Taskforce calls on Government to make the UK the go to destination for international investment in ground-breaking medicinal therapies.
The Advanced Therapies Manufacturing Taskforce (ATMT) has today published its action plan outlining a strategy on how the UK can become the global hub of advanced medicinal therapy manufacturing and ensure the long-term success of this industry in the UK.
The report, Advanced Therapies Manufacturing Action Plan, Retaining and attracting advanced therapies manufacture in the UK, was launched at the annual bioProcessUK conference in Newcastle today [23 November]. It looks at the medicines manufacturing industry of the future, where advanced therapy manufacturing, a broad term covering the highly specialised manufacturing necessary for innovative medical treatments, including cell and gene therapy, is expected to grow to be worth between $14-21bn globally per year by 2025.
Cell and gene therapies can either alter the patient's DNA or inject living cellular material to treat disease. It allows for treatments which are tailored to individual patients with a much greater certainty that they will be effective compared to alternative therapies.
The taskforce was launched by the Medicines Manufacturing Industry Partnership (MMIP) earlier this year and is co-chaired by Minister of State for Universities, Science, Research and Innovation, Jo Johnson MP and Ian McCubbin, SVP North America, Japan & Global Pharma Supply, GlaxoSmithKline. The action plan outlines the key actions the UK can take to capture manufacturing investment and ensure that the UK assumes a leading position in the global advanced therapies space to equip manufacturers to supply patients with these cutting-edge medicines at scale.
There is an ongoing dialogue between the sector and the government on the pivotal role the life sciences sector has to play in the UK's overarching Industrial Strategy. The Government has recognised the ambition within the sector, for the UK to become a global hub leading on research, development and manufacture of advanced therapies, seeing regenerative medicine as one of the eight great technologies. Securing these in the UK through future Industrial Strategy will support the UK's agenda to drive productivity, exports and inward investment and help to capture the estimated over £300million worth of business available.
The action plan's recommendations, which are the result of collaboration within the industrial and ministerial taskforce, are that we seek to:
• Secure an internationally competitive fiscal landscape to attract investment
• Capture investments through a proactive and targeted marketing approach and simplify the process of engagement between investors and Government
• Capture internationally mobile investment through capacity and capability growth in the UK
• Set out an end-to-end talent management plan to secure the relevant skills for emerging manufacturing technologies
• Clearly set out a swift, predictable and viable route to market for these innovative products and give industry confidence the UK is a progressive global hub
• Develop a long-term regulatory strategy and plan for the MHRA to lead in global standards, supporting the scientific activities and international outreach of NIBSC
Minister of State for Universities, Science, Research and Innovation, Jo Johnson MP, said: "The report comes at an opportune time with development of the Government's Industrial Strategy. This is a critical part of the Prime Minister's ambition to build an economy that works for everyone. The strategy will set out how we will boost productivity, create good jobs, and ensure sustainable economic growth. Life Sciences, and within that, Advanced Therapies – hold great potential for the UK to develop new sources of economic competitiveness. The report provides a valuable input as we develop the Industrial Strategy. I welcome continued commitment and engagement from your industry."
SVP North America, Japan & Global Pharma Supply, GlaxoSmithKline, Ian McCubbin, said: "The life sciences have always been strong in the UK and, as the Government sets out its forthcoming Industrial Strategy, we recommend that it proactively targets future areas of growth – advanced therapies manufacturing being one of these areas. The UK needs to act with urgency and differentiate itself as a global destination for advanced therapies development and manufacturing and set the sustainable foundations for this emergent sector to take root and grow"
Click here to download the full report.
The UK is a world leader in the research and development of Advanced Therapy Medicinal Products (ATMPs), however without action we risk losing the benefits to the UK economy of manufacturing these medicines and bringing these innovative treatments to UK patients through a clear route to market
The Conservative Party's 2015 Manifesto committed the Government to 'increase the use of cost-effective new medicines and technologies' and to 'support our long-term economic plan by fostering research, innovation and jobs in the life science industry'.
In March 2016 a Government/industry Advanced Therapy Manufacturing Taskforce (ATMT) was set up to help anchor advanced therapy manufacturing in the UK. It involves stakeholders including Innovate UK, the medicines industry and Government. Today's report is timely as the Government develops its Industrial Strategy.
In addition to today's report the sector has developed a Comprehensive approach on what would help to make a big impact in the medium term and send a strong signal to internationally mobile investors that the UK is the place to build this key industry of the future.
• Biomedical Catalyst (already agreed)
On 1 October Philip Hammond confirmed £100m to support the Biomedical Catalyst (BMC) and the commercialisation of research. The BMC aims to de-risk innovative science and commercialise ideas arising out of academia and industry helping UK SMEs to develop into competitive and sustainable organisations.
• Cell and Gene Therapy Treatment Centres (£30m)
The action plan recommends the establishment of a network of Cell and Gene Therapy Treatment Centres with new Government funding delivered through a competitive process managed by Innovate UK with widespread industry involvement to develop and implement the new systems needed to allow these Centres to operate.
• Establish competitive funding to support viral vector capability growth within two years
The Taskforce proposes the development of a specialist manufacturing operation leveraging where possible existing infrastructure. The operator(s) should be mandated to work with academic groups to supply viral vectors and therefore gain exposure to cutting edge developments, whilst at the same time industrialising the academic processes. The Taskforce will work with the funders by early Spring 2017 on delivery and process
• Establish an end-to-end talent plan (£1.5m)
The growth of the advanced therapies sector in the UK will rely on a commensurate growth in the available talent pool. The ATMT action plan proposes the creation and implementation of an end-to-end talent plan for the sector. The plan will encompass integrated strategies to develop the talent pool at multiple entry-points. These range from Manufacturing Technicians to Post-doctoral and Professional levels.
• Supporting advanced therapy manufacturing investments in 2016/17 (£30m p.a. for 3 years)
As the UK seeks to capture £350m in advanced therapies manufacturing investment, the ATMT report suggests a level of competitive or loan/grant funding in the range of £30m p.a. over three years to attract and anchor this strategically important and transformative sector in the UK.
• Route for patient access to these medicines To ensure we retain advanced therapy research and manufacturing in the UK, we must establish a route for patient access to these medicines. Since each medicine is tailored to the patient, patients are more likely to travel to where the medicine is produced. If treatments are not available to UK patients then it is illogical for them to be manufactured in the UK. The NHS will need to ensure it is ready for these therapies in terms of commissioning, funding, data collection, and clinical pathways, to ensure the health benefits of these new technologies reach NHS patients in the UK
As other countries continue to invest heavily in this industry, they will begin to attract manufacturers. If the UK does not remain competitive then this will lead to a transfer of expertise to those countries. We will lose our current advantage.
Medicines Manufacturing Industry Partnership (MMIP) represents the voice of medicines manufacturers in the UK. It was established jointly by Government and the biopharmaceutical industry in 2014 to ensure that the UK is recognised by the global medicines industry as a world-class, advanced centre for medicines manufacturing. MMIP is supported by the Association of the British Pharmaceutical Industry (ABPI), the BioIndustry Association (BIA) and Knowledge Transfer Network (KTN), and includes leadership from Allergan Biologics, AstraZeneca, Eisai, FUJIFILM Diosynth Biotechnologies, GlaxoSmithKline, Pfizer and ReNeuron.
A Joint Industry/ Ministerial taskforce was established in early 2016, at the instigation of the then Minister for Life Sciences, George Freeman and Ian McCubbin, GSK and Chair of MMIP, to look at securing advanced therapies manufacturing investments in the UK. Chaired by Ian McCubbin and Jo Johnson, the key objectives were to set the conditions for productivity and commercial scale industrialisation to anchor Advance Therapy manufacturing in the UK. The Taskforce has representation from industry, academic institutions, MMIP, Trade Bodies, KTN, Government Departments and associated bodies, including funders and regulators. The Action Plan published today sets out the recommended actions as a conclusion to this aspect of the Taskforce work.
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