Adaptive Biomedical Innovation: Evolving Our Global System to Sustainably and Safely Bring New Medicines to Patients in Need

Abstract

The current system of biomedical innovation is unable to keep pace with scientific advancements. We propose to address this gap by reengineering innovation processes to accelerate reliable delivery of products that address unmet medical needs. Adaptive biomedical innovation (ABI) provides an integrative, strategic approach for process innovation. Although the term “ABI” is new, it encompasses fragmented “tools” that have been developed across the global pharmaceutical industry, and could accelerate the evolution of the system through more coordinated application. ABI involves bringing stakeholders together to set shared objectives, foster trust, structure decision‐making, and manage expectations through rapid‐cycle feedback loops that maximize product knowledge and reduce uncertainty in a continuous, adaptive, and sustainable learning healthcare system. Adaptive decision‐making, a core element of ABI, provides a framework for structuring decision‐making designed to manage two types of uncertainty – the maturity of scientific and clinical knowledge, and the behaviors of other critical stakeholders.

Frameworks for Evaluating Medicines in Children

“…Multistakeholder forays are important and potentially productive ways to minimize research waste and maximize the benefits of research. 25,41,42 Work toward a shared and interoperable framework at strategic 43 and practical levels 44 is an important goal and pediatrics is at the forefront of these activities. Data sharing requires technical and semantic interoperability, which is under development in pediatrics.…”

Leaping Together Toward Sustainable, Patient‐Centered Innovation: The Value of a Multistakeholder Safe Haven for Accelerating System Change

“…Adaptive biomedical innovation (ABI) is a principle‐driven approach to the development, access, and use of biomedical products that enables sustainable, patient‐centered innovation . ABI represents a broadening of lessons learned from the Massachusetts Institute of Technology (MIT) New Drug Development Paradigms (NEWDIGS) Adaptive Licensing Project (2011–2014) and the related European Medicines Agency (EMA)–led Adaptive Pathways pilot project (2014–2016) .…”

The DIY Digital Medical Centre

“…This has led to significant fragmentation of clinical expertise, healthcare responsibilities, patient data, financing and infrastructure, policy development and governance, etc., and thus collectively provide for major potential to improve efficiency and cohesion (see e.g. Hirsch et al, 2016;Stange, 2009). In addition, diverse factors, such as increases in life expectancy and average income, health system configuration, (Chernew and Newhouse, 2011), etc., have substantially contributed to unsustainable rates of expenditure increases for what is arguably our most valued public service.…”