVSc PhD MBA

Assistant Professor

Anesthesiology

Associate Medical Director

Tufts Cummings School of Veterinary Medicine

North Grafton MA USA

Alasdair Breckenridge MD FRCP FMedSci

Professor

University of Liverpool

Liverpool UK

Scott Brown PhD

Founder

Altair Biostatistics

Saint Louis Park MN USA

Daniel Burkhoff MD PhD

Adjunct Associate Professor of Medicine

Columbia University

New York NY USA

-and-

VP Medical Science

HeartWare International Inc

Framingham MA USA

Deborah Castillo

Biomedical Engineer

Lead Reviewer at FDA

U.S. Food and Drug Administration

Center for Devices and Radiological Health

Silver Spring MD USA

Christiane Chène PhD

Senior Scientific Expert

Medical & Preclinical Services

Dr Regenold GmbH

Development, Regulatory, Market Access

Badenweiler Germany

Yanping Cheng MD

Assistant Director of Cardiovascular Imaging

CRF Skirball Center for Innovation

Cardiovascular Research Foundation

Orangeburg NY USA

Adrian H Chester BSc PhD

Honorary Senior Research Fellow

Imperial College London

National Heart & Lung Institute

Heart Science Centre

Harefield Middlesex UK

Alain Cribier MD FACC FESC

Chief of Cardiology

Professor of Medicine

Charles Nicolle Hospital

University of Rouen France

Rouen France

Janna Crittendon

Founder & President

JC Consulting Group Inc

Cohasset MA USA

Karen L Christman PhD

Associate Professor

Department of Bioengineering

Stanford Consortium for Regenerativ Medicine

University of California San Diego

La Jolla CA USA

Michael T Debney MRCP

Clinical Research Fellow

National Heart & Lung Institute

Imperial College London

London UK

Nabil Dib MD MSc FACC

Professor of Medicine

University of Arizona

Director, Cardiovascular Research

Dignity Health

Phoenix AZ USA

Florian Dick MD

Research Group Leader

Department of Cardiovascular Surgery

Inselspital

Berne University Hospital and University of Berne

Berne Switzerland

Stefanie Dimmeler PhD

Institute of Cardiovascular Regeneration, Centre for Molecular Medicine

Goethe University Frankfurt

Frankfurt/Main Germany

Jonathan Dinsmore PhD

Director Cancer Clinical Research

Beth Israel Deaconess Medical Center

Boston MA USA

Georgina M Ellison PhD

Associate Professor of Physiology

Faculty of Life Sciences & Medicine

King’s College London

London UK

Peter Feldschreiber FFPM LLB

Barrister at Law

Chambers of Ben Hubble QC

Four New Square Lincolns Inn

London UK

Todd Flower PhD

Biochemistry and Molecular Biology

Laboratory Director

Celebration Stem Cell Centre

Gilbert AZ USA

Louis Garrison PhD

Professor School of Pharmacy

Adjunct Professor Global Health

Adjunct Professor Health Services

Pharmaceutical Outcomes Research & Policy Program

University of Washington School of Pharmacy

Seattle WA USA

Juan F Granada MD

Executive Director and Chief Innovation Officer

CRF Skirball Center for Innovation

Cardiovascular Research Foundation

Orangeburg NY USA

MaryAnn Guerra MBA

Co-Founder and CEO

BioAccel

Phoenix AZ USA

Juan F Iglesias MD

Department of Cardiology

Lausanne University Hospital (CHUV)

Lausanne Switzerland

Xavier Jeanrenaud MD FESC

Department of Cardiology

University Hospital of Lausanne (CHUV)

Lausanne Switzerland

Toshinobu Kazui MD PhD

Clinical Instructor

University of Arizona Medical Center

Tucson Arizona USA

Zain Khalpey MD PhD FETCS

Director Heart Transplant Program

Director Mechanical Circulatory Support

Director Robotic Mitral Valve Program

Tony Marnell Sr Distinguished Chair in Cardiothoracic Surgery

Associate Professor of Surgery, Medical Imaging, Physiological Sciences,
Biomedical Engineering, Cellular & Molecular Medicine

University of Arizona College of Medicine

Tucson Arizona USA

Ron G King PhD MBA

Chief Scientific & Investment Officer

BioAccel

Phoenix AZ USA

Robert E Kohler MS

Director of Research and Development

Cardiovascular Systems Inc

New Brighton MN USA

Destiny Lagrand BA

Cardiothoracic Translational Research Administrator

Department of Surgery

University of Arizona

Tucson Arizona USA

Annarosa Leri MD

Associate Professor

Department of Anesthesia and Medicine

Harvard Medical School

-and-

Associate Professor Anesthesiology

Brigham and Women’s Hospital

Boston MA USA

John C Lewin MD

President and CEO

Cardiovascular Research Foundation (CRF)

New York New York USA

Wei Liang PhD

Pharmacologist

Office of Cellular Tissue and Gene Therapies

FDA Center For Biologics Evaluation & Research

Silver Spring MD USA

Didier Locca MD FESC FACC

Cardiologist

Cardiovascular Centre Grand-Chêne

Lausanne Switzerland

-and-

Hon Consultant and Clinical Senior Lecturer

The London Chest Hospital

Barts Health NHS

Queen Mary University of London

London UK

Sarah Longnus PhD

Research Group Leader

Department of Cardiovascular Surgery

Inselspital

Berne University Hospital and University of Berne

Berne Switzerland

Andrew J Ludman MRCP MD

Consultant Cardiologist

Royal Devon & Exeter NHS Foundation Trust

Exeter UK

Anthony Mathur MD FRCP FESC PhD

Professor of Cardiology

Queen Mary University of London

Barts Health NHS Trust

London UK

Brent McCright PhD

Research Biologist

Office of Cellular Tissue and Gene Therapies

FDA Center for Biologics Evaluation and Research

Silver Spring MD USA

Larry McNeely

National Coalition on Health Care

Washington DC USA

Pierre Monney MD

Department of Cardiology

University Hospital of Lausanne (CHUV)

Lausanne Switzerland

Marion Muhly-Reinholz MTA

Technical Assistant

Institute for Cardiovascular Regeneration, Center of Molecular Medicine

Goethe University Franfurt

Frankfurt/Main Germany

Christopher M Mullin MS

Director Quality and Regulatory Services

NAMSA

Golden Valley MN USA

Bernardo Nadal-Ginard MD PhD

Honorary Professor

Faculty of Life Sciences & Medicine

King’s College London

London UK

Fu Siong Ng MRCP PhD

Clinical Lecturer in Cardiology

National Heart & Lung Institute

Imperial College London

London UK

Neil K Nydegger Esq

Patent and Trademark Attorney

Nydegger & Associates

San Diego CA USA

Nicholas S Peters MD

Professor of Cardiology

Head of Cardiac Electrophysiology

National Heart & Lung Institute

Imperial College London

London UK

Stéphanie M Perruchoud Fluri MD

Department of Cariology

Hôpital du Valais

Sion Switzerland

Tia Pilikian MS

Clinical Research Coordinator

Department of Surgery

University of Arizona

Tucson Arizona USA

Aboli A Rane PhD

Department of Bioengineering

University of California San Diego

La Jolla CA USA

David G Reuter MD PhD

Director Cardiac Innovations

Seattle Children’s Hospital

Seattle WA USA

Johannes Riegler PhD

Postdoctoral Fellow

Stanford Cardiovascular Institute

Department of Radiology

Stanford University School of Medicine

Stanford CA USA

Robert Roberts MD FRSC FRCP MACC

Scientist Emeritus and Advisor University of Ottawa Heart Institute

Past President and CEO University of Ottawa Heart Institute

Founding Director Ruddy Canadian Cardiovascular Genetics Centre

Adjunct Professor Baylor College of Medicine

Ottawa Canada

André Roland MSc

Patent Attorney

Andre Roland SA Intellectual Property Services

Lausanne Switzerland

-and-

Patent Judge

Swiss Federal Patent Court

St-Gall Switzerland

Marcello Rota MD

Assistant Professor of Medine and Anaesthesia

Brigham and Women’s Hospital

Boston MA USA

Richard G Smith MSEE CCE

University of Arizona Medical Center

Tucson Arizona USA

Jérême Sohier PhD

Research scientist

Laboratory of Tissue Biology and Therapeutic Engineering

Centre National de la Recherche Scientifique (CNRS)

Lyon France

Olaf Stanger MD

Research Group Leader

Department of Cardiovascular Surgery

Inselspital

Berne University Hospital and University of Berne

Berne Switzerland

Patrick M Sullivan MD

Fellow Pediatric Cardiology

Seattle Children’s Heart Hospital

Seattle Children’s Hospital

Seattle WA  USA

Andre Terzic MD PhD

Professor of Medicine

Director Center for Regenerative Medicine

Department Cardiovascular Diseases

Mayo Clinic

Rochester Minnesota USA

Hendrik Tevaearai MD EMBA

Professor of Cardiac Surgery

Head of Research & Development

Department of Cardiovascular Surgery

Inselspital

Berne University Hospital and University of Berne

Berne Switzerland

-and-

CEO

Swiss Cardio Technologies

Stansstad Switzerland

Daniele Torella MD PhD

Associate Professor of Cardiology

Department of Medical and Surgical Sciences

Magna Graecia University

Catanzaro Italy

Marc Vanderheyden MD PhD

Director Cardiovascular Center

OLV Hospital

Aalst Belgium

John Watson PhD

Professor Bioengineering

Department of Bioengineering

University of California San Diego

La Jolla CA USA

Joseph C Wu MD PhD

Director Stanford Cardiovascular Institute

Professor of Medicine Cardiology & Radiology

Stanford University School of Medicine

Stanford CA USA

Sir Magdi Yacoub MD FRS

Professor of Cardiothoracic Surgery/ Faculty of Medicine

National Heart and Lung Institute Imperial College London

London UK

-and-

Founder and Director of Research

Harefield Heart Science Centre (Magdi Yacoub Institute)

Harefield Hospital

Harefield Middlesex UK

Andreas M Zeiher MD

Professor of Medicine

Chariman Department of Medicine III

Goethe University Frankfurt

Frankfurt/Main Germany

Bram D Zuckerman MD

Director

Division of Cardiovascular Devices

FDA

Silver Spring MD USA