The idea of Progressive Translation is based on three basic principles:
Progressive Licensing: Focus on unmet medical need and orphan products in order to allow access to the current legislative frameworks already in place of “Specials”, hospital exemptions, conditional approvals or exceptional circumstances and run these in parallel with randomised clinical trials. This will both provide early access to patients but also inform the clinical studies in terms of protocols, statistical analysis plans and estimates of patient numbers which will increase the chances of a clinical trial meeting its endpoints.
Progressive Development : A close partnership between client, contract developer and hospital allowing rational, iterative development of new treatments and the optimisation of product and protocol as clinical data becomes available without having to completely re-start the development pathway.
Progressive Reimbursement: The utilisation of a combination of systems already in place such as NHS Specialised services, patient pays, patient charity, national commissioning etc, to reimburse the company for the therapy in the early stages which as well as reducing the need for investment capital will also require the early provision of important health economic data which will in turn inform the business plans.