Project: A life-changing treatment to reverse injury-related sight loss was made available to patients at specialist centres across England, thanks to a partnership between Newcastle Hospitals and Italian medicines manufacturer, Holostem.
The specialist advanced therapy, known as Holoclar, uses stem cells to treat sight loss due to physical or chemical burns to the eye.
The treatment is made by taking healthy cells from the patient’s uninjured eye before sending them to Italy where they are used to cultivate a new corneal epithelium – the clear ‘barrier’ that protects the eye.
The product must be transplanted onto the damaged eye within 36 hours of release.
How we helped: This short shelf life makes timing critical and legislative constraints were making it difficult to import Holoclar for use at the four NHS sites approved to carry out the treatment.
David Caulfield, Deputy Director of Pharmacy (Quality Assurance) at Newcastle Hospitals, and his team worked to unlock access for the wider NHS.
Over a number of months, quality assurance specialists from our pharmacy directorate worked extensively with Holostem, providing advice, guidance and support to overcome the import challenge and obtain appropriate regulatory authorisations.
The team’s work addressed the previous supply constraints, making the treatment quickly and easily available for NHS use, so specialist centres can now restore the sight of the patients who receive it.
We supported the project with commercial advice, costings and putting together a contract for our partners.
Using the same authorisations, our team is now in a position to assist other manufacturers to offer innovative products within the NHS.
Outcome: Irving Donadon from Holostem explained that Holoclar is available to patients in a number of other European countries and the team wanted NHS patients in the UK to benefit too.
The new distribution model is a fantastic collaboration between NHS pharmacists and private industry and has been fundamental to overcoming the access constraints the company experienced.
With a joint focus on improving patient’s lives, the partnership proves how different sectors can work together to make the best possible treatments available to people
The partnership between the Newcastle Hospitals and Holostem was facilitated by the Northern Alliance Advanced Therapies Treatment Centre, which works to support the use of advanced therapies and ensure access for NHS patients.