annual report 2016 >
ONE GOAL: A CURE
MAKING PROGRESS POSSIBLE "As we look back over the past year, we are reminded of the very personal and painstaking efforts of our supporters…"
Highlights of the Year
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National Board of Directors
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Executive Officers' Message
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Honorary Board of Directors
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Financial Summary
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Regional Boards of Directors
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To our Donors
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DRI Foundation Staff
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DRI Heritage Society
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HIGHLIGHTS OF THE YEAR: ADVANCING RESEARCH TO PATIENTS Overcoming the remaining hurdles to discovering a biological cure is the priority for all of us at the Diabetes Research Institute and Foundation. Over the last year, thanks to your generous support, DRI scientists have been able to advance a number of promising initiatives to the clinical phase of testing and are gearing up for new patient studies. From testing a tissue-engineered BioHub platform for housing transplanted islets to tackling the complex challenges of the immune system, DRI researchers are intensely focused on translating research to patients in the fastest, safest and most efficient way possible. We are pleased to provide a summary of five clinical studies that will be underway at the DRI in the coming months:
BIOHUB TRIAL: ISLET TRANSPLANTATION ONTO THE OMENTUM As part of its ongoing FDA-approved Phase I/II clinical trial, the DRI’s clinical cell transplant team, led by Drs. Rodolfo Alejandro, Director of Clinical Islet Transplantation, and David Baidal, assistant professor of medicine, produced the first clinical results demonstrating that pancreatic islet cells transplanted within a tissue-engineered platform can successfully engraft and achieve insulin independence in type 1 diabetes. The objective of testing the novel technique is to initially determine if insulin-producing cells can function in this biological scaffold, and then to introduce additional technologies that can protect the cells from immune attack without the need for antirejection drugs. The preliminary findings, published in the New England Journal of Medicine, are an important step toward developing the DRI BioHub. The results thus far have shown that the omentum is a viable site for islet implantation using the new platform technique. Further evaluation and testing will determine the safety and feasibility of this strategy.
DIPIT TRIAL
The Diabetes Islet Preservation Immune Treatment (DIPIT) study will combine five different clinically approved agents, given at varying time points, which have demonstrated significant benefits when used alone or in small combinations of two or three of the drugs. This first-ever, multi-combination therapy will test the effects of the agents for halting the immune system attack, preserving the remaining islet function and, possibly, giving the body a chance to recover and regenerate its own insulin-producing cells. Led by Drs. Camillo Ricordi, DRI Director, and Jay Skyler, Deputy Director for Clinical Research and Academic Programs, the multicenter, Phase I/IIa study, which is expected to move forward at the beginning of 2018, will be conducted in a group of patients, ages 18-35, who are within four months of diagnosis with T1D. The data from the study will also provide vital information for developing treatment strategies in people with long-standing type 1 diabetes.
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LOW-DOSE IL-2 IN ESTABLISHED T1D TRIAL One of the five agents used in the DIPIT trial, interleukin-2 (IL-2), is a protein produced by the body that plays a key role in regulating the immune system by boosting the number of desired regulatory T cells (Tregs). Numerous studies conducted by Drs. Tom Malek, professor and Interim Chair of Microbiology and Immunology, and Alberto Pugliese, Dodson Chair in Diabetes Research and head of the Immunogenetics program, suggest that IL-2 at low doses may correct autoimmunity and help preserve insulin production. Low-dose IL-2 has already been shown to provide clinical benefit to patients affected by other immunemediated diseases. The FDA-approved Phase I/II trial will test the safety of IL-2 and its effectiveness in improving or preventing further loss of beta cell function. The trial will enroll patients ages 12-21 who are between four months and 12 months post-diagnosis. Several scientific reports have suggested that the use of high-dose omega-3 and vitamin D, both of which have known anti-inflammatory properties, POSEIDON TRIAL may offer a potential beneficial effect on autoimmune conditions, like type 1 diabetes. DRI researchers hypothesize that the treatment may delay or forestall the disease and will test that theory in a new clinical trial. Pending regulatory approval to proceed, the POSEIDON study (Pilot Study of Omega-3 and Vitamin D High Doses in T1D), will compare the effects of the proposed intervention in children and adults newly diagnosed and in those with longer-standing T1D to evaluate any benefit of early and late interventions. DRI Director Dr. Camillo Ricordi, Stacy Joy Goodman Professor of Surgery and Distinguished Professor of Medicine at the University of Miami, and collaborators in Italy recently reported case study results examining the role of omega 3/vitamin D in preserving beta cell function in a young child with type 1 diabetes. The results now warrant further investigation of this potential therapeutic strategy. The DRI will compare children and adults with type 1 diabetes, both newly diagnosed and those more than six months post-diagnosis, who take either vitamin D alone or in combination with omega-3 fatty acids. In this clinical trial, researchers will test the safety and efficacy of the eye as a potential site for islet transplantation in a very select group of patients. Drs. Per-Olof Berggren, who is the Mary Lou Held Visiting Professor of Surgery at the DRI and was recently elected to the prestigious National Academy of Medicine, and Midhat Abdulreda, assistant professor of surgery, are pursuing a novel method to establish immune tolerance by transplanting islets within the anterior chamber of the eye (ACE). Since the eye is recognized as an immune-privileged site in the body, it could offer potential benefits in protecting the transplanted islets from immune attack in the ACE and elsewhere in the body. The researchers have already demonstrated the long-term survival of intraocular (within the ACE) islet transplants without continued anti-rejection drugs in preclinical models. The data suggest two possibilities for establishing long-term islet survival: either through local immune tolerance in the ACE, or as a means to induce peripheral/systemic tolerance whereby islets can be transplanted elsewhere in the body following the initial intraocular transplant. Experiments are currently ongoing to define the immune mechanism(s) contributing to the immunosuppression-free graft survival. In the meantime, the FDA-approved clinical study slated to start in the latter half of 2017 will test this approach in select patients with type 1 diabetes. This trial will pave the way for future trials aimed at testing immune tolerance induction in pancreatic islet transplants to treat T1D.
INTRAOCULAR ISLET TRANSPLANT TRIAL
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EXECUTIVE OFFICERS' REPORT
At the Diabetes Research Institute Foundation, we are solely committed to one goal:
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Providing the Diabetes Research Institute with the funds necessary to cure diabetes now. That singular focus has been our mission since the very beginning, when five families touched by type 1 diabetes banded together to support a small research program at the University of Miami in an effort to find a cure.
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Today, we have a myriad of families, individuals, and organizations who are as serious and passionate about – and committed to – finding a cure as those founders. We want to express our gratitude to every person who has helped propel the DRI to where it is today – a world leader in the search for a biological cure. As we look ahead in that fight for a cure, we know that science is moving forward more quickly than ever before. Advanced technologies that weren’t available but a few years ago are now being put to use, quickening the pace to a cure. With every new achievement and discovery, we are further energized to fulfill our Foundation’s responsibility to ensure that the DRI has the funding necessary to achieve its mission. Without that support – which you so generously provide – this extraordinary progress simply would not be possible. To shine a light on that word – progress – we look to the advancement of several DRI clinical trials. The ongoing DRI BioHub trial, an FDA-approved Phase I/II clinical trial testing a novel islet transplant technique, is already producing positive results. Testing in this trial will continue, allowing us to further develop a Site in the body in which cells can thrive within a tissue-engineered platform. The need to overcome the significant challenges posed by the immune system in type 1 diabetes has become the central focus of the DRI’s work. Research on Sustainability – that is, the ability to keep transplanted or regenerated insulin-producing cells protected from and tolerated by the immune system – is now receiving the majority of our Foundation’s financial support. To that end, we are excited to inform you that the DRI is rolling out several new clinical trials, each of which will address this critical issue in some way. As summarized within this report in the Highlights of the Year, these clinical studies are all focused, in whole or in part, on tackling these challenges to the immune system. The final pillar of Supply, developing a safe and plentiful source of insulin-producing cells or regenerating a patient’s own cells, continues to gather momentum. The DRI’s Pancreatic Stem Cell team has discovered that an FDA-approved agent, bone morphogenetic protein-7 (BMP-7), has demonstrated success in converting non-insulin-producing cells of the pancreas to insulin-producing cells without genetic manipulation. The findings have already been published in peer-reviewed journals. Progress in this area of work will be further bolstered by the significant funding generated through our #MultiplyCellSupply campaigns, and we offer our sincere thanks to everyone who supported this effort.
We’d be remiss if we didn’t recognize the leadership and members of North America’s Building Trades Unions (NABTU). Their tireless commitment has made an enormous impact on our organization for decades. Earlier this year, NABTU President Sean McGarvey reaffirmed the Unions’ support with a new five-year commitment to the DRIF of $6 million. We are grateful for their ongoing partnership. We’d like to extend special thanks to the members of the Inserra Family, who continue to inspire us with their unparalleled drive to raise funds for our life-saving work, and to Betty Dunn, who has bolstered the DRI’s Education Center and its expertly organized programs for patients. In addition, we pay tribute to Betty and Jim Guy. Although Jim and Betty are no longer with us, the provisions they made to support us through their estate plans will ensure that their dedication to our work will continue long into the future. We are grateful for each family, foundation, and corporation that has helped make our fundraising efforts successful. Special events like the Empire Ball, the Love and Hope Ball, Dreams in the City, the Donaldson Organization Golf Outing, All In for a Cure, Out of the Kitchen, and more help us significantly as they enable us to provide a steady stream of support to the Institute. We made a lot of new friends when we partnered with Beyond Type 1 for an art-crowd soiree, #BeyondBasel, that took place during the ever-exciting Art Basel in Miami. And looking ahead, we have high hopes for the return of the Ray Allen Golf Classic and Ray of Hope Luncheon, planned for early 2018. As we look back over the past year, we are reminded of the very personal and painstaking efforts of our supporters, none of whom will rest until the DRI finds the cure for all of our loved ones living with diabetes. The progress has been wonderful, but as we know, the job is not complete. We look forward to your continued partnership in making the cure a reality. Without doubt, advancing research to patients in the fastest and safest way possible matters beyond anything else. Thanks to you, we truly are making progress possible. Sincerely,
While the DRI research team remains focused on advancing research toward a cure, our team at the Foundation remains dedicated to all of you, the very people who give generously or volunteer their time in support of our mission.
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William J. Fishlinger
Joshua W. Rednik
Chairman
President and CEO
FINANCIAL SUMMARY
Research Funding Makes Progress Possible
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The Diabetes Research Institute has become the world leader it is today as a result of the substantial funding provided by the Diabetes Research Institute Foundation (DRIF). This funding stream is at the heart of the DRI's ability to make 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 belief that tomorrow is not soon enough to cure this disease.
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Diabetes Research Institute Foundation Statement of Activities for the Year ended June 30, 2016
Through the support of private philanthropy, the Diabetes Research Institute Foundation has funded six chairs totaling almost $13.5 million.
Support and Revenue The J. Enloe and Eugenia J. Dodson Chair in Diabetes Research
Contributions Reimbursement Contracts Special Events, Net of Expenses Investment Income
5,473,750 304,999 3,055,987 (221,235)
Total Support and Revenue
$8,613,481
Stacy Joy Goodman Chair in Diabetes Research Mary Lou Held Chair for Diabetes Research Martin Kleiman Endowed Investigatorship Daniel H. Mintz Visiting Professorship Ricordi Family Chair in Transplant Immunobiology
Expenses and Fund Balances Program Services Research (Provided to the Diabetes Research Institute) Community Education Total Program Services
7,453,658 840,114 $8,293,772
Support Services Administration and General Fundraising
895,599 1,725,721
Total Support Services
$2,621,320
Change in Net Assets
(2,301,611)
Net Assets, Beginning of Year
29,780,968
Net Assets, End of Year
$27,479,357
Fundraising Percentage Fundraising Expense as a Percentage of Support and Revenue
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20.0%
TO OUR DONORS
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We wish to gratefully acknowledge all of our donors and volunteers, who are enabling us to make great strides toward our one goal: a biological cure for diabetes. Together, we are making progress possible. Our entire DRI family is extraordinary. We would not have been able to come this far without you.
“I've talked to people in the past that didn't think they could play sports anymore because they have diabetes. I just hope to show them that you can.” – Dustin McGowan, Miami Marlins Pitcher (center, standing)
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> “ A cure would be the sweetest thing I could ever taste."
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– Dara Melnick (second from right)
DRI HERITAGE SOCIETY
The Heritage Society of the Diabetes Research Institute Foundation recognizes individuals who have generously made provisions in their estate plans, through life insurance, charitable remainder trusts and gift annuities, or other deferred giving vehicles to ensure that critical funding for the Diabetes Research Institute continues into the future. Over the years, planned giving programs have enabled many donors to make substantial gifts to the DRI in ways that have complemented their individual financial 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.
“Knowing Jim and Betty for over 40 years, I can say they were good and generous people who wanted to support the great work being done at the DRI.”
“Having diabetes makes this gift very personal for me. I don’t want others to live with this disease, and I truly believe that the DRI’s research will change the lives of people in the future.”
– Frank Iannuzzi, CPA – Rick Tonkinson
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NATIONAL BOARD OF DIRECTORS
HONORARY BOARD OF DIRECTORS
Chairman William J. Fishlinger
Lynne and Martin Baron Bernard Beber, M.D. Barbara Berman Juan Elias Calles Paul Cejas John Drury Annie Esformes Linda and Jay Finkelstein Bernard Fogel, M.D. Jeanine Forman Ham Samuel J. Fox Lisa and Mark M. Freedman C. Thomas Gallagher Douglas Gallagher Gladys and Martin Gelb Linda and Barry Gibb Dwina Gibb Yvonne Gibb Lawrence E. Glick Jay N. Goldberg Bella Goldstein Jane Goodman Senator Bob Graham Lawrence Howard, M.D. Fana and Abel Holtz Lola Jacobson Martin P. Klein Harvey M. Krueger Robert Leichtung Sidney Levy Charlotte Milgram Martha Mishcon Marge Kleiman Mintz Stephen Muss
Immediate Past Chairman Harold G. Doran, Jr. Vice Chairman Bonnie Inserra Treasurer John C. Doscas Secretary Bruce A. Siegel President and CEO Joshua W. Rednik Directors Diane Beber Marlene Berg Ronald Maurice Darling, Jr. Piero Gandini Marc S. Goldfarb Esther Goodman Marc S. Goodman Arthur Hertz** Glenn Kleiman Eleanor Kosow Sandra Levy Sean F. McGarvey Ramon Poo Charles Rizzo Ricardo Salmon David Sherr Rick Tonkinson Jill Viner Bruce Waller **Deceased
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Judy and John P. Newell, lll Edward James Olmos Allan L. Pashcow Michelle Robinson Blanche Rosenblatt Donna Shalala Kathy Simkins Serena and Leon J. Simkins Oscar Sotolongo Ferne and Daniel Toccin Dottie and Jack S. Weiss Lenny Wolfe Sonja Zuckerman
REGIONAL BOARDS OF DIRECTORS Florida Region Sari Addicott Bernard Beber, M.D. Diane Beber* Crystal Blaylock Sanchez Sabrina R. Gallo Bruce Fishbein Joel S. Friedman Rene W. Guim Javier Holtz Norman Kenyon, M.D. Vito La Forgia Sandra Levy*
*Also member of National Board of Directors
Northeast Region Ramon Poo* Cristina Poo Deborah Rand Michelle Robinson Rosa Schechter James Sensale Jacci Seskin Don Strock Richard P. Tonkinson Stephen Wagman Rita Weinstein
Chairman Bruce A. Siegel* Executive Committee William J. Fishlinger* Marc S. Goodman* Barbara Hatz Bonnie Inserra*
Meryl R. Lieberman John R. Luebs Allan L. Pashcow* Charles Rizzo*
Directors Samantha Shanken Baker Gregory H. Besner John Carrion Diane L. Cohen Delia DeRiggi-Whitton Peter L. DiCapua Douglas R. Donaldson Iris Feldman Joan Fishlinger Marc S. Goldfarb* Lindsey Inserra-Hughes Louise Pashcow Ricardo Salmon* Thomas P. Silver Jonathan Tepper Bruce Waller* Roberta Waller Wendy Waller
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DRI FOUNDATION STAFF National Staff
Oneida Osuna
Northeast Region
Accounting Assistant
Meagan O'Neil
Joshua W. Rednik President and Chief Executive Officer
Marisol McKay Data Entry Clerk
Jeffrey Young Chief Financial Officer
Natallie Nichols Administrative Assistant
Jill Shapiro Miller Senior Vice President
Eddy Garcia Courier
Lori Weintraub, APR Senior Vice President
Florida Region
Tom Karlya
Kit Wills
Vice President
Director of Development
Lauren Schreier
Sheryl Sulkin
Senior Director of Marketing and Communications
Director of Special Events
Nicole Otto Nicole Lesson
Associate Director of Special Events
Communications Manager
Dena Kawecki Karen Paraboo
Special Events Manager
Administration and Technology Manager
Sarah Mehan
Director of Development
Amy Epstein Director of Special Events
Lily Scarlett Director of Special Events
Melinda Megale Events Manager
Tricia Pellizzi Special Events Manager
Jill Salter Development Manager
Jenna Julien Executive Assistant
Gloria Keyloun Administrative Assistant
Special Events Coordinator
Joelle Parra Communications and Social Media Manager
Jessica DeBlois Development Coordinator
Mary Revie Executive Assistant
Laurie Cummings Communications Assistant
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"With every new achievement and discovery, we are further energized to fulfill our Foundation’s responsibility to ensure that the DRI has the funding necessary to achieve its mission."
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National Office Florida Region
Northeast Region Jericho Office
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Telephone 954.964.4040
Telephone 516.822.1700
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Fax 516.822.3570
Fax 954.964.7036
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info@drif.org
Manhattan Office 259 West 30th Street Suite 402 New York, NY 10001 Telephone 212.888.2217 Fax 212.888.2219
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DiabetesResearch.org
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