21% of new drugs approved from 1990-2007 involved PSRIs

It’s been about a year now since the New England Journal of Medicine published an article by AUTM President Ashley Stevens finding public-sector research had a more immediate effect on improving public health than was previously realized. (Stevens AJ, et al. N Engl J Med 2011;364:535-41)

Just about the same time, I was advising Bioscience Bridge on connections for university research from Boise State, Tulane, and Purdue.

This research article underscores the important role the universities play in improving healthcare.  And why Bioscience Bridge continues to create attention to commercialization of intellectual property.

In the introduction to the article, Stevens states that historically, “public-sector researchers have performed the upstream, basic research that elucidated the underlying mechanisms of disease and identified promising points of intervention.”

This is contrasted with corporate researchers who performed the downstream, applied research resulting in the discovery of drugs for the treatment of diseases – and who carried out development activities to bring them to market.

Today, however, the boundaries between the roles of the public and private sectors have shifted substantially since the dawn of the biotechnology era, and the public sector now has a much more direct role in the applied-research phase of drug discovery.

The authors (organized by Stevens, and including researchers from Boston University Schools of Medicine, Law and Management, the Radium Hospital, Oslo, along with collaborators from the National Institutes of Health led by Mark Rohrbaugh, Ph.D., J.D.) found that during the past 30 years, 153 new FDA-approved drugs, vaccines, or new indications for existing drugs were discovered through research carried out in public sector research institutions (PSRIs). These drugs included 93 small-molecule drugs, 36 biologics, 15 vaccines, 8 in-vivo diagnostic materials, and one over-the-counter drug.

Their conclusion:

“We believe that our study supports the concept that the emergence of biotechnology in the mid-1970s, combined with policy changes implemented in the early 1980s regarding the ownership and management of the intellectual property of PSRIs, allowed these institutions to play an important role in the downstream, applied phase of drug discovery.”

Specifically, the data show that PSRIs have contributed to the discovery of 9.3 to 21.2% of all drugs involved in new-drug applications approved during the period from 1990 through 2007. It also suggests that PSRIs tend to discover drugs that are expected to have a disproportionately important clinical effect.