Accelerated Development of Appropriate Patient Therapies: a Sustainable, Multi-stakeholder Approach from Research to Treatment-outcomes - Sofia ref.: 115890

Deliverables

Other (8)

List of relevant stakeholders (and updated)

Migration

Operational portal to allow for internal team information

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Press releases (various releases during project)

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Project meetings scheduled and organized

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Organisation of closing event

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Create ADAPT SMART infographic

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Management of IP

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Project templates and materials for communication

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Documents, reports (26)

Identification of legal constraints for MAPPs

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Position paper on the impact of adaptive licencing and adaptive access on IP and regulatory data protection periods and recommendations

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Update D1.02 – Document- analysis of already completed IMI and non-IMI projects and their outputs

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Short report-horizon scanning of future IMI and non-IMI projects with release of a summary of the findings

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Document-analysis of already completed IMI and non-IMI projects and their outputs

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Select methods, toolset (such as the Janus program) and datasets to perform scenario studies in order to facilitate stakeholder’s engagement

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Detailed work plan for each deliverable including staffing 3

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Detailed work plan for each deliverable including staffing 2

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Collaborative research proposals based on gap analysis

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Matrix that contrasts decision points in current vs. future processes by stakeholder groups and implications for a roadmap for implementation. (workshop in M7)

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Inventory/Paper on the available managed entry agreements, including pricing models and their experiences as judged by the different stakeholders

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Proposal for pragmatic operational criteria for the respective decision(s) to use the MAPPs pathway, the timing and the stakeholders needed for this decision. (workshop in M6, briefing document M4)

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Map of the different transition/engagement moments with stakeholders, and identify the information and data needs of these stakeholders at each of these moments

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Gap analysis and where appropriate recommendations for projects addressing enablers of decision making in an adaptive environment (e.g. managing uncertainties at HTA level). (interim: M6, M18)

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Six-monthly reports on project progress and completion (first in M6, then every 6 months)

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Briefing documents during project about EMA pilots to relevant leads of the working groups in the project

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Detailed work plan for each deliverable including staffing 1

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External communications plan (and updated)

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Report with recommendations on current tools and systems to guide the appropriate use by the targeted patient groups, both at the European and national level (also input for D3.09). (workshop in M16)

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Recommendations on applicability of managed entry agreements and pricing arrangements to possible adaptive scenarios

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Review/paper on the ethical and legal aspects of prescribing and use by target populations

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Points to consider document on ethical and legal aspects of adaptive decision-making and recommendations on how these can be addressed

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Glossary with agreed operational definitions of the terms used in international literature

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Inventory and analysis of increased uncertainties for patients and other stakeholders and the issues these raise

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Reports to IMI (first in M18, then M30)

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Detailed project plans/tools for use by the consortium

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Websites, patent fillings, videos etc. (1)

Project website

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Publications

Peer reviewed articles (3)

Medicines Adaptive Pathways to Patients: Why, when and how to engage?

Author(s): Hans-Georg Eichler, Nicola Bedlington, Mathieu Boudes, Jacoline C. Bouvy, André W. Broekmans, Francesca Cerreta, Stuart D. Faulkner, Sue Forda, Angelika Joos, Yann Le Cam, Mark Mayer, Vinciane Pirard, Solange Corriol-Rohou
Published in: Clinical Pharmacology & Therapeutics, 2018, ISSN 0009-9236
DOI: 10.1002/cpt.1121

Managed Entry Agreements for Pharmaceuticals in the Context of Adaptive Pathways in Europe

Author(s): Jacoline C. Bouvy, Claudine Sapede, Sarah Garner
Published in: Frontiers in Pharmacology, Issue 9, 2018, ISSN 1663-9812
DOI: 10.3389/fphar.2018.00280

The evolution of adaptiveness: balancing speed and evidence

Author(s): Hans-Georg Eichler, Richard Barker, Nicola Bedlington, Jacoline C. Bouvy, André W. Broekmans, Anna Bucsics, Francesca Cerreta, Solange Corriol-Rohou, Alicia Granados, Yann Le Cam, Ad Schuurman
Published in: Nature Reviews Drug Discovery, 2018, ISSN 1474-1776
DOI: 10.1038/nrd.2018.90

Other (1)

Patient Access in the Context of Adaptive Pathways for Medicines: What Could Make It Work?

Author(s): C. Sapede
Published in: Value and Outcomes Spotlight, 2017, Page(s) 11-13