title: Pharmaceutical tangents: the good, the bad and the ugly.
abstract: In this article a "tangent" means a change from the plans or path one has agreed to follow in drug discovery, development, production or marketing. There are positive and negative tangents. It is important for companies to have a method for approving tangents in a systematic way. There are two major issues to consider about tangents: Who is proposing the tangent and what are his or her motives? and What are the "pros" and "cons" of adopting a tangent presented as a fait accompli? Tangents include changes in the major direction or orientation of a project such as pursuing a new indication, a new route of administration or a new patient population. It is important to recognize these and other proposals or recommendations as tangents when they are initially proposed. There are a series of specific issues and questions to address when evaluating tangents and a number of straightforward ways to minimize nonproductive tangents in pharmaceutical companies.
authors.affiliation: Scientific and Regulatory Affairs of PhRMA, Washington, DC, USA.
authors.forename: B
authors.initials: B
authors.lastname: Spilker