A critical friend for industry

In an exclusive interview Dr Monica Darnbrough talks about the state of the biotechnology industry and the influence she hopes the Bioscience Innovation and Growth Team's report will have on improving our health.

The UK boasts an excellent science base, with favourable economic and political conditions, and a clear and fair regulatory regime.

So the Department of Trade and Industry's (DTI) Biotechnology website tells me, but as I enter the DTI buildings near Victoria station in London, I wonder how much of this true, and how much is 'PR speak'. There are many biotech companies who say economic conditions are far from 'favourable'.

The UK currently has more than 480 specialist biotechnology companies, employing nearly 26,000 people. UK companies account for 43% of the products in clinical trials by European public companies, and 43% of new biotechnology drugs in late stage clinical trials in Europe are from the UK. In 2002, UK companies raised e670m in equity funding - a third of the EU total.

dynamic culture

'The UK is in a unique position in what it is doing in bioscience for three reasons: the high quality basic research, the dynamic culture, which encourages small enterprises, and the presence of large pharmaceutical and biotech companies,' says Dr Monica Darnbrough, director of the DTI's Bioscience Unit.

'If we are going to continue to turn our science into business and economic opportunities we need to make sure the regulatory environment is right to encourage companies to remain and grow in the UK (particularly doing r&d here). My unit can help by influencing people in other parts of government in terms of the tax regime, and the training of skilled people.'

Both the small and large companies require the skilled base, and this is a determining factor in where a company locates, Dr Darnbrough added.

With Acambis' decision to move its primary facility to the US, I wondered how the UK could continue to attract investment in the industry when other countries such as Ireland and Puerto Rico have attracted biotech companies, very successfully by offering incentives such as reduced taxation.

According to Dr Darnbrough, the UK government decided not to put in place such incentives, even though they have been successful. 'We have decided to concentrate on building up the manpower, keeping the science strong, and setting the regulatory environment to be appropriate. And, to be fair, this has paid dividends.

'For instance, we have a competitive edge over several other countries because of the firm regulations on the use of human embryonic stem cells. While it is a firm regulatory environment, it is one in which this country is allowing this research to go ahead,' she pointed out.

'The government decided that licensing this research was the right way forward. While some countries are still debating the ethics, especially in the US, the UK has clear policies on this research. This highlights the government's commitment to biosciences where the science is important to the sector, and where it's got the regulatory environment in place earlier than some.'

teenage angst

One area of concern to both the bioscience industry and the pharmaceutical industry has been the withdrawal by the University of Cambridge of its application for a primate research facility. Ostensibly on the grounds of security costs and problems with ensuring staff safety from animal extremists, the government still believes such research is valid. 'Lord Sainsbury, the minister for science, has taken a consistently strong line, and is determined that the actions of a few animal extremists are not going to put a stop to this sector of research in the UK.'

A couple of years ago Manufacturing Chemist reported the BioIndustry Association as describing the industry as 'a strapping youth, looking forward to the future with confidence'. Dr Darnbrough admits that there is still some teenage angst in the industry, and it would be nice to see more companies grow into profitability from UK start-ups. But she says that this year there is a new mood of optimism: 'One or two companies have raised quite sizeable amounts of money this year, which is obviously a good sign.

number of initiatives

'There are companies that are showing maturity, and becoming profitable, with Celltech being the shining example of a company having its origins in UK research, being helped by the government, but which for many years now has been developing as an independent company. I think ministers would like to see more companies developing like that, grown in the UK, bringing their products to market and becoming profitable.'

The question of whether professors - or indeed their students - in universities do enough to translate their excellent blue-sky research into start-up companies and IPOs is something both the industry and government needs to think about, but there are and have been government projects to encourage this.

'I believe we should recognise that people are different and are good at different things, so while some are keen on turning their ideas into a business, others are not. However, there are more young people thinking about exploring the business opportunities. Government programmes such as the Science Enterprise Challenge, which is one of a number of initiatives to help people in the universities think about becoming entrepreneurs, have helped.

'We are beginning to see a generation of people coming through who are much more prepared and enthusiastic to think about their work in that way. But one thing the Bioscience Innovation and Growth Team report did highlight was the need for management skills,' Dr Darnbrough admitted.

challenging aims

One scheme that successfully encouraged the capturing, protecting and exploiting of early bioscience research outputs was the Biotechnology Exploitation Platform (BEP) Challenge.

Supported by grants of up to £400k, awarded on a competitive basis, the challenge encourages universities and other publicly funded research institutions and intermediaries with complementary bioscience research to work together through the formation of consortia (the BEPS) to better manage and exploit the results of research.

The challenge also aims to help improve the strategic management of intellectual property (IP), to stem technology leakage from the UK, and to enable the BEPs to hire the necessary skills to manage the IP and match its potential to the market place.

Launched in 1996, there are currently 22 BEP consortia at different stages of development across the UK, involving 107 organisations (including 56 universities and 25 NHS Trusts). The results are certainly encouraging:

some 1,300 technologies have been identified with potential for commercial exploitation, with more than 550 selected for commercialisation;

since the project began 277 patents have been applied for, of which 30 have been granted;

132 commercial licences have been signed, with an estimated life value of £23m;

85 new biotechnology start-up companies have been established, securing private investment of £30.5m, and creating 250 jobs

Dr Darnbrough said one of the long term benefits of this is that the technology transfer people involved have become very specialised in biotechnology transfer, and are able to help future start-up companies, even though the scheme itself has come to an end.

group recommendations

The publication in November 2003 of the Bioscience Innovation and Growth Team's (BIGT) strategy provided both government and industry with a blueprint for a successful UK bioscience sector. It was created under the chairmanship of Sir David Cooksey to secure the UK's position as a global leader in bioscience, and brought together the private sector, in the form of the BioIndustry Association and more than 70 individual contributors with officials from the Department of Trade and Industry and the Department of Health. It identified the dual goals of improved national health and increased national wealth, which could simultaneously be achieved by uptake in the NHS of cost-effective innovative medicines.

If the UK were to become the best place in the world for doing clinical trials, patients would benefit as would the NHS and companies. It would help to keep r&d based industry in the UK.

The team's vision for 2015, table 1, is set out in the recommendations to build a mutually advantageous collaboration between the NHS and industry for patient benefit, and is being taken forward by Sir John Pattison, the director of r&d at the department of health, who is leading a group that will develop practical proposals for improving patient benefits from clinical trials and translational research within the NHS.

'The hope is that we can get more innovative products to the patient more quickly, Dr Darnbrough said. 'The IGT sees this as a three-way win. Primarily the patients get a better quality of care, with access to new and emerging drugs; secondly there could be a benefit to the NHS, not only in terms of innovative products, but in cost savings - with some diseases novel treatments might prove to be more cost effective than current regimens.

'And finally many drug companies in the recent past have done their clinical trials overseas following up initial research in the UK, so the group hopes to enable companies to do more of their clinical trials in the UK.' The recommendations are expected in the second quarter of 2004.

The Bioscience Leadership Council has developed from BIGT and is industry driven with the aim of monitoring progress on the delivery of the report's recommendations. It is chaired by Sir Richard Sykes, rector of science, technology and medicine at Imperial College.

thriving sector

One of his first decisions was to set up a working group to take forward the recommendations in BIGT to build a strong bioprocessing subsector. The group will include industrialists and will work closely with the BIA, with the idea of developing the interface between the real needs of companies and the kinds of research that is going on in universities by building networks on centres of excellence.

As David Cooksey, chairman of BIGT said: 'The acid test is not whether each and every recommendation has been implemented in full, but rather whether the bioscience industry thrives in the UK. If the sector grows in line with the best of its overseas rivals, shows increased profitability, and an increasing pipeline of new therapies, I will count [BIGT] a success.'