Webinar Report: Status Updates from ADAPT SMART Work Package Leads
On 8th January 2016, the ADAPT SMART work package leads participated in a webinar to share status updates, and compare notes on progress made and hurdles to overcome. ADAPT SMART Consortia members were invited to participate in the webinar, and were invited to ask questions via live chat after the work package leads finished their presentations.
Topics discussed included modifications to timelines and deliverables of the different work packages, and coordination activities planned for 2016. The webinar held 8th January 2016 was internal and for ADAPT SMART Consortia members only. This summary report is designed to inform all interested stakeholders and the public at large of the latest updates among the ADAPT SMART work packages.
Participating among the work package leads were:
- Solange Rohou, AstraZeneca (WP1)
- Elin Haf Davies, Centre for the Advancement of Sustainable Medical Innovation (CASMI) (WP1)
- Andre Broekmans, Top Institute Pharma (WP2)
- Luk Maes, Bristol-Myers Squibb (WP2)
- Richard Barker, Centre for the Advancement of Sustainable Medical Innovation (CASMI) (WP3)
- Alicia Granados, Sanofi-Aventis Research and Development (Sanofi Genzyme) (WP3)
- Pieter Stolk, Top Institute Pharma (WP4)
Work Package 1: Evidence generation throughout the entire product life cycle
Lead Solange Rohou kicked off the discussion addressing key logistical changes in the work package leadership. Elin Haf Davies of CASMI has joined WP1, replacing Sarah Garner and Jacoline Bouvy of NICE – who have been moved to WP3, where they are focussing on managed entry agreements. They will rejoin the WP1 team in June 2016. The work plan (D1-01) has been updated to reflect these temporary changes.
Explaining how she came to be part of WP1, Elin Haf Davies explained that CASMI were invited to look at IMiPACT and to examine the tools from that project and translate it to the current WP1 initiatives. This is part of the review of EU IMI projects (D1-02) – an ongoing action of WP1.
Rohou noted that step 1, the review based jointly agreed criteria derived from IMiPACT, is completed and that projects of interest have been selected for an in-depth review by four distinct work streams: CMC/Quality, Preclinical, Clinical & HTA Evidence Generation During Clinical Development, Real World Data Generation). The aim is to identify MAPPs enablers and perform an initial gap analysis, prior to reviewing other non-IMI EU projects of interest. The review of IMi projects will be conducted January to April and those individuals who had volunteered to take part in specific work streams were to be notified.
Regarding ongoing communications for WP1, monthly teleconferences have been organised to update WP1 members, and ad hoc TCs will be organised to progress specific work stream activities. A face-to-face meeting will probably be organised, possibly in collaboration with other work packages (still to be determined).
Work Package 2: Designing the MAPPs Pathway
Luk Maes opened the presentation on Work Package 2, beginning with the latest update on the glossary of MAPPs-related terms, which is scheduled for publication in January 2016 (D2.02). Maes noted that the glossary is a dynamic document, with regular updates anticipated. If new terms arise, ADAPT SMART consortia members are asked to contact the WP2 team. The leads confirmed that the glossary is intended to align understanding on key terms. It will first be available via the internal TI Plaza platform and later on the ADAPT SMART site.
Continuing, on to activities on seamless pathway (D2.05) Maes noted that these would be partially combined with D3.02 on economic impact. An internal workshop between these two working groups is planned for February 2016, while a broader consortium workshop is anticipated in June/July 2016.
An additional action, the survey on the European Medicines Agency’s adaptive licensing pilot (D2.06) has progressed and been split into two surveys. One survey is being conducted among participants of pilot by the EMA and another on the interests of other stakeholders is being conducted by Adapt Smart. The survey shall be available on the Adapt Smart website soon. .
Taking over the discussion, Andre Broekmans elaborated on the upcoming workshop on selection criteria for MAPPs (D2.03) to be held in Amsterdam on 29th February 2016. The workshop will include 40 participants from all stakeholders groups (5 per group). Each stakeholder group will select its own representation at the 12th January Navigator Group.
The aim of the workshop is to establish agreement among all stakeholders on:
- Eligibility of a medicine for the adaptive pathway;
- Feasibility to collect relevant information on quality, safety & efficacy/effectiveness continually during development and real world use;
- Decision points (in time) to assess whether a medicine is still complying with the eligibility criteria (an exit strategy).
The workshop will kick off with presentations by all stakeholders, followed by breakout sessions. A report will be shared with all consortium members, and a scientific paper will be written and shared with a journal based on the outcomes.
Concluding the updates from WP2, Maes noted that there are plans to hold regular teleconferences with all working group leaders more regularly as of 2016. He added that there were no significant updates on D2.04 – which will get underway later, while other activities (i.e. D2.07) are currently on track.
Work Package 3: Decision-making, sustainability and their implications
Opening the presentation for WP3, Alicia Granados spoke on the “ambitious” objectives and explained that five major blocks of work have been identified:
- Mapping economic health resources and business impact;
- Management and reduction of uncertainties for all stakeholders;
- Dealing with IP and regulatory data protection;
- Legal and ethical implications;
- Identifying potential legal liabilities for all decision makers.
In October several informal meeting took place with the co-leads of the different deliverables. Fine-tuning of the deliverables’ different profiles is still needed and this remains a work in progress.
Granados noted that two deliverables have been merged: D3.05-07 on managed entry agreements. NICE, as well as both Roche and Novo Nordisk, are co-leading, and activities are under way.
Joint workshops are planned for a number of deliverables. D3.02 and .03 have identified certain synergies that will be implemented with WP2 (D2.05), including a joint workshop. Additionally, a joint workshop is also planned for D3.09 and D2.07
The formal WP3 kick-off meeting took place on 4th November 2015. Here and it was decided to hold monthly coordination meetings with all co-leads of WP3 deliverables.
Finally, Granados noted that a literature review and grey literature review are both in place, as well as surveys to stakeholders aiming to identify stakeholder uncertainties. In addition, a compilation of information from other IMI projects that could be a useful source for ADAPT SMART (such as GetReal) is also underway.
Work Package 4: ADAPT SMART Operational Project Management
Concluding the WP lead presentations, Pieter Stolk updated the group on progress made in ADAPT SMART operational project management.
Stolk reminded participants that an overview of the project plan and tools for use by the consortium is available via the internal TI Plaza Workspace (only for consortium members). This contains the most current information on where the consortium stands with deliverables, planning in terms of timelines, and more. (D4.01)
Reports on project progress and completion are just getting started (D4.07) with the first progress update ongoing. The first report to IMI is not expected until month 18 (D4.08). The scheduling and organisation of project meetings (D4.09) is ongoing.
Regarding external communication activities, project templates and materials for communication (D4.03) are available to ADAPT SMART consortia members on TI Plaza. The project website launched in September 2015 and is regularly updated: www.adaptsmart.eu (D4.04). Press releases (D4.10) are an ongoing activity. An official press release was published to announce the ADAPT SMART formal launch in September 2015, and is available on the ADAPT SMART website.
Management of IP (dissemination of policy and awareness) is an ongoing activity. There is little to report at this stage; participants are encouraged to get in touch with Pieter Stolk if any issues arise. (D4.11).
Bringing the webinar to an end, participants from the ADAPT SMART consortium had the opportunity to pose questions. These have been incorporated and addressed throughout this report. Moving ahead, a common consensus among ADAPT SMART WP leads was the need to continue enhanced communication and pinpoint areas for collaboration – not just between WP leads, but within the consortium as a whole.
Concluding the updates on WP3, Richard Barker emphasised the need for strong engagement across all stakeholders. ADAPT SMART is not meant to be an academic exercise that people can stand back from – active participation is crucial:
“There is a need to remain fully involved, so you can expect us to be reaching out to companies – especially in areas like IP and legal and ethics, where there are a lot of strong viewpoints and extensive expertise. We want to make sure those viewpoints are on the table.”