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: Translational Pathway for Devices
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
Part IV: Translational Pathway for Drugs
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 |