BIOTECH AND BUSINESS:Irish researchers are being encouraged to link with big business, but what are the risks and how can it be done properly?

A DECADE or two ago, it was considered murky in Ireland. Something to be viewed with suspicion, tantamount to treason or selling your soul. Yet today, mixing academic research with big business is positively encouraged, particularly in biotech and related areas, because of the benefits it can bring.

Funding arrangements in Ireland now actively link basic academic science with industry partners - some partnerships support innovative and early-stage research in universities that the industry partners couldn't otherwise carry out, while others seek to harness academic expertise more directly from the outset for specific customer needs.

It's a huge change in the biotech research landscape of Ireland and one that offers potential for translating academic discoveries into marketable products. But just how easy is it to enmesh academic science with business - two cultures that, on the face of it, are fundamentally different?

"There are roadblocks: it certainly needs a lot of work to get these partnerships to be successful," says Frank Barry, professor of cellular therapy at NUI Galway.

Based at the Regenerative Medicine Institute (Remedi), Barry has worked closely with a range of companies through his research on understanding how stem cells repair injury. He says any wariness around such collaborations needs to be addressed.

"I think the first problem would be the mentality that it reduces the excellence of academic research. Traditionally there was a view that having industry partnerships or dealing with commercialisable research was tainted, that it was not pure research." The idea of industry funding redirecting the research ('he who pays the piper calls the tune') has also been detrimental, he says.

"It is possible to do very good science and to have a commercial output - it is perfectly possible to do that," Barry says.

There are issues around managing people's expectations of a project, which can be very different depending on which side of the fence you stand. Timelines in particular can pose something of a challenge, according to Barry.

"There are different concepts about timelines and project management in that the industry research tends to be very tightly managed and academic research tends to flow along in a way that's more creative and freeform," he says.

"That is an area where we have seen conflicts in the past because typically if a company invests in a research project, they would expect something meaningful to emerge within a year, but in the academic environment that figure would be maybe three to five years instead. So I think some kind of merging with respect to the expectation of the timelines would be helpful, and both sides need to work on that." What happens to the valuable intellectual property (IP) that arises from a discovery also needs to be set out early on, and inventors or small companies linking cogs with a larger business should take steps to ensure they are protected, according to Dr Mark Heffernan, CEO of Opsona Therapeutics.

Heffernan moved from Australia to Ireland and set up the company in 2004 with Trinity College Dublin professors Luke O'Neill, Kingston Mills and Dermot Kelleher to develop antibodies that can control inappropriate inflammation in the body.

Early on they linked with Genentech, and then forged partnerships with other pharma companies, including Wyeth Pharmaceuticals, which has no share in the company but collaborates on early-stage research, says Heffernan.

The company has gone from strength to strength, and next year it plans to start clinical trials of compounds that could ultimately have applications in medically challenging conditions like arthritis, Crohn's disease and post-transplantation. The links with big players have been an advantage, says Heffernan.

"As a small company it's fantastic to have the validation of a big company over your therapeutic approach, but obviously it's also good for a small company like us to know how big pharma do it, what their expectations are, and it does move your own internal processes up a notch. We have learned a lot from working with them," he says.

"From a general perspective, it has always been viewed as a negative or taboo subject that academics shouldn't get involved in industry. Speaking from an industry perspective and someone who was in academia myself, I would encourage it because it does open up your perspective on things and it may have a benefit at the end of the day because what we are all are trying to do is help patients. You shouldn't lose sight of that. Small companies like us can't do everything, big companies like Wyeth can't do everything, which is why we must work symbiotically together to develop things."

But how can one symbiotic partner protect themselves from the other engaging in an unseemly practice? Large pharma companies are not always angels when it comes to selling their products, as recent events testify.

Earlier this year it emerged that Wyeth had paid a communications firm to "ghostwrite" 26 journal papers, many of them reviews between 1998 and 2005.

The articles were subject to the usual peer review process once submitted to journals, but papers made public through a US District court order indicated that article contents had been drafted substantially by the contracted ghostwriters before named physicians had an input.

A spokesman for Wyeth was reported by the New York Times as saying that the articles in question were scientifically accurate and that pharmaceutical companies routinely hired medical writing companies to assist authors in drafting manuscripts.

But the concern remains that doctors could change prescribing habits based on a paper where they were unaware of the level of a drug company's involvement. According to Wyeth, in 2006 they adopted a new policy to involve doctor-authors more in the process.

In the US, Pfizer was hit with an unprecedented $2.3 billion (€1.6 billion) fine last month for illegally marketing the off-label use of Bextra and other drugs. Bextra was taken off the US market in 2005 over concerns of increased risk of cardiovascular events like heart attack and stroke.

The ins and outs of convincing doctors to prescribe lucrative therapies to patients might seem far removed from a university lab bench, but as products and processes grow from academia towards the marketplace, how can we best safeguard the science from marketing spin or other potentially damaging practices?

Part of the solution lies in making researchers more aware and confident about issues of research integrity - the proper generation and handling of scientific data, according to Dr Maura Hiney, head of research policy, evaluation and external relations unit at the Health Research Board.

As academics and clinicians here come increasingly under the umbrella of industry collaboration, there's a growing need to have uniform codes of good practice so they keep their house in order, she says.

"There's a lot of pressure on to have commercial co-funding and that's going to be a challenge I think. The best we can do is keep the pressure on the commercial people and try and ensure that our academic population is getting educated about research integrity, so if there was a situation, they can't say they didn't know that it was misconduct," says Hiney, who says the new structured PhD programme offers a perfect opportunity to educate young researchers about good practice.

"It's about creating a culture of integrity in the long term."