Learning Ecosystems Accelerator for Patient-centered, Sustainable innovation

Our successful transition to value-driven healthcare, where biomedical innovation is both patient-centered and sustainable, depends largely upon our ability to generate better evidence, more efficiently, to enable better decision-making for all stakeholders across the value chain of research and development (R&D) and healthcare delivery (patients, manufacturers, regulators, payers, providers, and academic researchers).

The goal of the LEAPS Project is to design and pilot an innovation ecosystem for one disease that drives more value, faster, to patients, in ways that work for all stakeholders. Ultimately, patients will receive timely access to the most appropriate therapeutics for their needs, and stakeholders will have the evidence they need, when they need it, to improve their decisions related to the development, access, and use of therapeutics for the target disease. Decision-making will be improved through the collaborative design of a distributed, purpose-driven evidence generation infrastructure – the LEAPS “Learning Engine”- that stakeholders both contribute to and benefit from, in order for it to be efficient, scalable, and sustainable over time.

The LEAPS Project provides a unique opportunity for stakeholders to collaborate on the design of a next-generation innovation ecosystem for a target disease. This showcase prototype will be piloted using Massachusetts as a statewide, testbed environment. LEAPS will leverage proven NEWDIGS methods and tools in designing and catalyzing pilot activities.

Participants in the first LEAPS Design Lab in July 2018 were tasked with considering disease areas offering the prospect of significant healthcare impact and identifying early practical and technical challenges to the pilot project’s success.  Four possible diseases were considered and discussed: Asthma, Type 1 Diabetes, Type 2 Diabetes, and Rheumatoid Arthritis.

After careful deliberation with the MIT CBI Leadership Team, the LEAPS Strategic Advisory Network, and the LEAPS Steering Committee, the program will advance Rheumatoid Arthritis (RA) as the primary target for the MA Pilot project.  In addition, building on input from the Design Lab, Asthma will become a secondary disease target, helping the teams to make sure that the toolkits and learnings are scalable in different disease areas.  Though RA will move forward as the first pilot, LEAPS hopes to catalyze other pilots through dissemination of its generalizable principles for application in other disease ecosystems.

LEAPS will drive impact in three critical domains: product innovation, regimen optimization, and disease modification/prevention. Its work streams will evolve over time but are guided initially by the following aims:

  • Enhance evidence planning and production across the drug development life span to fuel sustainable, patient-centered innovation
  • Apply systems engineering methods and tools to enable seamless, continuous learning and improvement across the innovation value chain (from R&D to care delivery) for a target disease
  • Assess potential applications of transformative technologies and methods, such as blockchain and artificial intelligence/machine learning

Elements of the strategic vision for LEAPS were explored at the Next Wave Forum hosted by MIT NEWDIGS on December 12-13, 2017 in Cambridge, Massachusetts. The 2-year pilot design phase of LEAPS was launched in January 2018.

Image of research documents Image of man jumping a chasm from research to medical care Screen capture from video, Gigi speaking with David Image of documents, databases, and other work symbols in a cloud
Research and publications
Get original LEAPS Project research and learn about the complex challenges and potential solutions for a patient- and disease-oriented learning ecosystem

LEAPS Overview 2021
Get an overview of the project, see who's involved, and learn how to get involved.

LEAPS Playbook v2.0
An overview of the evolution of the LEAPS Project from its inception through December 2020.

LEAPS video and interviews
Gigi Hirsch discusses LEAPS and the NEWDIGS initiative for SSRC

Gigi Hirsch interviewed for The Evidence Forum
LEAPS news
Scipher Medicine is the latest NEWDIGS collaborator for the LEAPS Project

Cerevel Therapeutics joins LEAPS as a new collaborator

IQVIA joins NEWDIGS Initiative at MIT

W2O named first LEAPS Pioneer Site

Dynamic Dossier in the Cloud (first LEAPS Incubator project)

LEAPS December 2019 Design Lab

LEAPS June 2019 Design Lab

LEAPS December 2018 Design Lab

LEAPS July 2018 Design Lab

PPD Evidera joins LEAPS

MIT News of the LEAPS the launch announcement

The Next Wave in Adaptive Biomedical Innovation: Advancing Platform Trials into End-to-End Rapid Learning Systems