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Cardiovascular Translational Research

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

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

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

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

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