Accelerated Development of Appropriate Patient Therapies A Sustainable, Multi-stakeholder Approach from Research to Treatment-outcomes 1 INTERNAL WEBINAR

Accelerated Development of Appropriate Patient TherapiesA Sustainable, Multi-stakeholder Approach from Research to Treatment-outcomes

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INTERNAL WEBINAR

WP LEADS PROGRESS REPORT

8th January 2016 – 12:00 Noon CET

© Copyright IMI ADAPT SMART | This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 115890. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.

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Objectives of this Webinar

• A status report from the different work packages:

– modifications to timelines/deliverables– progress made and hurdles needed to overcome– Coordination activities

• An opportunity for WP leads to touch base and to share progress reports internally within the ADAPT SMART consortium– You will be allowed time to ask questions after the presentations


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Presenters


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Work Package 1: Evidence generation throughout the entire product life cycleWP 1 Leads:• Solange Rohou, AstraZeneca• Elin Haf Davies, Centre for the Advancement of Sustainable Medical

Innovation (CASMI)


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Work Package 1: Evidence generation throughout the entire product life cycle

WP 1 Updates:

• The work plan (D1-01) was updated and finalised to reflect the temporary change in WP1 leadership: Elin Haf Davies (CASMI) replacing Sarah Garner and Jacoline Bouvy (NICE) until mid- 2016

• The review of EU IMI projects (D1-02) is ongoing – Step 1 review is completed (based on IMiPACT) and projects of interest have been selected for an in-depth review by 4 workstreams (CMC/Quality, preclinical, clinical & HTA evidence generation during clinical development and, Real World data generation)– Review process and workstreams have been identified– Aim is to identify MAPPs enablers, perform an initial gap analysis, prior to reviewing other EU non

IMI projects of interest

• Monthly TCs have been organised to update WP1 members, workstream adhoc TCs will be organised to progress the activities

• A face-to-face meeting in collaboration with WP2 - TBD


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Work Package 2: Designing the MAPPs Pathway

WP 2 Leads:• Andre Broekmans, Top Institute Pharma• Luk Maes, Bristol-Myers Squibb


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Work Package 2: Designing the MAPPs Pathway

WP 2 Updates:

• Glossary of terms (D2.02) will be released on website this month. It remains a dynamic document with regular updates during the project.

• Workshop on selection criteria for MAPPs (D2.03): 29 February 2016 in Amsterdam (see separate slide)

• Activities on seamless pathway (D2.05) will be (partly) combined with D3.02 (economic impact): internal workshop with working group in February 2016 in London. Planned consortium workshop in June/July 2016.

• Survey on adaptive licensing pilot EMA (D2.06): two surveys, one by EMA among participants of pilot and one by EFPIA on interests of other stakeholders, will be held in 2016

• Other activities on track. Will hold tc’s with all working group leaders regularly.


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Workshop Selection Criteria for MAPPs:Exploring and aligning stakeholder needs

• 29 February 2016 in Amsterdam (before a Ministry of Health invitational expert meeting)• Workshop: 40 participants from all stakeholders ( 5 per stakeholder group)• Rationale for the programme:

At the start of the MAPPs process all stakeholders should have agreement on:– the eligibility of the medicine for the adaptive pathway; – the feasibility to collect relevant information on quality, safety and efficacy/effectiveness in a

continuous way during development and real world use, – the decision points (in time) to assess whether the medicine is still complying with the

eligibility criteria (exit strategy)• Briefing paper to be circulated before work shop• Morning session: presentations by all stakeholders• Afternoon session: break out sessions

• Report of workshop will be shared with all consortium members. A scientific paper will be developed based on the workshop outcomes.


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Work Package 3: Decision-making, sustainability and their implicationsWP 3 Leads:• Richard Barker, Centre for the Advancement of Sustainable Medical

Innovation (CASMI)• Alicia Granados, Sanofi Genzyme, Research and Development


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Work Package 3: Decision-making, sustainability and their implications

WP 3 Updates:

1. In October several informal meetings, took place with the co-leads of deliverables. The aim was to identify the profiles needed and some adjustments were made accordingly. This is still a work in progress since still some fine tuning is needed. Two deliverables merged D3.05-07 on manage entry agreements. NICE, and both Roche and NovoNordisk, are co-leading, and have started the activities planned. D3.02 and 03 have identified some synergies to be implemented with WP2 (D2.05) including a joint workshop. Additionally D3.09 will be holding a joint workshop with D2.07

2. November 4th - the formal WP3 kick-off meetings took place and it was decided to have monthly coordination meetings with all co-leads of WP3 deliverables

3. Literature review, grey literature review and surveys to stakeholders, to identify stakeholders uncertainties are in place, as well as a compilation of information from others IMI projects that could be a sound source for ADAPT SMART such as GetReal.


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Work Package 4: ADAPT SMART Operational Project Management

WP 4 Leads:• Pieter Stolk, Top Institute Pharma


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Work Package 4: Operational Project Management (1) 1. Project management / governance supportD4.01 Detailed project plans/tools for use by the consortium

-> See TI Plaza Work plans (in WP) & (Reference documents > Project overview)


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Work Package 4: Operational Project Management (2)

1. Project management / governance support (cont)

D4.02 Operational portal (TI Plaza) to allow for internal team information -> Platform operational -> Please update regularly. -> More and more information about project and resources can be found there.

D4.07 Reports on project progress and completion-> First progress update ongoing

D4.08 Reports to IMI-> First report in month 18

2. Organization of project meetingsD4.09 Project meetings scheduled and organized

-> Ongoing activity

D4.05 List of relevant stakeholders -> Collected for events. Overall contact list available on TI Plaza (Reference Documents > List of Participants)


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Work Package 4: Operational Project Management (3)4. External communication activities

D4.03 Project templates and materials for communication -> Available from TI Plaza (Communication & Media > Logos and templates)

D4.04 Project website -> Launched and regularly updated (www.adaptsmart.eu).

D4.06 External communications plan -> Communications plan on TI Plaza (Communication & Media > Communication Plans), details:

– Objectives– Oversight & Editorial Approval– Key Messages– Proposed Communications Calendar – Annexe 1: ADAPT SMART Social Media Style Guide

D4.10 Press releases-> Ongoing activity. One official press release so far (at launch).

5. IP ManagementD4.11 Management of IP (dissemination of policy and awareness) -> Ongoing activity.


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Questions?