Accelerated Development of Appropriate Patient Therapies
a Sustainable, Multi-stakeholder Approach from Research to Treatment-outcomes
On 6 September, Nicola Bedlington from The European Patients Forum (EPF) and Yann Le Cam from Eurordis, two of Europe’s leading patient representatives, discussed the need for Adaptive Pathways (MAPPs) in Europe.
ADAPT SMART welcomes the European Medicines Agency (EMA) report on its adaptive pathways pilot, considering this as a positive step in the current multi-stakeholder discussions about early access to medicines via a Medicines Adaptive Pathways to Patients in the EU.
On 5 July, key stakeholders involved in the MAPPs conversation met to discuss the tools needed to define endpoints and success measures in MAPPs. Participants included Richard Barker, founding director, Centre for the Advancement of Sustainable Medical Innovation (CASMI); Claudine Sapede-Kniffel, Global HTA & Payment Policy Lead, F. Hoffmann-La Roche; Anja Schiel, Senior Advisor and Statistian, NOMA (The Norwegian Medicines Agency).
There is much debate about the need to allow patients with serious diseases early access to promising new therapies. Some concerned stakeholders argue for “the right to try any treatment option for every patient in need” while others oppose this position, saying “only thoroughly studied treatments should be allowed on the market - we need to take our time”.
The ADAPT SMART glossary provides working definitions for common terms relevant for the consortium and includes references. The glossary is based on the input from members of the ADAPT SMART consortium representing different stakeholder groups. The definitions are based on relevant legislation or literature sources and written in the context of the ADAPT SMART project; where applicable, [...]
On the 29th of February, ADAPT SMART hosted an invitation-only multi-stakeholder workshop around selection criteria for MAPPs in Amsterdam, The Netherlands. The programme from the event can be found here. A full report of the event will be available in due course. A preliminary overview of conclusions was prepared for the participants in the “Innovation for the [...]
On the 29th of February, ADAPT SMART hosted an invitation-only multi-stakeholder workshop around selection criteria for MAPPs in Amsterdam, The Netherlands. Angelika Joos of MSD and Mathieu Boudes of EURORDIS attended the workshop in their capacity as ADAPT SMART Task 2.03 leaders. Here they share an update on the workshop’s progress. More information about the workshop can [...]
On 7 April, key participants associated with the IMI ADAPT SMART project met to discuss the consortia's progress in finding ways to implement MAPPs in Europe. Participants included: Hans-Georg Eichler, Senior Medical Officer at the European Medicines Agency (EMA); Luk Maes, Executive Director, Regulatory Scientific Policies – Europe, for Bristol-Myers Squibb; Ad Schuurman, Head of the Business Contact Centre & International Affairs National Health Care Institute of the Netherlands (ZIN); and Sarah Garner Associate Science Policy and Research, National Institute of Health and Care Excellence (NICE).
This Q&A aims to address some frequently addressed queries around MAPPs. MAPPs, broadly, are a multi-stakeholder approach to developing an "RCT-plus" to evaluating new medicines. In order for outcomes-based healthcare to succeed, we need to know the performance of a treatment, both at a population level and an individual level. We need to expand [...]
On 17th February, Jacoline Bouvy of NICE and Claudine Sapede of F. Hoffmann-La Roche met in London to discuss managed entry in the context of the ADAPT SMART initiative.
