THE JDRF ARTIFICIAL PANCREAS FUND:
THE NEXT STEP

Click here to see recent local media on this topic.
Click here view a brief KENS video.

Click here to view a presentation on the Artificial Pancreas Project
that was given recently in San Antonio by Aaron J. Kowalski, Ph.D.,
Research Director, JDRF Artificial Pancreas Project.
 

JDRF has taken the lead in accelerating the development of an artificial pancreas – a system that can revolutionize diabetes care and dramatically improve the lives of people with type 1 diabetes. Now, JDRF is poised to actively drive the creation of the first commercially available artificial pancreas by partnering with industry. The ultimate endpoint of this effort is a safe and effective artificial pancreas which has been approved by the Food and Drug Administration (FDA) and is available to people with type 1 diabetes. To support this goal and the industry partnerships needed to reach it, JDRF has created the JDRF Artificial Pancreas Fund with an initial goal of $50 million. An artificial pancreas will integrate two currently available technologies – continuous glucose monitors and insulin pumps – with an algorithm that provides the right amount of insulin at the right time. It will enable people with diabetes to achieve tight blood glucose control avoiding both highs and dangerous lows, thereby significantly reducing the risk of the disease’s devastating complications. It will also help advance JDRF’s replacement and regeneration cure therapeutic strategies, where treatment success will be greatly aided by the ability to keep blood sugar tightly controlled. WHAT WE’VE ACCOMPLISHED Two years ago, JDRF launched the Artificial Pancreas Project to validate the effectiveness of newly emerging continuous glucose monitoring technology and to spur the development of computer programs that “close the loop” by linking continuous glucose monitors with insulin pumps. Concurrently, JDRF also began working closely with the federal government, private insurers, and the medical community, each of which will play an important role in the widespread availability of an artificial pancreas. To date, JDRF has invested more than $10 million in the project, achieving extraordinary progress in a short time frame. JDRF has:

Launched a study to validate the effectiveness of continuous glucose monitoring technology: JDRF is sponsoring the world’s largest study to demonstrate the benefits of continuous glucose monitoring, an essential component of an artificial pancreas. Closed the loop for the first time in children: Human clinical trials at Yale University have proven that a closed-loop artificial pancreas is feasible and that it works particularly well overnight in a hospital setting. Developed closed loop algorithms for various real world situations: JDRF has established a consortium of top diabetes scientists, doctors, and engineers to develop and test sophisticated algorithms that can automatically control glucose levels in a variety of circumstances and types of people. Partnered with the FDA to make the development of an artificial pancreas a priority for the agency: The FDA has named the artificial pancreas a “critical path opportunity,” establishing it as a top goal.

THE NEXT STEP JDRF’s successes have demonstrated that an artificial pancreas is now within reach – and they have underscored our conviction that the time is right to make a substantial push towards realizing the long-held dream of creating an artificial pancreas to immediately improve the lives of people with type 1 diabetes. Now, we are taking the next steps to make it happen. Because of JDRF’s investment to date, leading researchers across the world have developed computer algorithms for the artificial pancreas, which are being tested and refined to make them more effective for real world situations such as meals, exercise, and stress. Once this testing is complete, these algorithms will need to be integrated with next generation glucose monitoring and insulin delivery technologies to achieve an artificial pancreas system. However, an artificial pancreas will then need to be shown to be safe and effective in clinical trials, reviewed and approved by the FDA, and manufactured by a company before people with diabetes will have access to it. The first generation of an artificial pancreas, like any new or emerging technology, will not be as sophisticated as later generations. For example, the first generation may require some user intervention while later refinements will fully automate insulin delivery while adding hormones such as glucagon. To move the artificial pancreas along this development pathway as quickly as possible, JDRF is seeking to partner with industry. JDRF has recently issued a special “Expression of Interest” (see attached) that outlines our intention of partnering with one or more companies to spur development of the next generation artificial pancreas technology and accelerate its commercialization. JDRF has a critical role to play in spurring the involvement of industry. In 2005 JDRF set the pace by launching an aggressive effort to create and validate the building blocks of an artificial pancreas. The momentum of the last two years will now grow to include partnering with industry. Our new collaborations will leverage the financial resources of both JDRF and industry to accelerate the development and testing of these highly sophisticated devices. The companies will bring assets to such a partnership that are necessary for a closed-loop system to be commercialized and delivered to people with diabetes:

Expertise in device development, and ownership of components essential to an artificial pancreas; Practice in navigating the FDA; and Extensive experience in bringing products to market.

JDRF will bring many capacities as well, including:

A sense of urgency to achieve an artificial pancreas as quickly as possible; The connections to the “best and brightest” scientists in the diabetes research community; A commitment to provide funding to speed development; and A strong relationship with FDA officials, who know JDRF has the interests of the type 1 community at heart.

Preliminary JDRF-funded studies have shown an artificial pancreas to be feasible, but the work needed to make it a reality is highly complex. To carry this life-altering project forward will require significant resources – we estimate at least $50 million. JDRF has created the Artificial Pancreas Fund, specifically earmarked for projects that complete the Artificial Pancreas Project and deliver on our promise to change the lives of people with type 1 diabetes. We helped create and drive the momentum for an artificial pancreas. Now, we are determined to see this therapy through to development, as quickly as possible, for the benefit of people worldwide with type 1 diabetes.