What is the New Drug Development Paradigms initiative (NEWDIGS)?

Founded at the Massachusetts Institute of Technology in 2009, NEWDIGS is a collaborative “think and do” tank focused on enhancing the capacity of the global biomedical innovation system to deliver the right treatments to the right patients at the right time, in ways that are sustainable for all healthcare stakeholders. NEWDIGS designs, evaluates, and catalyzes health system innovations that are too complex and cross-cutting to be addressed by a single organization or market sector.

How does NEWDIGS work?
We can’t get where we need to go one silo at a time. We focus on patient-centered challenges that no single stakeholder can address alone.

NEWDIGS engages a diverse community of stakeholders—patient advocates, clinicians, provider systems, healthcare payers, drug therapy developers, diagnostics companies, academic researchers, investors, and others—in its participatory design processes to balance all interests, overcome barriers and align incentives. NEWDIGS acts as a neutral intermediary between these players to integrate, shepherd, and catalyze change on a systems level, producing solutions that can be generalized beyond a single product, disease, or case.

NEWDIGS provides a safe haven design laboratory for stakeholders who make clinical, business, research and policy decisions to work together – across silos – on new approaches to reducing uncertainty, managing risks, and most importantly: getting the best treatments to patients in timely ways.

Why is NEWDIGS important?
Helping the system catch up with the science.

Science is advancing rapidly in exciting ways, leading to the emergence of long awaited treatments that address unmet medical needs. But to fully capture the value of these new therapies, we need to make sure that the right patients can access them. Overcoming barriers to access that currently exist requires a new approach (multi-stakeholder collaboration) and focus (downstream, or “post-market”, system innovation), reflected in two current projects of NEWDIGS:

LEAPS (Learning Ecosystems Accelerator for Patient-centered, Sustainable Innovation) Project
LEAPS seeks to modernize how we plan, produce, and use real world evidence (RWE) in order to optimize drug therapy regimens for patients. LEAPS seeks to improve patient outcomes in economically sustainable ways through new patient-centered learning healthcare system designs, RWE platform infrastructures, and alignment of incentives across stakeholders. Design collaborators in LEAPS include patient advocacy groups, clinicians, provider systems, healthcare payers, biopharmaceutical and diagnostics companies, regulators, and academic researchers in data science, informatics, biostatistics, epidemiology, and healthcare policy, financing, and reimbursement.

FoCUS (Financing and Reimbursement of Cures in the US) Project
Medical research is making significant advances toward treatments that cure major diseases, but these treatments will often entail very high up-front costs. The FoCUS Project seeks to collaboratively address the need for new, innovative financing and reimbursement models for durable therapies in the US that ensure (1) patient access for needed treatments; (2) affordability for public and private payers; and (3) the sustainability of innovation by manufacturers. This multi-stakeholder effort unites developers, providers, regulators, patient advocacy groups, payers from all segments of the US healthcare system, and academics working in healthcare policy, financing, and reimbursement.

How can my organization get involved?
NEWDIGS consortium members benefit from their participation by helping to shape and gain early strategic insights into next generation solutions; collaboration with other stakeholders and experts; and an environment/tools for driving real-world impact toward shared goals of improving patient outcomes in economically sustainable ways.

Participation in NEWDIGS can take many forms, from receiving periodic newsletters to fully participating in closed-door working team meetings to co-authoring of publications. Consortium Members receive direct access to the Executive Team, as well as guaranteed seats on working teams, advisory roles, and Design Lab participation. Our Design Lab attendees include a carefully curated community of collaborators and experts who share the goals and ideals of NEWDIGS. Opportunities also exist for collaboration on sponsored research projects and joint grant proposals.

To learn more and get started, write to tuftsmcnewdigs@tuftsmedicine.org.

About Tufts Medicine and Tufts Medical Center
Tufts Medicine is the parent organization of Tufts Medical Center, a world renowned 415-bed academic medical center in Boston that cares for the sickest patients in the region, includes a level one trauma center and one of the largest heart transplant centers in New England, and also serves as the primary health system of Tufts University School of Medicine. Tufts Medicine is also the parent organization of Lowell General Hospital, MelroseWakefield Healthcare, an expansive home care and hospice network, and a large clinically integrated physician network that cares for more than one million patients per year. The health system is dedicated to providing patients with the highest quality of care as close to home as possible.

About the Institute for Clinical Research and Health Policy Studies
The Institute for Clinical Research and Health Policy Studies (ICHPS) within Tufts Medical Center is a distinct environment to conduct and collaborate on clinical, health services and health policy research. The mission to do research that ultimately has an impact on health has generated groundbreaking studies and new approaches in work that spans biomedical and clinical sciences, behavioral and social sciences, community engaged research, public health studies, and health policy research.

About the Center for Biomedical System Design
The Center for Biomedical System Design (CBSD) is the home for NEWDIGS within the Tufts Medical Center Institute for Clinical Research and Health Policy Studies. Strategic plans for CBSD are now being defined and will prioritize initiatives that accelerate and amplify the real-world national and global impact of emerging NEWDIGS solutions.

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