Accelerated Development of Appropriate Patient Therapies
a Sustainable, Multi-stakeholder Approach from Research to Treatment-outcomes
Moving MAPPs into Practice through ADAPT SMART’s Legacy Now that the ADAPT SMART project is coming to a close, one of the project’s goals was to develop the frameworks and knowledge base that could put MAPPs into practice in Europe. In an interview with Hans-Georg Eichler and Solange Corriol-Rohou, the sustainability approach of [...]
How will the normal timelines be impacted by MAPPs given there is no hard starting point? The Centre for the Advancement of Sustainable Medical Innovation (CASMI) is one of the world’s thought leaders in the theory and implementation of adaptive pathways and a very active partner in the ADAPT SMART project. Stuart Faulkner [...]
Has ADAPT SMART been successful in changing the way we think about approving new therapies? Ad Schuurman sits at the confluence of three key circles in European healthcare. His principal day job is at the National Health Care Institute of the Netherlands (Zorginstituut Nederland), but he is currently seconded to the EMA, and [...]
Have Stakeholders Been More Involved at the Centre of Decision Making? Yann Le Cam from Eurordis and Mathieu Boudes from the European Patients’ Forum, two of Europe’s leading patient representatives participating in ADAPT SMART, discussed adaptive pathways from the patient perspective. EURORDIS is a non-governmental patient-driven alliance of patient organisations representing 792 rare disease [...]
Evidence Generation Throughout the Life Cycle The National Institute for Health and Care Excellence (NICE) provides national guidance and advice to improve health and social care in England. NICE co-leads work package 1 of ADAPT SMART on ‘evidence generation throughout the product life-cycle’ and has contributed to the work on the suitability of [...]
Work-stream D3.09 has explored some general ethical and legal issues that may arise through the introduction of the MAPPs concept, the implications for each stakeholder – in particular, patients and healthcare professionals (HCP) – and any liability change or shift between stakeholders and ethical considerations of prescribing control.
One of the original thought leaders of the concept of Adaptive Pathways was the NEWDIGS initiative of MIT's Center for Biomedical Innovation. ADAPT SMART has had the pleasure of collaborating with NEWDIGS throughout. ADAPT SMART interviewed NEWDIGS Strategic Director Mark Trusheim about the interactive case study he will facilitate at the ADAPT SMART closing event, as well as some of their current research.
Within the ADAPTSMART consortium, the remit of work-stream D3.08 has been to explore general ethical and legal issues that may arise through the introduction of the MAPPs concept, the implications for each stakeholder - in particular, patients and healthcare professionals (HCP), and what recommendations could be made to mitigate against identified issues. Specific legal issues relating to intellectual property law are the subject of another ADAPTSMART work-stream and are not discussed here.
A broad review of the main legal areas governing medicinal product development, approval and market access, in the context of MAPPs, was undertaken - except any potential impact of MAPPs on Intellectual Property and Regulatory Exclusivity Rights that will be analysed by D3.06 working group, within Work Package 3. The two documents should be read and understood together.
A broad review of the rules governing IP and RER as they are today, and with respect to MAPPs, was undertaken in the context of the following 4 scenarios deemed likely to occur with MAPPs: (i) Stand-alone MA (i.e. single indication only); (ii) MA with subsequent indications with the same compound, i.e. indication 1, subsequently followed by indication 2; (iii) MA under exceptional circumstances or conditional approval that subsequently gets approved for ‘full’ MA; and (iv) MA (full, conditional, or exceptional MA) that subsequently is revoked / suspended from a regulatory perspective. Any direct legal impact of MAPPs were assessed along with an exploration of several perceptual issues pertaining to the incentives of adopting and using MAPPs from an IP and RDP perspective.
