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Combinatorial Domain Hunting (CDH) technology is a technique for producing fragments of proteins that are soluble and tractable for biophysical analysis. It was developed between 1999 and 2008 at Birkbeck College, in the laboratory of Dr Renos Savva. This technology was patented in 2001 and the biotech company Domainex Ltd was then formed to commercialise it. In 2007, Domainex merged with a UCL spinout company, NCE Discovery Ltd. The company has attracted over £3m in investment and employs about 31 people. In addition to its contract research programme, it has developed an in-house drug discovery programme utilising CDH. Early in 2012 a patent was filed on a series of inhibitors of the protein kinases IKK03b5 and TBK1, which are validated drug targets for cancer and inflammation, and the first of these are expected to begin clinical trials in 2014.
The CATH classification of protein structure, developed at the Institute of Structural and Molecular Biology, UCL, by Janet Thornton and Christine Orengo, has been used widely across the pharmaceutical industry and academia to guide experiments on proteins. This has led to significant cost and time savings in drug discovery. The UCL-hosted online CATH database receives around 10,000 unique visitors per month, and is a partner in InterPro — the most frequently accessed protein function annotation server available.
Protein modification represents a highly significant and growing source of new products for the biopharmaceuticals market. This case study outlines the development of PolyTherics, a highly successful spin-out company from the UCL School of Pharmacy, and the impact that their enabling technology has had on the pharmaceutical and biotechnology industries. The company was developed as a direct result of new conjugate technology developed by Professor Steve Brocchini and coworkers at the School. The company moved to independent premises in 2006 and now manages a portfolio of over 100 granted and pending patents. Several licensing agreements are in place, including with Celtic Pharma Holdings for haemophilia treatments and Nuron for a multiple sclerosis treatment based on PEGylation conjugation technology. Revenue is expected to be £8m in 2013. The impact of Polytherics is therefore as a significant and effective technology provider to the pharmaceutical and biotechnology industries.
The Institute of Cancer Research (ICR) founded the spin out company Domainex in 2002 in collaboration with UCL and Birkbeck. The company was set up on the basis of novel research into the expression of soluble protein domains to provide services to a range of bioscience-based companies. Within the period 2008-2013, Domainex has established profitability and positioned itself as a successful company employing over 30 scientists at its laboratories in Cambridge. It has established programmes and contracts with over 20 international clients in medicinal chemistry, drug discovery, monoclonal antibody development and agrochemical science, making a major commercial impact in all these fields.
Impact: EaStCHEM spin out Albachem (1994), subsequently incorporated into the Almac group, enabling the latter company to become a world leader in the provision of chemically synthesised proteins.
Significance: Chemical synthesis is competitive with recombinant methods for commercial production of the therapeutic polypeptides that represent ~50% of drugs in big pharma pipelines and have a market value in 2008 of over $13B. The value attributable to Ramage's methods for polypeptide syntheses over the REF period is estimated at approximately £6M.
Beneficiaries: Drug manufacturers, contract research organisations, patients, clinicians.
Research: Studies (1993-6) led by Ramage (at the University of Edinburgh) on new methods for high-yield total syntheses and purification of long polypeptides.
Reach: Almac's protein-manufacturing team remains in the UK with 24 staff members. The Almac Group, headquartered in N. Ireland, has 3300 employees globally (1300 outside UK) and sells to 600 companies worldwide.
A computer technology has been invented to accelerate drug discovery. It predicts locations in disease-associated biomolecules where drug molecules could bind, induce shape changes, and thereby bring the activity of the biomolecule under control. A U.S. drug discovery company, Serometrix, has exclusively licensed this technology and incorporated it within their core discovery process. The impact upon them has been:
Professors Zhelev (UoA5) and Bradley (UoA15) explored the scope and demonstrated the feasibility of using light-scattering methods for quantitative analysis of macromolecular associations and aggregation, including protein-protein and protein-DNA interactions. 16 years of design and development research was translated into a marketed product — the PAM™Zero — a novel hand-held, low-cost protein aggregation monitor capable of detecting macromolecule aggregation in microliter sample volumes. Manufactured and sold through a spinout company, Norton Scientific Inc. (established in 2010 and valued at $7M), this portable instrument is used in commercial Quality Control and academic research and has been sold to a range of stakeholders e.g. drug development companies, for food safety and water pollution monitoring.
Novel rapid methods for predicting protein structure, particularly functional loop structures, have been developed by researchers at the University of Oxford. These have been made accessible to a large audience through a suite of computational tools. The methods have had general impact through download and online access and specific impact through extensive use within UCB Pharma. The tools are much faster than other methods, creating equal or better predictions in approximately a thousandth of the time. Commonly exploited by UCB Pharma in their drug discovery pipeline, they have cut computational cost, but, more importantly, they have greatly reduced the time for process improvements. UCB Pharma estimate that the tool pyFREAD alone saves over £5 million in the discovery costs for a single drug molecule. FREAD (a version of pyFREAD coded in C) is also being used more widely, for example by Crysalin Ltd and InhibOx.
The Fuller Longer™ (FL) food range was developed by Marks & Spencer (M&S) with expertise from the University of Aberdeen Rowett Institute of Nutrition and Health. Product development was based on Rowett research into the efficacy of high protein and mixed carbohydrate diets for sustained appetite control and weight loss. Obesity is a major public health challenge; therefore it is not surprising that FL has become an established brand for M&S's 20 million customers. This industry-academia partnership to develop a food range based on scientific input, was a first for M&S, and has led to one of the UK's most popular retail healthy-eating food ranges.
Therefore the claimed impact here includes benefits to health and welfare, on commerce, business performance and the economy.
Professor Neil Barclay and Dr Nick Hutchings established Everest Biotech Ltd in 2000 in response to the increasing demand for high quality antibodies within the research community. This successful spin-out company has since become a major power in antibody research and production, a position reflected by its portfolio of more than 6,000 antibodies recognising human, mouse and rat proteins, and the generation of 60 new antibodies each month. With offices in the UK and Nepal, Everest Biotech Ltd also benefits one of the poorest communities in the world by providing additional income to hundreds of farmers in the Nepalese foothills.