MIT NEWDIGS focuses on enhancing the capacity of the global innovation system to more reliably and sustainably deliver new, better, affordable therapeutics to the right patients faster.
Its first project area centers around catalyzing the evolution of global pharmaceutical regulation from the current binary go/no go model to one involving a more progressive reduction of uncertainty over the lifecycle of the product. This “adaptive licensing” (AL) model 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. AL has been discussed by regulators and other stakeholders for many years under a variety of different names (e.g., staggered approval, progressive licensing, etc), but has not previously progressed from idea into action.
MIT NEWDIGS provides an open and transparent “safe haven” environment, with the MIT Center for Biomedical Innovation serving as neutral intermediary, for a global cross-stakeholder collaboration team to design, evaluate, inform, and catalyze real world advancements toward AL. Collaborators include regulators, payers, and HTA officials from the US, EU, Asia, and Canada, as well as biopharmaceutical companies, clinicians, patients, and academic researchers, among others.
The MIT NEWDIGS approach to collaborative system-level innovation has been recognized by leaders in government, industry, and academia as one with the potential to address other complex, high impact challenges in biomedical and healthcare innovation. Additional NEWDIGS project areas are now being explored for possible launch in the coming months.