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  /  ISCTR eTextbook


Table of Contents

(The first 5 sections are unlocked and available to all our website visitors.)


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

Click/Tap a chapter title to enter

I.1A 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.2Intellectual Property and Strategy Development
Neil K Nydegger Esq
I.3Investigational 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.4Sources of Funding for Early Stage Ventures
Ron King PhD MBA and MaryAnn Guerra MBA
I.5Anesthesia and Care of the Large Animal for Survival Studies: Sheep
Cheryl Blaze BVSc PhD MBA
I.6Anesthesia and Care of the Large Animal for Survival Studies: Pig
Cheryl Blaze BVSc PhD MBA
I.7Echocardiography in Translational Research
Pierre Monney MD, Xavier Jeanrenaud MD,
Hendrick Tevaearai MD EMBA and Didier Locca MD
I.8MRI in Translational Research
Andrew J Ludman MD, Stéphanie M Perruchoud Fluri MD,
Juan F Iglesias MD, Anthony Mathur PhD and Didier Locca MD
I.9Biomarkers in Cardiovascular Medicine
Christiane Chène PhD, Sarah Longnus PhD
and Hendrik Tevaearai MD EMBP
I.10Clinical Study Design for Translational Research
Christopher M Mullin MS and Scott Brown PhD

Part II: Translational Pathway for Devices

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


Part III: Translational Pathway for Biologics

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III.1Cellular and Gene Therapy for Cardiac Disease: FDA Product and Pre-Clinical Regulatory Considerations
Wei Liang PhD and Brent McCright PhD
III.2Cellular Therapy Product Development for Cardiac Repair and cGMP Manufacturing
Todd R Flower PhD
III.3Autologous 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.4Tissue Engineering and Applications for Treatment of Myocardial Infarction
Aboli A Rane PhD, John Watson PhD and Karen L Christman PhD
III.5Mouse, Rat, Sheep and Pig as Functional Models for Cell Therapy
Jonathan Dinsmore PhD
III.6Pathology 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.7Cellular and Molecular Imaging in Translational Cardiovascular Research
Johannes Riegler PhD and Joseph C Wu MD PhD
III.8Methods of Stem Cell Delivery
Nabil Dib MD MSc
III.9Clinical 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: Translational Pathway for Drugs

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IV.1Regulatory Considerations for Drug Development
Christiane Chène PhD and Hendrik T Tevaearai MD EMBA
IV.2Translational 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.3Personalized Medicine and Translational Genomics
Robert Roberts MD
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