Medical Device Daily Correspondent
and Staff Reports

Biotech leaders in the UK have put together a plan to raise £100 million of public money ($189.3 million) 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 as £7.5 million per product. More than 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 Par- ker; Richard Sykes, former CEO of GlaxoSmithKline 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. But 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 backers of the project say the UK might see a new brain drain of scientists, technologies and companies, leaving 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 fundraising, 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.

New authentication system for Boots Group

Boots Group (Nottingham, UK), one of the UK's largest pharmaceutical and health and beauty product companies, has selected an authentication system featuring fingerprint sensors from AuthenTec (Melbourne, Florida) to replace passwords, speeding user login and helping to identify operators at its Nottingham drug manufacturing plant.

Boots chose the V-Flex finger scan reader from Bioscrypt (Mississauga, Ontario), which features AuthenTec's FingerLoc sensor.

As with many other industries, pharmaceutical manufacturing is required to have an irrefutable audit trail detailing which individual performed which job at what time. “Using biometrics as an alternative to cards, bar codes or passwords has the benefit of very rapid log-on and user ID in our process plant, where the operator is frequently asked to authenticate identity on each step of a complex operation. Typing their password repetitively is very time-consuming,“ said Rob Mallett, healthcare engineering projects manager for Boots.

AuthenTec's sensors and Bioscrypt's finger scan technology have been combined with Wonderware process control software supplied and supported by Pantek Ltd. (Stockport, UK), the distributor of Wonderware in the UK and Ireland.

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