science 2008-2009: 9: translational research
By Jon Agar, on 27 September 2009
There’s a paradoxical relationship between the flourishing of biotechnology and the commercialisation of science. On one hand the received narrative says that the patenting of recombinant DNA techniques led to the launch of the biotech companies, the celebration of the professor-entrepreneur, and the pressure to further commercialise academic research. So the Bayh-Dole Act, which granted intellectual property rights on publicly-funded research to the universities, prompted the growth in technology transfer offices (TTOs). By 2008 there were TTOs at 230 universities in the United States; data from two years earlier records 16,000 patent applications, 697 licenses for products and 553 start-up companies. Some made generated immense income streams: the Gatorade sports drink (shared between faculty inventor Robert Cade and the University of Florida), taxol (discussed earlier), and cisplatin (a platinum compound, found to have anti-cancer properties at Michigan State University). Big funds such as Royalty Pharma specialise in acquiring biomedical patents and licensing them to manufacturers: Royalty moved the anti-convulsant pregabalin from Northwestern University to Pfizer to make Lyrica in a $700 million deal; and Royalty, again, moved filgrastim substances, which stimulated white blood cell production, from the Memorial Sloan-Kettering Cancer Centre to Amgen to make Neupogen/Neulasta in a $263 million deal.
TTOs were a model to copy. A wave of TTOs was set up in European countries in the 1990s and 2000s. In other countries, institutes with special briefs to transfer technology have been established, for example the A*STAR institutes of Singapore.
‘A multi-continental chorus of academic researchers’, notes Meredith Wadman in Nature, complain that the ‘plethora of TTOs that have sprung up…are at best a mixed blessing’. TTOs, they say, overvalue intellectual property, hoard inventions, have small stretched staff, of which the talented are poached by industry and venture capital firms, and drive the over-commercialisation of academic science. Nevertheless, the assumption is that biotech is the cause of this movement close to market.
On the other hand, an examination of biomedical science in the thirty years since the late 1970s, precisely the same period that saw the growth of the TTOs, shows that basic biomedical science has grown away from clinical application and product, and the cause of the drift was biotech. In the 1950s and 1960s, notes Declan Butler in Nature, a typical medical researcher was a physician-scientist. But with the growth of molecular biology, clinical and biomedical research began to separate. Basic biomedical researchers looked to top academic journals for credit rather than their contribution to medicine. Basic scientists also regarded unfamiliar regulation and patenting with trepidation. Clinicians, meanwhile, ‘who treat patients – and earn fees for doing so – have little time or inclination to keep up with an increasingly complex literature, let alone do research’. Furthermore, in parallel, genomics, proteomics and so on generated so many possible drug targets, on average more expensive to develop than older therapies, that the pharmaceutical firms felt overwhelmed.
In this second account, then, biotech has had the effect of driving the laboratory bench further from medical application. To counter the trend, key funding agencies have promoted offices of “translational research”, a term that first appeared in 1993 as part of the BRCA1 controversy. In teh United States, the National Insitutes of Health began funding, from 2003, Clinical and Translational Science Centers, which encouarge multidisciplinary teamwork and business-style assessment. In Britain the Wellcome Trust and the Medical Research Council followed suit. Europe was in the course of setting up, in 2008-2009, its new European Advanced Translational Infrastructure in Medicine, linking translational research in Denmark, Finland, France, Greece, Germany, Norway, the Netherlands, Italy, Spain, Sweden and the United Kingdom.
So biotech led both to and away from the market and application.
By way of contrast, a footnote: in 2008, Nature reported that Bell Labs, generator of six Nobel prizes, was pulling out of basic physics research completely.