Regulatory
Regulatory frameworks that promote innovation
The next generation of therapies for type 1 diabetes (T1D) will be revolutionary. Breakthrough T1D is working today to ensure those therapies have a clear and reasonable pathway from research to approval anywhere in the world.
Breakthrough T1D is working to make the regulatory pathway for cell therapies for T1D clear and reasonable. This includes aligning the outcomes studied to the latest science and the perspective of those with T1D.
Now that one disease-modifying therapy has made it through the regulatory process, we are working to optimize the pathway for the next generation of therapies. Multiple additional disease-modifying therapies have shown efficacy in early clinical trials with more coming. We want to accelerate the pathway to approval for those therapies to give individuals and their doctors the best options for care.
Breakthrough T1D is working with regulatory agencies to increase choices and interoperability for diabetes devices such as automated insulin delivery systems. Our priority is for components made by different manufacturers to work together, giving individuals with T1D the option to use the components that work best for them.
Breakthrough T1D is working with regulatory agencies and other stakeholders to integrate new outcomes for T1D glucose control and complications therapies, including those measured by CGMs, into the regulatory paradigm. Emphasis is placed on ensuring the input of people with T1D on the outcomes measured and how benefits and risks of therapies are viewed.
Our team works every day to bring innovators and regulators together. This ensures T1D therapies move as quickly—and safely—as possible towards approval.”
A history of success
The roadmap to automated insulin delivery
Breakthrough T1D created the Artificial Pancreas Consortium in 2005 to make these systems a reality. A key part was bringing together everyone, including government agencies, to pursue this lifesaving technology, which is the standard of care today.
Breakthrough T1D partnered with the FDA to create a regulatory pathway for approval of this technology, leading to the 2012 FDA guidance for artificial pancreas systems.
Industry experts have said Breakthrough T1D’s involvement cut five years off the approval process for the Medtronic 670G artificial pancreas system in 2016, the first approved system.
I think [Breakthrough T1D] got us here a lot faster than we could have any other way.”
Learn more about our advocacy
The regulatory group is just one part of Breakthrough T1D’s advocacy team.
