SIPPING an espresso in the lobby of the Edinburgh International Conference Centre, Aisling Burnand does not look like a bruiser. But the chief executive of the BioIndustry Association has been fighting on at least three fronts over the past year and is not ready to give up.
Her challenges include a drop in funding for early-stage biotechnology companies, a public backlash against drug testing following the so-called "elephant man" trials in London, and an ongoing battle with animal rights protesters.
Burnand was in Scotland last week for her organisation's annual Thistle Bioscience Forum. According to Scottish Enterprise, 27,000 work in the wider life sciences industry in Scotland, making it comparable in size to the electronics industry. So trends in the industry are studied particularly closely north of the Border.
And right now, those trends look a little worrying. Burnand and a few hundred other biotech industry leaders have just heard that total investment in European healthcare companies fell by 13% to 980m in 2006, and the number of deals plunged by 31% to 239. The figures, from Ernst & Young, the accountancy firm, suggest that a smaller number of companies are landing slightly bigger funding deals.
Burnand shivers slightly and pulls her black jacket around her as a cold draught, literally and metaphorically, blows through Edinburgh. "There is a funding issue in Europe," she says. "While there are some things that mean the UK is a better place to invest than our competitors it is not great right now."
Even the news that Abingworth, a venture capital firm, has just raised 300m to invest in life sciences does not mean a guaranteed boost in the UK: "Over the past decade, venture capitalists have become global, so if somebody raises 300m here, you would expect a significant percentage of that to be invested in the US."
According to Burnand, US biotech companies have a significant advantage because the Washington-based National Institutes for Health there spends 2.5bn a year supporting clinical research into drugs. "That effectively de-risks that early-stage for drugs firms and makes companies in the US much more investable."
Despite her reservations, Burnand sees Scotland as a model for the rest of the UK, with Scottish Enterprise's Proof of Concept and Co-Investment fund taking some of the risk out for early-stage businesses developing drugs. "SE recognised that there is a funding problem at the early stages," she says. "These are really good initiatives. They may now need to be capitalised at higher levels because it takes 10 to 12 years to get a drug to market."
Burnand has the assured tones of an experienced public relations professional and frequently moves her hands, describing imaginary shapes in the air to emphasise points.
She has been running the BIA, which represents 300 companies and a 2.5bn revenue industry, for five years, following a stint as the organisation's public affairs director. Before she joined in 1998, she worked for Rhone-Poulenc, the French pharmaceuticals giant, and for the Rowland Company, a division of the Saatchi & Saatchi empire.
A self-confessed crisis management specialist, she faced one of the biggest challenges of her career last March when six drug trial volunteers at Northwick Park hospital in London suffered severe adverse reactions, including severe swelling, after being given a drug developed by a biotech company in Germany.
"I heard a small clip on the radio before I went to bed, and thought 'this is going to get bigger'. By the time I was in the shower in the morning, it was clear that this was an unprecedented incident."
Part of her job was to assure the public that 17 other similar products which were already on the market were safe. "It was obviously devastating for the people involved and it was important that we should not stick our heads in the sand and shut up shop."
But explaining what had happened was tricky when nobody really knew. She spent most of the week putting journalists in touch with experts who could explain how monoclonal drugs worked. But the questions persisted - how could this have happened, and how could it be prevented from happening in the future?
A report published by scientists from Imperial College last month showed that the drug had a provoked a reaction in human cells which would not have been picked up by earlier tests on animals.
The BIA recommends that patients should be given the drug one by one, starting with the smallest possible dose and then increasing it.
Improved testing could lead to more work for Scottish companies such as CXR Biosciences and Biopta which have developed drug screening technology which can test for human tissue reactions without using human testers. "Clearly the use of animals [in cases like this] may not be the best way to test for safety," says Burnand.
The disastrous trials marked a watershed in drug testing. Anecdotal evidence suggests that some testing companies have had trouble attracting volunteers since last March, although Burnand believes there was a somewhat surprising increase in willing patients after the trials.
While events at Northwick Park may demonstrate the need for an extra layer of drug testing, nobody has yet come up with an alternative to animal experiments for early-stage drug testing. Here, Burnand is fighting on another front as she argues for tough laws to tackle violent animal rights protesters. At Wednesday's Thistle Biotechnology conference, she spent some time talking to a representative of Lothian & Borders Police about the issue.
Despite the occasional unpleasant incident, anti-vivisection campaigners have never been as violent in Scotland as around the Cambridge and Oxford areas, the UK's other biotech hotspots. And there are signs that extremist activity may be dying down. Figures for the first half of 2006 showed 15 violent attacks on the homes of people connected with vivisection compared to 110 in the same period in 2004, before the Serious Organised Crime and Police Act which outlawed many extremist practices came into force.
Burnand joined the BIA as its sixth employee when the industry was in its infancy in the UK. During that time, hope has grown that at least some of tomorrow's blockbuster drugs will come from outside the big pharmaceutical groups like GlaxoSmithkline which have dominated the industry in the past. Now, Burnand has 25 lobbyists and industry experts working for her in London and a satellite office near Edinburgh.
But there is still a start-up atmosphere at the London-based organisation, which is chaired by Simon Best, founder of Scottish biotech hopeful Ardana Bioscience. "The BIA understands the ups and downs of its members because we are like a small company. Working with Simon is good because he is a scientist and an entrepreneur and he can talk about the issues from that point of view."
Burnand and Best were both guests at last week's Scottish Enterprise life sciences dinner at the EICC, which attracted 700 entrepreneurs and academics to listen to the likes of Enterprise Minister Nicol Stephen sing the industry's praises.
In spite of the feelgood factor, some business figures question in private whether a loss-making and very risky industry like this is a suitable recipient for public cash.
Burnand, who has two young sons, believes long-term health requirements make investing in biotech essential: "Healthcare is a growing business, and we have a real advantage here in areas such as stem cell research and gene therapy, and it makes sense for us to capitalise on the intellectual property we have developed.
"The alternative is that these medicines will be developed in America and we will end up having to pay to use them. It is a risky business, but the rewards will be great in the long term."
Right now, the sheer quantity of cash pouring into life sciences elsewhere has Burnand worried. South Korea has just pledged to invest 8bn over 10 years to build up its biotechnology industry, and the French government plans to pump billions of Euros into high-growth companies. Poland, the Czech Republic and India are breathing down our necks.
The UK is still the world's second-biggest developer of new drugs after the US, but Burnand sees worrying signs in a drop-off in the rate at which new biotechnology companies are formed. "There are a lot of merger and acquisition deals, which would not matter so much if we were seeing a renewal of the company base, but that is not happening now," she says.
The BIA is considering ideas which could make it more attractive to start biotech companies. One is to push for the Treasury's research and development tax credit scheme to be extended to drug trials. Another is to tap into the NHS's vast database of patient information and potentially willing drug test subjects.
"The UK has a real opportunity because the NHS's patient records make this a unique place in the world to study clinical trends," says Burnand. "We are not there yet, but that is the vision."