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Maintaining the UK lead in advanced therapy medical research

Posted on 08/12/2016

Taskforce action plan lays out comprehensive strategy for driving sector growth.

Taskforce action plan lays out strategy for driving sector growth.

By Mark Bustard and Sarah Goulding, KTN Health Team

It is reported that over 60,000 stem cell transplants are performed worldwide annually for the treatment of oncology and blood-based disorders. In 2012, cell therapy products distributed by biotherapeutic companies generated over $900 million, with 160,000 patients receiving treatments.

Advanced therapies like these are driving an exciting and revolutionary new paradigm in science and healthcare. As part of a broader field known as regenerative medicine, they offer unprecedented promise for the long-term management and even cure of disease, especially in areas of high unmet medical need.

The UK took an early lead in capturing advanced therapy medical research, and now has a recognised leading international position in the discovery and development of advanced therapies, with world-class academics, innovation infrastructure including the Cell and Gene Therapy Catapult, investors, many SMEs, and now pharmaceutical companies, concentrating their research in the UK.

This emerging industry is at a critical stage in translating research into manufactured products, with the focus now on planning manufacturing scale-up in order to commercialise these therapies. In this context, the UK has the opportunity to secure its position as a global hub for researching, developing, manufacturing and adopting advanced therapies.

The Advanced Therapies Manufacturing Taskforce (ATMT) was set up in early 2016 at the instigation of the then-Minister for Life Sciences, George Freeman, and Ian McCubbin, GSK and Chair of the Medicines Manufacturing Industry Partnership – an industry initiative led by the ABPI and BIA (trade associations for pharmaceuticals and biotechnology business) and the Knowledge Transfer Network.

The ATMT’s key objectives were to identify actions that the UK must consider taking in order to anchor manufacturing of advanced therapies in the UK and capture investments to secure the UK position as a world-class hub. These investments are globally mobile, and we know that similar initiatives are taking place in countries such as Japan and the USA. The UK will lose out on its early lead and potential early investment if no action is taken.

The taskforce has representation from industry, academic institutions, MMIP, trade bodies, KTN, Government departments and associated bodies, including funders and regulators. Through our role in the Medicines Manufacturing Industry Partnership (MMIP), KTN was asked to lead the secretariat function for the taskforce, working alongside the Office for Life Sciences, ABPI, BIA, MMIP and the Cell and Gene Therapy Catapult.

KTN’s role in this work has been to lead on strategy and engagement with industry; to facilitate discussion across public sector stakeholders, industry and academia.

A key reference point has been the biopharmaceuticals industry – the UK similarly led, and still retains, a global reputation in research and development, but then lost out globally in anchoring the wider supply chain in high-value jobs for manufacturing of these products. What can be done differently now to ensure that the UK captures the full value of the industry, both economically in terms of GVA and jobs, and importantly, for the early benefit of UK patients?

A major milestone was the publication in November of the Advanced Therapies Manufacturing Taskforce Action Plan – Retaining and Attracting Advanced Therapies Manufacture in the UK. It sets out interventions needed for the UK to become the global hub of advanced therapies manufacturing and ensure the long-term success of the UK industry.

The Action Plan was launched by Ian McCubbin at the BIA’s Annual bioProcessUK Conference in November, and simultaneously presented to the Government’s Ministerial Industry Strategy Group (MISG) by Roger Connor, Global President for Manufacturing for GSK.  Minister of State for Universities, Science, Research and Innovation Jo Johnson welcomed the report, noting the work as being very opportune timing with the development of the Government’s Industrial Strategy, and building on government commitments and investments in this sector to date through Innovate UK, the Catapults and research council funding more broadly.

Key recommended actions that the UK can take are:

  • 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.

The taskforce will meet in early Spring to review progress, and is expecting to see the Action Plan integrated as part of the Government’s Industrial Strategy.