Susan Aldridge

Once famous for coal and steel, Wales now aims to make its mark in the life sciences sector. The recent BioWales 2008 (UK) conference demonstrated how much the region has progressed, thanks to the support of the Welsh Assembly government, the EU and the enthusiasm of the Welsh biotech community. The country's bioscience sector, which comprises approximately 200 companies, grew by 18% last year and is now worth £1.3 billion (€1.6 billion) in annual turnover, employing 15–20000 people.

Addressing more than 400 delegates at the conference, Dr John Patterson, Executive Director for the development of AstraZeneca's new medicines, spoke of the patents that are expected to expire on many of the world's best-selling drugs by 2011, the increasing frequency of patent challenges and the limits of data exclusivity. "Generic erosion is steeper and faster each year," he said. Added to this, the public is increasingly critical of the pharmaceutical industry, while having ever higher expectations. People seem to have bought into an instant gratification mentality; as soon as a gene is discovered, a cancer cure is expected to swiftly follow.

"So why do we bother?" Patterson asked. The answer is that there are so many unmet medical needs — some of them clearly related to aspects of modern life, such as stress, pollution and obesity. Then there is the problem of antibiotic resistance and the demands of an ageing population. Pharma must try to grab these opportunities, but how can the industry boost its flagging success rate?

Patterson noted that academia and small companies are very good at discovering new therapeutic molecules, but they are unable to turn them into medicines. Biotech companies are flexible and innovative but, unlike big pharma, they cannot fund failure or scale-up. Pharma has the global reach, the manufacturing standards, the track record and the ability to withstand failure, but it is just too big?

"You are now seeing the whole of the pharmaceutical industry undergoing a revolution," Patterson said. In the future, he believes the winners will be the companies who access both big and small molecules — a blend of biotech and traditional pharma, although where the balance between the two will lie is debatable. The winners will be those who use translational medicine, meaning closer collaboration between the research and clinical sides, and those who leverage emerging markets.

Many of these lessons are being put into practice in one of Wales's leading biopharmaceutical companies, Ipsen BioPharma, which is headquartered in France, but has a manufacturing facility in Wrexham that opened in 2000. Ipsen has five products in oncology, endocrinology and neuromuscular disorders, including Dysport, which competes with Botox, and Decapeptyl, a GnRH analogue. The Wrexham facility is dedicated to the manufacture of these therapeutic proteins and others that are moving through Ipsen's pipeline.

According to Mike Harvey, VP of Manufacturing Supply Operations for Ipsen, design is the key to pharma success. "We so often hear of a discovery being stillborn because of a factor like dosage or distribution," he says. "Design must be thought through right at the beginning if you are to be successful in this industry." Although neither easy nor cheap, earlier commitment and decision making are needed to assure product quality in its broadest sense. "Product form and presentation must be thought of early, and early analytical development is vital for biologics," he adds. "Quality by design is here to stay and it is important for proteins too. It must be used."

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Design is what keeps a company competitive as 85% of the cost of goods is set by how a product or process is designed. Harvey believes that the key to Ipsen's manufacturing success in Wales is "a constant drive, a burning desire to improve, with focused teams in manufacturing with a mixture of skills, including those with commercial awareness." This is particularly important when products are manufactured far from the site where they were developed; for example, by a contract manufacturer.