The Burrill Report


Public-sector research institutes usually focus on basic research and leave the applied research that leads to new drugs to industry to perform. But a new study in the New England Journal of Medicine finds that these research institutes have played a critical role in discovering 153 approved drugs and vaccines, suggesting they have a more direct role in improving public health than often realized.

The study’s release comes at a critical time for public-sector research, which finds itself once again in the crosshairs of members of Congress looking to find places to cut the budget. After a long-fought battle to reverse Bush era losses in National Institutes of Health funding in real terms, a just passed House resolution pushed to roll back the NIH budget to 2008 levels.

Researchers at Boston University’s School’s of Medicine, Management, and Law along with collaborators at the NIH, found during the past 40 years, 153 new FDA-approved drugs, vaccines, or new indications for existing drugs were discovered through research carried out in public-sector research institutes. The researchers broadly define the term “public-sector research institutes” to include all universities, research hospitals, nonprofit research institutes, and federal laboratories in the United States.

While these institutions have not historically played a major role in applied drug discovery, the study authors say a combination of science and policy have brought about changes. The development of biotechnology tools allowed researchers at these institutes to develop biologics. At the same time, the passage of the Bayh-Dole Act and its federal laboratory counterpart the Stevenson-Wydler Technology Innovation Act, gave the institutes the ability to patent, manage, and transfer the intellectual property they create.

Overall, the research tally public-sector research institutes are responsible for 93 small-molecule drugs, 36 biologic agents, 15 vaccines, 8 in vivo diagnostic materials, and one over-the-counter drug. These drugs tend to be ones that the researchers say have a disproportionately large therapeutic effect. More than half of these drugs have been used in the treatment or prevention of cancer or infectious diseases.

Public-sector institutes will likely play a greater role in discovering new drugs going forward. There is increasing pressure to demonstrate the federal government’s big investment in research by ensuring discoveries that translate into products that benefit public health. At the same time, pharmaceutical companies, wrestling with the rising cost of drug development and the poor returns on their own R&D efforts, are forging relationships with public-sector institutes. But for the budget battles ahead, expect to hear more about studies like this one.



February 10, 2011
http://www.burrillreport.com/article-props_for_the_public_sector.html