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Home / ISCTR eTextbook

(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.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: Translational Pathway for Devices

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II.1	Regulatory Pathway for 510k, IDE, and PMA
	Deborah G Castillo PhD, Bram 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 Magdi 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 H Yacoub MD and Zain Khalpey MD PhD

Part III: Translational Pathway for Biologics

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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: Translational Pathway for Drugs

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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

ISCTR Donation

Table of Contents

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

Part II: Translational Pathway for Devices

Part III: Translational Pathway for Biologics

Part IV: Translational Pathway for Drugs

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