“All stakeholders involved in developing and delivering health care innovations face enormous challenges in translating new science and technology into public-health value,” said Thomas Unger, the executive director for worldwide regulatory strategy at Pfizer, Inc. “It is urgent that we find new ways to improve the efficiency and the effectiveness of innovation in the health care 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, CBI faculty director, who is a professor of biology and engineering systems at MIT and of health sciences and technology at the Harvard-MIT Division of Health Sciences and Technology (HST).
The five new members will contribute 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 health care 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 health care policy designs under specific situations in order to inform consideration of evolving standards, practices and potential proposals for reform.
To design and execute these activities, NEWDIGS is working with Singapore’s Health Sciences Authority (HSA), 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, payers, 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 HSA. “These new models may also provide the opportunity for regulators, clinicians and patients to obtain important data prospectively to help address longstanding 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, Institute Professor and Nobel laureate; Sinskey; Ram Sasisekharan, HST director and Edward Hood Taplin Professor of Health Sciences and Technology and Biomedical Engineering; and Charles Cooney, Robert T. Haslam Professor of Chemical Engineering.
Press release also available on the CBI website.