CAMBRIDGE, MASSACHUSETTS, 12 DECEMBER 2017— MIT’s Center for Biomedical Innovation announced today its New Drug Development Paradigms (NEWDIGS) Initiative will pilot a next generation healthcare innovation ecosystem designed to deliver more value from new medicines to patients faster, in ways that work for all parties.
The Learning Ecosystems for Accelerating Patient-Centered and Sustainable Innovation Project (LEAPS) focuses on connecting knowledge generation across the siloes of drug development (R&D) and delivery (patient care) through platform clinical trials linked with a real-world evidence “Learning Engine.” The first pilot in LEAPS will leverage Massachusetts as a statewide testbed.
“While pharmaceutical R&D 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 US,” said Gigi Hirsch, M.D., Executive Director of the MIT Center for Biomedical Innovation and the NEWDIGS Initiative. “Our goal is to integrate a number of emerging but fragmented policy, process, and technology innovations into a system that works better for everyone, and especially for patients.”
LEAPS will leverage proven 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,” said Massachusetts Health and Human Services Secretary Marylou Sudders. “By engaging the entire health care systems 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.”
LEAPS project design 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:
- 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/disease registries.
- Accelerating healthcare insights from data analytics tools such as artificial intelligence, machine learning, and blockchain technologies.
- Establish community hospitals and clinics as key elements of the broader innovation ecosystem.
“Massachusetts is uniquely suited to serve as the testbed 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,” said Robert K. Coughlin, President and CEO of the Massachusetts Biotechnology Council (MassBio).
Current NEWDIGS collaborative members GSK, Merck, and Sanofi are providing the $500K start-up funding, with other corporate and nonprofit members contributing in-kind resources.
“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,” said Susan Shiff, PhD, MBA, Senior Vice President and Head of the Center for Observational and Real World Evidence (CORE) at Merck.
Elements of the strategic vision for LEAPS will be explored in the Next Wave Forum (http://nextwaveforum.org), hosted by NEWDIGS on December 12-13, 2017 in Cambridge, Massachusetts. The event includes keynote speakers Janet Woodcock (FDA), Hans-Georg Eichler (European Medicines Agency), Trent Haywood (Blue Cross Blue Shield), Donald Berwick (former 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 https://newdigs.mit.edu/leaps
Project leader Dr Gigi Hirsch (Executive Director, MIT Center for Biomedical Innovation and NEWDIGS Initiative) announces LEAPS at the Next Wave Forum on December 12. Also pictured, left to right: Krystyn, J. Van Vliet, Associate Provost, MIT; Kourtney Davis, Global Head of Real World Data and Analytics, GlaxoSmithKline; Felipe Dolz, Vice President Global Regulatory Science and Policy at Sanofi; and Elizabeth J. Cobbs, Executive Director, HTA Strategy at Merck & Co., Inc.
About MIT NEWDIGS
MIT NEW Drug Development ParadIGmS (NEWDIGS) is an international “think and do tank” dedicated to delivering more value faster to patients, in ways that work for all stakeholders. NEWDIGS designs, evaluates, and initiates advancements that are too complex and cross-cutting to be addressed by a single organization or market sector. Its members include global leaders from patient advocacy, payer organizations, biopharmaceutical companies, regulatory agencies, clinical care, academic research, and investment firms. For more information, visit http://newdigs.mit.edu.