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Report from Europe
"There is a bottleneck [in biopharmaceuticals, for example] when it comes to processing large and complex molecules on a scale to meet the potential demand," explains Celia Caulcott, director of innovation and skills at the United Kingdom Biotechnology and Biological Sciences Research Council (BBSRC). "This is an area where there is clear value in bringing together public and private organizations to rapidly improve products, technologies, and processes."
If collaboration is to work effectively, however, a balance needs to be found between what are often the conflicting interests of universities and research institutes and pharmaceutical companies over issues such as funding and intellectual property (IP) rights. There is also concern among some sections of the research community and in industry that the growing number of projects across the EU will overlap with an already existing plethora of national (i.e., within some EU countries) partnership schemes.
To date, most of the new initiatives seeking to take advantage of public–private partnerships benefits (e.g., from the pooling of knowledge through collaboration) are already being driven by individual European countries. In the UK, for example, the Bioprocessing Research Industry Club (BRIC), a public–private partnership, has organized 25 biopharmaceutical research projects, 40% of which are already reporting success on the development of new processes, technologies, and products.
In Ireland, whose pharmaceutical sector accounts for more than 50% of its exports, the government is leading a drive to bring government agencies, industry, and academia together to form new R&D partnerships. The goal is to make the country a global center for advanced production techniques by linking research directly to manufacturing.
"Partnerships are the way forward for process improvements and development," says Matt Moran, director of Pharmachemical Ireland, an association representing pharmaceutical and chemical manufacturers. "Our members can not only learn a lot from each other and academia but also from other industries. We have to reduce costs and increase efficiency in order to compete against Indian and Chinese producers. There is no alternative to development collaborations as a means of doing this," he says.
Ireland's Limerick University is heading a research project on solid-state particles in medicines that involves the country's leading universities and global pharmaceutical companies such as GlaxoSmithKline (London), Roche (Basel), Pfizer (New York), and Eli Lilly (Indianapolis). The scheme brings together chemists and other experts in pharmaceutical technology and chemical and mechanical engineering to tackle the problem of the lack of reproducibility of solid-state dosage forms because of inadequate crystallization, phase transformations, and other phenomena.
At the EU regional level, one of the most prominent collaborations in process development is a €30 million ($38 million) unit at the Bayer group's site at Leverkusen, Germany, which aims to create a modular continuous production plant. Among its 25 partners, in addition to Bayer, is AstraZeneca (London). Another partnership underway at London's Imperial College is coordinating an EU project involving nine partners from seven countries to develop a new generation of molecular purification technologies for the manufacture of active pharmaceutical ingredients.
However, the largest EU public-private partnership in pharmaceuticals–the €2 billion Innovative Medicines Initiative (IMI)—has already run into trouble because of disagreements over funding and IP rights among its academic and industrial participants. IMI, which launched its first projects two years ago, has been focusing on small-molecule R&D, but recently its scientific committee called for more attention be paid to biological-production processes. The university and research institute members of IMI complain that academia is being asked to pay too high a proportion of the project's direct costs, and that its industrial partners are being given too generous IP rights.
"The IMI model in its present form cannot be used as model for future [public-private partnerships] in EU programs," says Linda Polik, head of European research services at Oxford University, one of the IMI academic partners.
Nonetheless, these types of partnerships and other forms of industrial-academic research partnerships are continuing to gain strong support within the European pharmaceutical industry, particularly as the current economic climate puts pressure on the R&D funds of both the public and private sectors.
No matter how things turn out, BBSRC's Caulcott says, "This presents us with some great opportunities to work together through joint funding and sharing of knowledge and resources."
Sean Milmo is a freelance writer based in Essex, UK.