The MIT Center for Biomedical Innovation on Dec. 12 announced its New Drug Development Paradigms (NEWDIGS) initiative to pilot a next-generation health care innovation ecosystem. This pilot is designed to deliver more value from new medicines to patients at a faster pace, in ways best suited for all parties. Current NEWDIGS collaborative members GlaxoSmithKline, Merck, and Sanofi are providing the $500,000 startup funding, with other corporate and nonprofit members contributing in-kind resources.
One component of the NEWDIGS approach is the Learning Ecosystems for Accelerating Patient-Centered and Sustainable Innovation (LEAPS) Project, which focuses on connecting knowledge generation across the silos of drug development and patient care through platform clinical trials linked with a real-world, evidence learning engine — a system for managing and sharing knowledge across stakeholders. The first pilot in LEAPS will leverage Massachusetts as a statewide test bed.
“While pharmaceutical research and development is a global enterprise, the value of new medicines is assessed and driven locally. This has always been true in other countries, but is increasingly the case in the U.S.,” says Gigi Hirsch, executive director of the MIT Center for Biomedical Innovation and of the NEWDIGS initiative. “Our goal is to integrate emerging but fragmented innovations in policy, process, and technology into a system that works better for everyone, and especially for patients.”
LEAPS will leverage NEWDIGS methods and tools for collaborative systems engineering involving patients, providers, payers, biotechnology and pharmaceutical companies, information technology firms, regulators, payers, public health officials, and academic researchers.
“It is critically important that we align priorities in pharmaceutical drug development with unmet public health needs,” says Massachusetts Health and Human Services Secretary Marylou Sudders. “By engaging the entire health care system and its key stakeholders, this pilot project has the potential to serve as a model for person-centered health care and break down barriers that currently exist when linking patients with timely, essential treatments.”
The LEAPS project will launch in January 2018. Target diseases under consideration for the pilot are rheumatoid arthritis, Type 2 diabetes, Alzheimer’s disease, and opioid addiction. Objectives, beyond improving patient outcomes, include the following:
- Enhancing the value of the growing array of disparate data and evidence from electronic medical records and insurance claims to mobile apps and longitudinal patient and disease registries;
- Accelerating health care insights from data analytics tools such as artificial intelligence, machine learning, and blockchain technologies; and
- Establishing community hospitals and clinics as key elements of the broader innovation ecosystem.
“Massachusetts is uniquely suited to serve as the test bed for this pilot project, which offers an exciting opportunity to better serve patients by connecting the unparalleled strengths of the state’s biocluster, world renowned provider systems, and payers, who play an increasingly important role in access to new products,” says Robert K. Coughlin, president and CEO of the Massachusetts Biotechnology Council.
“We look forward to building on the work we have done with the NEWDIGS collaborative to design and pilot a next-generation biomedical innovation system in Massachusetts. Done well, we believe this effort can help transform the way new therapies are developed and delivered, and serve as a model to replicate in other states, and for other diseases,” says Susan Shiff, senior vice president and head of the Center for Observational and Real-World Evidence at Merck.
Elements of the strategic vision for LEAPS were explored in the Next Wave Forum, hosted by NEWDIGS on Dec. 12-13, in Cambridge, Massachusetts. The event included keynote speakers Janet Woodcock (Food and Drug Administration), Hans-Georg Eichler (European Medicines Agency), Trent Haywood (Blue Cross Blue Shield), Donald Berwick (formerly Centers for Medicare and Medicaid, and Institute for Healthcare Improvement), and MIT’s Alex “Sandy” Pentland, Jonathan Gruber, and Michael Cusumano.
Further details on MIT NEWDIGS LEAPS are available at newdigs.mit.edu.