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Center for Biomedical System Design


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 reliably and sustainably deliver new, better and affordable therapeutics to the right patients faster. 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.

A broad range of new initiatives are now under consideration for launch within CBSD, all centered around accelerating and amplifying real-world impact from downstream system design innovations developed to date in NEWDIGS.

CBSD researchers + staff

Gigi Hirsch, MD
Executive Director
Center for Biomedical System Design & NEWDIGS

Azrina Azhar
Project Director

Jane F. Barlow, MD, MPH, MBA
Senior Advisor, FoCUS Project

Amita Dasmahapatra, MD
Senior Advisor, LEAPS

Karen Geary, MHA
Senior Advisor, FoCUS
Paying for Cures Toolkit Team Lead

John Glasspool
Senior Advisor, FoCUS

Keileen Hopps
Program Manager

Fotios Kokkotos, PhD
Director of Data Science

Kay Larholt, ScD
Senior Advisor, NEWDIGS

Tsega Meshesha, MS
Program Manager

Casey Quinn, PhD
Research Advisor, FoCUS

Eric A. Small
Program Manager

Mark Trusheim, MSc
Strategic Director

Colin Young, PhD
Director, Drug Development Pipeline Research

Center for Biomedical System Design
The Institute for Clinical Research and Health Policy Studies
Tufts Medical Center
800 Washington Street, Box #63
Boston, MA 02111
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