Five Companies Join NEWDIGS to Support Regulatory Science, Cancer Innovation


Gigi Hirsch, MD
Executive Director

For Immediate Release

Bristol-Myers Squibb, Johnson & Johnson, Life Technologies, Pfizer, and Quintiles Join NEWDIGS to Support Initiatives in Regulatory Science and Oncology Innovation

(June 2, 2011)

Cambridge, MA – June 2, 2011, MIT’s Center for Biomedical Innovation (CBI) today announced that five companies—Bristol-Myers Squibb, Johnson & Johnson Corporate Office of Science and Technology, Life Technologies, Pfizer, and Quintiles have joined CBI’s NEWDIGS (NEW Drug Development ParadIGmS) program as members to support the launch of its first demonstration projects in regulatory science and oncology innovation. NEWDIGS focuses on redesigning the healthcare innovation system to deliver greater value to all stakeholders and to ensure its sustainability.

“All stakeholders involved in developing and delivering healthcare innovations face enormous challenges in translating new science and technology into public health value,” said Thomas Unger, PhD, Executive Director, Worldwide Regulatory Strategy, Pfizer, Inc. “It is urgent that we find new ways to improve the efficiency and the effectiveness of innovation in the healthcare industry. NEWDIGS provides a unique opportunity for disruptive innovation at the level of the overall system, rather than simply improving the current environment.”

“These five companies have recognized the merits of NEWDIGS’ approach and the opportunities it presents to establish the new forms of cross-stakeholder collaboration that are needed to drive transformation of the industry,” said Anthony Sinskey, ScD, CBI’s Faculty Director and Professor of Biology, and Health Sciences and Technology (HST), and Engineering Systems at MIT.

The five members are contributing funding, human and intellectual capital, and other resources such as R&D compounds and data, to NEWDIGS projects.

The NEWDIGS approach brings together pharmaceutical R&D pipeline assets, business model and technology innovation, and research in science, engineering, management, and clinical medicine, to create real-world demonstration projects. The tight cross-sector coordination, led by MIT and HST, enables rapid cycle learning and the generation of the rigorous evidence needed to provide a foundation for new approaches to drug development within the global healthcare industry.

NEWDIGS’ initial program in regulatory science is focused on evaluating components of more flexible, adaptive regulatory models, with an initial focus on Progressive Authorization. (PA). PA seeks to maximize the public health benefits of new drugs while balancing the need for both timely access and appropriate information on benefits and risks. NEWDIGS is launching a series of demonstration and research activities to understand the design elements, and the impact of PA on a number of therapeutic areas and drug classes. In addition, critical technology, process, and policy enablers for the successful implementation of adaptive regulation will be developed and evaluated in the context of the demonstration projects.

One goal of NEWDIGS activities in regulatory science is to develop a rigorous methodology for empirically evaluating healthcare policy designs under specific situations in order to inform consideration of evolving standards, practices, and potential reform proposals.

To design and execute these activities, NEWDIGS is working with Singapore’s Health Sciences Authority, a leading innovative regulatory and scientific authority in Asia, and is drawing on the expertise of stakeholders from the pharmaceutical industry, other global regulatory authorities, payors, patients, and clinicians.

“HSA is committed to advancing more flexible and adaptive regulatory models that can help reduce the time and cost to develop high quality, safe and innovative treatments,” said Dr. John Lim, CEO of the Health Sciences Authority of Singapore. “These new models may also provide the opportunity for regulators, clinicians and patients to obtain important data prospectively to help address long standing questions of how heterogeneous patient populations respond to new drugs.”

NEWDIGS’ first oncology program will focus on advancing the co-development of two or more investigational drugs into combination treatments, including the creation of cooperative business models that allow for combining the assets of multiple companies.

NEWDIGS is supported at MIT through a strategic advisory team that includes, Phillip Sharp, Ph.D, Institute Professor and Nobel Laureate; Dr. Sinskey; Ram Sasisekharan, Ph.D., HST’s Director and Edward Hood Taplin Professor of Health Sciences and Technology and Biomedical Engineering; and Charles Cooney, Ph.D., Robert T. Haslam Professor of Chemical Engineering.


Massachusetts Institute of Technology’s (MIT) NEWDIGS program is a unique, collaborative platform with a vision for transforming the healthcare innovation system to deliver greater value to all stakeholders and to ensure its sustainability. NEWDIGS integrates a coordinated network of innovation test bed environments for “real world” demonstration projects, tightly coordinated with research in science, engineering, management, and clinical medicine, led by MIT and the Harvard-MIT Division of Health Sciences and Technology (HST). This systems approach enables rapid cycle learning in the testing, validation, and continuous improvement of transformational “levers” in technology, process, and policy designed to accelerate our collective capacity to diagnose, treat, and prevent disease. NEWDIGS participants include senior leaders in biopharmaceutical firms, regulators, payors, patients, providers, and other key stakeholders from the global healthcare industry.

About CBI

CBI’s mission is to improve global health by overcoming obstacles to the development and implementation of biomedical innovation. CBI provides an open and transparent environment for collaborative research among industry, academia, and government, and draws on the expertise of MIT’s schools of engineering, science, and management, as well as HST. Residing within the MIT Engineering Systems Division (, CBI catalyzes research by targeting areas where breakthroughs would have important and immediate impact on healthcare innovation, productivity, regulation and practice. Learn more at: