Diabetes Research Institute Foundation Annual Report 2014

annual report 2014 >

MAKINGPROGRESSPOSSIBLEThank you to every individual, family, foundation, and business that has given generously over the last year and through the years.

Highlights of the Year 2

Executive Officers' Message 4

Financial Summary 6

To our Donors 8

Heritage Society 10

National Board of Directors 11

Regional Boards of Directors 12

DRI Foundation Staff 13

THE SITE

The Food and Drug Administration (FDA) approvedthe DRI’s submission to initiate a Phase I/II clinicaltrial that will test islets transplanted in a new site in the body called the omentum, an apron-like lininginside the abdomen. The omentum closely replicatesthe physiological drainage of insulin from thepancreas and has many other beneficial properties. In this trial, human donor islet cells will betransplanted within a “biodegradable scaffold,” a DRI BioHub platform. The biodegradable scaffolduses a patient’s own plasma, the liquid part of the blood, together with thrombin, a commonly-used, clinical-grade enzyme. Several patients have completed the islet transplantation screening process and have been selected as candidates for the transplant.

SUSTAINABILITY

Drs. Alberto Pugliese and Thomas Malek have been collaborating with Paris-based Dr. David Klatzmann, who recently conducted clinical trials using low-dose IL-2 (Interleukin-2) in patients with type 1 diabetes (T1D). The study compared three low doses of IL-2 todetermine whether these would be safe and result in increased Regulatory T cells (Tregs),which regulate the immune system and suppress autoimmunity. Results of thesecollaborative studies were published this year in several peer-reviewed journals, includingDiabetes and the Journal of Autoimmunity. New trials are now enrolling patients with recent onset type 1 diabetes (within 3 months from diagnosis) to determine whether low-dose IL-2 can preserve or improve the ability of the pancreas to produce insulin.

The DRI team is very encouraged by these results and is now planning to conduct asubsequent clinical trial in Miami that will begin to expand the window to longer timeframes post-diagnosis. They believe that patients may benefit from this type of therapy aslong as they maintain a certain level of stimulated insulin production. Data has shown thatsuch levels may be present in patients for years after type 1 diabetes develops. The trial beingplanned will involve patients with residual insulin secretion after one year. They will also bestudying whether this therapy can be applicable to patients who receive a pancreas or isletcell transplant as a means of halting the autoimmune attack that caused the onset of T1D.Recent findings in mouse models also suggest that IL-2 may promote some level of beta cellregeneration, in addition to improving immune regulation.

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Throughout the year, Diabetes Research Institute scientists continued to build upon critical research programs while launching new scientificinitiatives necessary for developing the DRI BioHub, a bioengineered mini organ that mimics the native pancreas to restore natural insulinproduction. It was an exciting year in which we witnessed progress across the three main research challenges of the Site, Sustainability and Supply, with some projects advancing to or nearing the clinical trial phase of testing. Below is a summary of the year’s research highlights that were made possible by your generous support.

In its Phase I/II clinical trial, the DRIis testing the omentum as a newtransplant site. The omentum is richwith blood vessels, is easily accessedsurgically, and has the same insulindrainage characteristics of thepancreas, among other benefits.

Human islet cells embedded in thebiodegradable scaffold. The magnification of the mesh shows the fibrin fibers that hold the islets in place.

Dr. David Klatzmann from the Université Pierre et Marie Curie in Paris, France, (second from left) with the DRI’s Drs. Alberto Pugliese, Jay Skyler, and Thomas Malek. The researchers are collaborating to conduct clinical studies using low-dose IL-2 to boost Treg function, reverse autoimmunity, and restore insulin production.

Highlightsof the Year

Dr. Alice Tomei, assistant professor of surgery and cell transplantation, together withcollaborators at the École Polytechnique Fédérale de Lausanne (EPFL) in Switzerland,demonstrated that their unique conformal coating process allows efficient encapsulation of islets without compromising viability and function of the cells. The team's novel methodencases the islets within complete, uniform, and thin capsules of similar density, and has been designed to specifically address what are considered to be the limitations oftraditional cell encapsulation strategies. The results of their study earned the cover position in the prestigious journal Proceedings of the National Academy of Sciences.

Dr. Luca Inverardi and his team have continued their work with Myeloid-Derived SuppressorCells (MDSCs), a special population of immunomodulatory cells that help tumors escapedestruction by the immune system. MDSCs prevent tumor rejection by recruiting RegulatoryT cells to surround the cancer cells. The researchers are investigating the potential of MDSCsto protect insulin-producing cells from autoimmune destruction using a similar mechanism.MDSCs are usually harvested from the bone marrow, but this past year the team was thefirst to discover and characterize a novel subset of MDSCs that they have named fibrocyte-Myeloid-Derived Suppressor Cells (f-MDSC). The cells were isolated from the umbilical cordblood of healthy newborn babies and have a powerful immunosuppressive effect. Theseparticular cells are also easy to grow, expand, and bank. The team’s discovery and results oftheir studies were published in the European Journal of Immunology and Genomic Data.Their efforts are now focused on developing ideal conditions for expanding and preserving f-MDSC for their possible clinical use in achieving tolerance to transplanted insulin-producing cells in those with T1D.

Dr. Peter Buchwald, director of drug discovery, and his team are targeting a recentlyidentified signaling pathway that leads to autoimmune destruction of insulin-producingcells. They have had promising results in experimental models demonstrating that new-onset diabetes can be reversed by blocking this pathway with a protein known as Smad 7. There is also scientific evidence supporting his theory that the use of Smad 7 not only controls the autoimmune destruction of the islet cells, but can also lead to islet regeneration. Dr. Buchwald and his team are investigating the possible beta cell-enhancing effects of this treatment with the goal of quickly translating this research to clinical therapies.

In this three-dimensional model of human Smad 7, each colored region is believed to interact with a critical receptor (called TGF-ß) in this important pathway under study at the DRI.

SUPPLY

The exocrine, or non-insulin-producing, cells of the pancreas have been shown to give rise to insulin-producing endocrine cells. However, previous attempts to achieve this have thus far relied on the use of genetic manipulation, which remains a translationalhurdle for diabetes therapies. Drs. Juan Dominguez-Bendala and Ricardo Pastori and their teams have been able to convert adult human exocrine tissue into insulin-producingcells – and have done so using a single molecule that is already in clinical use for otherconditions. The DRI team is the very first group in the world to achieve this result usinghuman cells with a compound that is already FDA-approved. The non-genetic conversion of human pancreatic exocrine to endocrine cells is a novel strategy and represents a saferand simpler alternative to genetic reprogramming, while opening the door to the design of new therapies.

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By the very nature of our work at the Diabetes Research Institute Foundation, we meet countless individuals and families who are personally affected by diabetes. Some have been living with this disease for decades, while others arerelatively new to it. Throughout the course of their involvement with us, they all come to realize the very same thing: the DRI and Foundation are, together,quite a special place.

We are special for many reasons, chief among them being our unparalleled commitment to see this job to the end by discovering a biological cure for diabetes. The drive to fulfill this mission is palpable throughout our entire organization. It underscores everything that we do.

ExecutiveOfficers’Message


At the DRI Foundation, where the majority of volunteers andprofessionals have a loved one with diabetes, our resolve could not be stronger. We want a cure, period.

At the DRI, our team of researchers – many of whom are also touched by this disease – are in lockstep with us. They passionately share the same mission.

Our passion and commitment drive us, but alone they will not defeat such a complex disease. It takes expertise,experience, and vision to achieve something so challenging.Thankfully, we have these, too, a fact that is evident to oursupporters, as well as to the DRI’s esteemed colleaguesthroughout the scientific community.

On that point, several months ago we attended the two-daymeeting of the DRI’s Scientific Advisory Board (SAB), anexternal council of distinguished investigators who meet every three years to review, and make recommendations on,the Institute’s research program. Their report is then presentedto the Dean of the University of Miami Miller School ofMedicine, of which the DRI is a part. The SAB’s membersoffered a glowing review of the DRI’s work, reporting that, “The committee was unanimous in its feeling that majorstrides have been made in both basic and translationalresearch programs at the DRI…There is no better clinicaltranslational group working on type 1 diabetes in the world.”

Receiving this impressive validation from such a distinguishedpanel of experts reinforces our belief that we have invested our time and resources in the right place. Yet for all of theaccolades, we know there is still much work to be done,because tomorrow is not soon enough to cure this disease. That is why we would be remiss if we did not persistently askourselves: how do you take something that is clearly specialand make it better? That is precisely what we are charged withdoing, in the interest of our loved ones, each of you, and themillions of people living with diabetes.

One answer to that question is to continuously employ thehighest standards of financial stewardship and accountability.Over the years, we have gone to great lengths to maintainexpenses at acceptable levels, to meet the rigorous guidelinesestablished by various non-profit oversight groups, and toprovide the necessary transparency about our operations.

Another answer is to ensure that research progress continues, allowing us to keep moving toward our ultimategoal. Much of that depends on our ability to fund the DRI’sresearch initiatives.

In other words, we rely on you and all of our generous donors to help us meet this ongoing need. Highlights of the progress that you helped our researchers achieve arepresented in this report.

This past year, many have made a significant investment in ourresearch program. Thousands have led and/or participated inthe various events held in our regions and other communitiesacross the country. Others have generously donated whateverthey could to help move the science along. We are grateful foreach and every gift, regardless of the amount, because we willnot get there any other way.

We are all a part of this special place. Our mission is to find a cure, and we need each and every one of you to join us. On behalf of all of us at the DRI andFoundation and the millions counting on us to cross the finish line, thank you for your continued support,trust, and friendship.

Sincerely,

Harold G. Doran, Jr. Chairman

Joshua W. RednikPresident and CEO

"There is no better clinical translationalgroup working on type 1 diabetes in the world."


Research Funding is CriticalThe Diabetes Research Institute has become the world leader it is today as a result of the substantial funding provided by the Diabetes Research InstituteFoundation (DRIF). This funding stream is at the heart of the DRI's ability tomake significant strides toward a cure. Supported by your donations, the DRIF ensures that our scientists can jump-start new ideas while continuing innovative, cure-focused research projects. Our mission – to provide the DRI with the funding necessary to cure diabetes now – is testament to the beliefthat tomorrow is not soon enough to cure this disease.

FinancialSummary


Through the support of private philanthropy, the Diabetes Research Institute Foundation has funded six chairs totaling almost $14 million.

The J. Enloe and Eugenia J. Dodson Chair in Diabetes Research

Stacy Joy Goodman Chair in Diabetes Research

Mary Lou Held Chair for Diabetes Research Martin Kleiman Endowed InvestigatorshipDaniel H. Mintz Visiting ProfessorshipRicordi Family Chair in Transplant Immunobiology.

Diabetes Research Institute Foundation Statement of Activities for the Year ended June 30, 2014.

Support and Revenue

Contributions 5,300,455Reimbursement Contracts 139,017Special Events, Net of Expenses 3,757,157Investment Income 2,055,447

Total Support and Revenue $11,252,076

Expenses and Fund Balances

Program ServicesResearch (Provided to the Diabetes Research Institute) 6,792,936

Community Education 930,994

Total Program Services $7,723,930

Support ServicesAdministration and General 955,229Fundraising 1,409,158

Total Su pport Services $2,364,387

Change in Net Assets 1,163,759

Net Assets, Beginning of Year 26,307,331

Net Assets, End of Year $27,471,090

Fundraising Percentage

Fundraising Expense as a Percentage of Support and Revenue 12.5%


To Our Generous Donors with Deepest Gratitude...The Diabetes Research Institute and Foundation wish to gratefully acknowledge all of our donors and volunteers, who are enabling us to make great strides toward a biological cure for diabetes.

Thank you to every individual, family, foundation, and business, many of whom are pictured within this report, that have given generously over the last year and throughout the years. We would not have been able to come this far without you.

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To ourdonors

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“We need to continueto bring this cause and ourmission to find a cure to theforefront for the millions whosuffer with diabetes, including my son.”

– Doug Donaldson (left)


HERITAGESOCIETY

The Heritage Society of the Diabetes Research Institute Foundation recognizesindividuals who have generously made provisions in their estate plans, through life insurance, charitable remainder trusts and gift annuities, or otherdeferred giving vehicles to ensure that critical funding for the Diabetes ResearchInstitute continues into the future.

Over the years, planned giving programs have enabled many donors to makesubstantial gifts to the DRI in ways that have complemented their individualfinancial objectives. Heritage Society members have chosen to create their own personal legacies and perpetuate their philanthropic goals for all those affected by diabetes.

We are exceptionally grateful to all of our Heritage Society donors, who demonstrate the passion and vision to advance a cure beyond their lifetime.


ChairmanHarold G. Doran, Jr.

Immediate Past ChairmanThomas D. Stern

Vice ChairmenWilliam J. Rand, M.D. Charles Rizzo

TreasurerWilliam J. Fishlinger

SecretaryBonnie Inserra

President and CEOJoshua W. Rednik

DirectorsDiane BeberMarlene BergRonald Maurice Darling, Jr.John C. DoscasPiero GandiniMarc S. GoldfarbEsther E. GoodmanMarc S. GoodmanArthur HertzGlenn KleimanEleanor KosowSandra Levy

Sean McGarveyShelia F. Natbony, D.O.Allan L. PashcowRamon PooRicardo SalmonDavid SherrBruce A. SiegelKathy SimkinsJill VinerBruce Waller

NATIONAL BOARDOF DIRECTORS

REGIONAL BOARDSOF DIRECTORS

Florida Region

ChairmanWilliam J. Rand, M.D.*

DirectorsSari AddicottBernard Beber, M.D. Diane Beber* Crystal Blaylock SanchezSabrina R. FerrisBruce FishbeinJoel S. FriedmanRene W. GuimJavier Holtz Norman Kenyon, M.D.

Vito La Forgia Sandra Levy* Ramon Poo* Cristina Poo Deborah Rand Michelle Robinson Rosa SchechterJames Sensale Jacci Seskin Don Strock Richard P. Tonkinson Stephen Wagman Rita Weinstein

Northeast Region

Co-chairsMarc S. Goldfarb*Bruce A. Siegel*

Executive CommitteeWilliam J. Fishlinger*Marc S. Goodman*Barbara HatzBonnie Inserra*

Directors Greg BesnerJohn CarrionDiane CohenDelia DeRiggi-WhittonPeter L. DiCapuaKim DicksteinDouglas R. DonaldsonIris FeldmanJoan FishlingerLindsey Inserra-Hughes John LuebsLouise PashcowHon. C. Raymond RadiganMarie RizzoRicardo Salmon*Samantha Shanken Baker

Meryl LiebermanAllan L. Pashcow*Charles Rizzo*

Thomas P. Silver Bruce Waller*Roberta WallerWendy Waller

*Also member of National Board of Directors


Joshua W. RednikPresident and Chief Executive Officer

Deborah L. ChodrowChief Operating Officer

Jeffrey YoungChief Financial Officer

Barbara TavrowSenior Vice President

Tom Karlya Vice President

Jill Shapiro Miller Vice President of Gift Planning

Lori Weintraub, APR Vice President of Marketing and Communications

Lauren Schreier Director of Marketingand Communications

Barbara Singer Director of Special Projects

Karen ParabooAdministration and Database Coordinator

Joelle ParraCommunications andSocial Media Coordinator

Melissa PeñaDevelopment Coordinator

Mary Revie Executive Assistant

Laurie CummingsCommunications Assistant

Aurora Nunez Administrative Assistant

Oneida OsunaAccounting Assistant

Mylinda Auguste Data Entry Clerk

Marisol McKay Date Entry Clerk

Eddy GarciaCourier

Florida RegionSheryl SulkinDirector of Special Events

Nicole Otto Associate Director of Special Events

Dena KaweckiSpecial Events Manager

Sarah MehanSpecial Events Coordinator

Northeast RegionAnthony E. ChildsRegional Director

Amy Epstein Director of Special Events, Manhattan Office

Lily Scarlett Director of Special Events, Jericho Office

Jill SalterDevelopment Manager

Melinda MegaleSpecial Events Coordinator

Tricia PellizziSpecial Events Coordinator

Gloria KeylounAdministrative Assistant

DRI FOUNDATIONSTAFF


The organization of choice for those who are serious,passionate, and committed to curing diabetes.

DiabetesResearch.org

National OfficeFlorida Region 200 South Park RoadSuite 100Hollywood, FL 33021 Telephone 954.964.4040 Toll-free 1.800.321.3437 Fax 954.964.7036

Northeast RegionJericho Office410 Jericho TurnpikeSuite 201Jericho, NY 11753Telephone 516.822.1700Fax 516.822.3570

Manhattan Office381 Park Avenue SouthSuite 1118New York, NY 10016Telephone 212.888.2217Fax 212.888.2219

Diabetes Research Institute Foundation Annual Report 2014

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