The pharmaceutical industry’s business model has been in a crisis since the early 2000’s. With huge investments in research and development and very little output, companies have been forced to rethink their strategy. The industrials have looked at externalizing their research to university research centers, to reduce costs and access their academic expertise. They helped create collaborative teams with both academic and industrial researchers, to take fundamental innovations and turn them into drugs and treatments. But this translational research isn’t just a demand from the industry, it’s a dynamic that also comes from both federal government initiatives and change in the academic perspective.
To understand this problematic more deeply, we interviewed Kenneth Kaitin, director of the Center for the Study of Drug Development at Tufts University (Boston), an institute that has been analyzing for the past 40 years scientific, economic and legal issues that affect pharmaceutical and biopharmaceutical development.
The government’s initiatives
Translational research was created in the early 2000’s by initiatives from the federal government. The pharmaceutical academic research was mainly funded by the National Institute of Health, that supported basic research projects. Researchers would look at the fundamental disease mechanisms, but not much money was put into transferring those innovations into efficient drugs. In 2004, the NIH offered, through the “NIH Roadmap for Medical Research”, very large grants to universities that would create research institutes focused on applied research, taking those basic innovations and finding a way to transform them into useable treatments. At the same time, the Food and Drug Administration focused its attention on this growing gap between the academic expertise and innovation capacity and the very little number of new drugs that found their way to the market. The FDA created the “Critical Path Initiative”, that helped create collaborations between public and private research institutes, and produced guides for industries on how to have more efficient drug development, in clinical studies for example.
The industry’s perspective
While government institutions were starting to foster public/private collaboration, the pharmaceutical industry was seeing its business model go into crisis. The Research and Development strategy – investing colossal, growing amounts of money – was showing a rather small output in terms of marketable innovative drugs. The industry players also had very little access to the academic expertise and to the innovation taking place in the universities. And since a lot of profitable drug patents were set to expire soon, the industry looked to make drastic savings in its expenses. A new model of outsourced research came in place : industries started funding academic research groups, not only for one specific, time-limited project, but for all areas of research or even entire labs. Many pharmaceutical companies, such as Pfizer or Eli Lilly have created collaborative research institutes, where researchers from universities and the industry work together on large innovation thematics.
The new attitude of academia
The federal government’s investments in research had increased in 2010, due to the Obama 2009 Stimulus plan. But now, with the expected 2012 budget to shrink investments in research, the academic research teams need to look elsewhere for additional fundings. With the industry looking for new partnerships with universities and the NIH offering large grants for translational research centers, a lot of universities have jumped on the opportunity to open such institutes. There are now 60 research centers that were funded by the NIH 2006’s awards, of which the Harvard Catalyst, Tufts’ Clinical and Translational Research Center or the soon-to-be-opened Center for Novel Therapeutics of University of California San Diego are just a few examples. If new projects of translational research are being more and more fostered by universities, the academic world still show some reluctance to these close partnerships. Questions have been raised concerning the overseeing of fundamental research, which is still the main source of innovation, but which has been less funded since trends of higher investments in applied research have appeared. The universities are also concerned about conflicts of interest for researchers working with the industry, and regulations are being locally put in place to make sure that, for example, researchers will be able to publish their results, either positive or negative. Another risk of those important collaborations with the industry is that whole areas of pharmaceutical research might be put aside because of their low industrial output.
These new translational research centers are less than ten years old. It will take some more time to see this new model’s effects in terms of innovative drugs and treatments and economical results. An important factor of these centers’ viability is their ability to make both industries and universities save on investment, which their first reason for collaboration, and to make public and private researchers with different goals work together.