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.
Book Chapters
Understanding Conflict of Interest for Academic Entrepreneurs
Deepthi Alapati, Patrick Egan, and Janet Holcombe
Development Strategies for Animal Medical Therapeutics
Alexander H. Morrison, Nicola J. Mason, and Yvonne Paterson
FDA Device Regulation: 510(k), PMA
Jason Van Batavia and Seth Goldenberg
Working with the University Technology Transfer Office
Ryan Fauzan and Nalaka Gooneratne
FDA Drug Regulation: Investigational New Drug Applications
Bike Su Oner, Sergio R. Labra, and Shelly Fehr
Pediatric Medical Device Development Pathways
Claire Phoumyvong and Matthew Maltese
Reimbursement Strategies and CPT Codes for Device Development
Tai-Yun Kuo and Scott Manaker
My Invention Already Exist? Conducting a Patent / Prior Art Search
Toshitha Kannan, Elliot Stein, and Mark Maloney
Intellectual Property Protection for Biologics
Megan Brewster and Pallab Singh
Development of Radiographic Contrast Agents for Diagnostic Imaging
Ryne Didier and David Mankoff
Orphan Drugs: Understanding the FDA Approval Process
Gauri Srivastava and Ashley Winslow
Department of Defense: SBIR/STTR Grants and Other Contracts
Julia Kelly and Richard Sensenig
Overview of Drug Development
Nalaka Gooneratne
Overview of Device Development
Anupam Kumar and Nalaka Gooneratne
Surgical Device Development
Nicolette Driscoll, Mohit Prajapati, and Ari Brooks
Digital Health: Software as a Medical Device
Mauricio Novelo, Nalaka Gooneratne, and James Weimer
Preclinical Animal Models
Sunghee E. Park and Thomas P. Schaer
Laws and Ethics in relation to Medical Entrepreneurship
Ramesh Iyer and Jeremy Solomon
