Accelerated Development of Appropriate Patient Therapies
a Sustainable, Multi-stakeholder Approach from Research to Treatment-outcomes
By Neena Brizmohun
The “glass is half full,” the European Medicines Agency’s senior medical officer says of efforts to get everyone onboard the adaptive pathways approach for accelerating the approval of drugs for high unmet needs.
By Neena Brizmohun
Payers often worry about where they would stand if a drug that was approved in the context of adaptive pathways should subsequently underperform. But they should not be concerned, according to the latest discussions on this relatively new concept for getting drugs to market faster.
19th April 2017, 14-15h CET
The first public webinar of ADAPT SMART will highlight how consortia members are collaborating with key stakeholder groups to incorporate their feedback into the project's deliverables during the calendar year of 2017.
Putting Patients at the Centre – The Ethical and Legal Considerations of MAPPs
By Paul Robinson of Merck Sharp & Dohme
One of the key factors in the future success of any MAPPs implementation will be the need for continuous monitoring, in health data registries, of how patients respond to new therapies. On January 17th, 2017, the ADAPT SMART consortia hosted a multi-stakeholder workshop to explore the ethical and legal considerations of MAPPs and the uncertainties of patients. The workshop covered several topics including the use of patient data in registries.
Location: European Medicines Agency, London 9:30 AM –1 PM
This report highlights the main outcomes of the General Assembly of the IMI ADAPT SMART consortium.
On 17 February, ADAPT SMART had a discussion with Professor Hans-Georg Eichler, Senior Medical Officer EMA and ADAPT SMART project leader on what exactly are Adaptive Pathways and why they are important.
18th January 2017
London, United Kingdom
On the 18th of Janaury, ADAPT SMART hosted it’s Annual Meetings and General Assembly at the EMA in London.
8th December 2016
London, United Kingdom
On the 8th of December 2016, the European Medicines Agency has organised a workshop in collaboration with the European Commission to gather the views and proposals from stakeholders on the adaptive pathways approach.
ADAPT SMART’s General Assembly, held at the European Medicines Agency (EMA), agrees to focus its final year on incorporating stakeholder feedback into the development of Medicines Adaptive Pathways to Patients (MAPPs) tools and methodologies.
It is difficult to imagine, but the IMI’s ADAPT SMART project has been operational for eigtheen months, having launched officially at the EMA on September 4, 2015. ADAPT SMART is investigating the tools and (processes) interaction moments required for the use of Adaptive Pathways, but seeks a consensual, multi-stakeholder approach to the continuous lifespan evaluation of the evidence used in regulatory decision making for new therapies that address medical needs.
