Editorial Contribution: André Broekmans, Coordinator ADAPT SMART, Looks Ahead

With the first few months of the ADAPT SMART project underway, coordinator André Broekmans (Escher Platform, TI Pharma) shares his views on what is needed to continue to drive the project forward.

After the successful kick-off meeting in September, the ADAPT SMART project is now underway. ADAPT SMART is not a regular IMI research project but a ‘coordination and support action (CSA)’. As such, ADAPT SMART will make an inventory of potential gaps in knowledge on the tools and methodologies needed to facilitate an adaptive pathway. The great thing is that we have nearly all stakeholders ‘around the table’; this makes the project unique and will enable us to achieve a common understanding of what we mean by MAPPs, what we already know, what key questions we need to answer and what is the available in terms of common ground between stakeholders. For example, in some instances industry may have a different perspective than the payer community, and ADAPT SMART may help to identify a way forward. Of course, such a dialogue begins with making sure that we speak the same language. For this purpose, ADAPT SMART will release in early 2016 a glossary of common terms so we will have a common starting point.

ADAPT SMART is working within a compressed period of time and (just as everyone in the world) with limited resources, therefore, we have to ‘hit the ground running’. In a time frame of 2 ½ years ADAPT SMART will produce 22 deliverables: summary reports, position papers, opinions and recommendations. This requires very precise planning, especially with 32 partners. However, we are now able to say that the work plans have been finalised and potential synergies between deliverables highlighted. In order to increase the efficiency of the project, the leadership team has decided to combine certain activities and to cross-link more intensely with other work packages and EU initiatives. Just to give an example: the work on seamless pathway models will be combined with the work on mapping decision points. The workshop to be held in summer 2016 will also be used to discuss the interim-results of the discussion on managed entry arrangements and pricing arrangements.

The plans for the workshop on the selection criteria for MAPPs are taking shape. We intend to organise the workshop in the Netherlands in the first quarter of 2016, before or after an event organised by the Dutch government during its Presidency of the Council of the European Union. The aim is to have about 40 participants with representation of all stakeholders.

On a more practical level: per 1 January 2016 TI Pharma will change its name into Lygature after the merger with another public-private partnership organisation, CTMM (Center for Translational Molecular Medicine). The combined organisation will continue to serve as coordinator of ADAPT SMART.

All in all, very exciting times are ahead for ADAPT SMART. The project is approaching the adaptive pathways concept from a variety of angles, with a broad range of stakeholders. Some of these routes will be easy, while in other areas we may encounter some steeper terrain. However, ADAPT SMART has all the tools and expertise on board to complete its journey and to provide a valuable contribution to the discussion on how we can get valuable medicines to patients at the earliest appropriate time in a sustainable and affordable manner. I look towards the future with confidence!