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Intellectual Property-Regulatory

Intellectual Property is often carefully monitored by academic entities, with varying degrees of flexibility around licensing. Major regulatory concerns exist with regard to medical and health sciences, particularly around Conflict of Interest and ethical conduct of research. This section will cover the disclosure, patent, and licensing processes, and how to navigate the network of industry regulation that shapes academic entrepreneurial work.

Individual chapters are under Book Chapters, all chapters for this section are combined in the Full Section file, and the summary section from all chapters are found in the Summary file.

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Book Chapters

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Understanding Conflict of Interest for Academic Entrepreneurs
Deepthi Alapati, Patrick Egan, and Janet Holcombe

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Development Strategies for Animal Medical Therapeutics
Alexander H. Morrison, Nicola J. Mason, and Yvonne Paterson

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FDA Device Regulation: 510(k), PMA
Jason Van Batavia and Seth Goldenberg

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FDA Drug Regulation: Investigational New Drug Applications
Bike Su Oner, Sergio R. Labra, and Shelly Fehr

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Pediatric Medical Device Development Pathways
Claire Phoumyvong and Matthew Maltese

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Does My Invention Already Exist? Conducting a Patent / Prior Art Search
Toshitha Kannan, Elliot Stein, and Mark Maloney

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Intellectual Property Protection for Biologics
Megan Brewster and Pallab Singh

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Orphan Drugs: Understanding the FDA Approval Process
Gauri Srivastava and Ashley Winslow

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Overview of Device Development
Anupam Kumar and Nalaka Gooneratne

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Surgical Device Development
Nicolette Driscoll, Mohit Prajapati, and Ari Brooks

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Digital Health: Software as a Medical Device
Mauricio Novelo, Nalaka Gooneratne, and James Weimer

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Preclinical Animal Models
Sunghee E. Park and Thomas P. Schaer