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This briefing examines issues of time and timing in the clinical translation of therapies based on gene editing, induced pluripotent stem cells, and 3D bioprinting. Co-ordinating timing is a perennial challenge for innovation across sectors, but it takes on particular importance in medicine, with the current impetus for getting promising new therapies to patients more quickly. Producing and delivering advanced therapies requires co-ordination between developers, manufacturers, investors, regulators and clinical staff in hospitals. Policy support could beneficially target innovation in supporting technologies that improve the speed of manufacture and delivery, but a distinction needs to be made between instances where state support is appropriate and those best left to market-led initiatives. Support is warranted to better align the timeframes of regulation and of healthcare budgets to account for the uncertain, often non-linear development trajectories of our case study technologies. We also recommend that patient and public input be sought as to the acceptability of risk-sharing arrangements to enable faster translation in the NHS.

Type

Other

Publisher

RegMedNet.com

Publication Date

01/09/2020