Research partnerships
Guiding the regulation of new Regenerative Medicine products
Company
British Standards Institution, Organogenesis, Intercytex
Expertise
Centre for Biological Engineering
Loughborough University is working to support and develop the manufacture of life-changing Regenerative Medicine (RM) products.
The practical landscape for applying this science is a challenging one. Loughborough is leading the EPSRC Centre for Innovative Manufacturing in Regenerative Medicine, in collaboration with Nottingham and Keele Universities. This £5.3 million research centre is designed to aid the translation of pioneering RM ideas into safe, affordable, cost-effective treatments that combine life-changing impact for patients with maximum commercial value for industry.
In support of the centre’s aims, the University is working to develop knowledge around the regulation and reimbursement of RM products through a project funded by the Engineering and Physical Sciences Research Council through a Knowledge Transfer Account (KTA) awarded to the University.
Businesses and academia hoping to commercialise discoveries related to cell-based therapy are in need of clear guidance on the regulatory pathways for cell-based products. There is also a need for information on the requirements for payment, as key stakeholders such as investors and healthcare providers will want to see that a product is worthy of reimbursement in terms of both its cost to manufacture and effectiveness.
The KTA funded project “Supporting the Regulation and Reimbursement of Regenerative Medicine Products in the UK” is playing an important role in meeting these two needs.
Impact
- Loughborough University is helping to shape new British Standards Institution (BSI) regulations governing the regenerative medicine industry
- US-based company Organogenesis are working with Dr Ginty on a confidential project that requires a very specific form of regulatory knowledge in order to help the business grow and develop
- UK firm Intercytex is developing ICX-RHY (Vavelta), an RM product to treat a variety of skin related problems including Epidermolysis Bullosa and scar contractures. Dr Ginty is working with Intercytex to help gain reimbursement for the product and develop their knowledge of the funding landscape