By Daniel Cresey
The early stages of drug development could be freed from the shackles of intellectual property under a proposal to be tabled at a meeting of leading pharmaceutical players this week.
Amid layoffs, drying pipelines and the closure of research centres, many observers have warned that, in its current form, the pharmaceutical industry faces a troubled future. The bleak outlook seems even more so in the wake of this month's announcements by Pfizer of plans to reduce research and development spending by as much as US$2 billion and to lay off hundreds of researchers (see'Pfizer slashes R&D').
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Chas Bountra is trying to find a way forwards.
Bountra, who is head of the Structural Genomics Consortium at the University of Oxford, UK, has been talking to academics, research funders and industry representatives to try to get backing for his plan.
He envisions a global initiative worth about $200 million a year -- half from private money and half from public and charitable sources -- that would focus solely on new therapeutic targets. The initiative would rush these through to phase II clinical trials -- the stage at which drugs are given to larger groups of people, but before the huge phase III trials that represent a drug's final hurdle before reaching the market.
If drug candidates proved successful, they would then be made available for the initiative's commercial sponsors to buy and bring to market. This Wednesday, 30 people, including high-level industry experts and academics, will meet in Toronto, Canada, to try to push the idea forwards.
Parallel lines
"We have all this parallel activity and most of it is going to fail. I believe that [intellectual property] is slowing down science," Bountra told a group of journalists at the Science Media Centre in London.
According to his proposal, until a molecule has successfully reached the end of early phase II trials, no intellectual property rights would be asserted and all data would be published. This would hopefully assist other researchers working in similar areas.
A key problem with the current system is that companies tend to work in parallel, identifying similar or identical targets and developing their own molecules -- unaware of other similar products that have already been tested and discarded.
Bountra cites one example of a target for pain, an receptor called TRPV1. In the late 1990s, "the whole industry jumped on that target" after papers in Nature and Science suggested it could lead to treatments for pain.
A number of companies have worked on drugs to target TRPV1, says Bountra, but many in the pain field now think it unlikely that the work will yield a new analgesic. Much of the company data has not been published, however, and in 2006 there were at least 60 companies working on the same target.
"What we're trying to do is reduce that duplication," Bountra says. "If I had done a clinical study and I'd published it in 2002, I hope it would have stopped 50 other companies doing that study."
In addition to the financial benefit, Bountra adds, "there is an ethical argument; we are exposing patients to molecules other organizations know are going to be ineffective".
Risk assessment
At present, many details remain to be ironed out. Bountra hopes that the meeting will establish work streams to deal with these, as well as securing commitments from the players.
He imagines that the collaboration will focus on areas that industry is currently exiting owing to their high risk -- for example Alzheimer's disease, for which many promising drugs have failed in clinical trials.
Various public-private partnerships have been mooted for the pharmaceutical industry in recent history, especially in the field of neglected diseases. And, to some extent, pharmaceutical companies are already moving in the direction proposed by Bountra, explicitly outsourcing more and more of the early stages of drug discovery. GlaxoSmithKline, for example, will sign contracts with ten leading academics this year to partner with the company in developing drug candidates, reports the Financial Times.
There are an increasing number of areas that industry is exiting, says Judy Slinn, a business historian who researches the pharma industry at Oxford Brookes University, UK. She points out that the industry is, to a large extent, still focused on blockbuster drugs and it may take some time for people to switch to a new mindset.
There is also a question over whether academe will be willing to forgo the money it gains from spin-out work by its academics.
"It's a very interesting idea," says Slinn. "It's going to need a lot of good will."
