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Workshop: The Impact of Adaptive Pathways and Adaptive Access on Intellectual property and Regulatory exclusivity rights (D3.06)

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.

Workshop: The Impact of Adaptive Pathways and Adaptive Access on Intellectual property and Regulatory exclusivity rights (D3.06) 2018-04-11T14:25:58+00:00

Joint workshop: tools and systems used for prescription control & the ethical and legal aspects of adaptive decision making (D2.07 & 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: tools and systems used for prescription control & the ethical and legal aspects of adaptive decision making (D2.07 & D3.09) 2018-04-11T14:20:03+00:00

ADAPT SMART Webinar Report – Putting Patients at the Centre

On April 19th, 2017, the ADAPT SMART Consortia, comprising over 30 international partners including regulators, patients, academia and industry, held its first public webinar to give an update on the project’s progress and milestones, as well as its efforts to incorporate the feedback of key stakeholders groups during the calendar year of 2017.

ADAPT SMART Webinar Report – Putting Patients at the Centre 2017-10-30T12:39:56+00:00

Seamless Process and Decision Points of an Adaptive Pathway (D2.05)

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 (D2.05) 2018-04-11T14:34:09+00:00

Initial Review Report On Imi Projects (D1.02)

D1.02 aimed to analyse and monitor IMI and non IMI project outputs, and to perform a gap analysis of the wealth of evidence generation in the context of MAPPs. In other words, tools and methods developed by IMI and other EU projects, which could benefit MAPPs have to be identified. To this effect, a two-phase process was identified.

Initial Review Report On Imi Projects (D1.02) 2018-04-11T13:38:04+00:00

EMA Official Dismisses Claims That Prescribers & Companies Won’t Play By Adaptive Pathways Rules

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.

EMA Official Dismisses Claims That Prescribers & Companies Won’t Play By Adaptive Pathways Rules 2017-06-20T11:17:45+00:00

Adaptive Pathways: A Solution For Worried Payers in Europe

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.

Adaptive Pathways: A Solution For Worried Payers in Europe 2017-06-20T11:17:45+00:00

Webinar: ADAPT SMART “Putting Stakeholders at the Centre”

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.

Webinar: ADAPT SMART “Putting Stakeholders at the Centre” 2017-08-03T08:36:39+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 2018-04-11T14:51:09+00:00