Leading industry players, Sistemic and Roslin Cells, are going to work together with Scottish Development International (SDI) to make the process of undertaking clinical trials in cell therapy easier, faster and more successful in reaching commercial realisation.
By bringing together unique Scottish investments such as Health Sciences Scotland, NHS Research Scotland, NHS Scotland and leading technology-based industrial partners, the country believes it can offer cell therapy companies a streamlined process for clinical trials. This will not only provide access to the right patients, but will support product development, characterization and potency development, making the regulatory process much easier.
$120 million has been invested into the Scottish stem cell cluster since 2004 to build state of the art clinical infrastructure and fund essential projects for this industry, such as manufacturing GMP grade hESC. Its commercial landscape has developed some of the most promising advancements in enabling technologies that have helped guide cell functionality and have created viable cell therapy products fit for the clinic. Scotland was selected as the location to conduct the UK’s first approved ATMP stem cell clinical trial and already has active cell therapies in clinical practice, which include a pancreatic islet transplantation programme for Type 1 Diabetes and EBV Cytotoxic T Lymphocyte (CTL) bank for post-transplant lympho-proliferative disease. “Thanks to the outstanding collaboration across NHS, academia, government and industry, Roslin Cells has been able to accelerate the expansion of its cell therapy manufacturing facilities based in the Scottish Centre for Regenerative Medicine. "We and our NHS partners are working on the development of a number of cellular therapies which will enter clinical trial within Scotland and Europe in the coming years. This pipeline of new therapies demonstrates the exceptional resources Scotland has to offer,” Roslin Cells’ CEO, Aidan Courtney said.
Supportive regulatory environment
The supportive regulatory environment in Scotland including high ethical standards for stem cell research activities, has ensured cell therapy companies have a streamlined clinical research approach that ultimately enables new medicines to get to market faster. “Understanding the cell therapy products being placed into trial as well as selecting the right patient population is essential to conducting a successful clinical trial. "Sistemic’s SistemQC™ technology is already helping some of the world’s leading cell therapy companies to achieve this and it seems fitting that, as a company founded in Scotland, we work with Scottish Development International, NHS Scotland and other leading companies to make Scotland the go to place for conducting trials in cell therapy of the highest caliber,” Sistemic’s CEO Jim Reid explained. This week, a Scottish delegation including Roslin Cells and stem-cell focused companies such as Sistemic, will attend the Stem Cell Meeting on the Mesa conference in San Diego.