Work Packages

Work Packages 2017-08-03T14:19:12+00:00

Work Package 1

Evidence generation throughout the entire product life cycle

Work Package Leads:
AstraZeneca, National Institute for Health and Care Excellence

Contact Persons:
Solange Rohou Jacoline Bouvy
MAPPs function around a continuous evaluation of a new product throughout its entire lifecycle, where the actual performance of the new therapy dictates its usage based on an evolving understanding of its effectiveness & safety through a growing body of evidence.

Work Package 1 has two core objectives:

  1. Analyse and monitor activities that occur both within and outside of IMI programmes that provide and generate evidence about MAPPs;
  2. Develop a gap analysis of the current and future needs of evidence generation to support MAPPs.

These objectives will be realised through a review of current and future research projects and assessment of tools and methods to support evidence generation and data interpretation throughout the product life cycle. The focus will include practical issues around data generation, validation of biomarkers and endpoints such as patient reported outcomes, interoperability of data standards and innovative methods for data generation such as use of registries and data mining of electronic Health Records (EHR). The challenges of pharmaceutical development will be also considered since modifications to the traditional CMC (Chemistry and Manufacturing Controls) development paradigm will need to be supported.


Work Package 2

Designing the MAPPs pathway

Work Package Leads:
Lygature, Servier

Contact Persons:
Andre Broekmans  Patricia Maillère
ADAPT SMART Work Package 2 will work towards a pragmatic proposal for a future formal MAPPs pathway, covering all phases of development and licensing, and supporting efficient access of the products to patients that addresses clear medical needs.

All stakeholders, including patients, regulators, HTA/payers, practitioners, and industry, must align on the evidence package and success metrics early in the development and access journey, and continue to assess the performance of the therapy through the life-cycle of the product.

The topics addressed in WP2 include the following:

  • Develop a glossary of standardised terms to be used in MAPPs;
  • Identify knowledge gaps that allow for a seamless pathway from pre-clinical research, to clinical development, and ultimately to a new therapy being used by patients;
  • Define the selection criteria and the timing for using the MAPPs pathway in “beneficial treatment” and how stakeholders will be involved in that decision;
  • Uncover any potential legal constraints to implementing a MAPPs pathway;
  • Create the tools to ensure appropriate prescribing and appropriate use by patients in MAPPs;
  • Integrate the findings of the EMA pilot project and other global initiatives that are relevant to MAPPs;

Share best practices, case studies, modelling, and simulations of pathway options in MAPPs.

Work Package 3

Decision-making, sustainability and their implications

Work Package Leads:
Centre for the Advancement of Sustainable Medical Innovation, Sanofi-Aventis Research and Development (Sanofi Genzyme)

Contact Persons:
Richard Barker Alicia Granados
Work Package 3 has to identify and address the opportunities and obstacles to a successful, sustainable and ethically responsible implementation of adaptive decision making in research, regulatory, and medical practice.

It will identify all decision points in adaptive approaches throughout product lifecycle, and the steps required to align all the stakeholders around evidence needed and implications. It will also assess and communicate the impact of MAPPs on health ecosystem, including the dissemination of the learnings from early access pilots and on-going research initiatives.

This includes:

  • R&D efficiencies and inefficiencies;
  • Pricing arrangements, risk-sharing, effective patient access and business cases for sponsors;
  • Ethical implications for patients and clinicians;
  • Intellectual property and regulatory data protection;
  • Legal implications for all decision makers;
  • Personal data protection considerations.

Work Package 4

ADAPT SMART Operational Project Management

Work Package Leads:

Contact Person:
Pieter Stolk
Work Package 4 defines the coordination, management, organisation and communication of the project. The work package is managed by TI Pharma in close collaboration with the Navigator Group. All operational decisions and planning are made under the supervision of the Navigator Group.

The key objectives are to:

  • Support and monitor the effective execution of the work plan including the control of deliverables, milestones and budgets;
  • Enable collaboration between the various work packages, and making regular progress reports to the Navigator Group and IMI JU office as required;
  • Organize and prepare meetings for project governance;
  • Inform partners as well as European and global stakeholders on the project’s progress;
  • Manage key interactions of consortium;
  • Plan and coordinate a broad platform of external communication;
  • Manage Intellectual Property rights and any foreground information generated.