Publications

Publications 2017-07-10T11:34:34+00:00

General

Report – ADAPT SMART General Assembly, 18th of January 2017

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.

Webinar Report: Status Updates from ADAPT SMART Work Package Leads 

On 8th January 2016, the ADAPT SMART work package leads participated in a webinar to share status updates, and compare notes on progress made and hurdles to overcome. ADAPT SMART Consortia members were invited to participate in the webinar, and were invited to ask questions via live chat after the work package leads finished their presentations.

ADAPT SMART Project Overview

The project overview of ADAPT SMART (Accelerated Development of Appropriate Patient Therapies: a Sustainable, Multi-stakeholder Approach from Research to Treatment-outcomes) provides information regarding participants, objectives, expected impact, and a work plan, among other details.

Work Package 1

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.

Discussion paper on Engagement Criteria for MAPPs

On the 29th of February, ADAPT SMART hosted an invitation-only multi-stakeholder workshop around selection criteria for MAPPs in Amsterdam, The Netherlands.

Work Package 2

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.

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).

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.

Discussion paper on Engagement Criteria for MAPPs

An issue of divergent views became apparent early in the course of the ADAPT SMART project, namely; to what kind of novel medicines and clinical scenarios/conditions should a MAPPs approach be applied? The ADAPT SMART consortium convened discussion fora with stakeholders to elaborate MAPPs engagement criteria that may be acceptable to all concerned within the existing legislation. In this paper, we summarize viewpoints from these discussions.

ADAPT SMART Glossary

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 [...]

Blog From D2.03 Leaders: Takeaways From the ADAPT SMART Workshop on Selection Criteria for MAPPs

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 [...]

Work Package 3

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.

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

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.

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).

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.

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.

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: “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.