Literature DB >> 25066849

Bench to bedside: integrating advances in basic science into daily clinical practice.

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


  2 in total

Review 1.  Ethical considerations in tissue engineering research: Case studies in translation.

Authors:  Hannah B Baker; John P McQuilling; Nancy M P King
Journal:  Methods       Date:  2015-08-14       Impact factor: 3.608

2.  How efficient is translational research in radiation oncology? The example of a large Dutch academic radiation oncology department.

Authors:  Maria Jacobs; Liesbeth Boersma; Frits V Merode; Andre Dekker; Frank Verhaegen; Luc Linden; Philippe Lambin
Journal:  Br J Radiol       Date:  2016-08       Impact factor: 3.039

  2 in total

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