North of the Border
Further North in the U.K., there are sizeable clusters of biotech firms in Scotland, sited at science parks such as the Edinburgh BioQuarter, a $1 billion investment into the co-location of Edinburgh University Medical School and commercial life science R&D space, BioCity Scotland, and the Dundee MediPark.
Scotland specializes in drug discovery and also has a growing cell therapy base. “As pharma needs and their model changes they are increasingly accessing and funding early-stage research,” Allison comments, “so there is a lot of work with commercial potential focused around the research institutes, as well as biotech companies in Scotland.”
One of the advantages of developing drugs in Scotland, according to Allison, is the ability to access the whole supply chain from R&D to manufacture and then translational and clinical studies. For example, drug manufacture with close access to patients for clinical trials either co-located or in a relatively small area. This is particularly attractive for cell-therapy trials, and there are currently six cell and regenerative medicine clinical studies ongoing in Scotland. In addition, 60% of Europe’s safety testing of biopharmaceuticals is carried out in Scotland.
“Scotland has electronic health records for our 5.3 million population, which records all patient contact with the healthcare system from ‘womb to tomb’,” says Allison.
“Link this with access to well-characterized cohorts of patients in specific disease areas (for example Generation Scotland has access to over 30,000 Scot’s biological samples with full genotyped and phenotyped information) and very competitive clinical trial permission times of around 14–18 working days, and you can imagine how powerful (and cost-effective) many companies are finding this for first-in-man, Phase II, and postmarketing studies.”
Allison notes that the WOSCOPS 15-year follow-up study demonstrates this power, as it cost a fraction of the original study, and in a fraction of the time demonstrated the long-term benefits to patients using statins.
Up-and-coming companies in Scotland that highlight these areas include MGB Biopharma, Angel Biotechnology, and Roslin Cells.
MGB is developing a new small molecule antibiotic class known as DNA minor groove binders. Its lead candidate, MGB-BP03, has shown promising preclinical potency and activity against MRSA, VRE, and Clostridium difficile. The company recently announced that MGB-BP03 will be advancing into clinical trials at the end of this year—initially for oral treatment of C. difficile and later as a parenteral formulation for the other indications.
Angel is a contract manufacturer specializing in producing biopharm proteins and cell therapies. The firm produced the ReN001 stem cell therapy from ReNeuron. This is currently being used in Scotland in the Phase I PISCES study, a fully regulated clinical trial of a neural stem cell therapy to treat stroke patients.
Roslin Cells produces cells and recently relocated to a 1,000 square meter facility at the Edinburgh BioQuarter to extend its clinical-grade stem cell production capability and the development of new cell therapies. It is also developing the capacity to produce induced pluripotent stem cells from selected donors for drug discovery.