| Literature DB >> 25066849 |
Rory B McGoldrick1, Kenneth Hui2, James Chang2.
Abstract
This article focuses on the initial steps of commercial development of a patentable scientific discovery from an academic center through to marketing a clinical product. The basics of partnering with a technology transfer office (TTO) and the complex process of patenting are addressed, followed by a discussion on marketing and licensing the patent to a company in addition to starting a company. Finally, the authors address the basic principles of obtaining clearance from the Food and Drugs Administration, production in a good manufacturing practice (GMP) facility, and bringing the product to clinical trial. Published by Elsevier Inc.Keywords: Clinical trials; Commercialization; Company startup; Food and Drugs Administration; Licensing; Marketing; Patenting; Technology transfer process
Mesh:
Year: 2014 PMID: 25066849 DOI: 10.1016/j.hcl.2014.04.004
Source DB: PubMed Journal: Hand Clin ISSN: 0749-0712 Impact factor: 1.907