Objectives:

1. To analyse and monitor IMI and non IMI activities outputs relevant to evidence generation in the context of MAPPs;

2. To perform a gap analysis of wealth of evidence generation in the context of MAPPs.

 

DESCRIPTION	MONTHS	STATUS	DELIVERABLE
D1.01 Establish a detailed work plan for each deliverable including staffing	1-3		Document (Work Plan) & Jan 2016 Webinar
D1.02 Complete a document analysis of already completed (related) IMI and non IMI projects	1-9		Report completed in Q1 2017
D1.03 Create a short horizon scanning report of future (related) IMI and non IMI projects	1-12		Report completed in Q1 2017
D1.04 Create collaborative research proposals based on gap analysis of what needs to be done	1-12		Report completed in Q1 2017
D1.05 Establish an update on Horizon scanning	26-30 & 21-25		Update Previous Document
D1.06 Establish an update on Horizon scanning	21-24 & 27-30		Update Previous Document

Objectives:

1. Develop a glossary of terms used in the MAPPs discussion;

2. Identify the knowledge and procedural gaps to allow for seamless pathway from pre-clinical, clinical and pharmaceutical development to market access and clinical use;

3. Identify the selection criteria and the timing for using the MAPPs pathway (definition of “beneficial treatment”) and the way stakeholders will be involved;

4. Identify potential legal constraints for implementing the MAPPs pathway;

5. Identify the tools needed to ensure appropriate prescribing for/appropriate use by the targeted patient group(s);

6. Integrate the learning of the ongoing EMA pilot project and other global initiatives on MAPPs into the work package. Share best practices of scenario case studies including modeling and simulation of MAPPs alternatives.

 

DESCRIPTION	MONTHS	STATUS	DELIVERABLE
D2.01 Establish a detailed work plan for each deliverable including staffing	1-3		Document (Work Plan) & Jan 2016 Webinar
D2.02 Establish a glossary with agreed operational definitions of MAPPs terms	1-6		Available on website, update foreseen by early 2017
D2.03 Create proposal for pragmatic operational criteria for MAPPs decision(s)	1-8		Report published
D2.04 Select the methods/toolset (such as the Janus project) & data for sample scenarios	1-13		Workshop report available on website
D2.05 Create a map of the different transition/engagement moments with stakeholders that are part of the MAPPs process	4-14		Report published shortly
D2.06 Create briefing documents about the EMA pilots for working groups in the project	4-15		Continued feedback/survey on website and webinar to be organized by EMA in Spring 2017 on their AP Pilot and report on EMA website
D2.07 Create a report with recommendations for the tools/systems to be used to guide appropriate use	4-19		Planned workshop with D3.09 at Annual Meeting (Jan 2017)
D2.08 Identify legal constraints for MAPPs	12 – 25		Expected start in Feb 2017, after completion of D2.03 ad D2.05. A workshop is foreseen together with D3.06 in Spring 2017

 

Objectives:

1. Identify major decision drivers, align understanding of all stakeholders and communicate on the impact of adaptive pathways on decision-making in the health ecosystem, including based on knowledge gained from current early access experiences;

2. Identify opportunities and obstacles for a successful sustainable and ethically responsible implementation of adaptive decision-making.

 

DESCRIPTION	MONTHS	STATUS	DELIVERABLE
D 3.01 Establish a work plan for each deliverable including staffing	1-3		Document (Work Plan) & Jan 2016 Webinar
D 3.02 Create a matrix that contrasts key decision points in current vs. future processes	1-13		Expected in Q1 2017 after D2.05 has been published
D 3.03 Create a gap analysis and recommendations for projects	1-30		Document
D 3.04 Establish an inventory and analysis of increased uncertainties for stakeholders related to MAPPs	1-9		End Document + Managing Uncertainties Podcast as a Preview May 2016 (delayed)
D 3.05 Create an inventory and possible paper on currently available managed entry agreements	1-9		Summary report published on website More extensive journal paper will follow in Q1/Q2 2017
D 3.06 Create a paper on adaptive licensing/access & related IP/regulatory data issues	5-15		Expected Q2 2017
D 3.07 Establish recommendations on the applicability of managed entry agreements	5-19		Summary report published on webiste> More extensive journal paper will follow in Q1/Q2 2017
D 3.08 Establish the points to consider on ethical & legal aspects of adaptive decision making	5-19		Expected Q2 2017
D 3.09 Create a review/paper on the ethical and legal aspects of prescribing and use	5-19		Expected Q3 2017
D 3.10 Create suggestions/paper for addressing the limitations noted in D3.08 & D3.09)	11-24		Document
D 3.11 Draw conclusions on adaptive pathways & new legal liabilities	11-24		Document
D 3.12 Create a paper with a proposal on how new legal liabilities could be mitigated	16-30		Document