Over the past decade or so, aggregate R&D investment within the Drug Development industry has headed north while Productivity - defined as the annual number of FDA approvals of new drugs often referred to as New Molecular Entities (NMEs) - has declined steadily from a high of 56 in 1996 to a mere 17 in 2007. In an era of unprecedented patent expirations and human resource contraction, much of the industry continues to march to the tune of ‘outsourcing’ to better manage its cost structure while many of the fundamental problems that beleaguer Drug Development remain in a seemingly unflagging state. These include (a) poorly predictive pre-clinical disease models leading to high attrition rates in late clinical development, (b) a dearth of genuine pipeline opportunities, (c) inefficient decision-making created by the fear of making too many Type II errors, (d) the unfulfilled promise of the ‘omics’ revolution, and (e) despite modest successes, a general failure to radically alter the course of disease progression.

What therefore is the prognosis for the Drug Development industry? How much longer can it support an inefficient and waning R&D Productivity Business model? Who is/are incentivised to, and will lead the charge to radically alter Drug Development or will good, old fashioned logical incrementalism continue to prevail? Who is/are responsible for Strategic Planning and Portfolio Management and how well are they connected? Whatever happened to the core competence of the corporation?

This entry was posted on Friday, March 14th, 2008 at 9:14 am and is filed under Uncategorized. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.