Correspondence: Paul W. Tebbey, Kolabri Consulting, LLC, PO Box 508, Chalfont, PA 18914, USA. E-mail: ptebbey@kolabriconsulting.com

¹is the Managing Director at Kolabri Consulting, LLC, a life sciences product strategy consultancy.

²is an engagement manager with the Strategy & Portfolio Analysis unit at IMS Health Inc.

Received 20 September 2009; Revised 20 September 2009; Published online 30 October 2009.

Abstract

The Target Product Profile (TPP) is supposed to be the cornerstone of pharmaceutical product development. But how often is it utilized or updated, and how closely does it resemble the product that originally was envisaged? At a watershed moment for a drug development industry that recognizes the need for profound change in order to increase productivity, and with the US Food & Drug Administration promoting dialogue with pharmaceutical manufacturers via a 'TPP', it is an opportune time to revisit the important role that the TPP should play in the drug development process. In its traditional form, the TPP has proven to be insufficient for effective commercial evaluation of the clinical development strategy. But, rather than redefining the currently accepted form of the TPP, the authors propose a Strategic Evaluation Framework that encompasses the TPP, the vision for the brand and the prevailing needs of the marketplace. The Strategic Evaluation Framework augments the TPP with the additional information necessary for the assessment of a product's commercial potential. The Strategic Evaluation Framework constitutes the yardstick to track the developing product's actual clinical profile versus that necessary for commercial success and thereby serves as the guide for strategic clinical development decision making.