BioWorld International Correspondent

LONDON - UK biotech leaders have put together a plan to raise £100 million (US$189.3 million) of public money for a Stem Cell Foundation that will plug the funding gap that has emerged between early stage research and clinical proof of concept.

The foundation, to be modeled on the research charity the Wellcome Trust, also will pull in private money to fund the development of between 10 and 20 stem cell therapies up to proof of concept.

Proponents of the Stem Cell Foundation estimate the cost of taking a typical stem cell therapy product through preclinical and early clinical trials is £7.5 million per product. Over three-quarters of the foundation's funds would be spent on those stages of research with the balance allocated to scale-up and manufacturing and regulation of clinical trials and commercial products.

Those supporting the establishment of the foundation include biotech entrepreneurs Chris Evans and Stephen Parker; Richard Sykes, former CEO of GlaxoSmithKline plc and now head of Imperial College London; Trevor Jones, who recently retired as director of the Association of the British Pharmaceutical Industry; and Simon Best, CEO of Ardana Biosciences.

Having made a significant investment in early stage research and provided a clear regulatory framework, the UK has the potential to lead the world in clinical applications of stem cells. However, a funding gap has emerged that might prevent UK science from being translated into the clinic. Venture capitalists, financial institutions and the pharmaceutical industry are refusing to invest until proof of principle has been demonstrated in patients, yet that proof of principle will not be obtained unless major funding is provided.

"Everyone seems to be waiting instead of doing, leaving biotech companies in the field to struggle against increasing odds," Evans and Parker said in a paper outlining the aims and objectives of the foundation.

With many countries investing significant sums of public money in stem cell research, the UK might see a new brain drain of scientists, technologies and companies, as they leave for places where funding is not an issue. Evans and Parker said several British stem cell companies are looking for funding in the U.S. after failing to attract UK investors, and they are aware of British discoveries at risk of instead being exploited in the U.S. due to the lack of funding for translating stem cell research from the laboratory to the clinic.

Parker has been proposed as interim CEO of the foundation, which will be run by a board of trustees, a scientific advisory board and a management team. Apart from fund raising, the foundation would award grants, initiate the development of clinical and manufacturing infrastructure, and develop an ethical and regulatory framework for clinical trials and authorization of stem cell therapies.

Foundation supporters now are approaching the UK government and other potential funders. The aim is to agree on funding in principle, paving the way for the first board of trustees meeting to be convened before the end of March.

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