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Center for Biomedical System Design

About

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
phirsch@tuftsmedicalcenter.org
617.636.7792

Azrina Azhar
Project Director
nazhar@tuftsmedicalcenter.org
617.636.7785

Jane F. Barlow, MD, MPH, MBA
Senior Advisor, FoCUS Project
jbarlow@tuftsmedicalcenter.org

Amita Dasmahapatra, MD
Senior Advisor, LEAPS
adasmahapatra@tuftsmedicalcenter.org

Karen Geary, MHA
Senior Advisor, FoCUS
Paying for Cures Toolkit Team Lead
kgeary@tuftsmedicalcenter.org

John Glasspool
Senior Advisor, FoCUS
tuftsmcnewdigs@tuftsmedicine.org

Keileen Hopps
Program Manager
khopps@tuftsmedicalcenter.org
617.636.7899

Fotios Kokkotos, PhD
Director of Data Science
fkokkotos@tuftsmedicalcenter.org
978.314.7937

Kay Larholt, ScD
Senior Advisor, NEWDIGS
klarholt@mit.edu

Tsega Meshesha, MS
Program Manager
617.636.2570
tmeshesha@tuftsmedicalcenter.org

Casey Quinn, PhD
Research Advisor, FoCUS
cquinn5@tuftsmedicalcenter.org

Eric A. Small
Program Manager
esmall@tuftsmedicalcenter.org
617.636.4491

Mark Trusheim, MSc
Strategic Director
mtrusheim@tuftsmedicalcenter.org

Colin Young, PhD
Director, Drug Development Pipeline Research
cyoung2@tuftsmedicalcenter.org
617.636.8747

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