Adaptive Licensing Pilot Project
On 2 June 2014, the Association of the British Pharmaceutical Industry (ABPI), the BioIndustry Association (BIA) and the Centre for the Advancement of Sustainable Medical Innovation (CASMI) jointly organised a stakeholder event in London to publicise the EMA’s Adaptive Licensing pilot project.
This workshop allowed pharmaceutical and biotech companies, as well as patient groups, to understand better which medicines (the EMA terms ‘live assets’) would be appropriate to put forward for the Adaptive Licensing pilot and to appreciate how the pilot would work in practice. In some cases this could be complementary to the MHRA’s Early Access to Medicines Scheme (EAMS).
Download the full report from the event here: ABPI-BIA-CASMI Adaptive Licensing Meeting Report
For more information on the project, contact Emily Algar
Medicines Adaptive Pathways to Patients (MAPPs)
MAPPs is a new, more adaptive approach to medicines development currently being explored and piloted by the European Medicine Agency (EMA). In 2015, in collaboration with the UK’s Department of Health and its Office for Life Sciences, CASMI investigated the ethical implications of MAPPs and explored the topical views of patients and professionals about the opportunities and challenges it may bring with its future implementation. The 12-month project was undertaken via a series of workshops convened in the first half of 2015 and additionally investigated both barriers and enablers of current and future real world data collection in the UK and how that may be applicable to MAPPs.
Outputs from this report have been considered in the Department of Health’s Accelerated Access Review – which sets out a new roadmap to accelerate access to innovative drugs, devices and diagnoses for NHS patients.
To view the full report click here (published 2016).
For more information, please contact Dr Stuart Faulkner.