The first quarter of 2014 saw a number of important Strategy commitments come to fruition. For example, details of an Early Access to Medicines scheme, the launch of a European Adaptive Licensing pilot and a new National BioResource were all announced last month. Budget 2014 included a number of significant measures relevant to the life sciences community, underlining the important contribution of UK life sciences to growth. Our ambition is to maintain this momentum in the coming year, and we are confident that the joining together of the life sciences functions of our respective departments to create a new, expanded, BIS-DH Office for Life Sciences will help us achieve this.

On 14 March the Medicines and Healthcare products Regulatory Agency (MHRA) announced an Early Access to Medicines scheme. The purpose of the scheme is to enable earlier patient access in the UK to unlicensed or off-label medicines in areas of unmet medical need. Under the scheme, the MHRA will issue a scientific opinion on the benefits and risks of a new medicine or indication, assessed as having a positive risk/benefit balance. The opinion will provide additional information for clinicians and patients to assist in treatment decisions. The scheme will also offer a Promising Innovative Medicines (PIM) designation at an earlier stage similar to the US Breakthrough designation. Read more about the scheme.

The use of animals in scientific research remains a vital tool in improving our understanding of how biological systems work in health and disease where no practicable non-animal alternatives exist. Within this context, on 7 February the Government published a Delivery Plan setting out a science-led programme to replace, refine and reduce the use of animals in research which will assure high standards of animal welfare while continuing to deliver benefits for humans, animals and the environment and economic growth. This programme of work will be led by the National Centre for Replacement, Refinement and Reduction of Animals in Research (NC3Rs). Read the Delivery Plan.

Budget 2014 announced a suite of measures of relevance to life sciences. Of particular interest:

• £55 million to fund a Cell Therapy Manufacturing Centre for five years from 2014/15. This will be part of the existing Cell Therapy Catapult.
• £42 million over 5 years for the Alan Turing Institute – a national institute which will undertake new research in ways of collecting, organising and analysing large sets of data.
• £167 million to meet business demand for the Apprenticeship Grant for Employers initiative in 2014/15, and extend it to 2015/16, with funding prioritised for smaller businesses.
• £20 million to further support degree and post graduate Apprenticeships. This will part-fund the training of degree level or postgraduate apprentices, with employers meeting the remainder of costs.
• £106 million to create around 20 new Centres for Doctoral Training, to strengthen the UK’s science, maths and engineering research capability.
• Further support for innovative start ups and early stage companies to invest in R&D. The government will raise the rate of R&D tax credit payable to loss making SMEs from 11% to 14.5% from April 2014. 
• The British Business Bank has designed a new wholesale guarantee scheme to promote greater lending to small and medium-sized businesses (SMEs), and has launched a ‘Request for Proposals’ from banks interested in taking part in a pilot to test the concept in the market.
• Businesses will now have until March 2018 to locate on an Enterprise Zone to be able to get the five year business rate discount. On Enterprise Capital Allowance sites, businesses will have until March 2020 to make a qualifying investment.

The National Institute for Health Research Clinical Research Network (NIHR CRN) has achieved 27 first global patients in 2013/14. Recruiting a first global patient in a multi-country clinical trial is a key performance indicator of clinical research delivery. The continued growth in the number of global firsts demonstrates that the NIHR CRN has strong capacity to support the rapid establishment of life sciences studies in the National Health Service.

Strength and Opportunity is the annual report on the health of the life sciences sector. The 5th edition was published on 14 February. It indicates that against the current background of change and global recession, the UK life science industry has continued to show strength and resilience. In 2013 it was comprised of over 4,980 companies, employed around 167,000 people and generated a turnover of over £55 billlion. Read the report here.

On 27 March the National Institute for Health and Care Excellence (NICE) began a formal consultation on proposed changes to the way it makes recommendations on new medicines and other treatments for use in the NHS. The new proposals include ways to take more fully into account the severity of a disease, as well as the effect that diseases and conditions have on an individual’s capacity to participate in society. The closing date for the consultation is 20 June 2014. More information here.

£11 million of Advanced Manufacturing Supply Chain Initiative (AMSCI) funding has been secured by a consortium of 22 organisations led by GSK and including Astra Zeneca, the University of Cambridge and the University of Strathclyde. The consortium is an innovative partnership that aims to transform how medicines are made and ensure that the UK’s pharma manufacturing industry is able to embrace emerging technologies. The project will run for four years; its total value is £23 million.

BioDundee, in conjunction with the Scotland’s Cities Alliance will hold a Global Excellence Conference on 20-21 May 2014. The conference will showcase life sciences excellence on a global scale and will provide networking opportunities with over 150 life sciences companies. Further information and registration.

The Department for Business, Innovation and Skills and the Department of Health are formally joining together their respective functions around life sciences to create a new, expanded BIS-DH Office for Life Sciences. Nicole Mather has been appointed as the Director for the new Office for Life Sciences. Nicole has a D Phil in Neuroscience and is currently a Director in Deloitte’s Healthcare and Life Sciences practice. She will take up the post on 22 April.

The European Medicines Agency (EMA) is currently inviting companies to participate in its adaptive licensing pilot project. Companies who are interested in participating in the pilot are asked to submit ongoing medicine development programmes for consideration as prospective pilot cases. The adaptive licensing approach is part of the EMA’s efforts to improve timely access for patients to new medicines. It builds on existing regulatory processes and intends to extend the use of elements that are already in place. Read more here.

On 31 March, AstraZeneca and the Medical Research Council (MRC) announced a unique collaboration to create a joint research facility at AstraZeneca’s new research and development centre in Cambridge (due to open in 2016). The Facility will provide new ways to understand a range of diseases and potential treatment avenues. Academic researchers will benefit from unprecedented access to over 2 million molecules in AstraZeneca’s compound library, as well as its state-of-the-art screening equipment. AstraZeneca will work side-by-side with world-leading MRC-funded scientists and will have the first option to enter into negotiation to license any resulting drug discovery programmes of relevance to the company’s therapeutic areas of interest.

At a time of tight control over public spending, the Government continues to offer strong support for science and research by protecting the science ring fence in cash terms for financial year 15/16. The Chancellor has previously announced a long term commitment to investment in science infrastructure of £1.1bn in real terms to 2021. This brings overall investment in science and research to £5.8 billon in 15/16, an increase in overall spending compared with recent years. Read more here.

On 14 March, the Secretary of State for Health, Jeremy Hunt, announced the launch of the National Institute for Health Research (NIHR) BioResource. The BioResource is a panel of thousands of volunteers, both with and without health problems, who are willing to be approached to participate in research studies investigating the links between genes, the environment, health and disease. The establishment of this national resource was a commitment in the 2011 Strategy. Read more about the BioResource here.

The Office for Life Sciences new twitter account can be found at @UK_Life_Science – follow us for tweets about the Strategy for UK Life Sciences