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Clin Pharmacol Ther. 2016 Dec;100(6):685-698. doi: 10.1002/cpt.509. Epub 2016 Oct 22.

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

Author information

1
Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
2
Merck, Kenilworth, New Jersey, USA.
3
Sanofi, Seattle, Washington, USA.
4
National Institute for Health and Clinical Excellence (NICE), London, UK.
5
Bill and Melinda Gates Foundation, Seattle, Washington, USA.
6
Health Canada, Ottawa, Ontario, Canada.
7
Aetna, Hartford, Connecticut, USA.
8
National Organization for Rare Disorders (NORD), Danbury, Connecticut, USA.
9
Tufts University, Boston, Massachusetts, USA.

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.

PMID:
27626610
PMCID:
PMC5129677
DOI:
10.1002/cpt.509
[Indexed for MEDLINE]
Free PMC Article

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