KEVIN D LUSTIG*, MARIA L THOMPSON
*Corresponding authorAssay Depot, Inc. 433 Glencrest Drive, Solana Beach CA 92075 USA

Abstract

The centralized model of pharmaceutical development that was used successfully through most of the last century is no longer a good fit. Advances in modern molecular research have changed the playing field to such an extent that the old model is no longer viable. If drug companies can solve the problems of pre-clinical development and deliver a steady stream of new, high-quality compounds to the clinic, then the challenges currently facing pharma will become a thing of the past. The single most likely route to success is through the application of strategic outsourcing, which if done correctly, can dramatically reduce research costs while simultaneously improving research quality. Utilizing new online tools such as research exchanges, a “lean” pharmaceutical company can find and manage a large number of specialist scientific service providers and experts that can bring exactly the right skill set to bear at the right time in the project cycle.

INTRODUCTION

Few would argue that the Pharmaceutical Industry has been languishing in the doldrums now for well over a decade. Pharmaceutical companies are having to face three major issues involving drug approvals, development costs and patents expirations. Any of these alone would prove a tough nut to crack, but the fact that they are all converging at the same time is creating a perfect storm!

• A paucity of new drug approvals: 2010 was one of the worst years on record, with the European Medicines Agency showing only 41 finalized applications, compared to 125 in 2009. Applications were up in 2011, but still a long way off from the steady stream of new approvals that the industry needs in order to remain viable (1).
• Spiraling drug development costs: an analysis of 1,200 drug approvals dating back to the 1950s tells a grim story. The amount of money a company had to invest per drug in 1970 was around $100 million; by 1990 that figure had increased to $500 million; by 2009 it had reached $4 billion; and it is now heading towards $10 billion (2).
• The proverbial “patent cliff”: an unusually dense constellation of bes ...
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