text: ADAPT SMART Kick-off Meeting (September 4th, 2015) – ADAPT SMART
  ADAPT SMART Kick-off Meeting: Laying the Foundations and Building Consensus to Make MAPPs Work for All
  This unique project, led by the European Medicines Agency, seeks to establish collaborative solutions to foster the development of Medicines Adaptive Pathways to Patients (MAPPs) in Europe, encouraging more efficient ways of developing and regulating medicines. Bringing together patients, regulators, industry, Health Technology Assessment (HTA) bodies, payers, and academics, it has the key objective to provide patients with more appropriate access to innovative medicines.
  Called ADAPT SMART, (Accelerated Development of Appropriate Patients Therapies, a Sustainable, Multi-stakeholder Approach from Research to Treatment-outcomes), the 30-month project funded through the Innovative Medicines Initiative is an enabling platform for the coordination of Medicines Adaptive Pathways to Patients (MAPPs) activities, as the consortium aims to facilitate and accelerate the availability of MAPPs to all healthcare stakeholders. ADAPT SMART will support projects under the second Innovative Medicines Initiative (IMI2) investigating MAPPs tools and methodologies. 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 ADAPT SMART Kick-off plenary session was moderated by Dr. Hans-Georg Eichler, Senior Medical Officer at the European Medicines Agency (EMA), which is also leading the project, and Dr. André Broekmans, representing TI Pharma as the project coordinator. Dr. Eichler implored the various stakeholders present to, "keep our eyes on the ball to meet the goals of the project, and not become distracted." Dr. Eichler also pointed out that MAPPs will rely on evidence generation through the entire treatment life span. "My personal view is that, in the long-term, we'll see a growing number of products and research questions that can't be addressed in the conventional RCT. If our attitude is 'RCT or die', we won't succeed," said Eichler.
  Hans-Georg Eichler, Senior Medical Officer at the EMA, which is leading the project, and Solange Rohou, Senior Director Regulatory Affairs & Policy, Europe at AstraZeneca and ADAPT SMART Deputy Project Leader
  Solange Rohou, Senior Director Regulatory Affairs & Policy, Europe at AstraZeneca and ADAPT SMART's Deputy Project Leader, outlined the challenges Europe is currently facing in bringing new medicines to patients and what specifically ADAPT SMART will address in the coming months. She highlighted that the regulatory environment is lagging behind the new advanced therapies coming to market that are personalised and targeted. "The current RCT may not be the only way to address these new therapies in many cases," she said.
  Dr Rohou continued, "Many of the conventional R&D models of industry may no longer be viable within the current regulatory pathway, and a flexible pathway that measures the performance of a new therapy over its entire lifecycle would not only address patient needs, but also benefit society as a whole."
  The patient perspective was presented jointly by Mathieu Boudes, Operations and Projects Manager of The European Organisation for Rare Diseases (EURORDIS) and Kaisa Immonen-Charalambous, Senior Policy Adviser, European Patients' Forum (EPF). The patient organisations said that ADAPT SMART will be successful if the consortium, "identifies all opportunities and challenges to effective patient participation, while developing a clear roadmap to operate MAPPs in the near future. This will require an agreed and unified MAPPs concept for all stakeholders."
  Kaisa Immonen-Charalambous, Senior Policy Adviser, European Patients' Forum (EPF)
  Boudes and Immonen-Charalambous also pointed out that ADAPT SMART would be judged on its ability to achieve a consensus view and a clear picture of areas of disagreement between all key stakeholders, and to facilitate a patient-centred implementation of MAPPs, "which supports the integration of patients' needs and perspectives into the process." This sentiment was echoed by Luk Maes, Executive Director, Regulatory Scientific Policies – Europe, for Bristol-Myers Squibb, who stated, "What does successful ADAPT SMART look like? We're striving for a constructive and pragmatic solution that addresses stakeholder questions and concerns; thankfully, as we've heard from EURORDIS and other stakeholders, there is a willingness to succeed from all parties."
  ADAPT SMART brings together academics, industry, payers, regulators, patients and HTA bodies as part of the consortium. This collaboration, under the leadership of the EMA, ensures balanced input from the parties that will need to work together to identify how to make MAPPs actionable.
  This first-of-its-kind coalition puts ADAPT SMART in the position to address the drivers, opportunities, and obstacles to making MAPPs actionable and real. Nicola Bedlington, Secretary General of the European Patients' Forum, highlighted that ADAPT SMART will allow the consortia to, "understand each other's position in order to reach a common agreement and foster dialogue."
  Dr. André Broekmans, representing TI Pharma as the project coordinator
  In order to ensure that ADAPT SMART models and recommendations are viable, the consortium includes key participants from the EU payer community. Ad Schuurman, Head of International Affairs at the National Health Care Institute of the Netherlands and President of the Medicines Evaluation Committee (MEDEV), outlined several questions to be addressed so EU payers can implement MAPPs.
  He asked, "If we develop new approaches to data generation, how can we prevent a decline in the quality of evidence? Does an adaptive approval mean we also have an adaptive reimbursement? Should MAPPs be something for special cases, concentrating on the complexities of demonstrating the real-life added-value of unique treatments?" Which medicines should MAPPS focus on? A product which is licensed along MAPPs has a limited marketing authorisation accompanied by commitments to generate additional data. How can we ensure that the product will not be used off-label and the commitments are met?"
  Schuurman concluded his presentation with the statement, "We need to challenge ourselves and dare to experiment, with the understanding that there are many divergent views in this room and also among the payers. But, we will do our best to find solutions to these questions together."
  Finn Børlum Kristensen, Chairman of Executive Committee and Secretariat Director, EUnetHTA
  As well, the European network for Health Technology Assessment (EUnetHTA) was represented by its Chairman of Executive Committee and Secretariat Director, Finn Børlum Kristensen. He began by stating that, "with ADAPT SMART we will be implementing a programme in collaboration with regulators at the national and EU levels in Europe, and we're confident this will break down many barriers. We're fostering new methods for generating real world evidence which can be included in assessments of effectiveness and we're going to develop new, innovative technical working models across "silos". Ultimately, this project will contribute to the health of Europe's populations."
  Tomas Salmonson, Chair of the EMA's Committee for Medicinal Products for Human Use (CHMP), pointed out that, "If we in this room are going to move this initiative forward, we'll need to get a broad acceptance of what it is we exactly want to achieve. If ADAPT SMART is a train and someone brings a canoe oar, we won't be able to move this train forward at all."
  Near the close of the kick-off session, it was pointed out that one of the key bottlenecks and points of distrust to be addressed through ADAPT SMART is the need to involve both patients and prescribers. Yann le Cam, CEO of EURORDIS said, "We are focusing so much on putting the patients at the centre, we're forgetting that for the products we are addressing the key relationship is between the patient and the doctor at hospital centres, where prescriptions are prescribed and the capture of real world evidence takes place. This will be key to making MAPPs a success."
  In summarising the day, Richard Barker, Founding Director of the Centre for the Advancement of Sustainable Medical Innovation (CASMI) and Chairman of the Precision Medicine Catapult of the UK Government, made the point that there is a need across the entire ADAPT SMART project to ensure that all the public partners agree with the outputs, and the consortium works as an organic ecosystem.
  The final words of the day went to Hans-Georg Eichler, who closed the session by saying, "today, we find ourselves at the start of the project. But in 30 months, let's hope we'll be proud of what we have achieved when we meet at the finish line".
  Fore more photos from the ADAPT SMART kick-off, click here.
  The Innovative Medicines Initiative (IMI) is working to improve health by speeding up the development of, and patient access to, innovative medicines, particularly in areas where there is an unmet medical or social need. It does this by facilitating collaboration between the key players involved in healthcare research, including universities, the pharmaceutical and other industries, small and medium-sized enterprises (SMEs), patient organisations, and medicines regulators. IMI is a partnership between the European Union (represented by the European Commission) and the European pharmaceutical industry (represented by EFPIA, the European Federation of Pharmaceutical Industries and Associations). The second Innovative Medicines Initiative, IMI 2, started in 2014 and will run for 10 years.