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European Biopharmaceutical Review

World Class Potential in Partnerships

Celia Caulcott at the Biotechnology and Biological Sciences Research Council (BBSRC) looks at projects to encourage innovation on the European biopharmaceutical scene

There is world-leading bioscience research taking place in Europe and to maximise the benefits of this, it is absolutely essential that the generation of knowledge in this field does not operate in closed silos of either public or private endeavour; we need provision for collaboration and partnership across both sectors. For academic researchers, who are increasingly called upon to consider the wider implications of their research, partnerships with industry can ensure that the social and economic effects of excellent science are realised with the support of experts in technical and clinical development, intellectual property, marketing and finance. In the biopharmaceutical sector, it would be incredibly inefficient for industry to ignore the wealth of knowledge being generated by publicly-funded science. To do so would seriously limit the potential of new biopharmaceuticals to support the improvement of human health. With this in mind, several models for public-private partnerships (PPP) in research have been developed by various organisations.

The EU has a tremendous base of world-class research knowledge and expertise, and yet industry investment has grown far more slowly than in North America – PPPs have the potential to change this situation. There are now opportunities for public and private organisations to collaborate and share resources, create common methods and generate open-source data banks. This has proven to be an invaluable route to tackling some of the biggest challenges in realising the social and economic impact of research. In particular, PPPs can be very effective for addressing bottlenecks in the pipeline of discovery to product, such as the funding of research at the non-competitive stage, proof of concept and feasibility studies, and scaling up of production. The outcomes of these collaborations make biopharmaceutical research across both academic and industrial sectors more attractive to outside investment. This ensures the full potential of research is realised in drugs, treatments, tools and technologies that will have an impact on society and the European economy.

BIOSCIENCE, INNOVATION AND GROWTH IN BIOPHARMACEUTICALS

In 2003, Sir David Cooksey chaired a report to the UK Government from the Bioscience Innovation and Growth Team (BIGT). This report highlighted, among other things, issues around the slow development of biological products – large and complex molecules used as medicines and therapies – and the difficulties in processing them on a large enough scale. The report recommended increased investment in bioprocessing research and, in response, a working group was set up to identify key issues and challenges for future research in this area. To address bioprocessing research challenges the Bioprocessing Research Industry Club (BRIC) was formed and is led by Biotechnology and Biological Sciences Research Council (BBSRC). BRIC funds academic scientists to research bioprocessing, providing a mechanism for dissemination of academic research outputs and networking with BRIC members from industry. Ninety per cent of funding comes from research councils and 10 per cent from industrial partners.

To date, BRIC has awarded around £14 million to 25 research projects that have pushed forward knowledge in bioprocessing. Over 40 per cent of the research leaders report new products, processes or tools and technologies arising from their projects, which is impressive given the timescales. There has been a significant increase in the efficiency of producing large molecules for biopharmaceuticals as a result of partnerships within BRIC, which will make potentially effective drugs available to patients where high costs and inefficient production processes have so far prevented application in the clinic. A second phase of BRIC has just been announced, which, in addition to funding research projects, will aim to increase the numbers of trained bioprocessing professionals at all levels.

Another scheme arising from recommendations by BIGT in 2003 was the Engineering and Physical Sciences Research Council (EPSRC)-led innovation and knowledge centres. There are now four of these centres of excellence, which accelerate and promote business exploitation of an emerging research and technology field. They are effective in bringing together researchers, potential customers and skilled people from academia and business in order to develop applications, business models and routes to market. Funding is provided by the EPSRC, the Technology Strategy Board (TSB), a university host, and in some cases the BBSRC. To qualify for funding under this scheme there has to be support – either financial or in kind – from business partners, and an indication of support from sponsors such as the regional development agencies or devolved administrations.

The four innovation and knowledge centres are based at the University of Cambridge (Advanced Manufacturing Technologies for Photonics and Electronics – Exploiting Molecular and Macromolecular Materials), Cranfield University (Ultra Precision and Structured Surfaces), Queens University Belfast (Centre of Secure Information Technologies) and University of Leeds (Regenerative Therapies and Devices). The innovation and knowledge centre in Leeds looks at the creation of new technologies in regenerative therapies and devices and addresses issues around the adoption of these cutting edge products within a complex marketplace and with significant cost constraints.

PROOF OF CONCEPT, FEASIBILITY STUDIES AND SEEDING DRUG DISCOVERY

UK research councils primarily focus on fundamental research, but to gain economic impact, researchers have to progress beyond this stage and begin to engage with potential commercial opportunities. The research councils have created the Follow-On-Fund to support research council-funded researchers with grants to take their research on to proof of concept stage, where industrial partnerships may be secured or seed funding or venture capital investment can reasonably be sought to establish a spin-out company or licensing opportunity. Sometimes this will happen via engagement with TSB, which also provides funding for feasibility studies that are industryled with academics often participating as collaborative partners.

In September 2009, a TSB funding competition entitled “Regenerative Medicine Programme: Therapeutics Feasibility Studies” was launched. This was set up and is run by TSB, with funding often delivered in conjunction with other providers – particularly the research councils. TSB’s initial investment was £18 million with the Medical Research Council (MRC), EPSRC and BBSRC together providing a further £3.5 million to the programme, of which £3 million was earmarked within the programme for feasibility studies.

The Wellcome Trust – the largest biomedical research charity in the UK – has a programme for supporting researchers who have discovered a potential drug target. This enables researchers to carry out compound discovery and lead optimisation. The aim is to facilitate the development of drug-like small molecules that may act as a springboard for further research and commercial development in areas of unmet medical need. By developing academic research to the point of identification and protection of intellectual property around a novel disease mechanism and an optimised lead compound, it becomes feasible for pharmaceutical companies and venture capitalists to take up opportunities with publicly funded researchers.

EUROPE AS WORLD LEADER

Pharmaceuticals are hugely important socially and economically, but there are still a significant number of bottlenecks in the drug discovery and development process that will benefit from the collaboration between publicly funded and industry researchers. The EU has the potential to become the world leader in pharmaceutical research, and to achieve this the European Commission and the European Federation of Pharmaceutical Industries (EFPIA) have set up the Innovative Medicines Initiative (IMI) with an initial budget of €2 billion to fund public organisations and support smalland medium-sized enterprises. The European Commission brings partners together – these may sometimes be competing companies – to create tools and knowledge that will increase the likelihood of success for new medicines. The hope is that these improvements will make Europe more attractive as an investment opportunity for pharmaceutical companies.

Funding from IMI is for public sector and small and medium enterprise (SME)-based research. The large pharmaceutical companies involved in IMI get intellectual property rights automatically, which are usually shared with partners through negotiation within any collaboration agreements. Large companies are, however, expected to fund their own involvement and also contribute in kind costs such as people, space, equipment, materials and clinical research in return for the benefits of research results and strengthened R&D in the EU. Working together, the partners benefit from their different focus, expertise and capabilities, leading to the development of new and innovative solutions in medicines discovery.

A second call for project proposals under IMI was announced in 2009, to fund research that is expected to improve predictions about safety and efficacy of candidate drugs; develop systems to share data and knowledge; and invest in skills in the pharmaceutical sector workforce in Europe. In particular, effective drugs for cancer, infectious diseases and inflammation are considered urgent and important outcomes.

Another important EU-based scheme, under the European Commission Seventh Framework Programme (FP7), is the European Research Area Networks (ERA-NET). ERA-NETs bring together national and regional research efforts within the EU by coordinating funding organisations. The aim is to facilitate knowledge exchange and avoid duplication of effort. Several ongoing ERA-NET projects involve industry bodies or companies, for example PRIOMEDCHILD (Priority Medicines for Children) and ERA-AGE (Ageing).

A PPP SUCCESS STORY – LINK: APPLIED GENOMICS

The ‘LINK: Applied Genomics’ programme has now closed, but provides an excellent example of how PPPs can generate impressive outcomes. In terms of funds, this was an equal partnership between the public and private sectors, with half of the funding provided by BBSRC, MRC and the UK Department of Trade and Industry (since reformed as the Department for Business, Innovation and Skills, with this form of funding being supported by the TSB) and the other half from participating companies. The programme structure enabled research that was too technically risky for companies but more applied than many academic projects.

One of the participating companies was Prolysis Ltd, which in partnership with the University of Oxford, worked on tackling MRSA. Together they were able to develop new tools to find antibiotic candidates with over 5,000-fold increased potency. They also found 24 antibiotic targets in the bacteria and identified a number of compounds that kill MRSA and other bacterial pathogens. Following the programme, Prolysis Ltd received a £4.5 million investment from US venture capital and the further development of tools and technology from the programme enabled a total of £10 million investment. In November 2009, Prolysis Ltd was acquired by Biota Holdings Ltd, securing the antibiotic programmes through clinical trials.

Another company that was part of the LINK project was KuDOS Pharmaceutical Ltd. In partnership with the Wellcome Trust/Cancer Research UK Gurdon Institute and the MRC Clinical Sciences Centre at Imperial College London, they were successful in discovering a technique to characterise cancer cells according to which DNA damage response pathways are operating in the cells. This aids the development and prescription of treatments that are much more specific to a particular cancer cell type. In 2006, KuDOS was acquired for over £120 million and is now a wholly owned subsidiary of AstraZeneca.

More recently, Novacta – another company involved with the LINK: Applied Genomics programme – received a £13.1 million investment from Celtic Pharma Holdings to develop new antibiotics. Under the LINK-funded project, Novacta partnered with two BBSRC funded institutes: The John Innes Centre and the Institute of Food Research. They looked at new opportunities to synthesise novel antibiotics from bacteria. The progress made under LINK meant that their antibiotic discovery platform was an attractive prospect for larger companies to invest in.

APPLYING THE PRINCIPLES OF PPP TO COLLABORATIVE ACTIVITIES BETWEEN PRIVATE ORGANISATIONS

It is becoming increasingly difficult for individual pharmaceutical companies to meet the challenge of drug discovery at the precompetitive stage solely through the expertise that exists within their own organisation. So, in a cost driven environment, it is a natural course of action for companies to work collaboratively for mutual benefit. The 30 members of the Pistoia Alliance have recognised that there are opportunities to streamline the noncompetitive aspects of drug discovery, such as chemistry or biological screening and sample logistics, through collaboration. They have set up a forum for discussions that will lead to collaboratively managed projects and, ultimately, shared data, and the hope is that establishing common methodology and open-source technologies would benefit the industry by reducing duplication of effort. The members range from SMEs to major international pharmaceutical companies and the Pistoia Alliance is a not-for-profit incorporation.

FUTURE DIRECTIONS – PPPS ARE HERE TO STAY

In recent years, the costs of discovering and developing new pharmaceuticals and biopharmaceuticals have increased dramatically, and the numbers of new medicines discovered and developed has decreased. Alongside this there has been a substantial increase in the public sector investment in research coupled with an increasing interest in ensuring that such research makes the maximum impact for the widest public good, including through commercialisation.

It has also been recognised that some of the most exciting and innovative research takes place at the boundaries between subjects that do not traditionally work together: for example, advances in imaging at the cellular and whole body level reflect collaboration between physicists and bioscientists. New ways of thinking and working in bioscience have also greatly increased our understanding of how molecules work and affect the course of a disease.

Across the pharmaceutical sector, and not least in biopharmaceuticals, there is a need for a greater understanding of modes of action and patient responses to new drugs. This is particularly true as the possibilities grow for stratified and personalised medicines. These urgent drivers make the academic research base an increasingly attractive and logical partner for the pharmaceutical industry in the process of discovering new medicines and treatments.

Many factors combine to give the PPP model of funding considerable longevity. The cost of drug discovery continues to rise and so it becomes ever more important to use the limited private sector funds in the most efficient way. At the same time, public money is being used to increase the quality and quantity of research carried out in universities and research institutes – research that can make a great contribution to the drug discovery process. PPPs open up the possibilities for collaborative work and remove bottlenecks in drug discovery and development, helping to squeeze every ounce of value out of any bioscience research – private or public. This is clearly of mutual benefit to industry and academia: private companies get to use the very best research to develop profit-making products and academic researchers are facilitated to realise the social and economic impact of their work.


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Dr Celia Caulcott is BBSRC Director for Innovation and Skills. Initially trained in microbiology, following her PhD she joined Celltech Ltd, where she worked on, and subsequently led research on therapeutic recombinant monoclonal antibodies. After further career progression with ICI Pharmaceuticals and the WellcomeFoundation/GSK, Celia later became an independent biopharmaceutical consultant, working on projects for what was then the DTI and other government departments and agencies, including the Food Standards Agency and the Department of Health, as well as for BBSRC and the Medical Research Council. She also worked for the Wellcome Trust, in particular with the Sanger Institute on the Pathogen Genome Sequencing Programme and the Human Genome Project. She most recently worked as a Senior Research Manager for Imperial College London.
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