The Center for Biomedical System Design (CBSD) in the Tufts Medical Center Institute for Clinical Research and Health Policy Studies (ICRHPS) provides program leadership and serves as the neutral intermediary for the pre-competitive activities within its flagship NEW Drug Development ParadIGmS (NEWDIGS) program.
Founded at MIT in 2009 and relocated to ICRHPS in July 2022, NEWDIGS is a unique collaborative "think and do" tank focused on enhancing the capacity of the global biomedical innovation system to accelerate appropriate, timely, and equitable access for patients to biomedical products. All activities within NEWDIGS focus on driving sustainable patient-centered innovation.
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.
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. NEWDIGS provides a pre-competitive "laboratory" for multi-stakeholder change agents to advance beyond discussions and white papers into hands-on collaborative systems re-engineering.
By bringing together diverse collaborators within a safe haven setting, and leveraging collaborative expertise in systems and financial engineering, this group informs and enables meaningful high-impact change involving the coordinated evolution of technologies, processes, policies and people required to achieve its mission. NEWDIGS successes are built around a proven methodology of interactive multi-stakeholder, case-based simulation exercises.
NEWDIGS has advanced innovations in adaptive licensing of new drug therapies, outcomes-based payment models for durable cell and gene therapies, and real-world learning health systems designed to advance precision medicine.
Emerging work in CBSD introduces and explores an emerging pair of concepts: Biomedical System Readiness and Biomedical Health Efficiency, a framework and measurement approach for identifying, addressing, and measuring the impact of solutions designed to address targeted readiness gaps.
