Regen CTC

Regen CTC is a network of UK-based academic experts providing consultancy services for the clinical translation of human pluripotent stem cell (hPSC)-derived therapies. Established in 2018 under the UK Regenerative Medicine Platform, the company was co-founded by Zoe Hewitt and Roger Barker. Hewitt, the CEO, has over two decades of experience with hPSCs, including developing Quality Management Systems (QMS) and assisting in the UK's first-in-human clinical trial with a human embryonic stem cell-derived therapy. Barker, the company's Chair, is a Professor of Clinical Neuroscience at the University of Cambridge and a consultant Neurologist, focusing on neurodegenerative disorders like Parkinson's and Huntington's disease.

The company operates on a service-based business model, offering its expertise to the wider regenerative medicine community to facilitate the progression of therapies into clinical trials. Regen CTC's services include the development of stage-appropriate Quality Management Systems, assistance with cell line selection, supplier qualification, raw material selection, and bioprocess development. They also provide support in selecting contract manufacturing partners, designing clinical trials, and conducting gap analysis and due diligence to ensure processes are compliant with regulatory requirements. The firm's client base consists of early-stage product developers and other organizations in the cell and gene therapy sector navigating the complexities of regulated environments.

Keywords: cell therapy consulting, regenerative medicine, pluripotent stem cells, clinical translation, quality management systems, bioprocess development, due diligence, cell line selection, regulatory compliance, contract manufacturing