What Industrial Strategy Challenge am I leading?
I am the interim Challenge Director for Medicines Manufacturing, which seeks to dramatically enhance the pace of development, manufacture and delivery of novel medicines in the UK and thus to increase the rate at which patients can access new medicines. We want to equip the UK with greater capacity for manufacture of safe, economical and effective therapies. The Challenge will ensure that the medicines innovation system in the UK, by which new products are made ready for commercialisation, is further enhanced by novel and advanced manufacturing platforms that can be used by a range of companies and research organisations. We are doing this by investing in capital projects which enable rapid scale-up and by investing in process research.
Some of the advanced therapies that are based upon living cells, engineered tissue or genes are very sensitive to the conditions under which they are stored, transported, delivered and applied. It is essential to avoid mix-ups between products that are personalised and patient-specific. Therefore to realise our objectives we have to ensure that the supply chain and the traceability of the products is managed alongside the manufacturing operations. An example where the Medicines Manufacturing Challenge addresses this need is through the funding of three new Advanced Therapy Treatment Centres, where manufacturing and delivery to patient can be managed in carefully-designed operations.
Novel medicines of any kind tend to be more expensive to produce that established medicines and so a key emphasis through our collaborative R&D funding is to increase the cost-effectiveness of manufacture through process intensification and new manufacturing techniques.
Where have I come from?
Before working for UK Research and Innovation I was Professor of Regenerative Medicine Manufacture at Loughborough University for four years following 36 years in the healthcare industry. I still retain a Visiting Professor status at Loughborough.
I started out as a chemist and chemical engineer with Glaxo, Resolution Chemicals and Smith & Nephew (S&N). I began work in regenerative medicine in 1997 within the joint venture between Advanced Tissue Sciences, Inc. and S&N working on replacements for skin, ligament and cartilage.
Along the way I acquired industry-based experience in quality assurance, process design, regulatory affairs and economic analysis. I was privileged to lead international projects including a UK-Japan programme (with the Tissue Engineering Research Centre, Tsukuba) and a UK-Ireland project (with NUI Galway). I was made Fellow of the Royal Academy of Engineering in 2011 and am active in entrepreneurship initiatives with the Academy. I am a Chartered Chemist and a Chartered Chemical Engineer.
What are my hopes for the Medicines Manufacturing Challenge going forward?
I have a long-standing interest in improving the options for manufacture and supply of advanced therapeutics by making available appropriate technology for novel and effective models of business and operation. In particular I am keen to see the exemplar projects in the Industrial Strategy Challenge Fund portfolio giving rise to adventurous and enabling solutions to manufacture, operations and business models. It is very exciting to see the Challenge providing opportunities that bring together clinicians, industry large and small and regulatory and quality professionals.
In time the capability and capacity that is built by the capital part of the Challenge Fund will enhance and empower the UK’s already-strong manufacturing and skills base.
You can contact Nick Medcalf on Linkedin
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