January 1, 1970 (Vol. , No. )

Susan Aldridge, Ph.D.

‘George Bush gave us eight years breathing space. But without more government support, the UK’s regenerative medicine base will collapse and the industry will be lost to the US within three years.’ That was the stark message given out by Richard Archer at bioProcessUK’s annual meeting in York recently.

Archer leads the BioIndustry Association’s RegenMed Industry Group which was set up last year to head off this potential disaster. ‘The driver for RegenMed is the need for cures – not therapy – as the population ages,’ he said. There is a sense that both conventional pharma and innovative biotech are failing the public – treatments either don’t work, or they’re too expensive for the NHS. It’s time for something different.

The UK has a leading position in basic research – with a huge amount of activity in diabetes, dry AMD (with, notably, patients having their sight restored thanks to work at UCL), coronary failure of all kinds, and stroke. What’s needed now is an infrastructure to push the work forward and, said Archer, this need is not well understood elsewhere, so the UK could still have the edge. ‘We have the chance to build a long term high value industry base here,’ he stated.

But for that to happen, there are several hurdles to be overcome. The RegenMed market needs to be defined with clinicians, regulators and reimbursers. Several rounds of financing are needed (where from? VCs are nervous of RegenMed – there’s no exit model and they don’t understand the science). The market price of products – be they cell-based therapies, advanced materials, or small molecule growth factors – needs to be established and set against the potential cost of manufacture. There’s also a need to commission novel facilities, processes, equipment and technologies. Typically, a RegenMed product will have the ‘shelf life of a lettuce’, while a sterility test takes two weeks, Archer said. Added to this, RegenMed companies have to deal with multiple regulatory bodies.

Most RegenMed companies in the UK, besides having to take on these tough issues, have less than 12 months cash. There are positive signs though. MHRA is considering making one regulatory body for RegenMed and the new Office for Life Sciences has made it a priority on a par with low carbon technology. OLS is also pressing the NHS to become an ‘innovation champion’ (failure to get the NHS to take up biotech products being a long-running frustration for the UK sector). Meanwhile, the Technology Strategy Board has just announced the award of two grants to ReNeuron to progress its stem cell therapy for stroke patients into Phase 1, with more cash on the table next year.

The UK has a long and sorry history of its science being exploited elsewhere but, if the bioProcessUK people have anything to do with it, we’ll be keeping RegenMed at home.

Susan Aldridge, London. European News Reporter, GEN.

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