D2.07 final report on tools and systems to guide appropriate use of medicinal products in twelve EU Member States

The objective of D2.07 was to provide an overview of which tools and systems are available at the national level to guide the appropriate use of medicinal products in EU Member States. This report looks at all tools/systems for guiding appropriate use at the national level, even if these may not be directly applicable in the context of a MAPPs-type pathway.

D2.07 final report on tools and systems to guide appropriate use of medicinal products in twelve EU Member States 2017-12-18T14:50:43+00:00

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

Podcast: “The Regulatory Needs of MAPPs – What are the Evidence Requirements to Make Adaptive Pathways Work in Practice?”.

On 25 October 2017, ADAPT SMART had a discussion with François Meyer, Advisor to the President & International Affairs at the French National Authority for Health (HAS), Solange Corriol-Rohou, Senior Director Global Regulatory Affairs & Policy, Europe at AstraZeneca Global Medicines Development, Elin Haf Davies, CEO of Aparito and Stefan Lange, Deputy Director at IQWiG, moderated by Richard Barker, Director, CASMI.

Podcast: “The Regulatory Needs of MAPPs – What are the Evidence Requirements to Make Adaptive Pathways Work in Practice?”. 2017-10-30T12:37:12+00:00

Webinar Report: “Implementing Real World Data to Make Adaptive Pathways Work”

Webinar Report: “Implementing Real World Data to Make Adaptive Pathways Work” On 18 October 2017, the ADAPT SMART consortium presented a webinar hosted by the Estonian Ministry of Social Affairs. The webinar was the final event of eHealth week, an international conference occurring as part of Estonia’s Presidency of the European Council, and discussed [...]

Webinar Report: “Implementing Real World Data to Make Adaptive Pathways Work” 2017-11-03T16:55:03+00:00

EMA answers to questions from industry partners in the ADAPT SMART consortium regarding the EMA Adaptive Pathways pilot project 

EMA answers to questions from industry partners in the ADAPT SMART consortium regarding the EMA Adaptive Pathways pilot project Response: Adaptive Pathways is a concept that seeks to foster access to beneficial treatments for the right patient groups at the earliest appropriate time in the product life-span in a sustainable fashion. In so [...]

EMA answers to questions from industry partners in the ADAPT SMART consortium regarding the EMA Adaptive Pathways pilot project  2017-08-03T11:55:06+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

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

Initial Review Report On Imi Projects – WP1 Final Report

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 – WP1 Final Report 2017-08-03T09:03:45+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