Aaron Kowalski, Ph.D., CEO of Breakthrough T1D, the leading global type 1 diabetes (T1D) research and advocacy organization, testified today before the U.S. House of Representatives’ Committee on Energy and Commerce’s Subcommittee on Health about how America can maintain its leadership and investment in biomedical innovation and how the U.S. Food and Drug Administration (FDA) can accelerate cures for T1D and other chronic autoimmune diseases.
Dr. Kowalski’s testimony shared insights into life with T1D, drawing from his experience as both a scientist and someone who lives with the disease, and outlined some of the major milestones the community has reached through strategic partnerships and investments from Breakthrough T1D, FDA, and the private sector. It also called for modernizing FDA policies and procedures and emphasized opportunities for improvement to ensure that the agency can meet scientific progress as it happens.
Key quotes from the testimony include:
“America has a long, proud history of leading T1D research, innovation, and treatment,” said Dr. Kowalski. “But the rest of the world is catching up, and I saw that firsthand in China last December. Yet, the role of global leader in diabetes innovation is still America’s to lose. This country is well equipped to lead. NIH research funding and FDA regulatory approvals are the lynchpins to that success. It would be a tragedy to fall behind because we failed to keep pace with the speed of innovation, but that has begun to happen.”
“A robust FDA, one that is stable and well-resourced, consistent and transparent, modern in its clinical trial and endpoint policies, and that incorporates patient perspectives, is essential to our global leadership in biopharmaceutical innovation and manufacturing. An FDA with these qualities will be ready for the next wave of T1D innovation, which is already at our doorstep. Cell therapies are already resulting in insulin independence. One pivotal trial is happening in the U.S. now. With the right approach, we can be the first country to approve and manufacture a scalable cure for T1D.”
