The News:

The FDA released a Guidance Document yesterday, December 1, that promises to accelerate the testing and potential approval of the Artificial Pancreas.

What this means for the T1D Community:

I have had December first on my calendar for months now.

Two weeks ago at the Silicon Valley Summit, I gained an even better sense of the crucial nature of the FDA Guidance Document we were awaiting.

The fact is that the Medtronic VEO–a low glucose suspend insulin pump that can be thought of as a step toward a product like the Artificial Pancreas–is available in 40 countries across the globe but not the United States because the FDA has not approved the system.

The fact is that if the FDA doesn’t quickly approve life-changing products like the AP, then components of it–continuous glucose monitors and insulin pumps–will not be developed and improved in this country because no markets for them will exist.

If this becomes the case, important innovations in the United States will not proceed and people with T1D will never have access to them.

I googled “FDA Artificial Pancreas” at least a dozen times yesterday.

Late in the afternoon, an email from Hasan Shah of JDRF Advocacy landed in my inbox.  I was extremely pleased to learn that the FDA has come through with this important guidance.

According to Jeffrey Brewer, JDRF President and CEO: “Our initial review of the draft AP guidance indicates that the FDA has been responsive and listened to the recommendations of leading clinicians and researchers in the type 1 diabetes field. It also appears that the draft guidance lays out a rapid timetable to move from inpatient trials to outpatient trials to prove the AP’s safety and efficacy, and if that turns out to be the case it is good news.”

Good news indeed!

Before December first, the FDA felt like an adversary of researchers and JDRF and individuals with T1D.  Through the tremendous effort of JDRF–whose 110,000+ advocates signed a persuasive petition and whose media campaign drew significant attention and whose dialogue with senators and congressmen have meant great governmental support–we made our concerns and priorities very clear and the FDA responded just as we hoped they would.

With the Guidance Document, we feel more aligned.

I, for one, am more convinced than ever that we are closer to bringing a product to market that is thought to be as revolutionary for T1D as the discovery of insulin.

John Lipp, Executive Director of JDRF Bay Area said that yesterday was “a very good day.”  I couldn’t agree more.

If You Want to Read More:

From the FDA website

JDRF Press Release

New York, NY, and Watertown, Mass. – June 9, 2011 – The Juvenile Diabetes Research Foundation (JDRF) and Selecta Biosciences, Inc. announced today that they have established a research collaboration to support Selecta’s development of a vaccine technology, which may subsequently help to better treat and potentially prevent type 1 diabetes.

Through the research partnership, JDRF will provide milestone-based financial support and expertise, with the goal of applying Selecta’s vaccine technology toward the development of vaccines for type 1 diabetes.

Selecta’s vaccine technology would ultimately be applied to create a therapeutic that would halt or prevent the autoimmune response that causes type 1 diabetes. Known as antigen-specific tolerogenic vaccines, these vaccines are designed to specifically stop the autoimmune response that causes the disease without damaging the immune cells that provide protection against infection. Antigen-specific therapies have shown promise to date in animal models of type 1 diabetes.

In addition to their potential in preventing type 1 diabetes, tolerogenic diabetes vaccines could have other benefits. For example, they could be used in conjunction with other therapies to preserve remaining beta cell function in individuals recently diagnosed with type 1 diabetes. This type of vaccine could also help with regeneration and replacement therapies, and be used to protect newly regenerated or transplanted insulin-producing beta cells in established type 1 diabetes. In addition, this class of vaccines may also have applicability for other autoimmune diseases.

“Type 1 diabetes affects individuals of all ages, and the rate of incidence has increased dramatically in the past two decades. This marked increase, especially in children between the ages of one to five years old, has made the need for preventing type 1 diabetes all the more urgent,” said Richard Insel, M.D., Chief Scientific Officer of JDRF.

“We believe vaccine research is one of the most promising approaches to prevent or halt the beta cell-specific autoimmunity in type 1 diabetes. And we are excited to be teaming up with Selecta to support the development of this next-generation of vaccine technology,” added Insel.

“Selecta is excited that JDRF has recognized our technology platform’s potential to rationally design advanced vaccines, based upon synthetic, self-assembling nanoparticles. We view the development of a therapeutic vaccine based on Selecta’s technology to be an excellent opportunity to aid in the treatment of type 1 diabetes,” said Werner Cautreels, Ph.D., President and Chief Executive Officer of Selecta. “This collaboration accelerates our progress to apply Selecta’s novel vaccine technology to address the significant unmet medical needs in autoimmune diseases including type 1 diabetes.”

The research collaboration agreement between JDRF and Selecta is part of JDRF’s Industry Discovery and Development Partnership (IDDP) program. This is one of JDRF’s funding mechanisms through which JDRF partners with pharmaceutical, biotechnology, and medical device companies focused on the discovery, development, and delivery of therapeutics and devices for type 1 diabetes. Since the launch of JDRF’s IDDP and co-sponsored grants program in 2004, JDRF has funded 40 partnerships with 32 companies and committed approximately $75 million to accelerate research that will lead to better treatments and a cure for type 1 diabetes.

“Through partnerships like this, JDRF is helping to speed the development of products from the lab to the marketplace, to make sure breakthroughs in science are able to reach the people they are meant to help,” said Karin Hehenberger, M.D., Ph.D., Senior Vice President of Strategic Alliances for JDRF. “Pooling the resources and strengths of both JDRF and Selecta allows us to work together to advance research that could help many people who have or are at risk for type 1 diabetes, and we will be more effective in making these innovative products available to them.”

Type 1 diabetes is an autoimmune disease in which the body’s immune system mistakenly attacks the insulin-producing beta cells in the pancreas, causing dependence on injected or pumped insulin for life. As a result, people with type 1 diabetes must currently test their blood sugar levels and administer insulin through injections or a pump, multiple times every day. If the destruction of beta cells can be slowed or stopped, people with type 1 diabetes could continue to make more of their own insulin. This would result in better control of blood sugar levels, and likely fewer serious complications of diabetes, such as eye, kidney, and heart disease.

About JDRF

JDRF is the worldwide leader for research to cure type 1 diabetes. It sets the global agenda for diabetes research, and is the largest charitable funder and advocate of diabetes science world-wide.

The mission of JDRF is to find a cure for diabetes and its complications through the support of research. Type 1 diabetes is an autoimmune disease that strikes children and adults suddenly, and can be fatal. Until a cure is found, people with type 1 diabetes have to test their blood sugar and give themselves insulin injections multiple times or use a pump – each day, every day of their lives. And even with that intensive care, insulin is not a cure for diabetes, nor does it pre-vent its potential complications, which may include kidney failure, blindness, heart disease, stroke, and amputation. JDRF estimates that there are as many as three million people in the United States who have type 1diabetes.

Since its founding in 1970 by parents of children with type 1 diabetes, JDRF has awarded more than $1.5 billion to diabetes research, including $107 million last year. More than 80 percent of JDRF’s expenditures directly support research and research-related education. For more information, please visit www.jdrf.org.

About Selecta

Selecta Biosciences, Inc. is a biopharmaceutical company developing an entirely new class of targeted vaccines that induces an antigen-specific immune activation or antigen-specific immune tolerance for therapeutic and prophylactic applications. Selecta’s proprietary Synthetic Vaccine Particle (SVP™) platform creates a new paradigm in vaccine development, enabling completely new therapeutic applications while offering the potential of improved efficacy and safety profiles. Selecta’s fully synthetic engineering of novel vaccines offers a number of compelling benefits, including flexible modular vaccine design and accelerated development timelines using simplified manufacturing processes.

Selecta’s SVP™ platform technology is flexible to enable diverse vaccines and the company has created targeted antigen-specific Synthetic Vaccine Particles (tSVP™) and targeted antigen-specific tolerogenic Synthetic Vaccine Particles (t2SVP™). Targeted Synthetic Vaccine Particles (tSVP™) activate immune responses to a wide array of relevant antigens, including small molecules, peptides, oligosaccharides, and proteins. These particles can target humoral or cellular pathways of the immune system. Examples for applications include cancer, infectious diseases and addiction. Targeted tolerogenic Synthetic Vaccine Particles (t2SVP™) are designed to induce antigen-specific immune tolerance. Examples for applications include autoimmune diseases, allergies and transplant rejection. Building on the company’s novel approach, Selecta’s product candidates have the potential to become first-in-class or best-in-class therapeutics to treat and prevent diseases.

Selecta Biosciences is based in Watertown, Massachusetts, USA. For more information, please visit www.selectabio.com.

Media Contacts:
Selecta: Kathryn Morris, The Yates Network, (845) 635-9828, kathryn@theyatesnetwork.com
JDRF: Joana Casas, (212) 479-7560; mcasas@jdrf.org

JDRF-funded study reveals that a glucose-sensing enzyme signals the production of new insulin-producing cells, suggesting a new path of treatment possibilities for type 1 diabetes.

Yuval Dor, Ph.D.

JDRF-funded researchers have identified a key signal that prompts existing insulin-producing beta cells in the pancreas to form new beta cells in mice, a breakthrough discovery that may ultimately help researchers find ways to restore or increase beta cell function in people with type 1 diabetes.

The study, led by Yuval Dor, Ph.D., a professor at the Institute for Medical Research Israel-Canada, the Hebrew University of Jerusalem, shows for the first time that a high rate of glucose metabolism, a process that converts glucose into energy that cells can use, triggers beta cells to regenerate. Coupled with a mechanism that prevents the immune system from attacking beta cells in the first place, the long-awaited finding may help pave the way to a full cure for type 1 diabetes. The study, which took five years to complete, will be published in the April 6 issue of Cell Metabolism.

“Our work shows that as glucose is metabolized, it tells the beta cells to regenerate,” says Dor, who is also a 2010 recipient of the JDRF Gerold and Kayla Grodsky Basic Research Scientist Award. “It’s not blood glucose per se that is the signal, but the glucose-sensing capacity of the beta cell that’s key for regeneration.”

In type 1 diabetes, the immune system launches a misguided attack on insulin-producing beta cells, resulting in their eventual loss and decline of function. Without insulin, the body’s cells cannot absorb glucose from the blood and use it for energy. As a result, glucose accumulates in the blood, leaving the body’s cells and tissues starved for energy. That’s why people with the disease must inject insulin and monitor their blood glucose levels vigilantly every day, multiple times a day, to stay alive and maintain optimal health.

In their work, Dor and co-lead author Benjamin Glaser, M.D. of Hadassah Medical Center, used a genetic system to destroy 80 percent of the insulin-producing cells in adult mice, rendering the mice diabetic. When the researchers compared these mice with control mice, they found that those mice with diabetes and elevated blood glucose levels had regenerated a greater number of new beta cells than mice without diabetes, suggesting that glucose is a key player in beta cell regeneration.

To determine how glucose plays a role in triggering beta cells to regenerate or proliferate, the researchers tweaked various steps in the glucose metabolism pathway within the beta cell. They found that an enzyme, glucokinase, which triggers the first step in converting glucose for energy, also stimulates beta cells to replicate.

“This means that the more work that beta cells are required to do, the more of themselves they make,” says graduate student Shay Porat, who, along with Noa Weinberg, spearheaded the study.

Because this study also showed that regeneration depends on glucokinase levels, rather than glucose levels, researchers may be able to use drugs to trigger beta cells to regenerate without exposing the body to elevated glucose levels, which can cause organ damage and even kill beta cells. The finding may pave the way for developing a new kind of drug or therapy to modulate glucokinase or other steps in the glucose-sensing pathway to direct beta cells down the path of regeneration and survival rather than death.

“This study shows that pharmacologic activators of glucokinase, a novel class of drugs being developed for the treatment of type 2 diabetes because of their ability to increase insulin production, also have the ability to increase beta cell replication,” says Patricia Kilian, Ph.D., director for regeneration research at JDRF. “These or other drugs which affect glucose metabolism in the beta cell may have additional benefits for helping to restore beta cell function in both type 1 and type 2 diabetes. That’s our hope.”

Regeneration Research at JDRF

Among the fastest-growing scientific areas that JDRF supports is research aimed at protecting and regenerating insulin-producing cells in people who are at risk or have diabetes. This includes finding therapies to trigger the body to increase the number of beta cells, either by forming new beta cells from existing ones – some beta cells may be present even in people who have had diabetes for decades – or inducing the formation of new beta cells from a precursor or other cell types in the pancreas.

JDRF has been a leader in this new and exciting research field. The foundation funds a wide range of research projects that include pinpointing the signals that prompt beta cells to regenerate, such as the Dor study, as well as creating innovative diabetes drug discovery and development partnerships focused on beta cell regeneration.

Glucose-responsive insulin advances toward clinical development

NEW YORK – Today pharmaceutical company, Merck & Co., Inc. announced it will acquire SmartCells, Inc., a private biotech developing a glucose-responsive insulin whose proof-of-concept preclinical trials were partially funded by the Juvenile Diabetes Research Foundation (JDRF). SmartCells’ product for the treatment of diabetes is designed to be a once-a-day injection that will maintain continuous, tight control of blood glucose levels while reducing the risk of hypoglycemia – like the pancreas does automatically in the absence of diabetes.

“This is exciting news for the diabetes research field and for JDRF. We believe this novel technology may lead to a practical solution to the real needs of people with diabetes,” said Dr. Richard Insel, Chief Scientific Officer at JDRF. “We are pleased to see that SmartCells’ technology has attracted the support of a leading pharmaceutical company that has the capacity to translate this opportunity to patients,” added Insel.

JDRF funds critical gaps in the type 1 diabetes drug and device pipeline by supporting discovery and proof-of-concept research for innovative ideas that might otherwise remain unexplored. This is the sixth time that an early-stage product supported by JDRF has attracted the attention of industry, which has the expertise and resources to bring novel technologies to patients as quickly as possible. From 2008 to 2010, JDRF provided significant financial support – a total of over $1.5 million in funding – to the early-stage development of SmartInsulinTM.

“A measure of JDRF’s success is identifying and advancing promising research that may benefit people with type 1 diabetes,” says Dr. Karin Hehenberger, Senior Vice President of Strategic Alliances at JDRF. “Merck’s acquisition of SmartCells is an example of exactly this. A potentially transformational innovation has now been taken up by a large pharmaceutical company thanks in part to our support. This acquisition adds important financial and drug development capabilities to this promising glucose-responsive insulin.”

Biotechnology companies often face challenges in advancing novel therapies beyond the initial stages of research. Through its Industry Discovery and Development Program (IDDP), JDRF identifies unique technologies that would not be advanced otherwise and partners with companies to test concepts and bring better treatments and therapeutics leading to a cure to patients faster. To date, JDRF has funded type 1 diabetes projects at 30 companies, committing approximately $72 million in research funding.

“Our funding to SmartCells was an important step in what has become the JDRF Insulin Initiative,” noted Dr Sanjoy Dutta, Director of Glucose Control research at JDRF. “We are focused on supporting an effort towards the development of faster-acting insulins, other glucose-responsive insulins and novel therapies that will help people with diabetes maintain glucose control with less effort.”

Diabetes is a large and growing challenge with as many as 3 million people in the United States living with type 1 diabetes and another 30,000 are newly-diagnosed each year. A recent CDC modeling report indicated that as many as one in three individuals could have diabetes, either type 1 or 2, by the year 2050. Better treatments are desperately needed to help people live better with the disease today as research continues toward an eventual cure.

About JDRF

JDRF is a leader in setting the agenda for diabetes research worldwide, and is the largest charitable funder of and advocate for type 1 diabetes research. The mission of JDRF is to find a cure for diabetes and its complications through the support of research. Type 1 diabetes is an autoimmune disease that strikes children and adults suddenly, and can be fatal. Until a cure is found, people with type 1 diabetes have to test their blood sugar and give themselves insulin injections multiple times or use a pump – each day, every day of their lives. And even with that intensive care, insulin is not a cure for diabetes, nor does it prevent its potential complications, which may include kidney failure, blindness, heart disease, stroke, and amputation.

To help improve the lives of people with type 1 diabetes while working toward a cure, one of JDRF’s research goals is to support research to develop products that can dramatically improve blood glucose control in people with type 1 diabetes so they can live healthier lives with less risk of developing disease-related complications.

Since its founding in 1970 by parents of children with type 1 diabetes, JDRF has awarded more than $1.5 billion to diabetes research, including more than $107 million last year. More than 80 percent of JDRF’s expenditures directly support research and research-related education. For more information, please visit www.jdrfbayarea.org.

Clinical proof-of-concept study will also evaluate whether metreleptin can reduce the amount of insulin needed by patients with type 1 diabetes

NEW YORK and SAN DIEGO, Nov. 16, 2010 — The Juvenile Diabetes Research Foundation (JDRF) and Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) announced today that they entered into a research collaboration agreement to provide financial support for a clinical proof-of-concept study to investigate the effects of metreleptin, an analog of the human hormone leptin, in patients with type 1 diabetes. Researchers at The University of Texas (UT) Southwestern Medical Center will conduct the study.

Prior studies at UT Southwestern conducted in animal models with type 1 diabetes showed an improvement in blood glucose, blood fats, and cholesterol following administration of the hormone. The clinical study will help to determine if similar improvements in glucose, and reduction of the amount of insulin required, can be achieved in people with type 1 diabetes. Leptin is a hormone secreted by fat cells that plays a fundamental role in the regulation of glucose metabolism.

“Better blood glucose control means healthier living for people with type 1 diabetes,” said Aaron Kowalski, Ph.D., Assistant Vice President of Treatment Therapies at JDRF. “If effective in humans, metreleptin, when used with insulin, could change the way people manage their disease. Less insulin usage and fewer low blood sugar episodes would represent a significant improvement in quality of life for certain people living with type 1 diabetes today.”

“Building on our development experience with type 1 diabetes, we continually look for ways to unleash the potential of peptide and protein science to help the millions of patients with diabetes better manage their disease,” said David Maggs, MD, MRCP, Vice President for R&D Strategic Relations at Amylin. “We are pleased to partner on this important research program with an organization that shares our passion for investigating the potential promise of new and innovative therapies.”

The research collaboration agreement between JDRF and Amylin is part of JDRF’s Industry Discovery and Development Partnership (IDDP) program through which JDRF partners with pharmaceutical, biotechnology, and medical device companies focused on the discovery, development, and delivery of therapeutics and devices for type 1 diabetes and its complications. Since the IDDP program was established in 2004, JDRF has funded 35 partnerships with 29 companies and committed approximately $71 million to accelerate research that will lead to better treatments and a cure for type 1 diabetes.

About the Study

This proof-of-concept clinical study will investigate whether treatment with metreleptin can help improve blood sugar control and decrease the daily doses of insulin required in patients with type 1 diabetes. This is the first clinical study evaluating metreleptin treatment in patients with type 1 diabetes. The study will also evaluate whether treatment with metreleptin can improve variability in blood sugar levels, including the propensity for hypoglycemia (low blood sugar levels), which affects many people with type 1 diabetes.

Conducted by researchers at UT Southwestern in Dallas, Texas, including Roger Unger, MD, professor of internal medicine, the study will enroll 12 to 15 patients with type 1 diabetes. Patients will add metreleptin twice a day to their usual insulin therapy over a five-month period. The insulin dosage will gradually be reduced to further characterize the effect of metreleptin on overall blood glucose. This study will build on recent preclinical findings by Dr. Unger and his team that showed leptin administration improved blood glucose levels, blood fats, and cholesterol in animal models of type 1 diabetes.

Abhimanyu Garg, MD and Greg Clark, MD will conduct the clinical arm of the project. Additional information about UT Southwestern can be found at www.utsouthwestern.edu.

“We were highly encouraged by the results of our study of leptin in animal models and look forward to learning whether using metreleptin with insulin yields similar results in humans,” said Dr. Unger. “Achieving a substantial reduction in insulin doses and lowering the risk of low blood glucose levels could enhance the quality of life for people with type 1 diabetes.”

About Leptin

Leptin, a fat cell hormone that plays a key role in regulating metabolism, was first discovered in 1994 by Dr. Jeffrey Friedman of The Rockefeller University in New York. Dr. Friedman has won numerous awards during his career and recently won the 2010 Lasker Award in basic medical research for his work. Metreleptin, an analog of human leptin, has been studied as a potential treatment for obesity, type 2 diabetes, and severe lipodystrophy.

About JDRF

JDRF is a leader in setting the agenda for diabetes research worldwide, and is the largest charitable funder of and advocate for type 1 diabetes research. The mission of JDRF is to find a cure for diabetes and its complications through the support of research. Type 1 diabetes is an autoimmune disease that strikes children and adults suddenly, and can be fatal. Until a cure is found, people with type 1 diabetes have to test their blood sugar and give themselves insulin injections multiple times or use a pump – each day, every day of their lives. And even with that intensive care, insulin is not a cure for diabetes, nor does it prevent its potential complications, which may include kidney failure, blindness, heart disease, stroke, and amputation. To help improve the lives of people with type 1 diabetes while working toward a cure, one of JDRF’s research goals is to support research to develop products that can dramatically improve blood glucose control in people with type 1 diabetes so they can live healthier lives with less risk of developing disease-related complications.

Since its founding in 1970 by parents of children with type 1 diabetes, JDRF has awarded more than $1.5 billion to diabetes research, including more than $107 million last year. More than 80 percent of JDRF’s expenditures directly support research and research-related education. For more information, please visit www.jdrfbayarea.org.

About Amylin Pharmaceuticals, Inc.

Amylin Pharmaceuticals is a biopharmaceutical company dedicated to improving lives of patients through the discovery, development and commercialization of innovative medicines. Amylin has developed and gained approval for two first-in-class medicines for diabetes, SYMLIN®(pramlintide acetate) injection and BYETTA® (exenatide) injection. Amylin’s research and development activities leverage the Company’s expertise in metabolism to develop potential therapies to treat diabetes and obesity. Amylin is headquartered in San Diego, Calif. Further information on Amylin Pharmaceuticals is available at http://www.amylin.com.

This press release contains forward-looking statements about Amylin, which involve risks and uncertainties. Amylin’s actual results could differ materially from those discussed herein due to a number of risks and uncertainties, including that clinical trials or studies, including the metreleptin clinical study mentioned in this press release, may not start when planned, confirm previous results, be predictive of real world use, or achieve intended clinical endpoints; preclinical studies, including the preclinical study mentioned in this press release, may not be predictive; our product candidates may not receive regulatory approval; and inherent scientific, regulatory and other risks in the drug development and commercialization process; SYMLIN and the SymlinPen, and the revenues generated from these products, may be affected by competition, unexpected new data, technical or safety issues, or manufacturing and supply issues. Commercial and government reimbursement and pricing decisions and the pace of market acceptance may also affect the potential for SYMLIN and the SymlinPen®. These and additional risks and uncertainties are described more fully in Amylin’s most recently filed SEC documents, including its Form 10-Q. Amylin undertakes no duty to update these forward-looking statements.

Experts Present at FDA-NIH Workshop

WASHINGTON, D.C., Nov. 10, 2010 — Diabetes experts at a meeting convened by the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) took the next step in advancing efforts toward the development of an artificial pancreas: putting forth clinical recommendations to ensure the safe and effective testing of artificial pancreas technology in real-life situations. We are pleased at today’s meeting there was a strong consensus among leading clinicians, researchers and industry leaders regarding the path toward outpatient studies for both low-glucose suspend and artificial pancreas systems.

Even with treatments available today, tight blood sugar control remains a challenge and daily struggle for those living with type 1 diabetes. In fact, the majority of people living with the disease are not achieving recommended target levels. “An artificial pancreas, essentially a device that would both measure blood sugar and dispense appropriate amounts of insulin to keep levels in optimal range, would take much of the guesswork out of daily management of the disease,” said Dr. Aaron Kowalski, Assistant Vice President of Treatment Therapies at JDRF. “In the long-run, controlled blood sugar levels will help to lessen or avert the devastating complications from type 1 diabetes.”

To date, artificial pancreas devices have been successfully tested in controlled inpatient or hospital settings, demonstrating the potential for this technology to improve blood sugar control. Now it must be tested safely in real-world conditions. And clear and reasonable regulatory guidelines must be established to ensure that the upcoming studies advance the technology to reach patients as soon as possible.

“We believe a safe and effective first generation artificial pancreas system is possible with today’s technology, even as we continue to encourage development of improved devices. Experts at today’s FDA workshop outlined a clear path forward to safely speed the development and delivery of artificial pancreas systems to patients,” said Jeffrey Brewer, President and CEO of JDRF.

To help advance these efforts, JDRF formed a Clinical Panel of internationally renowned leaders in the diabetes field to make recommendations to FDA on key clinical steps and issues critical to the advancement of studies of these systems outside of the hospital. Panel members speaking at today’s workshop included David Nathan, Director, Clinical Research Center and Diabetes Center at Massachusetts General Hospital and Professor of Medicine, Harvard Medical School; and William Tamborlane, Professor and Chief of Pediatric Endocrinology and Diabetes, Yale University School of Medicine.

The panel developed a series of clinical recommendations that were shared at today’s meeting. They were based on key areas addressed by the FDA, NIH, JDRF, clinicians and industry. First, the recommendations addressed questions on how should studies on artificial pancreas systems move safely from inpatient (hospital) settings to outpatient (real-world) testing. Second, the panel identified which subset of patients should be considered when testing artificial pancreas systems. The third area focused on how to ensure the safety of patients participating in the studies and eventually for everyday use. Lastly, the panel identified what outcomes should be measured in studies to demonstrate the safety and effectiveness of the device.

A summary of the panel’s recommendations is available here. A full report by the panel will be forthcoming.

According to panel chair Robert Sherwin, M.D., Yale University, “The panel believes, with certain safeguards, artificial pancreas systems can be safely tested in real world settings.”

“The incidence of type 1 diabetes is on the rise. Today’s tools to manage the disease are insufficient. We have the technology at our disposal to make an artificial pancreas work. Now it’s time to move forward quickly to define the regulatory pathway so final studies can be completed and better technologies can be made available to adults and children struggling with this difficult disease,” added Mr. Brewer.

About JDRF’s Artificial Pancreas Project

JDRF launched the Artificial Pancreas Project in 2005 to speed the development of automated diabetes management systems. A self-regulating system, the artificial pancreas would be able to sense sugar levels continuously and automatically release the right amount of insulin at the right times – eliminating the need for multiple blood tests, insulin injections and therefore lifting the daily burden associated with managing diabetes.

Since that time, JDRF has supported a number of initiatives that have advanced progress toward the development of an artificial pancreas. This has included the formation of the Artificial Pancreas Consortium, a group of university-based mathematicians, engineers, and diabetes experts to develop the computer algorithms that are needed to connect the devices needed to form a closed-loop system.

In addition to the consortium, JDRF has collaborated with several industry partners to develop a first-generation artificial pancreas system, as well as better and faster-acting insulin products, a key component of developing a safe and effective artificial pancreas system.

More information about JDRF’s Artificial Pancreas Project can be found online at www.jdrf.org/artificialpancreasproject. The site includes information for people with type 1 diabetes about research leading to the development of an artificial pancreas, as well as interactive tools, project timelines, chats with researchers, and access to information about clinical trials.

Renewal of U.S. Government Special Diabetes Program Will Ensure Progress toward Better Treatments and a Cure for Type 1 Diabetes

NEW YORK, Nov. 5, 2010 – Thanks to significant research advances in recent years, people living with type 1 diabetes have received better treatments and therapies.  Scientists have made headway in uncovering the possible cause of type 1 diabetes, and in their efforts to find ways to prevent, treat, or reverse the autoimmune disease and its complications. Despite this progress, we still have a long road ahead of us to identify a cure that will eliminate type 1 diabetes once and for all.

Diabetes of all types continues to grow at an alarming rate – in the last 30 years , the number of people with diabetes has skyrocketed to about 24 million people in the United States alone, including as many as three million Americans affected by type 1 diabetes. The cost of diabetes is staggering – one out of every five health care dollars is spent caring for someone with diagnosed diabetes, and one out of every three Medicare dollars is attributed to diabetes. The national price tag for diabetes is at an astounding $174 billion per year and that cost is estimated to almost triple in the next 25 years.  Sustained scientific commitment and funding for research are needed to ensure we reach our goal of eliminating type 1 diabetes and its complications.

“November is National Diabetes Awareness Month, a time to bring attention to priority issues for those of us trying to bring about an end to type 1 diabetes. Chief among our priorities is to ensure that federal funding levels remain sufficient to support the necessary research to drive the field toward a cure for the disease and its complications,” said Jeffrey Brewer, President and CEO of JDRF.

JDRF is encouraging the public to learn about a key source of diabetes support, the Special Diabetes Program (SDP), a federal-funded program that has contributed significantly to many advances in diabetes research. The program is currently up for renewal before Congress. And without continued funding, support for much-needed clinical research will be in jeopardy.

The Special Diabetes Program (SDP), established by Congress in 1997, currently funds $150 million annually for type 1 diabetes research, representing 35 percent of the federal government’s support for type 1 diabetes research. JDRF, also committed to funding research toward a cure for type 1 diabetes, is calling for the multi-year renewal of the program before Congress adjourns for the year. “This would ensure that the research advancements made from the program’s early years that have now translated to human clinical trials can continue uninterrupted to further our mission of treating and curing type 1 diabetes,” said Cynthia Rice, Vice President of Government Relations for JDRF. “Without the program’s renewal, total federal support for type 1 diabetes research would drop to below FY 2004 levels, and we have come too far to let that happen.”

Research Progress to Date

Important strides in diabetes research have been made with the support of the Special Diabetes Program (SDP), including studies that seek to unveil the root causes of type 1 diabetes, or to test therapies that could prevent the disease altogether. Studies aimed at developing cell-based therapies for beta cell replacement, or programs that play a critical role in testing and confirming new diabetes management technologies in children are also funded through the SDP.

Research supported by the SDP and others, including JDRF, has also led to the development of new technologies – like insulin pumps and continuous glucose monitors to test and control blood sugar – which have set the stage for what will ultimately lead to an artificial pancreas. As a result, people with type 1 diabetes can now manage their diabetes better than ever before. These tools have helped people to live better lives today, including lessening the risk for low blood sugar (hypoglycemia), which can be life-threatening, and high blood sugar (hyperglycemia), which can lead to long-term complications, such as blindness or kidney disease.

“In fact, thanks to better monitoring tools, people with type 1 diabetes now have a lower risk of complications than ever before,” said Richard Insel, M.D., Chief Scientific Officer for JDRF. “When complications do develop, doctors have better ways to diagnose them, slow their progression, and lessen their impact. All these research advances mean a better life and longer life expectancy for people with type 1 diabetes.”

JDRF Activities

“As we all participate in a variety of activities that will raise awareness about the urgency of diabetes this November, let’s remember to keep in mind that it is through progress in research, such as those funded by JDRF and the Special Diabetes Program, that we can continue to make improvements in the lives of people living with type 1 diabetes today and in the future,” continued Mr. Brewer.

As part of JDRF’s efforts to raise awareness for type 1 diabetes and encourage the importance of research, JDRF will participate in a number of events and activities around the country throughout the month. In particular, JDRF will host an event known as “Type 1 Talk,” an online and offline social media gathering initiated by a live UStream broadcast that will be presented by JDRF staff and volunteers on World Diabetes Day, Nov. 14. Type 1 Talk will allow people with type 1 diabetes from across the U.S. to converge in their local communities and engage in type 1 diabetes-related conversation with one another.

For more Bay Area events on World  Diabetes Day, visit our online event calendar: http://events.jdrfbayarea.org/calendar/day/2010/11/14

Also, JDRF is encouraging the public to learn more about type 1 diabetes and the importance of diabetes research through various efforts that include highlighting the warning signs and symptoms of type 1 diabetes, and the differences between type 1 diabetes and the more prevalent type 2 diabetes. For more information on JDRF during National Diabetes Awareness Month, please visit www.jdrf.org.

We have just realigned our staff, transitioning from an event-driven model to geographically-based teams.  In doing so we feel we are better prepared as partners to our volunteers; to meet the needs of the diabetes communities and communities in general; and to steward the donors within the Greater Bay Area.  This restructure creates an opportunity for an experience development professional for the newly created position of Development Director to serve as the team leader for the region which includes San Mateo County south of Highway 92, San Benito, Santa Clara, Santa Cruz and Monterrey Counties.  Reporting to the Executive Director, the selected candidate will support and maintain the vision, mission, priorities, and guiding principles of JDRF and will serve as a key leader in implementing the strategic direction and purpose of the Chapter.

Responsibilities include:

• Formulate, implement, and lead strategies and tactics for chapter fundraising and Development activities to sustain continued growth, maximum penetration of core market areas and opportunities for expansion where appropriate.

• Enhance and further develop existing Silicon Valley and Monterrey Bay communities to increase support of JDRF’s mission to find cures for type 1 diabetes and its complications.

• In collaboration with chapter volunteer and staff leadership, identify and cultivate key community and corporate relationships to achieve financial objectives critical to the advancement of JDRF’s mission to cure diabetes.

• Evaluate the resources within the market area and develop, implement and achieve a comprehensive plan of operation for all annual income development activities (including budgets, time lines, logistics, volunteer activities and recruitment, marketing, donor development, and sponsorship plans).

• Provide staff leadership and partnership for Walk to Cure Diabetes (Walk) . In collaboration with key volunteers, develop annual Walk plan including goals, objectives, revenue targets and principal operational strategies and time lines.

• Provide staff leadership for special event, including Spring Fling Golf Tournament, Luncheon and Evening Bash (gala), and achieve event revenue growth objectives.

• Direct and manage assigned resources including staff and volunteers. Supervise, coach and evaluate staff, consultants and temporary personnel. Provide ongoing growth and development by motivating, developing, and directing people as they work.

• Accountable for volunteer management (i.e. recruitment, training, motivation, recognition, supervision and evaluation) required to plan and implement assigned special events, donor activity and support programs.

• Serve as relationship manager on all assigned corporate and individual donor relationships in the Branch.

• Coordinate and assure the development of all marketing and communications materials required for the successful implementation of branch activities including recruitment material, promotional fliers and brochures, invitations, posters, training materials, pledge retrieval or motivational materials.

• Cultivate productive relationships with the media, hospitals, clinics and other referral sources including various constituents, and related groups in the geographic market area including professional, educational and political leadership.

• Coordinate the tracking of income and expenses (with Chapter Office Manager) associated with assigned events, and facilitate comprehensive special event records, evaluations and reports.

• Provide branch leadership, management and support for the development of government relations and outreach programs (i.e. adult and/or family networking activities, tool kits, coffees, etc.) in the branch market area.

• Represent the best interests, professionalism and integrity of JDRF in all activities and relationships through a unified message of the JDRF mission and a commitment to organizational standards and leadership by personal example.

We seek individuals with the following skills and experience:

• 5 -10 years of progressively responsible and related experience with a minimum of 5years in a supervisory capacity required or equivalent combination of education and experience. Professional background must include familiarity with Silicon Valley business community.

• Traditional donor development and special event experience required.

• Successful volunteer management experience required.

• Community development experience.

• Experience in developing and managing to strategic plans.

• Knowledge and skill in non-profit and fiscal management.

• Understanding of computer systems and databases. Proficiency in Microsoft Office (Outlook, Word, Excel & PowerPoint) is desired.

• Effectively multi-task, establishes priorities, and work in a fast-paced environment. Organized and highly efficient in time management; ability to meet deadlines under pressure.

• Team player that has the ability to interface with all levels of staff and volunteers. Must develop, maintain, and utilize relationships and have skills in leveraging relationships and negotiate agreements.

• Excellent written, oral, and communication skills including the presentation skills, conveying ideas, and instructing effectively.

• Superior active listening, observation, analytical, and problem recognition and solving skills. Exercise sound judgment.

• Ability to work and make judgments independently and take initiative. Well disciplined, resourceful and a self-starter

• Flexibility to travel as needed but mostly within the Bay Area.

We offer a competitive salary and benefits package.  Sound interesting?  You can learn more about JDRF, our national organization or about the Greater Bay Area Chapter.  If you’d like to join our team and have the background noted above, please send your resume and cover letter to me at gmartin@jdrf.org.

No Phone Calls, Please.  Sorry, but only those candidates that meet our qualifications will be contacted.

JDRF is an equal opportunity employer

The Juvenile Diabetes Research Foundation is the worldwide leader for research to cure type 1 diabetes. It sets the global agenda for diabetes research, and is the largest charitable funder and advocate of diabetes science worldwide.

The mission of JDRF is to find a cure for diabetes and its complications through the support of research. Type 1 diabetes is an autoimmune disease that strikes children and adults suddenly, and can be fatal. Until a cure is found, people with type 1 diabetes have to test their blood sugar and give themselves insulin injections multiple times or use a pump – each day, every day of their lives. And even with that intensive care, insulin is not a cure for diabetes, nor does it prevent its eventual and devastating complications, which may include kidney failure, blindness, heart disease, stroke, and amputation.

Since its founding in 1970 by parents of children with type 1 diabetes, JDRF has awarded more than $1.5 billion to diabetes research. The generosity of our supporters allowed JDRF to fund more than $107 million in FY2010. In FY 2010, JDRF funds research projects in 22 countries throughout the world, including more than 40 human clinical trials.

Nick Jonas, one third of the Grammy-nominated, multi-platinum group the Jonas Brothers, was announced today as  the National Chair of JDRF’s Walk to Cure Diabetes.

Nick Jonas, 17, was diagnosed with type 1 diabetes when he was 13 years old.  He becomes the key figure for the largest fundraising program for the Juvenile Diabetes Research Foundation. In this role, Nick will help JDRF increase participation and fundraising in its annual Walks, held in more than 200 locations worldwide.  Nearly 500,000 people took part in JDRF Walks last year, raising some $75 million.  As the National Chair, Nick will attend events to support fundraising efforts as well as take part in promotional videos and television public service announcements for JDRF.

Watch the NEW Walk to Cure Diabetes Video

To register for a Walk near you, visit Walk.JDRF.org

“As a person living day to day with diabetes and recognizing the tremendous contribution the Juvenile Diabetes Research Foundation has done for our community, I couldn’t be more honored to serve as the National Chair for the Walk to Cure Diabetes,” says Nick Jonas.

“Having Nick Jonas as National Chair will go far towards raising awareness of type 1 diabetes, and what needs to be done to find a cure. Nick has been a wonderful role model for kids and adults with diabetes, and has been invaluable in bringing visibility to efforts to cure this disease,” said Leo Mullin, Chairman of Board of Directors for JDRF.  “We have seen the impact he has firsthand, when he demonstrated his commitment to support diabetes research through the Jonas Brothers’ Change for the Children Foundation, and when he testified in Congress for JDRF on the need for continued federal funding for research.”

In addition, Nick has helped raise diabetes awareness through his partnership with Bayer Diabetes Care.  Last month, Bayer and Nick Jonas announced a new contest called “Give Back. Simply Win.” that encourages people with diabetes to share their stories about giving back, and rewards them for their charitable efforts.  For more information on this contest, please visit www.nickssimplewins.com.

Nick succeeds actor and celebrity advocate Kevin Kline, who was National Chair of JDRF’s Walk to Cure Diabetes for the past four years.

JDRF Volunteer, Philanthropist, Former Internet Executive to Lead Top Funder of Cures and Treatments for People with Type 1 Diabetes and Its Complications

The Juvenile Diabetes Research Foundation, the leader in type 1 diabetes research worldwide, announced today that Jeffrey Brewer has been named President and Chief Executive Officer.

Mr. Brewer, an entrepreneur and philanthropist, has been a passionate JDRF volunteer and donor for the past eight years, playing a key leadership role in the organization’s research activities. He became involved with JDRF since soon after his son, Sean, was diagnosed with type 1 diabetes in 2002. He has served as a director of JDRF’s international board since 2004, is a reviewer on JDRF’s Lay Review Committee (which judges the potential of diabetes research from the perspective of people impacted by diabetes), and has been an active member and donor for the foundation’s New York Chapter.

“Jeffrey Brewer has all the qualities we were looking for in a leader for JDRF: experience in managing large and growing organizations, a detailed understanding of diabetes research, and a track record of success,” said Frank Ingrassia, Chairman of the JDRF Board of Directors. “When you add to that a drive and passion for finding a cure, based on his own family experience with diabetes and the people around the world he has met in his years as a volunteer with JDRF, that’s a terrific combination to help us speed progress towards the cure.”

Mr. Brewer is the founder and a former senior executive of two successful internet businesses: Overture Services, which was acquired by Yahoo, where he served as CEO; and CitySearch, which is now a division of USA Interactive, where he was Chief Technology Officer. Since 2003, Mr. Brewer has served as Executive Chairman of Kickstart International, an award-winning non-profit organization providing poverty-stricken populations, primarily in Africa, with a revolutionary approach to becoming self-sufficient.

As a JDRF volunteer, he has been particularly involved in leading the organization’s Artificial Pancreas Project, which over the past four years has significantly accelerated both academic and industry research leading to the development of automated systems to better control diabetes in children, teens, and adults. In addition to improving the lives of people with type 1 diabetes, the improved control that these systems can provide will lower the risk of dangerous low-blood sugar emergencies, reduce the risk of long-term complications, and potentially improve the efficacy of cures and treatments as they become available.

“As a volunteer, it so humbling and rewarding to work side by side with our passionate volunteers and our impressive staff in our collective effort to advance the pace of research leading to better treatments and cures for people with diabetes,” Mr. Brewer said. “I feel we are on the cusp of exciting research progress that can make a real difference in the lives of people living with this terrible disease – including some tangible advances delivered to patients in the not-too-distant future. I’m honored to become a full-time part of driving us towards our goals, and helping us translate research into drugs and devices that will help people with type 1 diabetes live better, longer and healthier, and ultimately to remove this disease from people’s lives forever.”

Mr. Brewer was co-founder of Overture Services, formerly known as GoTo.com, in 1998; he also served as CEO and a director. GoTo.com was the first pay-for-placement and pay-for-click search advertising system, and set the standard for the current model of search advertising. After going public in 1999,, the company was acquired by Yahoo in 2002.

Previously, he co-founded CitySearch in 1995, where he was a director, Chief Technology Officer, and Vice President of Development. CitySearch was the first online city guide providing current localized information and recommendations for arts and entertainment events, community activities, shopping and services. It went public in 1998.

Mr. Brewer has a degree in Economics from Southern Methodist University. He and his wife Deborah live in New York City and have a daughter, Katherine, as well as their son, Sean.