An Update on Project ACT

October 9, 2025

Breakthrough T1D launched Project ACT (Accelerate Cell Therapies) in November 2024 as the flagship, strategic initiative to cure T1D.

The new project was featured in a JDCA report in January of this year, in which several essential questions were raised. At the time, the program lacked definitive structure and leadership, and it was unclear whether Project ACT was a fundraising package or a genuine strategic program.

This report takes a fresh look at Project ACT after some of the dust has settled. It incorporates input from members of Breakthrough T1D’s professional executive team, who generously shared their time with us. All conclusions and questions shared in this report independently reflect the JDCA’s analytical opinion and perspective.
 

What Is Project ACT?

Project ACT was announced on World Diabetes Day (Nov. 14) last year with the intent of “Accelerating cell therapies today for cures tomorrow.” The uniqueness of the initiative is that it is inherently cross-functional, encompassing research, advocacy, medical affairs, global development, and communications. It has a roadmap of five steps to accelerate accessible curative islet transplantation therapies, without immunosuppression. It begins with basic research and early development, progressing treatments quickly through the clinic to FDA approval, and ending in coverage and adoption.

Project ACT was initially funded by three large, philanthropic gifts of $25 million each. At launch, all direct donations were required to meet a $5 million minimum to secure the first $100 million of the total budget so Project ACT could begin operations.
 

JDCA Key Questions (from January 2025)

In the January report, JDCA raised five primary questions.

Q1: Is this a research, organizational, or fundraising strategy?
Q2: Who leads Project ACT?
Q3: Are there specific, measurable goals for ACT?
Q4: What type of research will receive priority funding?
Q5: Will the average donor be able to give to Project ACT?

 Q1: Is This a Research, Organizational, or Fundraising Strategy?

When we first reviewed Project ACT in January, it was unclear whether it was truly a new strategic initiative or a neat repacking of pre-existing research.

Breakthrough T1D leaders are unequivocal that ACT is the organization’s top strategic priority. They say it is not a marketing tactic nor a repacking of previous work. This is a good thing: Cure is job number one. We hope that this will lead to more cure breakthroughs in the months ahead.

Open Issues
If Project ACT is the top priority, it should be reflected in a substantial increase in cure research grants. This is not yet visible in the most recently available financial data but should be determined next year (fiscal data are typically released in April/May).

Recommendations
In our view, one significant area that can be improved is transparency in communicating new developments in Project ACT—both wins and challenges.

• Regular and thorough updates from both the board of directors and CEO on the progression, challenges, and emerging ‘breakthroughs,’ demonstrating to the community how this initiative is different from what was done in the past. Based on this feedback, Breakthrough T1D has begun tagging content relating to Project ACT in its News and Updates center. We urge them to continue doing so.
• Identify in the grant center when research is part of Project ACT. Based on this feedback, Breakthrough T1D states they will make this update in the grant center in the foreseeable future. Additionally, it would be beneficial to note what job each project aims to accomplish (supply, protection, etc.) or a combination thereof.

Q2: Who Leads Project ACT?

At launch, it was unclear if or who the specific leader was for Project ACT. This topic is important because priority initiatives typically have a clear leader. Project leadership by group consensus rarely works.

Open Issue
Breakthrough T1D leaders confirm that Project ACT does not have a singular leader. Each member of the executive team is tasked with different program aspects as this is a cross-functional effort. When pressed on who really leads ACT, executives noted that CEO Aaron Kowalski leads Project ACT and that each of his executive team members provides monthly updates on the initiative’s progress.

Recommendations
We recommend that Breakthrough T1D appoint an exceptionally talented executive whose sole purpose is to oversee the program. This person would keep the initiative on track to achieve specific goals, fight for funding needed to excel, and take accountability for setbacks.

For a project with such a high strategic profile, a dedicated leader is a smart and essential investment.

Q3: Are There Specific, Measurable Goals for Project ACT?

In January, detailed metrics for Project ACT were not identified. JDCA believes that what is measured is more likely to be achieved; what is not measured is achieved rarely.

Breakthrough T1D executives stated that many measures are utilized for ACT and are reported quarterly to the International Board of Directors. Each operating department has SMART (specific, measurable, achievable, relevant, time-bound) goals relating to the project. Some specific examples were shared regarding research, but confidentiality concerns precluded a broader program-wide discussion.

In general, this is a good development. If metrics are solid, specific, and managed with discipline, they should hone resources to deliver cure breakthroughs.

Open Issue
Since detailed program metrics could not be shared, we cannot form a point of view about their optimization. We do not know if the right outcomes are being measured, if too many or too few things are taken into consideration, or if the metrics are utilized to ensure performance and accountability.

Recommendations
There are several recommendations for measures that achieve maximum impact, transparency, and accountability. Given the importance of this initiative, donors have the right to know the project’s near-term effects and if it is fulfilling expectations.

• Share key performance metrics for ACT publicly—both achievements and misses.
• Build metrics with teeth: Reward achievements with performance incentives, apply consequences for lack of performance.
• Craft the ‘art’ of metrics carefully: Ensure the right things are measured that genuinely drive the desired behavior and outcomes, make sure that they cannot be gamed (or know how if so).

Q4: What Type of Research Will Receive Priority Funding?

Initially, it was unclear what type of research would receive priority funding and what shaped that decision.

According to organization leaders, there are three key review steps. First, the research must fit into one of three priority areas: Cell supply, cell protection (from immune attack), or cell survival (in general). Second, projects that are more developed—demonstrating potential or approaching clinical trials—take precedence. Third, projects must be considered a strategic fit by the board of directors.

Prioritizing funding for more developed projects is something JDCA has pushed for many years. We are glad to hear it has been adopted and look forward to seeing the results in the numbers.

We learned the organization is committed to providing pre-clinical-grade stem cell-derived beta cells (sBCs) to researchers for testing purposes. Representatives said that today, researchers “must reinvent the wheel” every time they get new cadaverous donor islets. Breakthrough T1D is funding two dedicated initiatives/centers that are manufacturing islets to scale to meet the needs for preclinical research, and hopefully, down the road, clinical trials. Wide availability of sBCs with consistent quality should accelerate cell protection research. In our view, this is an excellent example of Breakthrough T1D’s unique capabilities utilized at full value.

Open Issue
The three areas of prioritized research (supply, protection, survival) have equal importance in delivering a Practical Cure for T1D. However, they do not have equal funding allocations. Breakthrough T1D representatives stated cell protection research has received priority funding in the last fiscal year, as “it is the only way to remove immunosuppression.” This is reflected in JDCA’s most recent review of Breakthrough T1D’s research grant spending, in which $7 million was spent on protection solutions versus $4 million on supply in FY24. This is the right area to prioritize, but we must ensure the full equation—supply and protect—is solved.

Recommendations
We encourage Breakthrough T1D to continue balancing its investment in Project ACT with the right mix of research to deliver breakthroughs as soon as possible. While it seems like we are moving in the right direction, we must see if this is maintained in the next round of financial data and ultimately, breakthroughs.

Q5: Will the Average Donor Be Able to Give?

Project ACT was launched leveraging substantial, transformative philanthropic gifts. A question initially posed was if the average donor would be able to give to this initiative moving forward. A Breakthrough T1D representative confirmed that today, donors cannot give directly (unrestricted) unless they meet a $1 million minimum. The average donor was encouraged to give generally to Breakthrough T1D (unrestricted) as “Anyone making an unrestricted gift is supporting this work.”

JDCA representatives pointed out that donors could give purpose-specified gifts (restricted) to many other types of organizations, such as a university volleyball team, as opposed to the university itself.

Open Issue
Over a decade of annual T1D community sentiment surveys demonstrate that more than nine out of ten donors would give to a Practical Cure initiative if the option were easily available. The vast majority of people would prioritize giving to ACT over other areas, likely to the extent that there would be more cure-dedicated funding than could be spent. It is unclear why this is a point of hesitation for Breakthrough T1D.

Recommendations
JDCA recommends that Breakthrough T1D opens and encourages direct donations to Project ACT from all donors, not just the wealthiest. This would be a win-win situation, enhancing engagement, support, and commitment from the broader community.