Innovative Medicines Initiative Launches ‘ADAPT SMART’, an Adaptive Pathways Project with 32 International Participants

The project will establish a platform that enables the coordination of Medicines Adaptive Pathways to Patients (MAPPs) related activities within the Innovative Medicines Initiative (IMI) and engages in dialogue with all relevant stakeholders. MAPPs seek to foster access to beneficial treatments for the right patient groups at the earliest appropriate time in the product life-span in a sustainable fashion. The outcomes of the ADAPT SMART consortium will help inform future research agendas and discuss approaches for the implementation of MAPPs.

(4 September 2015 – London, United Kingdom): ADAPT SMART, a European public-private collaboration bringing together 32 international participants, is launched today at a meeting hosted by the European Medicines Agency (EMA) in London.

ADAPT SMART (Accelerated Development of Appropriate Patient Therapies: a Sustainable, Multi-stakeholder Approach from Research to Treatment-outcomes) is a multi-stakeholder project focused on laying the foundations for “Medicines Adaptive Pathways to Patients” (MAPPs) to be put into practice in Europe. MAPPs has the potential to bring new medicines to patients faster. ADAPT SMART will investigate MAPPs tools and methodologies, and engage all relevant stakeholders to develop workable MAPPs concepts. The project is led by the EMA and coordinated by TI Pharma via its regulatory innovation platform ‘Escher’, and is supported by a number of public and industry partners.

Hans-Georg Eichler
Senior Medical Officer, European Medicines Agency (EMA)

“With the challenges facing healthcare in Europe, we see MAPPs as a vital tool to make the increasing number of promising new therapies available at the earliest appropriate time for patients with unmet medical needs. We need to do so in a way that is sustainable for all stakeholders in the healthcare ecosystem. ADAPT SMART is a vital programme to help achieve this goal.”

Finn Borlum Kristensen
Secretariat Director, EUnetHTA, Danish Health and Medicines Authority

“As a network EUnetHTA has been exploring the usefulness of giving early scientific advice to drug and technology developers and we are developing synergies with drug licensing bodies and fostering systematic real world evidence of effectiveness post-launch. Through these efforts, we experienced the real value of working with multiple relevant stakeholders. ADAPT SMART will act as a catalyst with an expectation that, as a multi-stakeholder project, it will make a meaningful contribution to efforts aiming at seamless introduction and faster patient access to effective health technologies within sustainable health systems. Issues we will be considering are, for example, strategies for evidence development including pragmatic trials that meet the requirements of both regulators and HTA agencies.”

Solange Rohou
Director Regulatory Affairs AstraZeneca

“The overarching goal of MAPPs is to translate science into healthcare solutions that are available to patients earlier. To do so, diverse stakeholders, including payers, patients, practitioners, regulators, and industry, must be aligned in a truly cross-functional, cross sector engagement of continuous evaluation of the performance over the entire life-cycle of a new therapy.”

Yann Le Cam
Chief Executive Officer of EURORDIS, the European Organisation for Rare Diseases

“We need to connect innovation in medicines development with patient access in order to ensure that more, better and cheaper treatments are reaching patients across Europe, and faster.”

In the current access system, for both marketing authorisation and reimbursement, a “yes or no” decision takes place after completing a series of sequential and controlled research experiments which can take as long as 10 years. In contrast, after initial trials on a medicine that demonstrate its potential benefits, MAPPs aims at using a set of objective measures, including real world evidence data, to monitor the actual performance of a new therapy in patients over its entire lifespan, and adjust patient access based on this expanding knowledge base. In this way, MAPPs should offer flexible development and access pathways within the current regulatory framework to balance early patient access, public health and societal benefits.

This continuous evaluation of a therapy supports needed early access for patients, and provides an evolving understanding of benefits and risks that is better aligned with the realities of today’s emerging sciences in personalised medicine. However, the challenge for ADAPT SMART is to develop a MAPPs model that aligns the needs of all stakeholders, including patients, member state payers, regulators, medical practitioners and industry.

ADAPT SMART will address these challenges to the broad implementation of MAPPs by exploring new concepts to align the various stakeholders and create a consensus across healthcare stakeholders as to what evidence will be required, how multiple sources of available data can be best used to facilitate MAPPs and which scientific challenges related to MAPPs need to be addressed.

An impressive list of 32 participants encompassing all parts of the healthcare ecosystem is represented in ADAPT SMART, including patients, academia, regulators, HTA bodies, payers and industry. The complete list of participants can be found at In addition, ADAPT SMART will foster an active dialogue with organisations across Europe and beyond that may not be part of the initial consortium.

ADAPT SMART is a 30-month project under IMI2, which is the second phase of the Innovative Medicines Initiative (IMI) under the EU Horizon 2020 framework. IMI2 is a public-private partnership of the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Commission.

For further information on ADAPT SMART,
please contact:

Leonie Hussaarts
+31 6 55 46 38 76

For general questions on the Innovative Medicines Initiative,
please contact:

Catherine Brett
External Relations Manager
Innovative Medicines Initiative
Tel: +32 (0)2 541 8214