Analysis: Open-access R&D one answer to drug industry woes
LONDON (Reuters) - Drug companies are learning how to share.
In a bid to save both time and money, some of the industry's biggest names are experimenting with new ways to pool early-stage research, effectively taking a leaf out of the "open-source" manual that gave the world Linux software.
If it takes off, the approach could break the mold of current drug research and speed the development of tomorrow's life-saving medicines for diseases from cancer to autism.
At the University of Oxford on Wednesday, two more companies -- Pfizer and Eli Lilly -- signed up for the first phase of the concept by joining existing backers GlaxoSmithKline and Novartis in an unusual public-private research partnership.
As supporters of the international Structural Genomics Consortium (SGC), the rivals give cash and scientific resources for work into the three-dimensional structure of proteins -- important for drug discovery -- even though all the findings are made available to scientists worldwide without restriction.
In all, the SGC has secured $49 million in new funding.
Next year, a far more ambitious scheme is slated to take cooperation to another level by promoting open-access, patent-free research right up to mid-stage "proof of concept" clinical trials, known as Phase II.
The bold idea calls for drugmakers to trade exclusivity for the chance to get in on the ground floor of new therapies. After the initial sharing phase, companies could cash in by developing their own versions of any new medicines.
Patents may be the life-blood of the drugs industry but a growing band of rebels believe the current system of building walls around the science is counter-productive because companies end up working in parallel and duplicating research.
"It's a horrendous waste of money, a horrendous waste of resource and waste of peoples' careers," says Chas Bountra, the SGC's chief scientist, who is also a founder of the new project to take open-access research into the clinical arena.
"There is also an ethical and moral dilemma here because the way we are currently doing drug discovery means that we are exposing patients to molecules that other groups know are destined to fail. That is tragic."
Bountra, who knows the industry well after working for nearly 20 years at GSK, is convinced that no one company can fully grasp the myriad genetic and other factors behind complex diseases like cancer.
Stephen Friend -- another founder of the patent-free drug development project known as Arch2POCM -- is also an industry veteran, having founded Rosetta Inpharmatics and gone on to head Merck & Co's cancer research, before shifting to establish the non-profit group Sage Bionetworks in Seattle.
Friend told Reuters the new project, whose name derives from "archipelago" and "proof of clinical mechanism," was on track to launch in 2012, with an initial focus on cancer and two areas in neuroscience, autism and schizophrenia.
A meeting is planned with drug companies in November to hammer out details on the oncology program.
Friend hopes to have at least three companies on board in cancer, each putting in $4 million a year in cash and "in-kind" expertise, with extra funding from public and private bodies giving a total budget of around $150 million over five years.
The neuroscience program, which is running a couple of months behind, would be of a similar size, making the overall venture significant, though still a side bet by comparison with the $68 billion Big Pharma spent on research last year.
It amounts to a radical departure for an industry used to playing its cards close to chest.
But Keith Blundy -- who has a ringside seat as CEO of Cancer Research Technology, which strikes alliances with drug firms on behalf of Britain's leading cancer charity -- believes global drug companies are thinking outside the box these days.
"What people are prepared to entertain now is a long way away from what it was a couple of years ago," he says. "Industry has pulled all the levers it can and new models have got to be considered."
The stark fact is that current returns on drug research are dismal, prompting the first decline in R&D spending in 2010, after decades of relentless increases.
How far drug companies are prepared to go in embracing the Arch2POCM model remains to be seen.
Friend argues they would have two bites of the cherry to make a commercial drug -- either by buying exclusive rights to data generated from any successful unpatented drug or, more significantly, by using the research as a jumping-off point for developing their own proprietary molecules.
Patrick Vallance, head of medicines discovery and development at GSK, says the new approach makes sense in principle but commercial decisions by companies on when they need to secure intellectual property (IP) will inevitably vary.
"I think going through to Phase II with everything in an IP-free environment is not going to happen," he says.
"But there may be some areas that really benefit. For example, everyone is struggling with trying to understand aspects of neuroscience -- having a few more molecules that probe specific pathways could be really beneficial for the whole field and for industry."
(Editing by David Cowell)