Decision points in current vs. future processes by stakeholder groups, and resource implications for a roadmap for implementation (D3.02)

The introduction of a new concept introduces new dynamics to which the involved stakeholders need to adapt. When considering the feasibility and practicalities of being involved in an adaptive pathway to medicines – which includes multi-stakeholder interactions, iterative cycles of development and assessment, and long term real-world data (RWD) collection – each stakeholder must have a clear understanding of their remit (current or new), the type of input requested from them (advice or decisions), and the appropriate resources needed.

Decision points in current vs. future processes by stakeholder groups, and resource implications for a roadmap for implementation (D3.02) 2017-10-30T13:27:18+00:00

Patient uncertainties and exploring the ethical and legal considerations of MAPPs

In order to continue the instructive discussions of the ADAPTSMART programme of work, on January 17th 2017, the ADAPT SMART consortium hosted a multi-stakeholder workshop on ‘Patient uncertainties and exploring the ethical and legal considerations of MAPPs’, bringing together two work streams - D3.04 and D3.08. This workshop comprised of 40 representatives including; European regulators, Health Technology Assessment (HTA) bodies, the pharmaceutical industry, patient organizations, health care professionals, and academics

Patient uncertainties and exploring the ethical and legal considerations of MAPPs 2017-08-03T09:01:31+00:00

The Impact of Adaptive Pathways and Adaptive Access on Intellectual property and Regulatory exclusivity rights

On April 12th 2017, the IMI ADAPTSMART consortium hosted a multi-stakeholder workshop. Twenty-two representatives attended, including: medicine developers, independent IP and regulatory lawyers, payers, academics and policy makers.

The Impact of Adaptive Pathways and Adaptive Access on Intellectual property and Regulatory exclusivity rights 2017-08-03T08:53:44+00:00

Joint workshop on tools and systems used for prescription control (D2.07) & the ethical and legal aspects of adaptive decision making (D3.09)

On the 17th of January 2017, as part of its Annual Meeting, the ADAPT SMART consortium hosted a multi-stakeholder workshop on ‘Tools and systems used for prescription control and the ethical and legal aspects of adaptive decision making’. The topic of this workshop related to two different deliverables: D2.07 (focused on prescription control) and D3.09 (focused on ethical and legal aspects of adaptive decision making).

Joint workshop on tools and systems used for prescription control (D2.07) & the ethical and legal aspects of adaptive decision making (D3.09) 2017-08-03T08:49:34+00:00

Seamless Process and Decision Points of an Adaptive Pathway

This report proposes a framework with pictographic representation of an adaptive pathway containing key moments, events and involved stakeholders, in each phase. This model is purposefully presented rather simplistically in this first evolution, acknowledging that there remain several questions to be answered – both unique to each individual potential medicine as well as to full implementation of an integrated adaptive pathway approach.

Seamless Process and Decision Points of an Adaptive Pathway 2017-06-26T13:36:10+00:00

Blogpost: “Putting Patients at the Centre – The Ethical and Legal Considerations of MAPPs”

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.

Blogpost: “Putting Patients at the Centre – The Ethical and Legal Considerations of MAPPs” 2017-06-20T11:17:45+00:00

ADAPT SMART Workshop: “Seamless pathway and the impact on decision making: Exploring and aligning stakeholder needs”

6th July 2016

London, United Kingdom

On the 6th of July 2016 ADAPT SMART organised a one day workshops entitled "The Seamless pathway and the impact on decision making: Exploring and aligning stakeholder needs”. More than 30 representatives including; European regulators, Health Technology Assessment (HTA) bodies, the pharmaceutical industry, patient organizations, health care professionals and academics attended the workshop.

ADAPT SMART Workshop: “Seamless pathway and the impact on decision making: Exploring and aligning stakeholder needs” 2017-07-10T11:17:17+00:00

ADAPT SMART Workshop: “Managed entry in the context of adaptive pathways”

5th July 2016

London, United Kingdom

On the 5th of July 2016 ADAPT SMART organised a one day workshops entitled "Managed entry in the context of adaptive pathways.” The workshop was held in London and around 30 attendees represented key European stakeholder groups: health technology assessment (HTA) bodies, payer organisations, or manufacturers.

ADAPT SMART Workshop: “Managed entry in the context of adaptive pathways” 2017-07-10T11:16:01+00:00