December 01, 2006 Volume 1, Issue 1 

  In This Issue
 


A Message from the Founder

A Focus to Cure Diabetes
Diane and I are pleased to announce that we have changed the name of our foundation to reflect our ongoing personal and corporate mission.  



UVa Program Update

Another Transplant, A New "Clean Room" Approved by the FDA
The Center for Cellular Transplantation and Therapeutics has performed two islet cell transplants and can now isolate insulin-producing tissue from human pancreata.  



Resources for Managing Diabetes

Diabetes Health Magazine Offers Free Subscriptions to Online Resource
In honor of National Diabetes Month, Diabetes Health is offering (for a limited time) free subscriptions to its newly launched digital magazine. 



Living with Type 1 Diabetes

Former Tennis Star and Diabetic Ham Richardson Dies at Age 73
Ham Richardson, who overcame type 1 diabetes to become a leading U.S. tennis player in the 1950s and early 1960s, died in November at age 73. 



Foundation Newsroom

PULSE: A Newsletter of the UVa Health System (Spring 2006)
Paul and Diane Manning are once again providing generous resources to help UVa and other medical centers perform more islet transplants. 

  WVIR-TV NBC29 (September 8, 2006)
Alex O'Meara, the recipient of the state of Virginia's second islet transplant, is a triumph for UVa Medical Center. 

  The Daily Progress (October 26, 2005)
Paul B. Manning, the founder, president, and CEO of the company that bears his initials, wants to help people, particularly those with type 1 diabetes.  





 A Message from the Founder
 
A Focus to Cure Diabetes

First and foremost, Diane and I would like to thank everyone who has supported the Islet Replacement Research Foundation in working towards finding a functional cure for type 1 diabetes. Since 2002, our foundation has played a critical role in establishing a state-of-the-art islet cell transplant program at the University of Virginia that has improved the lives of two people living with type 1 diabetes.

Islet cell transplantation represents the most promising cure for the disease, but more research is needed before patient immune systems can accept transplanted islet cells without the use of immunosuppressive drugs. These medications are toxic to the islets themselves and have potential side effects.

As a foundation, we have taken on three initiatives to meet this remaining challenge:
  1. Funding islet cell transplants that enable patients to produce enough insulin to control blood glucose without immunosuppressive drugs.
  2. Supporting research to address the present shortage of islet cells by converting other cells into beta cells and leveraging live organ donations.
  3. Exploring regeneration strategies that will one day enable patients to renew their own beta cells.
The need for ongoing research and the serious shortage of islet cells available for transplantation presents donors with two important ways to give.

Until there is a cure, we will continue to fund diabetes research and have leveraged our consumer products company to make progress on this front. In fact, PBM Products recently introduced a line of diabetic products to help people better manage diabetes. A portion of the proceeds from the sale of GlucoBurst® Glucose Gel and GlucoBurst™ Diabetic Drink will be donated to diabetes research.

We believe a cure is right around the corner and want more people to join us in the fight against diabetes. Because of confusion over the word "islet" and feedback from many in the diabetes community, we have decided to change the name of our nonprofit organization to reflect our personal and corporate mission.

In recognition of American Diabetes Month, Diane and I want to provide an update on our diabetes work. Our renamed nonprofit, the Focus to Cure Diabetes Foundation, continues to support ambitious research projects that we believe will one day stamp out insulin dependence. To help keep you abreast of promising developments, we have launched an updated Web site at www.tocurediabetes.org, and are pleased to introduce The Insulin Independent newsletter.

We hope you find these communication vehicles useful and welcome your feedback.

Warm regards,

Paul B. Manning
Founder, Focus to Cure Diabetes Foundation


 UVa Program Update
 
Another Transplant, A New "Clean Room" Approved by the FDA

UVa's "clean room" facility is approved by the FDA as one of the only sites where donor pancreas islet-cells can be isolated.
Image courtesy of Dr. Kenneth Brayman's 9-12-06 presentation
The University of Virginia Health System is a national leader in the fight against diabetes. In fact, UVa is one of the only institutions in the United States that has cured diabetes in some patients by means of full-organ pancreas transplantation and islet cell transplantation.

A national leader in pancreas transplants, UVa's Center for Cellular Transplantation is curing people with type 1 diabetes by providing them with a healthy, insulin-producing gland. The center is also among a small number of facilities in this country that has successfully performed pancreatic islet cell transplants, which are still considered experimental.

Using state-of-the-art, cellular transplant technology, UVa doctors extract islet (insulin-producing) cells from a pancreas, purify them, and inject them into the patient’s liver where they can function. If conditions remain suitable, these islets begin to produce insulin, reducing the need for insulin injections.

“We have a high-level institutional commitment to being at the forefront of transplantation for the cure of diabetes,” said Center for Cellular Transplantation and Therapeutics Director Kenneth Brayman, M.D., Ph.D., in an August 2006 interview with the LINK Newsletter. “Early results show about 80 percent of people with this [islet cell] transplant will be off insulin one year after their treatments.”

In addition, UVa Medical Center recently completed construction of a laboratory on the Fontaine Research Park Campus where doctors can now isolate insulin-producing tissue from human pancreata for transplantation into diabetic patients. The Current Good Manufacturing Practices (cGMP) “clean room” facility is approved by the FDA as one of a select-few sites where donor pancreas islet-cells can be isolated.




 Resources for Managing Diabetes
 
Diabetes Health Magazine Offers Free Subscriptions to Online Resource

Type 1 diabetic Scott King, editor-in-chief of Diabetes Health magazine, had a chance to catch up with diabetes professionals and researchers at the June 66th Scientific Sessions of the ADA (American Diabetes Association) held in Washington, D.C. The meeting was attended by thousands of members of the diabetes community from around the world, including 1500 scientists and health-care professionals who could learn about new product offerings and attend 63 symposia and 49 oral sessions.

King filmed interviews with several diabetes professionals at the convention, and videos are now available for viewing online at DiabetesHealth TV. You will need to have Adobe Flash 7 or later installed on your machine in order to view these videos.

Published continuously for 14 years, Diabetes Health magazine provides objective, sometimes controversial, but always balanced articles about living with diabetes. Consumers and medical professionals alike recognize the value of this niche magazine that treads where no other is willing to go.

“Other magazines think people with diabetes can’t handle the facts, so they leave them out or oversimplify,” said King. “I find that people with diabetes want all the information they can get.”

King has edited more than 4,000 articles about diabetes. He is recognized as an expert on diabetes information and has been quoted by The Wall Street Journal, Parade, U.S. News and World Report, and Ann Landers.

Earlier in November, the magazine announced it is doing its part to honor National Diabetes Month by offering (for a limited time) free subscriptions to its newly launched digital magazine, Diabetes Health Digital Advantage™. The free subscription is available by visiting the Web site and clicking the Diabetes Health Digital Advantage link displayed on the home page.

This online version of Diabetes Health, virtually identical to the bi-monthly print magazine, has many additional useful features. While the pages turn in a similar fashion to a magazine's, direct hot links lead to research articles, products, and advertiser sites.




 Living with Type 1 Diabetes
 
Former Tennis Star and Diabetic Ham Richardson Dies at Age 73

Ham Richardson overcame juvenile diabetes to become a top tennis player in the 1950s and early ’60s.
Image courtesy of United Press International, 1962
Earlier in November, The New York Times reported that Hamilton F. "Ham" Richardson, who overcame juvenile diabetes to become a leading U.S. tennis player in the 1950s and early 1960s, died from complications of diabetes, at age 73.

Richardson learned he had diabetes at the age of 15, when he was regarded as one of the best junior players in the country. Despite struggles with his health, Richardson was able to manage the disease and achieve greatness on and off the tennis court.

“The first physician we went to said I could not play competitive tennis again,” Richardson said in a 1997 interview with The New Orleans Times-Picayune. “So I went to a second doctor. He said the same thing, so I went to a third. When I finally found one who said I wouldn’t have to give it up, my tennis picked up right where it left off.”

A native of Baton Rouge, Louisiana, the former athlete was a two-time N.C.A.A. singles champion at Tulane University before becoming an amateur tennis standout in the final decade leading up to tennis' open era. The diabetic's post-collegiate accomplishments were incredible:

  • Richardson was the No. 1-ranked player in the United States in 1956 and 1958.
  • He won 17 national titles and played on seven Davis Cup teams with a record of 20-2.
  • He partnered with Alex Olmedo to capture the men’s doubles title at the United States Nationals (the forerunner of the U.S. Open), in 1958.
In addition to the U.S. title, Richardson and Olmedo rebounded from a two-set deficit to win the doubles in the Davis Cup finals against Australia at Brisbane in December 1958, after the Aussies defeated the United States in the finals the three previous years. The Americans went on to a 3-2 victory.

When Richardson won the 1950 French junior championship, he had to spend every night at a Paris hospital while doctors tried to stabilize his fluctuating blood-sugar levels. The following year, he passed out because of low blood sugar the evening before he was to play in the finals of a Newport, R.I., tournament in 1951, then won the championship in a five-set match.

Richardson's academic accomplishments were equally as impressive. After earning a BA in economics at Tulane, Richardson was a Rhodes scholar. In fact, he was attending Oxford University, from which he received a master’s degree, the first time he was ranked No. 1.

After tennis, Richardson worked in the investment field for more than 35 years and at his death was president of Richardson and Associates, a New York investment and venture capital firm.

Richardson is survived by his wife, Midge Turk Richardson, his sons, Kevin and Kenneth, a daughter, Kathryn Ann Sawers, and five grandchildren.




 Foundation Newsroom
 
PULSE: A Newsletter of the UVa Health System (Spring 2006)

The Mannings are once again providing generous resources to help UVa and other medical centers perform more islet transplants.
Image courtesy of UVa Health System
Diane and Paul Manning are featured in the Spring 2006 issue of PULSE, a newsletter focusing on new programs, gifts, volunteers, needs, and other timely issues related to the University of Virginia Health System.

Leading by Example (pdf, page 5)

In 2004, UVa performed the state’s first islet cell transplant, a groundbreaking procedure that has the potential to give type 1 diabetics a chance to live free from daily insulin injections. Strong support from the Focus to Cure Diabetes Foundation, founded by Paul and Diane Manning of Keswick, Va., helped make the first transplant possible. Now the couple is once again providing generous resources to help UVa perform more transplants and help other medical centers do the same.

“Through the dedication and vision of the Mannings, UVa is building a premier transplantation program,” says Kenneth Brayman, M.D., director of the Center for Cellular Transplantation at UVa. “This gift will help us isolate islet cells here on Grounds, speeding our work and allowing us to offer hope to patients across the country.”

The Mannings are more than donors to the program—the couple has become active fundraisers for the program, and Paul Manning sits on the Board of Trustees of the UVa Health Foundation.

“We believe a cure for diabetes is right around the corner,” said Manning. “World renowned scientists and doctors at UVa are focused on curing this disease.”

Manning, CEO of PBM Products, is also leveraging his company to help make progress on the diabetes research front.

“PBM is developing innovative products that improve the quality of life for diabetics,” he said. “A portion of the proceeds from our GlucoBurst products will go towards diabetes research until we find a cure.”

For more information on the Focus to Cure Diabetes Foundation, visit www.tocurediabetes.org.


 
WVIR-TV NBC29 (September 8, 2006)

Richmond's Alex O'Meara is the second recipient of pancreatic islet cell transplantation at the University of Virginia, and his quality of life has improved greatly. The following story appears courtesy of Charlottesville's NBC29 television station, and aired on September 8, 2006.

New Transplant a Triumph for UVa Medical Center Patient

David Douglas / WVIR-TV NBC29 Reporter

As almost anyone with diabetes will tell you, it is not an easy disease to live with. In many cases it involves constant measurement of sugar levels, which can mean finger pricks. It also means needle sticks when the body needs more insulin. Alex O‘Meara’s case was no exception.

“You’re always preparing to do something, or seeing what the result was of not doing something,” Alex said. “Preparing to eat so you are counting how much insulin, how much exercise, it’s just a constant, it’s like walking a tightrope.”

A tightrope Alex told NBC29’s David Douglas can be tricky to travel across – a trip he’s been making for 30 years now, but a trip that might be coming to a happy ending. Alex had a pancreatic islet-cell (pronounced eye-let) transplant in May. He needed the transplant because as a diabetic, his body rejects his own islets, which is why it can’t regulate insulin on its own. Since the transplant procedure almost four months ago, things are really looking up.

“I’m not bouncing around, my sugar isn’t going crazy, and I feel better,” said Alex.

The University of Virginia Medical Center has recently completed construction of a laboratory on the Fontaine Research Park Campus. The “clean room” facility has just been approved by the FDA as one of a select-few sites where donor pancreas islet-cells can be isolated. Since Alex had his transplant several months ago, his cells were transplanted at UVa, but isolated at the University of Pennsylvania. And while several hundred thousand of those cells are too small to see, they are big enough to make a difference in Alex’s life.

“The potential’s already realized, I mean, I’m on four units of insulin, and I was on eighty when this first started,” said Alex. ‘So I still test, but in my world it’s like I’m not diabetic anymore, so that kind of difference is remarkable.”

A remarkable difference that Alex and researchers alike say comes with a tradeoff.

“There are certain mediations they have to take long term,” said UVa Clinical Research Associate Michael Hanshew. “They are maintained on these medications as long as they’re receiving benefit from the transplant.”

“The regime of having to take drugs, and write things down as a clinical transplant patient, compared to being diabetic is not a bad deal, because being diabetic, it is the great do-it-yourself disease,” said Alex.

He doesn’t mind the drugs, because they keep his body from rejecting his new islet-cells. And as long as those cells keep working, he remains free of a pager-sized insulin pump, something the runner in him appreciates.

“I got rid of my insulin pump and celebrated by going out and getting an iPod,” Alex told us. “I didn’t want to run with one earlier cause it was like I was a robot and I’d have wires here, and wires there. Now, I get to run with it 'cause I want to.”

From I-pump to iPod, it’s a tradeoff Alex is happy to live with. And the procedure that made it happen could one day mean a cure for diabetes.


 
The Daily Progress (October 26, 2005)
On October 26, 2005, The Daily Progress (Charlottesville, Va.) featured Paul Manning's personal and corporate mission to help people with type 1 diabetes. The article is noteworthy because it introduces PBM's product development efforts in the diabetic category until there is a cure for the disease.

PBM Seeks to Help Diabetics

By Sarah Barry  / Daily Progress staff writer

GORDONSVILLE - Hidden behind green hills and golden orchards, PBM Products has been quietly growing for the last eight years, distributing baby formulas, dietary supplements and a wide range of other products across the nation.

Paul B. Manning, President and CEO of PBM Products Inc., with a single serving of his company's new Gluco Burst gel, a product for diabetics to keep their blood sugar high, at his office in Gordonsville on Tuesday, October 18 2005. photo Brady Wolfe
Paul B. Manning, president and CEO of
PBM Products, sits with a single serving
of his company's new GlucoBurst gel.
The Daily Progress / Brady Wolfe

Working out of antebellum homes and hotels that have been converted into offices, the company takes in more than $100 million each year and is continually expanding its interests.

Paul B. Manning, the founder, president and chief executive officer of the company that bears his initials, has far-reaching goals for PBM Products and for himself. Aside from maintaining a healthy business, he wants to help people, particularly those with type 1, or juvenile, diabetes.

To that end, PBM Products has launched its new GlucoBurst glucose gel. The gel contains exactly 15 grams of glucose, the dosage recommended by the American Diabetes Guidelines for a diabetic whose blood sugar has dropped dangerously low.

People with type 1 diabetes produce little to no insulin and must take insulin shots to help their bodies convert sugar, or glucose, into energy. If they don’t take insulin, the sugar in their blood can build up.

If they haven’t eaten for a while or have been exercising, however, their normal dose of insulin can deplete their blood of glucose altogether.

“You are trying to lower the blood sugar but you want it within a range,” explained Shirley Fleishman, a certified diabetes educator who works at the University of Virginia. “It’s sometimes hard to achieve such perfection.”

The designer of the new GlucoBurst formula, Cindy Barber, is a diabetic herself and has had times where she needed to get her blood sugar up quickly. In such cases, diabetics often drink juice or eat candy, but juice can be cumbersome and candy melts. “I like to ride horses and it’s hard to carry stuff out there,” Barber said.

Glucose gels and tablets have been around for many years but Barber said past products were imperfect. “The gels that are currently out there are hard to squeeze out,” Barber said. As the vice president of research and development at PBM, she wanted GlucoBurst packaged in a user-friendly way.

Manning also has a special interest in helping diabetic patients. Two of his three children have type 1 diabetes. “Living with children with diabetes, you learn a lot about what their needs are,” Manning said.

He knew from past experience that candy and juice boxes pose problems. “For candy, they’re going to eat it when they don’t need it,” he said. And he didn’t like glucose tablets because they would be impossible to chew for someone in a diabetic coma.

Manning has been committed to helping people with type 1 diabetes for several years. Not only does he work to develop new products for diabetics, he also has created the Islet Replacement Research Foundation, which has donated more than $1 million to diabetes research, the majority of which has gone to UVa.

Islet research focuses on introducing healthy, insulin-producing pancreatic cells into the liver of someone who is diabetic. Researchers are hoping that the body of the diabetic will then begin to produce insulin of its own.

“Paul Manning’s passion for finding a cure for diabetes has had an enormous impact on the research being done at UVa,” said Dr. Arthur Garson, dean of UVa’s School of Medicine. “We are fortunate to have a friend in Paul who - and these are his own words - will settle for nothing less than ‘putting his thumbprint on the cure for diabetes.’”

Until doctors can find a cure, though, Manning wants to make life better for diabetics today by producing more products like GlucoBurst.

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