Welcome to MIT NEWDIGS

MIT’s NEW Drug Development ParadIGmS (NEWDIGS) program is a unique collaborative “think and do” tank focused on enhancing the capacity of the global biomedical innovation system to reliably and sustainably deliver new, better, affordable therapeutics to the right patients faster. MIT NEWDIGS takes a systems approach to designing, evaluating and catalyzing important advancements that are so complex and cross-cutting that they cannot be addressed by a single organization or market sector. Its first project area was focused on catalyzing the evolution of global pharmaceutical regulation.

Developing and delivering new, effective and affordable drugs to patients is a complex challenge involving manufacturers, regulators, payers, providers, academic researchers and patients—all of whom are operating within a dynamic social, political and economic environment. While the approach that each stakeholder takes may be appropriate in isolation, the divergent actions within this innovation ecosystem compromise our collective ability to serve the needs of patients effectively.

By bringing together diverse collaborators within a safe haven setting, and leveraging MIT expertise in systems engineering, this group is well positioned to inform and enable meaningful high-impact change involving the coordinated evolution of technologies, processes, policies, and people required to achieve its mission.

The MIT Center for Biomedical Innovation (CBI) provides program leadership and serves as the neutral intermediary for the pre-competitive activities within NEWDIGS.

NEWDIGS has been approached by a number of parties to replicate its work in regulation to address other complex, system-level challenges in biomedical and healthcare innovation. Updates on new areas of activity within NEWDIGS are anticipated within the coming months.


Save the Date

NEWDIGS to host Next Wave Forum
Gathering at MIT to map strategies for Platform Trials and Rapid Learning Systems
Read more

2017 Design Labs

NEWDIGS Hosts Design Lab on New Gene and Oncology Therapy Financing Models
Industry leaders, patient advocates, policymakers collaborate to lower barriers to potentially curative treatments Read more
Part of the 2017 Design Lab series: Learn more

Recent news

MIT NEWDIGS Director and advisor speak at LIGHT Forum on AI in Healthcare
AI and machine learning key enablers of healthcare value, expert panel says Read more

Recent publications

Clinical Pharmacology and Therapeutics Special Issue on Adaptive Biomedical Technology
Special Issue of Clinical Pharmacology & Therapeutics spotlights Adaptive Biomedical Innovation
Read more
FoCUS Initiative

NEWDIGS convenes healthcare leaders to pioneer new pharmaceutical financing strategies

October 27, 2016

Patient advocates, healthcare payers, industry, and academic stakeholders gathered today at the Massachusetts Institute of Technology (MIT) to map out a new strategy for designing and piloting innovative financing and reimbursement models for promising, and possibly curative, new medicines. The project is called Financing and Reimbursement of Cures in the US (FoCUS).

FoCUS will initially target three urgent medical areas—Curative Gene Therapies, Durable Oncology Treatments, and Antibiotics for Multi-Drug Resistant Infections. Working groups will use components of a dynamic design “toolkit” to tailor innovative finance and reimbursement models that address different characteristics of curative therapy types.

Read the news