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Building on work which has contributed, via NICE guidance, to £1 billion in annual savings to the NHS in its healthcare provision for osteoporotic fractures in older adults, research at the £14.4 million MRC Lifecourse Epidemiology Unit (LEU), University of Southampton, has inspired the world's first randomised controlled trial of vitamin D supplementation versus placebo in pregnancy. This work was designed to provide a definitive answer to the question of whether supplementing pregnant women with vitamin D leads to increased bone mineral accrual in the offspring. This work has also shaped national and international guidance on vitamin D supplementation both during pregnancy and in older age; Southampton's programme of osteoporosis research has attracted £10 million in research funding from health organisations and the EU.
The University has been at the forefront of Vitamin D research over the past decade, with the findings of the work used to change the dietary intake guidelines on the international stage, most notably in the U.S by the Institute of Medicine, the international body responsible for agenda setting of dietary recommendations worldwide. The extensive research has also been crucial in informing UK and Irish Health Service reports on vitamin D assessment and use during pregnancy and in infants and has provided robust scientific evidence to the food industry for fortification strategies. In addition to establishing the vitamin D requirements of population sub-groups, the research at Ulster has also focused on investigating the relationship between vitamin D status and skeletal & cardiovascular health and immune function.
John Williams and colleagues found that serum homocysteine predicted cognitive decline and predicted the potential for vitamin B12 in treatment of dementia, including Alzheimer's Disease. This finding has led to the production of 2 novel cobalamin compounds, glutathionyl cobalamin (GSCbl) and N-acetyl cysteinyl cobalamin (NACCbl), in collaboration with Kent State University (USA), the use of which were patented in USA. We have also identified a novel anti-oxidant activity of vitamin B12. This work has led to the production of Betrinac sold by the Chester company, Cobalz Ltd, in the UK and PamLab Llc, USA.
This case study summarises a body of research on Multiple Sclerosis (MS) developed at Plymouth University under the leadership of Professor Zajicek and Professor Hobart. Hobart's work on linical outcome measurements has directly influenced clinical research, trials and drug licensing, especially in MS and Alzheimer's disease. The MS scales developed by Hobart have been endorsed by the United States FDA and are in demand by commercial organisations in the development and trialling of treatments for MS and have led to the licensing of new drugs. Zajicek has led the topical field in evaluating the potential benefits and risks of cannabis for treating MS, contributing to the evidence base behind the medical use of cannabinoids in general, and pioneering its global potential use to slow neurodegeneration.
Our research has had a major impact on the way pharmaceutical trials in Alzheimer's disease are conducted. The Boundary Shift Integral technique, which we developed and validated, has changed commercial practice and has become the industry standard for measuring atrophy progression. Our methods have largely replaced previous manual measures and in 2008-13 were used in over 20 large international trials. This had significant economic benefits for several companies providing image analysis services. For UCL alone they generated over £5m of industrial contracts. Additionally, through licensing and collaboration, UCL's research contributed to IXICO establishing a significant market share in this important commercial area.
Our biomarker research and underpinning technologies have commercially impacted upon the global R&D strategies of Unilever, Philips and Mars, realising new market areas for them, resulting in several million GBP invested in related R&D as well as "claim support" for products both in development and already available on shelves. Unilever have adopted biomarker outcomes as endpoints in clinical trials of new products, and Philips and Mars are developing with us saliva-based near-patient diagnostic tests for the human and small animal markets. We have also spun out two SME's: A) Oral Health Innovations (OHI) Ltd has developed online risk and disease analysis software for oral conditions, which was piloted, adopted and launched by Denplan, the UKs largest dental capitation plan operator (accessing 6500 dentists and 1.8 million patients), at the 2013 annual British Dental Association conference; and B) GFC Diagnostics makes SmokeScreen™ a non-invasive, sensitive and objective saliva test developed from our biomarker research at Birmingham University. Both technologies have already provided demonstrable social and commercial impact and given their uptake to date, will also deliver economic, environmental and health impacts.