NEWDIGS Activities

The NEWDIGS initiative is aimed broadly at key areas with potential to transform the healthcare innovation system. NEWDIGS provides an open and transparent platform for stakeholder collaboration to design and test new models for enhancing the value of innovation. NEWDIGS enables participants to conceptualize and validate new policy frameworks, technologies, and development processes.

NEWDIGS activities are structured into discrete modules, each focused on a specific area of innovation.  Within each module, scalable programs are undertaken that combine real-world demonstration projects involving R&D pipeline assets from participating companies with research in science, engineering, management, and clinical medicine, led by MIT and the Harvard-MIT Division of Health Sciences and Technology. Each demonstration project is evaluated for success in terms of specific measurable improvements, while also informing the design of a future, better innovation system. The tight coordination between research and demonstration projects within NEWDIGS enables rapid cycle learning and the generation of rigorous evidence designed to provide a strong foundation for redefining the healthcare innovation system.

NEWDIGS’ initial program in Global Regulatory Systems is focused on evaluating components of more flexible, adaptive regulatory models, with an initial focus on Adaptive Licensing (AL).  AL 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 AL 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 methodology for empirically testing healthcare policy designs in order to inform recommendations for legislative reforms.

To design and execute these activities, NEWDIGS is working with Singapore’s Health Sciences Authority, a leading innovator in Asia, and is drawing on the expertise of stakeholders from across the healthcare value chain.

Oncology

There is a growing appreciation that effective cancer therapies must target multiple cellular pathways. The emerging science, together with the recently issued FDA guidance document on co-development of combination therapies, presents a timely opportunity for translational medicine.  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.