Project ACT series
This article is part of a series exploring the different ways that Breakthrough T1D’s Project ACT (Accelerate Cell Therapies) is shaping the future of cell therapies for type 1 diabetes (T1D). The next and final article in the series will focus on how Breakthrough T1D’s Medical Affairs team is working to bridge the gap between access to and adoption of cell therapies.
Read last month’s article about cell therapies for type 1 diabetes in clinical trials.
Right now, promising new manufactured cell therapies for type 1 diabetes are making their way to and through the clinical pipeline. Testing cell therapies in clinical trials helps us understand if they are safe and effective, and the data from these trials is ultimately used in decisions about whether a therapy should be approved and covered by insurers. From basic research to clinical trials, and from regulatory approval to access in the clinic, bringing cell replacement therapies to people with T1D as quickly as possible requires consistent advocacy and clear, thoughtful, and efficient policies from beginning to end.
Advocacy takes teamwork
This is where Breakthrough T1D’s Advocacy team comes in. They work on both sides of product approval—before and after—advocating for funding and policies that support research, development, approval, and access. This includes educating key players on the latest T1D science, modernizing and expanding approaches to manufactured cell therapy clinical trials, and working with payers to ensure access through insurance.
The ultimate goal is to work together—regulators, researchers, clinicians, policymakers, people with T1D, insurers, and industry—to accelerate the development and approval of manufactured cell replacement therapies, especially those that do not require broad immunosuppression. Breakthrough T1D’s Project ACT (Accelerate Cell Therapies) will make this a reality faster.
Read on to learn about the key areas towards which Breakthrough T1D’s Advocacy team is working to advance manufactured cell replacement therapies.
Advocating for funding and policies supporting cell therapy research
To ensure that there is government funding to support T1D research—including manufactured cell therapies—Breakthrough T1D’s Advocacy team regularly engages with policymakers in Washington, D.C. Importantly, we advocate for continuous renewal of the Special Diabetes Program (SDP), a federally funded initiative that contributes to T1D research at the National Institutes of Health (NIH). This funding is a critical accelerator of manufactured cell therapies research.
Special Diabetes Program
The SDP expires in September 2025. Sign up to be an advocate today and help us garner support for this incredible program.
Through other initiatives, such as Government Day and Children’s Congress, we convene advocates of all ages in Washington, D.C. to share the impact of life with T1D and research updates with Members of Congress. This work includes hundreds of meetings with Members of Congress and their staff each year and engagement with the Diabetes Caucus in the House and Senate. These lawmakers play major roles in making decisions about government policies and funding. Engaging with them about the realities of T1D and the importance of research into potential cures like manufactured cell therapies is essential to ensuring the continuity of government funding that keeps this critical research going.
Ensuring that manufactured cells are safe—and that there are enough for everyone
Before manufactured cell therapies can be put into people, researchers use animal models to study the safety of a new therapy and determine whether it has the potential to work in humans. This can be a time-consuming and costly process. Breakthrough T1D is developing a roadmap for researchers, encouraging focus on the most critical challenges for manufactured cell therapies. The goal is to expedite these studies and get manufactured cells into people faster.
Another critical step is how the cells are made and making sure there are enough manufactured cells for everyone. The challenge is finding the best way to manufacture islets in large quantities while keeping them safe and functional. Breakthrough T1D is partnering with the best and brightest scientists at the Advanced Regenerative Medicine Institute and the Cedars-Sinai Biomanufacturing Institute to make this possible.
Understanding risks and benefits from the perspectives of people with T1D
For decision-makers—which includes regulators that approve products, health insurers, and policymakers—to make the best recommendations possible about manufactured cell therapies, they must consider the perspectives of people living with T1D. Importantly, this includes what risks someone with T1D is willing to accept for the possibility of curing T1D. This is especially important considering the significant unmet needs that remain for the T1D community, which are not always well understood by policymakers who are removed from the daily realities of living with T1D.
Unmet needs and demographics of the T1D community
Breakthrough T1D published two papers in recent months that fully illuminate the true scale of type 1 diabetes (T1D) in America, the unmet needs of the global T1D community, and the barriers we must overcome to achieve our vision of a world without T1D.
As a new kind of therapy, the way we think about the clinical studies that test cell replacement therapies needs to change. Clinical trials up to this point have only included a small subset of the T1D population, but as we have gained more experience with these therapies, we’ve learned that the trials should include as many people with T1D who could benefit as possible. This is especially important given the great potential of manufactured cell therapies to cure T1D. Further, how we measure benefits in clinical trials needs to expand to better consider the perspectives of people who will receive these treatments.
Breakthrough T1D is spearheading a Patient Preference Study to better understand and quantify how people living with T1D consider tradeoffs between risks and benefits when deciding whether to receive a manufactured cell transplant. This involves gathering perspectives from both people with T1D and their caregivers to understand how they view different aspects of cell replacement therapies that may influence their willingness to try it. The results, expected in fiscal year 2026, can be shared with regulators and policymakers to incorporate into their decisions regarding manufactured cell therapies for type 1 diabetes.
Educating insurers and advocating for access
Once a manufactured cell therapy becomes approved, the next challenge to tackle is access through insurance. To achieve our vision, people must have affordable insurance coverage of manufactured cell therapies, and ideally people should be able to choose between multiple cell therapy options. Our Advocacy team is already engaging with insurers and government payers to make them aware of manufactured cell therapy research progress for T1D. We are working toward establishing the pathway to coverage for these therapies.
To support these efforts, Breakthrough T1D uses data-driven approaches. For example, a recent study determined key demographics and the health insurance status of the T1D population. Our Advocacy team is using this data to better understand the population that can benefit from manufactured cell therapies. Through continued data collection and analyses, we can further advance the pathway to coverage for manufactured cell therapies.
Advancing progress through Project ACT
Breakthrough T1D is working with stakeholders across the entire T1D spectrum—from researchers, to regulators, to payers, to clinicians, to people with T1D—to ensure that progress is moving along quickly and efficiently for new cell therapies for type 1 diabetes. These efforts are based on a model that has already proven successful, leading to the development and adoption of Artificial Pancreas systems.
With the launch of Project ACT, every day we move closer to our goal of manufactured cell therapies becoming a reality for everyone with T1D.
Project ACT
Scientific progress takes time, money, and effort. To accelerate islet replacement therapies faster than ever, Breakthrough T1D launched Project ACT (Accelerate Cell Therapies) to simultaneously advance research, development, regulatory policies, access, and adoption of manufactured islet therapies that do not require broad immunosuppression.
Breakthrough T1D’s Advocacy team regularly engages in conversations with decision-makers who play a major role in influencing when, and if, manufactured cell therapies will become available to people with T1D. Breakthrough T1D is bringing the T1D community into the conversation, changing the way we think about clinical trials, and opening the doors of manufactured cell therapies to as many people with T1D as possible.
More manufactured cells, faster clinical trials, accessible therapies—we are identifying challenges, working together to tackle them, and accelerating manufactured cell therapies for type 1 diabetes faster than ever.
