Adaptive Biomedical Innovation
Science is advancing in exciting ways, bringing long awaited cures increasingly within reach. In many ways, though, the science is advancing faster than the “system” – the policies, processes, and structures that shape the path for new medicines to patients. This evolutionary lag creates challenges for all stakeholders in the biomedical innovation ecosystem – and most importantly, it can delay or prevent access for patients to new, needed treatments.
The traditional innovation system needs to be modernized, but closing the evolutionary gap between the pace of scientific advancements and the system that shepherds innovation through to impactful medical treatments is a massive undertaking in terms of scope, scale, and complexity. The system is evolving, but in fragmented ways across traditional stakeholder, expert, and geographic siloes. “Adaptive Biomedical Innovation” (ABI) – a term coined by NEWDIGS – offers a shared vision and general principles to foster greater efficiency, coordination, and effectiveness as this evolution continues to unfold.
ABI focuses on aligning stakeholders in ways that drive sustainable patient-centered innovation, applying the principles of continuous learning and improvement across the product life span in ways that: (1) optimize benefit/minimize harm for patients, (2) progressively enhance knowledge and reduce uncertainties about the treatment, and (3) incorporate acceptable tradeoff decisions for all stakeholders.
NEWDIGS’ first project (2010-2013) in ABI focused on “Adaptive Licensing”. Findings have been widely disseminated through publications and conferences and have helped to inform the European Medicines Agency (EMA) ‘Medicines Adaptive Pathways to Patients’ (MAPPs) pilot rogram which was initiated in March 2014. MAPPs is a version of ABI that has been tailored for Europe, but many of its underlying principles have universal relevance. NEWDIGS remains actively involved supporting related activities in the EU while also enabling coordinated advancements and shared learning in ABI across regions globally.