Leading experts from industry, academia, and government came together the second week of April in Bethesda, MD, to discuss innovation in the development of an artificial pancreas system at a workshop hosted by the National Institutes of Health, the Food and Drug Administration (FDA), and JDRF. A commercially-viable artificial pancreas system would mimic the biological function of the pancreas in people with type 1 diabetes (T1D).
The workshop took a comprehensive approach to developing an artificial pancreas system and bringing it to market—research scientists presented their latest findings from laboratory work and clinical trials, industry investigators highlighted state-of-the-art advancements in technology, and government officials laid out the challenges to commercialization. Topics included everything from new device designs and approaches to optimize artificial pancreas systems, to improving insulin hormone replacement and ways to accelerate device production.
Roman Hovorka, Ph.D., director of research in the department of pediatrics at the University of Cambridge, shared successful results from a recent outpatient clinical trial of the artificial pancreas system that was used in children and adolescents overnight. Using unsupervised home studies that lasted an average of one week, Dr. Hovorka found that blood-glucose levels remained in healthy targeted ranges and that participants found the technology easy to use.
Arleen Pinkos, scientific reviewer at the FDA, addressed the challenges of making the artificial pancreas commercially available from a regulatory perspective. Pinkos told attendees that the FDA is relying on strong science, expert opinions, and clinical study evidence when reviewing the device. She emphasized that the challenge lies in labeling the device—it has to be easy to understand, with concise yet comprehensive directions. “If the user thoroughly understands the limits of the system, that helps mitigate risk and tips the balance in a favorable direction [for approval],” Pinkos said.
Other key presenters included Boris Kovatchev, Ph.D., from the University of Virginia, who spoke about the mobile platform of the artificial pancreas and how it operates; Kenneth Ward, M.D., senior scientist at Legacy Research Institute, who shared with participants the development of an “intelligent” catheter than combines hormone delivery with glucose sensing; and Steve Prestrelski, Ph.D., chief scientific officer at Xeris Pharmaceuticals, who shed light on novel glucagon formulations that are being developed for possible use in artificial pancreas systems.
In total, more than 40 presenters shared key findings in their field with the 175-person-strong audience.
“Incredible progress has been made on developing an artificial pancreas system,” says Aaron Kowalski, Ph.D., vice president of treat therapies at JDRF. “The ultimate goal is to get these devices into the hands of people with type 1 diabetes to ease the burden of living with this disease.”