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

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.