Progress in life sciences and related technologies offers the potential to bring a wide range of beneficial new therapies to patients over the coming years. There will be more personalised or stratified medicines, drug-device products, and advanced therapies that may require new ways of evaluation and managing, following utilisation in daily clinical practice while investigating patients’ populations that could best benefit of them.
Today’s paradigms of bringing innovation to patients are also challenged by transformative environmental developments: growing patient demand for timely access to promising therapies, increased fragmentation of patient populations due to better disease stratification, increased payer influence on product accessibility to patients, and pressure on pharma/investors to ensure sustainability of drug development. To address these environmental changes, while maximising the potential of scientific progress for patients in a timely and sustainable way, one needs major “adaptations” to current paradigms, albeit staying in the current EU legal framework.
The changes required go far beyond the well-defined remit of today’s regulatory evidence standards. We posit that all decision makers and stakeholders in the healthcare ecosystem will need to explore an integrated and holistic life-span approach to drug development, marketing authorisation (MA) and pricing and reimbursement (P&R) and use in daily clinical practice and monitoring. This life-span approach is hereafter referred to as Medicines Adaptive Pathways to Patients (MAPPs).
The overall scope of the project is to establish an enabling platform for the coordination of MAPPs related activities and engage a direct and open dialogue with all relevant stakeholders. MAPPs seeks to foster patient access to beneficial treatments for the right patient groups at the earliest appropriate time in the product life-span in a sustainable fashion.
Currently, several initiatives are exploring new pathways to market, e.g. the EMA’s Adaptive Pathway project, the New Drug Development Paradigms (NEWDIGS) initiative at Massachusetts Institute of Technology (MIT, USA), or the UK's Early Access to Medicines Scheme (EAMS). Parties directly involved with these initiatives, or other related projects such as IMiPACT or IMI GetReal, are joining forces in ADAPT SMART with the aim of defining and helping to implement the MAPPs concept.
ADAPT SMART is thus aligning a number of major EU stakeholders and acts as a neutral collaborative platform to engage with all relevant stakeholders, including patients’ organisations, industry, SMEs (Small and Medium sized Enterprises), regulators, Health Technology Assessment bodies (HTAs), payers (national and European Networks), academia representatives, and governments/policy makers.
