Cell & Gene Therapy Translation Roadmap
This roadmap provides a simplified workflow summarising key activities and considerations for development, evaluation and commercialisation of cell and gene therapies (viral and non-viral), to facilitate their effective translation into the clinic.
The first phase of Cell & Gene Therapy translation should be therapeutic design and planning. This consists of an idea to meet an unmet clinical need and the design of a gene/cell therapy vector to deliver this. Other considerations include Intellectual Property (IP), finance and Patient & Public Involvement (PPI).
Laboratory evaluation ensures the development of research grade cell and gene therapy vectors. Considerations include proof of concept and regulatory advice.
There are many factors to think about when considering which Contract Research Organisation (CRO) to work with when outsourcing work. Use the expertise of the UCL Translational Research Office (TRO) to decide on which CRO is the best fit for your project.
Ethical and regulatory compliance are required for clinical evaluation through phase I/II clinical trials, in order to study proof of concept in patients.
UCL has implemented and is growing strategic platform partnerships to facilitate the accelerated development, commercialisation and adoption of therapeutics into the NHS.