Today, Sir John Bell, Greg Clark and Jeremy Hunt announced that the Government, through its Industrial Strategy Challenge Fund (ISCF), is launching the Leading Edge Healthcare Challenge – which includes a £146 million commitment over the next four years to support the development of technologies and facilities for the manufacture of innovative medicines.
It aims to speed up patient access to new medicines and treatments, build on the UK’s position as a leader in medicines manufacturing, increase UK productivity, and stimulate further investment in this sector in the UK.
Medicines manufacturing already has great commercial value for the UK
We have over 1300 companies involved in medicines manufacturing, the direct gross value added (GVA) per UK employee is greater that £150,000, and the sector produced £26 billion in exports in 2015. But there is still significant opportunity to drive further growth in manufacturing jobs and exports in this sector.
Moving on from discovery & testing to producing final products
After years dedicated to their discovery, as each new medicine progresses through the stages of clinical testing towards approval, the challenge moves on to how they can be manufactured so that greater numbers of patients can access new medicines.
There are many different classes of medicines, such as:
- classic small molecule medicines
- new medicines that are being developed and still being tested such as cell and gene therapies
Each class of medicine has its different manufacturing challenge
These all offer very different challenges in their manufacturing processes; some are dependent on synthetic chemistry while others depend on living organisms for their production, or in some cases the medicine is a living cell. The manufacturing of medicines has to be robust, reproducible and produce medicines that are safe and without contaminants. It is a highly regulated field and this ensures that patient safety is at the forefront.
Similarity: need to be scaled up to meet patient need
What they all share is a need for innovative manufacturing solutions to scale up appropriately, so that once they are approved they can meet patient need.
Higher value but lower volume production
The pharmaceutical industry has seen a decline in the so-called blockbuster model and is moving towards high value but lower volume products as more medicines are being developed for smaller patient numbers that better match patients’ disease and therapy.
It is anticipated that batch sizes will shrink and there are opportunities to develop more agile and cost-effective manufacturing processes that could lower the cost of new medicines.
Vaccines need faster supply to better target emerging threats sooner
Vaccines have delivered great success in reducing the targeted infectious disease, however, resistance to antimicrobials and emerging pathogenic infectious diseases represent major global threats to human health.
Pandemic planning and next generation vaccines need faster supply to better target emerging threats sooner and these are often difficult to scale up quickly with old technology.
In addition, vaccines are now being developed for non-pathogenic diseases such as cancer that require manufacture on a different scale.
Next step: commercial supply of new therapies
Cell and gene therapies are novel therapies that offer cures for diseases that are poorly treated, if at all with currently available medicines. The next challenge for this exciting field is the commercial supply of the new therapies.
Creating significant opportunity for UK SMEs
The discovery and development of the next generation of these different medicines is now being increasingly carried out by lean SME organisations – sometimes focused on just one medicine.
Currently many of these potential medicines are being manufactured outside the UK as our capacity is challenged by current demand.
The investments announced by the Government today will allow companies to establish novel manufacturing processes and will provide significant opportunities for SMEs with limited manufacturing capacity or experience to add value to their company and their medicines by developing efficient and flexible manufacturing processes that can compete globally.
The first competition for £15 million of funding opens on the 4th of September.
Details of the other ISCF-supported competitions will appear soon on the Innovate UK competitions web page.
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