Publications

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

General

ADAPT SMART General Assembly (January 18th, 2017)

This report highlights the main outcomes of the General Assembly of the IMI ADAPT SMART consortium.

ADAPT SMART Kick-off Meeting (September 4th, 2015)

On Friday September 4th, 2015, a coalition of 90 European healthcare stakeholders from 32 organisations including patients, payers, regulators, HTAs, academic institutions, and industry took their first steps towards investigating MAPPs tools and methodologies, and engaging in a dialogue with all relevant stakeholders to prove and develop workable MAPPs concepts.

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 (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.

Work Package 2

Legal constraints with regard to MAPPs (D2.08)

A broad review of the main legal areas governing medicinal product development, approval and market access, in the context of MAPPs, was undertaken - except any potential impact of MAPPs on Intellectual Property and Regulatory Exclusivity Rights that will be analysed by D3.06 working group, within Work Package 3. The two documents should be read and understood together.

Tools and systems to guide appropriate use of medicinal products in twelve EU Member States (D2.07)

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: 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).

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.

Discussion paper on Engagement Criteria for MAPPs (D2.03)

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.

Workshop: Selection Criteria for MAPPs – Exploring and aligning stakeholder needs (D2.03)

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

ADAPT SMART Glossary (D2.02)

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 [...]

Work Package 3

Ethical And Legal Aspects Of Prescribing And Use By Target Populations (D3.09)

Work-stream D3.09 has explored some general ethical and legal issues that may arise through the introduction of the MAPPs concept, the implications for each stakeholder – in particular, patients and healthcare professionals (HCP) – and any liability change or shift between stakeholders and ethical considerations of prescribing control.

Ethical and Legal Aspects of Adaptive Decision Making (D3.08)

Within the ADAPTSMART consortium, the remit of work-stream D3.08 has been to explore general ethical and legal issues that may arise through the introduction of the MAPPs concept, the implications for each stakeholder - in particular, patients and healthcare professionals (HCP), and what recommendations could be made to mitigate against identified issues. Specific legal issues relating to intellectual property law are the subject of another ADAPTSMART work-stream and are not discussed here.

Impact of adaptive licencing and adaptive access on Intellectual property and regulatory exclusivity right periods (D3.06)

A broad review of the rules governing IP and RER as they are today, and with respect to MAPPs, was undertaken in the context of the following 4 scenarios deemed likely to occur with MAPPs: (i) Stand-alone MA (i.e. single indication only); (ii) MA with subsequent indications with the same compound, i.e. indication 1, subsequently followed by indication 2; (iii) MA under exceptional circumstances or conditional approval that subsequently gets approved for ‘full’ MA; and (iv) MA (full, conditional, or exceptional MA) that subsequently is revoked / suspended from a regulatory perspective. Any direct legal impact of MAPPs were assessed along with an exploration of several perceptual issues pertaining to the incentives of adopting and using MAPPs from an IP and RDP perspective.

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.

Joint workshop: Patient uncertainties and exploring the ethical and legal considerations of MAPPs (D3.04 & D3.08)

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

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.

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: Seamless pathway and the impact on decision making – Exploring and aligning stakeholder needs (D2.05 & D3.02)

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.

Joint workshop: Managed entry in the context of adaptive pathways (D3.05 & D3.07)

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.