Deconstructing the drug development process: the new face of innovation

Abstract

Forged in the early 1960s, the paradigm for pharmaceutical innovation has remained virtually unchanged for nearly 50 years. During a period when most other research-based industries have made frequent and often sweeping modifications to their R&D processes, the pharmaceutical sector continues to utilize a drug development process that is slow, inefficient, risky, and expensive. Few who work in or follow the activities of the pharmaceutical industry question whether change is coming. They know that the pharmaceutical sector, as currently structured, is unable to deliver enough new products to market to generate revenues sufficient to sustain its own growth. Nearly all major drug developers are critically examining current R&D practices and, in some cases, considering a radical overhaul of their R&D models. But key questions remain. What will the landscape for pharmaceutical innovation look like in the future? And, who will develop tomorrow’s medicines?

Figure 1

Clinical development times (from IND filing to NDA submission) and regulatory approval times (from NDA submission to approval) for new molecular entities approved by the US Food and Drug Administration during the 5-year period 2003–2007, grouped by therapeutic area. Analysis by the Tufts Center for the Study of Drug Development, based on data included in its approved products database. *Note that the anti-infectives category excludes AIDS antiviral agents. IND, investigational new drug application; NDA, new drug application.

Figure 2

New drug approvals (dots), represented on the left vertical axis, and pharmaceutical R&D expenditures (shaded area), represented on the right vertical axis, in the United States from 1963 to 2008. R&D expenditures are presented in terms of constant 2008 dollar value. The trend line is a 3-year moving average. The source of drug approval data is the Tufts Center for the Study of Drug Development (CSDD). The source of R&D expenditure data is the Pharmaceutical Research and Manufacturers of America; Industry Profile 2009; conversion of actual expenses to constant dollars was performed by Tufts CSDD.

Figure 3

Summary of clinical protocol design trends as presented in Getz et al. See the original article for a description of categories and periods of measurement.

Figure 4

Market capitalization of top-tier pharmaceutical companies in January 2001 and September 2009. Cumulative loss in market capitalization for these companies over the period is $626 billion. Ticker symbols are as follows: ABT, Abbott; AZN, AstraZeneca; BMY, Bristol-Myers Squibb; GSK, GlaxoSmithKline; LLY, Lilly; MRK, Merck; PFE, Pfizer; SGP, Schering-Plough; WYE, Wyeth. Data from http://www.valueline.com; Tufts Center for the Study of Drug Development analysis.

Figure 5

A FIPNet (fully integrated pharmaceutical network) model of drug development, in which the core capabilities of different stakeholders in the development process are leveraged. CRO, contract research organization.