November 9, 2011
Join JDRF’s President & CEO, Jeffrey Brewer, and Assistant Vice President of Treatment Therapies, Aaron Kowalski, Ph.D., on November 14 at 3:30 p.m. ET for a Special Webcast on World Diabetes Day
This is an exciting time for type 1 diabetes (T1D) research across the spectrum of curing, treating, and preventing the disease. In particular, there have been several important and promising developments just in the last few weeks in artificial pancreas research. The first outpatient trials testing these systems are now underway in Europe and more outpatient trials are expected to begin in the next year, furthering the prospect of bringing this innovative and potentially life-saving device to market. But how do we ensure that these innovative trials are also conducted in the United States? Furthermore, how do we ensure this progress will continue, and ultimately benefit people with diabetes?
In a few weeks, the U.S. Food and Drug Administration (FDA) will release draft guidance on artificial pancreas systems, a life-saving technology that could potentially benefit as many as 3 million Americans with T1D and would be transformational in the treatment of the disease. These recommendations from the FDA must be properly drafted or the research, development, and delivery of this innovative and potentially life-saving device will be delayed.
A growing body of evidence, based on JDRF and federally-funded studies of artificial pancreas systems conducted in inpatient or hospital settings, demonstrates the potential of an automated system in improving and maintaining glucose control. Based on this data, a safe and effective system can and should be made with today’s knowledge and technology, even as we continue to encourage the development of improved technology. Thus, JDRF has been working to ensure that this development is not delayed by unnecessary regulatory roadblocks.
Leading diabetes researchers and clinicians in the United States, Members of Congress, and the public have joined JDRF in urging the FDA to advance, not delay, the artificial pancreas. Already, over 100,000 people have signed JDRF’s artificial pancreas petition to urge the FDA to follow the expert recommendations, and the list continues to grow. Last week, Senators Susan Collins (R-ME) and Jeanne Shaheen (D-NH), who serve as co-chairs of the Senate Diabetes Caucus, Dr. Eric Orzeck of the American Association of Clinical Endocrinologists, and Caitlyn Ryan, a JDRF Children’s Congress delegate, urged the FDA to provide a clear and reasonable pathway for researchers and industry toward the development of these systems at a press conference on Capitol Hill. Check out the highlights from the event here.
So this World Diabetes Day, come join Jeffrey Brewer, JDRF’s president & CEO, and Aaron Kowalski, Ph.D., assistant vice president of treatment therapies at JDRF, for the latest developments on the artificial pancreas and next steps on what we can all do to ensure that the FDA does not delay patient access to this important technology.
The webcast will be moderated by JDRF volunteer and International Board of Directors member Douglas Lowenstein.Some topics that will be addressed include:
- How does an artificial pancreas work, and how would it benefit people with T1D?
- What is the current status of artificial pancreas development?
- What is the basis for concern among clinicians and JDRF scientists with respect to prior guidance in this field?
- What are the most important items for the FDA to include in the guidance for the artificial pancreas?
- What can I do to help the FDA understand that the artificial pancreas is a top priority for the T1D community?
Tune in and submit your questions via live chat at www.jdrf.org/livewebcasts on Monday, November 14 at 3:30 p.m. ET.You may also submit questions via email by sending them to firstname.lastname@example.org, or log on to Twitter or Facebook. The program is scheduled to last one hour and will be recorded and available in our archives later that week.