THE journey that a drug takes from an idea in a lab to a pharmacist鈥檚 shelves could match the making of a Hollywood epic: it鈥檚 a long, costly, risky project. And while pharmaceutical or biotech companies reap most of the glory and profit, most drugs on the market started life in university research laboratories or in research institutes funded by the public. Until recently these organisations gave away their intellectual property. But not any more.
The UK is known for its innovative biomedical research but has been notoriously bad at commercialising it. However, in recent years the major players in public and charity-sector medical research have restructured or launched their technology-transfer divisions, giving greater protection to their intellectual property (IP) and improved support to foster innovation. The leading biomedical research organisations 鈥� the Medical Research Council (MRC) and the Wellcome Trust, for example 鈥� are venturing into new territory to translate their discoveries into treatments. And this could be a valuable source of income, too.
鈥淭here is a huge gap opening up between research and industry, and our applied research division aims to address this problem,鈥� says Alison Campbell, director of IP development at MRC Technology, the MRC鈥檚 technology-transfer company. 鈥淲e are increasingly having to take on own-risk projects because industry is becoming reluctant to take on the risk of commercialising fundamental research.鈥�
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The MRC鈥檚 income from its technology-transfer activities has grown enormously in the past few years (see Chart), with MRC Technology bringing in 拢11 million last year. This may be only a fraction of the MRC鈥檚 total spend of 拢340 million, but it still represents a worthwhile sum that can be reinvested in research. 鈥淭he taxpayer can afford to fund research, but cannot afford to develop products,鈥� says Campbell. 鈥淭his is where our applied research division comes in.鈥�
This strategy has borne fruit. In 2002, the MRC issued 42 licences for external organisations to use its IP, launched three new companies, and applied for 50 patents. It has also created MVM, a venture capital company which raised 拢40 million in 1998 and a similar amount in October 2001 to invest in young life-science companies.
The MRC is not alone in this kind of commercial activity. The UK鈥檚 largest biomedical research charity, the Wellcome Trust, used to handle technology transfer through its subsidiary company Catalyst BioMedica. In the past five years, Catalyst concluded more than 60 licence agreements and funded projects that have led to more than a dozen start-up companies. Then, in March this year, the trust brought this activity in-house with the launch of its own technology-transfer division backed by development funds of 拢40 million.
Ted Bianco, director of technology transfer for the Wellcome Trust, says the restructuring is a sign that it is placing increasing importance on translating its research, while keeping its ultimate goal in sight. 鈥淚t is a very important part of our mission, but we must ensure that we exploit our research for the best public benefit.鈥�
Other major research charities are also beginning to see the pay-off for their labours appearing on pharmacists鈥� shelves. 鈥淭here are currently three drugs on the market which have been licensed from us,鈥� says Clive Stanway, director of technology development at Cancer Research Technology (CRT), the technology-transfer arm of Cancer Research UK. 鈥淔or a charity that is a hundred years old, this may not seem like much, but it was only in the mid-1980s that people became aware of the need to protect their intellectual property.鈥�
One of the three drugs licensed from Wellcome is temozolomide (marketed in the UK as Temodal), a new treatment for glioma, a form of brain cancer. Temozolomide is manufactured by Schering-Plough and has annual sales in excess of $270 million. 鈥淛ust one successful drug can create a significant income,鈥� says Stamway, although he won鈥檛 reveal how much comes CRUK鈥檚 way from the sales of temozolomide. He is optimistic that more successes will follow. 鈥淲e have two drugs in the last stages of clinical trials and plenty more in the pipeline,鈥� he says.
Like MRC Technology, CRT carries out early-stage applied research. Around 20 scientists are employed to develop the commercial potential of CRUK discoveries and make them a more attractive prospect for pharmaceutical companies. Stanway is keen to stress that this new focus will not affect CRUK鈥檚 commitment to fundamental research. 鈥淥ne could argue that we should focus more on applied research and increase the number of drugs on the market. But that would put a dent in the fundamental research and would be to the detriment of cancer patients in the long term,鈥� says Stanway. 鈥淲e need to find the right balance between fundamental and applied research.鈥�
The NHS has also woken up to the idea that the work carried out by its employees could bring the organisation financial rewards. 鈥淏efore 1998, most of the NHS鈥檚 intellectual property was lost, ignored or destroyed,鈥� says Tony Bates, the service鈥檚 IP adviser. 鈥淚n 1998, the NHS launched its Intellectual Property Policy Framework which for the first time allowed it to commercialise its R&D.鈥� Plans are afoot to create a network of technology-transfer offices to provide intellectual property management services to NHS trusts and primary care trusts.
While Bates believes these initiatives will lead to extra income for the NHS, he says that the real benefit will be in improved healthcare for patients. Recent successes include a device to measure the depth of burns to determine whether a patient needs a skin graft, developed by medical physicists in Newcastle. This device is now on sale and is expected to generate healthy revenues. 鈥淏ut the real benefit is that 25 per cent of skin grafts will no longer be needed,鈥� says Bates.
It takes over a decade to bring a drug to the market, so it will be some time yet before we see the full impact of these technology-transfer initiatives. But could this new-found enthusiasm for protecting intellectual property mean that the public sector will start concentrating only on research which has the potential to bring in income?
The Wellcome Trust, the NHS, the MRC and Cancer Research UK all refute this notion. They are, and will always be, committed to improving healthcare either by funding fundamental research or through clinical care, they insist. The ever-increasing income from their IP will help them do just that, but continued public funding is essential to ensure that fundamental research is still carried out.
Knowledge in the bank
The UK Biobank project is one of the largest medical research studies ever launched. It is funded to the tune of 拢45 million by the Wellcome Trust, the Medical Research Council (MRC) and the Department of Health, and aims to study the role of nature and nurture in health and disease. Using genetic information from DNA samples and the medical records of 500,000 volunteers aged between 45 and 69, the study will capitalise on knowledge from the Human Genome Project and combine this with information on environment and health.
Despite its huge potential benefits, Biobank has caused a storm among researchers who say the MRC has put so much cash into the scheme that it is unable to fund many other important projects.
John Newton, who was recently appointed CEO of UK Biobank, insists that his organisation is not to blame. 鈥淏iobank represents only 1 per cent of the MRC鈥檚 total budget,鈥� he says. 鈥淭he MRC overcommitted itself in previous years and there is now less money for new projects. The MRC received additional government funding for the Biobank project, and to say that Biobank has distorted spending budgets is simply not true.鈥�
The project will probably run for over 25 years, providing an unparalleled resource for researchers to study the intertwining roles of genes and the environment in human health. In some regions of England, for example, the mortality in the most deprived 20 per cent of the population is double that of the wealthiest 20 per cent. Striking as they are, these differences are still largely unexplained.
鈥淢any of our participants will inevitably develop the common disabling and fatal diseases such as heart disease, cancer, arthritis, dementia and so on,鈥� says Newton. 鈥淭he Biobank data record will then allow scientists to look back in time to see how those that became ill differed from those that did not. This in turn will give important clues to the causes of disease, and to specific disease mechanisms.鈥�
Newton is confident that the results of the Biobank project will not be exploited for commercial use. 鈥淭he data produced by Biobank will help industry identify new applications, but I cannot see how a marketable patent will come directly out of the Biobank project,鈥� he says. He says that Biobank will lead to 鈥渄iscoveries鈥�, which cannot be patented, rather than 鈥渋nventions鈥�, which can. 鈥淏iobank is also against the idea of patenting human DNA,鈥� says Newton. Safeguards such as an independent oversight body that Biobank is putting in place go well beyond what is required by law. 鈥淚ndeed, we are hoping that Biobank will set a new standard for ethics and governance in this area appropriate to its status as a flagship project for UK science.鈥�