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First Spinouts Emerging from Translational Medicine Center

By Nuala Moran
Staff Writer

EDINBURGH, Scotland – A 10-year plan to create an integrated translational medicine hub in the heart of Edinburgh is beginning to bear fruit, with the first spinouts starting to emerge from the research base and take up residence in a new bioincubator, which opens next week.

Alongside the incubator, the Edinburgh BioQuarter is now home to 650 researchers in the University of Edinburgh Medical Research Institute; a 1,000-bed teaching hospital; the Scottish Center for Regenerative Medicine, which includes a good manufacturing practice facility for culturing stem cells; and the Roslin Institute, where the world's first cloned mammal, Dolly the sheep, originated.

Other facilities include a clinical imaging center in which half the capacity is used for patients and half for medical research, and a Regenerative Neurology Clinic funded with a £10 million (US$16 million) donation given by J K Rowling, author of the Harry Potter books, in memory of her mother Anne, who died of multiple sclerosis at the age of 45.

"Science works when people are together, and the BioQuarter has pulled many formerly disparate groups into one location and created a very powerful research and translational medicine capability," noted Mike Capaldi, CEO of the Edinburgh BioQuarter.

At present, there are provisional agreements to take up 70 percent of the lab space in the first phase of the bioincubator, dedicated to very small spinouts with four to eight scientists, which opens its doors April 7. A later phase will accommodate larger companies.

To date, the BioQuarter project has consumed $956 million, with the money coming from the National Health Service (NHS), Edinburgh University and the Scottish and UK governments.

Other buildings planned for the campus are a children's hospital and an institute for brain and body research with 550 scientists.

"This is not just a science park. It is all about translation. Co-location will mean clinicians are running research labs and treating patients; they will understand basic biology and apply it. Ultimately, this will be one of the key sites in Europe for translational medicine," Capaldi said.

The BioQuarter is building on a very rich heritage – medicine has been taught in Edinburgh since 1583. It also will draw – less auspiciously – on the fact that Scotland's population of 5.2 million suffers some of the highest rates of chronic lifestyle-related diseases in Western Europe – to the extent that they are referred to locally as "the Scottish diseases." The country also has the highest incidence of multiple sclerosis anywhere in the world.

In addition to the local insights into those diseases, the access to clinical populations "is something that is a real strength for us," Capaldi said.

At the same time as aiming to deliver benefits to patients and helping to address those significant health needs, the BioQuarter has clear commercial objectives. Capaldi noted that although Edinburgh University has a good record for generating spinout companies, between 2005 and 2009 only one of these – ImmunoSolv Ltd. – drew on biomedical research carried out at the university.

"We aim to significantly increase the spinout rate and take a huge step-up in terms of the number of patents, the amount of venture capital and the number of industrial collaborations," Capaldi said.

Achieving that will require a culture change on the part of academics in Scotland. "We need to show them commercialization is not a dirty word," Capaldi said.

There are plans to monitor any change in that culture through an annual opinion survey. In the first such survey completed recently, only 15 percent of respondents said they want to participate in commercializing their research. The aim is to push that to 45 percent.

A concrete example of progress to date involves building on Edinburgh's role as a referral center for rare diseases.

That frequently involves prescribing marketed drugs off-label, and one of the five companies currently being groomed as a spinout will specialize in re-purposing drugs to treat orphan renal diseases.

Provisionally named Asclepius, the company has applied for European orphan drug status for one compound and owns a biologic drug that is in a Phase II trial.

"Asclepius could have six orphan drug designations by the end of the year," said Bill Blair, head of company creation at the BioQuarter.

Another company, NeurocentRx Ltd., specializes in central nervous system diseases, with a focus on pain and cognition. It was founded in 2008 by 14 academics from Edinburgh University, with Ron Lindsay, formerly of Regeneron Inc. and Millennium Inc., as chairman, and Howard Marriage, formerly of Genzyme Corp. and Cyclacel Inc., as CEO.

NeurocentRx's portfolio includes an orally available reformulation of an existing drug, which currently is used off-label for treating peripheral neuropathy that occurs as a side effect of treatment with Velcade (bortezomib, Millennium/Takeda); a number of topical and transdermal solutions for peripheral neuropathies; and a discovery project targeting the ion channel transient receptor potential 8 (TRP8), which is responsible for triggering the sensation of cold.

Blair said a third company to be housed in the bioincubator, Therapivo Ltd., will have the first platform to screen for drugs targeted at metastases, as opposed to primary tumors.

The platform is based on in vitro "complex biology" screening and in vivo quantitative imaging in mouse models.

"The philosophy is based on understanding downstream pathways using mice that express a number of different pathways," Blair said.

Underpinning those efforts to shape basic research and clinical practice into new therapies, a new national organization, Health Science Scotland (HSS), began operating in January 2012 with a brief to fill in gaps in the translation process and short circuit any bureaucratic longeurs in getting permission for clinical trials. Its remit includes running risk-sharing trials with industry and providing a scientific and clinical advisory service.

"We will be working with smaller companies to enable them to take advantage of NHS research, but also helping them selling to the NHS," said Graeme Boyle, senior project manager of HSS. "It's what we've been asked for by companies."