Diabetes Research Institute Foundation Annual Report 2018

a cure engineering

annual report 2018 >

a cure one goal:

Message from the Director I 2 Research Report I 4 The Diabetes Education & Nutrition Service at the DRI I 20 DRI Faculty & Staff I 22 DRIF Chairman’s Message I 26 Financial Summaries I 28 To our Donors I 32 Heritage Society I 36 National Board of Directors I 38 Regional Boards of Directors I 39 Honorary Board I 40 DRIF Staff I 41

message from the director [diabetes research institute foundation]

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I’m pleased to share with you this year’s annual report and some highlights from the work being conducted at the Diabetes Research Institute.

In this issue, you can read about our latest advances in cellular therapy and our integrated approach to tackle three basic hurdles we’ve identified on the path to a cure: an ideal place in which to transplant insulin-producing cells called islets, a robust supply of these cells, and ultimately, interventions to prevent rejection of these fragile cells once transplanted, as well as ways to prevent the recurrence of autoimmunity.

These three avenues of research, commonly called Site, Sustain and Supply, form the pillars of research conducted at the DRI, and each area includes multiple projects, and numerous teams of scientists working in tandem with collaborators both here in the US and with many colleagues abroad.

Here, too, you can read the latest updates on the DRI’s multiple clinical trials in which the latest advancements will be rolled out and put to the scientific test; some trials like the BioHub trial are already underway and some are nearing completion with results reported to the public in peer-reviewed publications soon.

The recently launched POSEIDON Trial now has several pediatric and adult subjects participating here in Miami; additional centers have expressed interest in starting collaborative trials using a similar protocol to determine whether it’s possible to halt progression of diabetes and/or reverse autoimmunity in individuals with long-term diabetes.

Many other areas of scientific investigation are reporting progress in this annual – from the latest in cellular therapies using regulatory T cells and the exploration of possible predictive biomarkers for diabetes, to work with promising immune pathways and regeneration of islet cells from multiple sources.

DRI teams are also making headway using novel biomaterials

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in sufficiently large scale production that would enable the testing of new approaches in pre-clinical models. We’ll hear more about the use of mesenchymal stem cells (MSCs) and their immune-modulating abilities, as well as the significant benefits they may offer to the islet transplant process – a growing area of research interest and activity.

Lastly, the scientists and members of the Diabetes Research Institute family encourage you to ask questions, come visit us, and participate actively in the research process that affects you and your loved ones.

Our doors are always open and we look forward to sharing with you the many advances we’ve made on our path to a cure.

Warm regards,

Camillo Ricordi, M.D. Stacy Joy Goodman Professor of Surgery Distinguished Professor of Medicine Professor of Biomedical Engineering, Microbiology & Immunology Director, Diabetes Research Institute and Cellular Transplantation University of Miami

3 areas for a

Biological C Site

Engineering a miniendocrine pancreas in a site within the body that can house transplanted islets and other “helper� cells.

Sustain

Developing safe and effective immunotherapies to halt autoimmunity and/or shielding islets from attack without anti-rejection drugs.

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How will we cure diabetes? By targeting the

major research areas needed to restore insulin production.

Cure Supply

Creating a reliable and plentiful supply of insulin-producing cells, or regenerating a patient’s own islets.

As one of the largest and most comprehensive research centers in the world, the DRI houses teams of scientists, engineers, and clinicians with the expertise required to tackle this disease from many angles.

This integrated approach, combining technology and medicine, drives the vision behind the DRI BioHub, a multidisciplinary, three-pronged strategy to cure diabetes. The BioHub strategy builds upon decades of cure-focused research and addresses critical challenges that stand in the way of a biological cure. It is based upon the premise that: • If we need to transplant insulin-producing islet cells to replace those that are destroyed by the immune system, then we must engineer a mini-pancreas in a Site within the body to house the cells.

• If we are to Sustain the survival of the transplanted islets, then they need protection from the immune system, as well as from the autoimmune attack that initially caused the onset of the disease.

• I f we can halt autoimmunity through safe and effective immunotherapies, then we may Sustain natural insulin production before all the insulinproducing cells are lost.

• If we can halt autoimmunity, we may regenerate a person’s own insulin-producing cells, creating a natural Supply within the body.

• If we need more insulin-producing cells for transplant, then we must create an unlimited Supply for millions of people with diabetes who can benefit.

These three principal research avenues, collectively referred to as the “Three S’s” – Site, Sustain, Supply – are being pursued simultaneously by the DRI’s investigators and global collaborators in a waste-no-time approach.

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clinical trials [diabetes research institute foundation]

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The DRI conducts research with the goal of translating findings from the bench (in the lab) to the bedside (in patients) as quickly as possible. After a promising treatment is developed and its safety and effectiveness in the preclinical setting proven, clinical investigators obtain regulatory approval to conduct studies in patients.

The DRI has received authorization from the Food and Drug Administration (FDA) to proceed with five clinical trials, some of which are ongoing or have begun recruiting patients this past year. The ability to advance this work to the clinical setting represents a significant step on the path toward a cure.

BioHub Trial: Islet Transplantation onto the Omentum The DRI’s FDA-authorized Phase I/II clinical trial was the first step in testing the safety and efficacy of islets transplanted within a tissue-engineered platform in a new site, the omentum. In the study, donor islets were combined with the patient’s blood plasma together with thrombin, a commonly used clot promoter. The mixture sticks to the omentum and holds the islets in place, providing them with spacing and support similar to the pancreas, their native home.

While the study is still ongoing, the early results have shown that the omentum appears to be very safe and the procedure is well tolerated by patients. The DRI team, led by Rodolfo Alejandro, M.D., director of clinical islet transplantation, and David Baidal, M.D., assistant professor of medicine, was also able to show in all patients that transplanted islets can function in the omentum, confirmed by measure of C-peptide, a by-product of endogenous (a person’s own) insulin production.

Overall, the patients had improved metabolic control and a better quality of life.

Further evaluation and testing will determine the long-term efficacy of this procedure, as well as how it compares to the long-standing data from islet transplantation in the liver.

DIPIT Trial (Diabetes Islet Preservation Immune Treatment) There is growing evidence that type 1 diabetes is caused by many factors, and that inflammation and beta cell dysfunction may also be important in the development and progression of the disease process. However, the majority of approaches to combat T1D have involved single agents that primarily targeted the immune system. So far, these immune interventions have not demonstrated sustained beneficial effects on the function of the insulin-producing cells.

The DIPIT trial, led by Camillo Ricordi, M.D., DRI director, and Jay Skyler, M.D., deputy director of clinical research and academic programs, involves a first-ever combination strategy that targets four separate pathways that researchers believe are implicated in type 1 diabetes.

Three of the interventions aim to block innate immunity, block adaptive immunity and enhance regulatory immunity, while another will simultaneously attempt to improve beta cell health.

Once fully funded, this innovative FDA-authorized trial will enroll adults with new-onset T1D (within four months of diagnosis). It will be conducted at the DRI and at multiple facilities throughout the United States. The data from this study may also provide vital information for developing treatment strategies in people with long-standing type 1 diabetes.

Low-Dose IL-2 Trial Interleukin-2 (IL-2), a naturally occurring protein, is important for immune system function. Not only does it stimulate the effector cells, the “attack arm” of the immune system that protects the body from infections and other harmful invaders, but IL-2 is also critical for the function of regulatory T cells (Tregs), the immune cells that prevent the destruction of the body’s own tissues.

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In patients with type 1 diabetes, the “regulatory arm” of the immune system is impaired and cannot provide the protective response against the effector cells. This loss of balance, or regulation, results in the continued destruction of the target, which in type 1 diabetes are the insulin-producing cells.

This clinical trial will test whether IL-2, used in low doses, can better regulate the immune system and correct autoimmunity in young people, ages 8 - 21, with established type 1 diabetes (from four months to one year post-diagnosis).

The DRI’s multi-center trial, led by Alberto Pugliese, M.D., deputy director of immune tolerance, and Thomas Malek, Ph.D., professor and chair of microbiology and immunology, will further test the safety of low-dose IL-2 and its effect on preventing beta cell loss. The trial will include patients who have been diagnosed with type 1 diabetes up to one-year, widening the typical enrollment window of less than three months. The reason for this extended time period is that many patients maintain a significant amount of insulin production for at least two to three years after diagnosis, if not longer. The continued presence of insulin secretion may offer the opportunity for preserving the surviving beta cells.

POSEIDON Trial Several scientific reports have suggested that the use of high-dose omega-3 and vitamin D, both of which have known antiinflammatory and immunomodulatory properties, may offer a potential beneficial effect on autoimmune conditions, like type 1 diabetes. Recent case studies led by DRI Director Dr. Camillo Ricordi together with collaborators in Italy have shown, anecdotally, a pattern of disease remission in young patients for up to two years following the use of these supplements at the time of disease onset. Additionally, the intervention appears to be well tolerated, affordable and sufficiently safe to be further tested in larger, controlled studies.

Earlier this year, the DRI received authorization from the FDA to proceed with a Phase I/ IIa clinical trial, named the POSEIDON study (Pilot Study of Omega-3 and Vitamin D High Doses in T1D) to compare the effects of this intervention in children and adults newly diagnosed and in those with longer-standing T1D to evaluate any benefit of early and late treatment.

The POSEIDON study, which has begun recruiting participants, will enroll children and adults, ages 6 – 65, who have been diagnosed with type 1 diabetes within the last 10 years.

Intraocular Islet Transplant Trial The anterior chamber of the eye, or the “Living Window,” has been a very innovative and useful tool for studying transplanted islets in vivo – in a living organism. DRI scientists have also used this site to study new islet transplant methods. The eye is one of few immune-privileged sites in the body: strong immunological reactions are dampened in these areas to avoid damage to vital tissues.

As such, the eye may offer potential benefits for protecting the transplanted islets from an immune attack and potentially controlling blood sugar levels in those with type 1 diabetes.

Per-Olof Berggren, Ph.D., head of cell biology and signal transduction, and Midhat Abdulreda, Ph.D., assistant professor of surgery, and their team have already demonstrated the long-term survival of intraocular (within the anterior chamber of the eye) islet transplants without continued anti-rejection drugs in preclinical models. The data suggest two possibilities for establishing longterm islet survival: either through local immune tolerance in the eye, or as a means to induce tolerance systemically. Results from their studies were recently submitted for publication in the journal Diabetologia.

This clinical trial will test the safety and efficacy of this approach in a very select group of patients. The researchers have been actively searching for patient candidates to participate in the study.

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In addition to testing promising findings in clinical trials, the DRI’s teams of scientists, engineers, and clinicians are advancing other research initiatives within the areas of the BioHub strategy — Site, Sustain, Supply — simultaneously tackling this disease from many angles. Over the last year, scientists jump-started new initiatives, delved further into ongoing projects, and continued to translate research closer to people living with diabetes.

The SITE: Engineering an ideal home for islets Recent studies have confirmed that for those with type 1 diabetes who suffer frequent and severe hypoglycemia – a potentially fatal low blood glucose level – islet transplantation can significantly improve quality of life. But for the majority of people with T1D, islet transplantation is not ideal. Patients who are eligible for the still-experimental procedure require life-long anti-rejection drugs. Plus, the liver, the usual site of implantation, poses some limitations.

Moving beyond traditional islet transplantation, DRI scientists are combining engineering principles and cellular therapies to create a more hospitable environment for the insulin-producing cells. These next-generation strategies aim to deliver immune modulation and other protective factors locally to promote the long-term health and function of islets without the need for immunosuppression.

While alternative transplant sites in the body have been explored over time, the DRI is focusing on locations that can accommodate the hundreds of thousands of transplanted islets together with these novel technologies. It also needs to be safely accessed with minimally invasive surgery.

The omentum is one such site currently being tested by DRI researchers. The omentum is a tissue that covers abdominal organs and is rich with blood vessels, important for carrying oxygen and other nutrients to the transplanted islets. Researchers have found that the omentum can also be manipulated with cellular therapies and other interventions more easily than other sites in the body that have been explored with very limited clinical success.

Identifying a location where the cells can be safely implanted and produce insulin is the first step. Next: engineering the site to mimic the endocrine (insulin-producing) function of the pancreas and ensuring that the cells survive for the life of the recipient.

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SUSTAIN: Ensuring Islet Cell Survival Until scientists can protect transplanted islets without the use of immunosuppressive drugs and, most importantly halt autoimmunity, many research advances will remain limited to a select group of people with type 1 diabetes. For this reason, the Sustain area – ensuring long-term islet survival – is an urgent DRI research priority.

From developing safe and effective immunotherapies to safeguarding islets locally at the site of implantation, DRI scientists are pursuing a number of immune-related avenues to sustain the survival of the insulinproducing cells.

The Role of Folic Acid: Immune Function and Cell Metabolism DRI researchers have observed that the dramatic increase in type 1 and type 2 diabetes, as well as other autoimmune conditions worldwide, seems to coincide with the mandatory fortification of flour products with folic acid that was put into effect in the mid-1990s.

However in populations where folic acid is readily available in food along with vitamin supplements, the additive might not be necessary and may actually be detrimental to certain people, according to Chris Fraker, Ph.D., research assistant professor of surgery and cell transplantation, and Allison Bayer, Ph.D., research assistant professor of microbiology and immunology.

The researchers have been examining the effect of folic acid on critical immune system cells called natural killer (NK) cells, in conjunction with the viral hypothesis related to the onset of type 1 diabetes. Drs. Fraker and Bayer believe that folic acid may cause a general weakening in the immune systems of those who are susceptible to diabetes or other autoimmune conditions. Their data shows that even a minimal increase in folic acid may impair insulin secretion and glucose uptake in experimental models.

Building upon their initial findings, published last year in Frontiers in Endocrinology, the team is further studying the potential effect of folic acid on NK cells to develop strategies to combat it.

Engineering New Techniques for Treg Therapy Dr. Allison Bayer and her team continue to develop novel immunotherapies using Regulatory T cells (Tregs), immune cells that prevent the attack cells (effector cells) from destroying “self” tissues. Their unique protocol, called adoptive Treg therapy, was able to reverse diabetes and reset autoimmunity in experimental models. In their studies, which tested islet-specific Tregs, they achieved disease remission in 100 percent of the recipients without the need for chronic immunosuppression.

Along with this success comes additional challenges, including how to obtain a sufficient number of islet-specific Tregs that are needed for the clinical setting. To address this issue, Dr. Bayer is collaborating with Alice Tomei, Ph.D., director of the DRI’s Islet Immunoengineering Laboratory, to engineer a new technique for releasing biomaterials that increase the numbers of these special Tregs.

In recognition of her pioneering research in this area, Dr. Bayer was awarded this past year two new grants that will help her build upon these promising findings: a multi-year grant from the American Diabetes Association and the Marc S. Goodman Prize for an Outstanding Young Scientist.

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Mesenchymal Stem Cells: “Mini-Immunomodulatory, Anti-Inflammatory Factories” Mesenchymal stem cells, or MSCs, are a group of stem cells that have many beneficial properties. Not only can MSCs can give rise to new tissues, like bone, cartilage, muscle and fat, but researchers have also discovered that MSCs can modulate, or control, the immune system, dampen inflammation, and promote the formation of new blood vessels. For all of these reasons, MSCs are being extensively explored by several DRI scientists.

Studies in pre-clinical models conducted by Norma Kenyon, Ph.D., deputy director and Martin Kleiman professor of surgery, microbiology and immunology, and Dora Berman-Weinberg, Ph.D., research associate professor of surgery, and their team have shown that the inclusion of MSCs resulted in significantly better islet engraftment and function post-transplant.

These initial studies have led to further characterizing different populations of MSCs, as well as identifying an optimal source of the cells for clinical use. New data from these latest studies were recently submitted for publication.

In other studies, Diego Correa, M.D., Ph.D., research assistant professor, has documented a specific sub-type of MSCs that have a powerful ability to modulate immune responses, as well as induce new blood vessel growth, both of which are critical for successful islet transplantation. Dr. Correa, together with Giacomo Lanzoni, Ph.D., research assistant professor, and their team have been testing the effects of co-culturing MSCs together with islets prior to infusion with the goal of preventing the immune system attack on the insulin-producing cells post-transplant. In a series of next steps, the researchers are working to translate this procedure into a new clinical islet transplant trial.

Developing a Better Biomarker Type 1 diabetes is typically diagnosed once a person begins displaying the usual signs and symptoms of the disease. In most cases, this is long after the majority of insulin-producing cells in the pancreas have been irreversibly destroyed, requiring patients to take life-long insulin therapy to normalize blood sugar levels.

Unlike other autoimmune diseases which can be seen on the body or felt through symptoms, the attack on the insulin-producing beta cells cannot be observed because they reside deep within the pancreas. Therefore, scientists must rely on more complex tests or on detecting certain markers in the blood. If scientists could detect the start of beta-cell destruction early enough, it may open the door to developing new therapies that can be more effective at preventing the further loss of these cells and possibly avoiding the need for life-long insulin treatment.

To address this challenge, Peter Buchwald, Ph.D., director of drug discovery, and his team are working to better pinpoint who is likely to develop autoimmunity and when the onset actually occurs. Their recent findings, published in the Journal of Proteome Research, were the first steps toward identifying a unique “metabolic signature” that could serve as an early biomarker of diabetes development. The researchers are further working to translate these results to people at risk for or now living with T1D.

Targeting a Key Immune Pathway T lymphocytes, or T cells, play a central role in the rejection of transplanted cells and tissues, as well as in the development of autoimmune disorders. These immune cells become stimulated after a “threat” is recognized and launch an attack against the target through a series of cell-to-cell communications, primarily involving two signals. Researchers have been investigating ways to interfere with these activation signals including via a strategy known as co-stimulatory blockade.

While several types of immune interactions are involved in the stimulation of T cells, DRI researchers have focused their attention on one pathway in particular, known as CD40-CD40L, because it is particularly promising for islet transplantation. [diabetes research institute foundation]

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There are several antibodies that are capable of blocking this pathway, however, DRI researchers are focusing on developing small molecules that could be safer and do not need to be administered as injections. The Drug Discovery team, led by Dr. Peter Buchwald, had identified the first small molecules that were capable of interfering with the CD40-CD40L pathway in research published in 2009.

The team has now developed the first set of promising compounds that can inhibit this pathway in experimental models. The findings were published this past year in the Journal of Medicinal Chemistry and more recently in Molecules. The ultimate goal is to develop clinically approved therapeutics that can be taken orally as tablets or capsules to provide better treatment in transplant recipients and possibly to prevent onset of autoimmunity in those likely to develop type 1 diabetes.

Encapsulation: Scaling Up, Refining Conformal Coatings DRI scientists have taken major steps to overcome the challenges that have limited the clinical application of islet encapsulation strategies by engineering a unique technology called conformal coating. Developed by Alice Tomei, Ph.D., director of the Immunoengineering Lab, and collaborators, conformal coating minimizes the space between the capsule wall and the islet within, offering many benefits over traditional cell encapsulation methods. The team has already shown that their conformal-coated islets can reverse diabetes and normalize blood sugar levels without immunosuppression in experimental models.

This past year, Dr. Tomei has begun designing and testing a new device that can produce the large numbers of capsules needed to translate this approach to preclinical models and humans. Working in collaboration with DRI colleagues Drs. Norma Kenyon and Dora Berman-Weinberg, the investigators will assess the safety and efficacy of this technology, as well as the duration of diabetes remission after transplantation. To support her ongoing research in this area, Dr. Tomei was awarded a JDRF Career Development Award.

Additionally, Dr. Tomei is working with DRI colleagues Drs. Allison Bayer and Peter Buchwald, to refine the conformal coatings to include therapeutic biomaterials that can help eliminate the need for anti-rejection drugs, deliver oxygen to the islet within, or dampen inflammation, among other benefits. This past year, Drs. Tomei, Bayer and Buchwald were awarded a prestigious R01 grant from the National Institutes of Health (NIH) to further support this promising research.

Optimizing the Capsule Environment One of the major reasons for the limited success of islet encapsulation is the inability to deliver sufficient oxygen and nutrients to the cells. While teams of DRI scientists are engineering tighter-fitting coatings that can improve the delivery of these critical factors, others are taking a closer look at the environment within the capsules themselves, which can also affect islet survival.

When encapsulated islets lack oxygen, they begin to die off and cause an immune reaction – the body’s way of cleaning out waste that it doesn’t need.

This process produces harmful free-radicals, further accelerating transplant failure. Chris Fraker, Ph.D., and his team are working on an innovative way to address this problem through a chemical reaction. The researchers have developed unique metal particles that immediately convert the free-radicals into oxygen, which is exactly what is needed by the islets.

This past year, Dr. Fraker and his team published their initial findings in the journal Acta Biomaterialia. The next step is to translate this research into experimental models of diabetes and test this encapsulation strategy in vivo.

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SUPPLY: Creating more insulin-producing cells Currently, islets used for transplantation come from the pancreases of deceased donors. With organ donation in the United States at critically low levels, there are clearly not enough cells for everyone who needs them.

The DRI’s cell supply and islet regeneration program is focused on finding alternative sources of islets to address this significant challenge.

Scientists have discovered that different types of cells within the non-insulin-producing portion of the pancreas, which makes up 98 percent of the organ, have the ability to become insulin-producing cells. In particular, they have focused on a unique population of stem cells that remain intact after the autoimmune attack in a large percentage of patients. The DRI’s Cell Supply team has been developing methods to stimulate these pancreatic stem cells to turn into insulin-producing cells with very promising results.

Beyond Transplantation: Regenerating a Patient’s Own Islets Using a naturally occurring protein called bone morphogenetic protein 7 (BMP-7), DRI researchers demonstrated that those stem cells within the non-endocrine cells in the pancreas can become new islets when cultured in a lab. In itself, that discovery could allow researchers to transplant multiple patients from a single organ.

The promise of this approach, however, also lies in the potential to regenerate a person’s own insulin-producing cells using this method. This past year, the the DRI team, headed by Juan Dominguez-Bendala, Ph.D., director of stem cell development for translational research, and Ricardo Pastori, Ph.D., director of molecular biology, confirmed the existence and exact anatomical location of these pancreatic progenitor cells that have the potential to regenerate islets. The significant findings, published in Cell Reports, open the door to developing regenerative cell therapies for those living with type 1 diabetes.

The team plans to extensively test the regeneration of insulin-producing cells by using this method. They envision this approach advancing to clinical trials as part of a “combination therapy” that also addresses autoimmunity, another key challenge in T1D. The addition of this type of molecule, which is already in clinical use for other conditions, to any approach designed to stop autoimmunity – including those being explored in DRI clinical trials – may result in permanent, functional beta cell regeneration.

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Multicenter Initiatives JDRF nPOD (Network for

Pancreatic Donors with Diabetes)

To combat type 1 diabetes, researchers need more knowledge about the disease and the mechanisms of the immune system that trigger an attack on insulin-producing beta cells. Historically, researchers could only collect blood samples from those with T1D in order to conduct patient studies; access to pancreata and other diseaserelated tissues was severely limited.

To overcome this challenge, in 2007 JDRF seeded the creation of the Network for Pancreatic Organ Donors with Diabetes (JDRF nPOD), a global network that procures and distributes pancreatic tissue from organ donors with type 1 diabetes to further study the key immunological, histological, viral and metabolic questions related to how the disease develops. The DRI’s Alberto Pugliese, M.D., deputy director and head of immunogenetics, and the University of Florida’s Mark Atkinson, M.D., director of the UF Diabetes Institute, serve as co-executive directors of nPOD, together with a multidisciplinary team of diabetes investigators.

During the past three years, The Helmsley Charitable Trust (HCT) has supported nPOD with the George Eisenbarth nPOD Award for Team Science, providing critical funds for infrastructure, pilot studies and working groups. Last year, HCT renewed this vital funding source to support continued pilot studies conducted throughout nPOD working groups.

The nPOD working groups investigate specific interest areas in diabetes research. Among these is nPOD-V, a self-assembled group of collaborators who investigate the role of viruses in type 1 diabetes through the study of nPOD samples. This past year, the nPOD-V group was awarded renewed grant support by JDRF in gaining a better understanding of the causes of T1D as it relates to the role of viruses. The goal of this research is to generate critical evidence to support and guide the production of an anti-viral vaccine and anti-viral therapies that are important for disease prevention, as well as treatment, given the chronic nature of autoimmunity and viral infections.

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Working closely with colleagues throughout the U.S. and globally, DRI researchers investigate more strategies, share more ideas, and accomplish more success for those living with diabetes.

Type 1 Diabetes TrialNet

Diabetes Prevention Program Outcomes Study (DPPOS) Phase 3

The Diabetes Research Institute is one of 25 participating centers in TrialNet, an international consortium of clinical research centers that conduct studies to prevent or delay type 1 diabetes. Led by David Baidal, M.D., the DRI’s TrialNet team collaborates with investigators throughout the entire network to recruit those who are eligible to participate in and carry out the clinical studies.

Under the direction of Ronald B. Goldberg, M.D., professor of medicine, and his team, the Diabetes Research Institute has played a key role in the Diabetes Prevention Program (DPP) and DPPOS since the study’s inception in 1994.

TrialNet has completed a number of clinical trials designed to preserve beta cell function in recent-onset T1D using different agents and treatment strategies. In June 2018, TrialNet presented the results of one of the most recent studies at the ADA Scientific Sessions, which are also pending publication.

This trial combined two immunomodulatory therapies – lowdose thymoglobulin and granulocyte colony stimulating factor (GCSF) – to create a durable effect on beta cell preservation in new-onset type 1 diabetes. Additional information is available at TrialNet.org TrialNet is supported by the National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), JDRF, American Diabetes Association (ADA), and Helmsley Charitable Trust.

Sponsored by the National Institutes of Health, the DPP was a major multicenter study that examined if intensive lifestyle changes (dietary changes and physical activity) or treatment with the medication metformin would prevent or delay the development of type 2 diabetes in people at high risk for the disease.

The DPP Outcomes Study (DPPOS) explored the longer-term effects the interventions on the further development of type 2 diabetes and diabetes complications, including heart, kidney and eye diseases. The DPPOS demonstrated that these effects were durable over the subsequent 10 years of follow-up.

The fact that DPPOS is the longest running clinical trial testing the effects of metformin has made this aspect of the study the centerpiece of the new DPPOS Phase 3 trial. Two years ago, Dr. Goldberg was awarded a five-year, $1.7 million grant, which initiated Phase 3 of the DPPOS. DPPOS Phase 3 will study the DPPOS patient cohort for 10 more years and examine outcomes that are of an increasing public health concern in the aging population with pre-diabetes and type 2 diabetes. The overarching goals of the DPPOS Phase 3 include examining the long-term effects of metformin therapy on the risk for cardiovascular disease and cancer, the effects on microvascular complications, and the clinical course of pre-diabetes and new onset diabetes.

To learn more visit: nPOD jdrfnpod.org TrialNet diabetestrialnet.org Diabetes Prevention Program dppos.org

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The Diabetes Education and Nutrition Service at the DRI

The DRI’s long-standing education program has been recognized for more than three decades by the American Diabetes Association for providing premier services to individuals needing counseling and care. Each year, the DRI Diabetes Education and Nutrition Program provides these life-changing services to more than 8,000 patients living with diabetes.

As the incidence of diabetes increases and education programs across the country close, the need for high-quality patient education and medical nutrition therapy has continued to rise. Generously supported by long time benefactor Betty Dunn and her late husband, Lowell, the DRI’s program has met that need, and provided critical services for both newly diagnosed children and adults, as well as for those who face longer challenges in their daily living with diabetes.

Led by Della Matheson, R.N., C.D.E., the team of educators and nutritionists has been able to meet the increased demand for these programs by providing individual, group, and highly sought-after clinical experience training for other healthcare professionals from industry.

Members of the education service take part in South Florida community outreach initiatives; give lectures to medical students and residents about diabetes education principles and practices, and the importance of multidisciplinary team approach in the management of patients with type 1 and type 2 diabetes; and serve as media experts across many platforms on the subject of nutrition and education in diabetes health and well-being.

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• The patient base continues to broaden with referrals largely coming from the DRI Clinic and University departments, including

Pediatric Endocrinology, Family Medicine, and Internal Medicine. However, a growing number of community providers from beyond University of Miami clinicians are referring patients to the DRI Education Department for both individual sessions and group classes.

The continued closure of large, community-based diabetes education programs over the past several years has made the services provided by the DRI even more crucial for patients and their families; the DRI Education Department is unique among programs in South Florida in that it accepts referrals from physicians outside of its own practice.

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In total, the DRI education team has served over 8,000 individual patients with approximately 2,200 separate patient visits occurring this year. Services are provided primarily at the DRI Education Department at the University of Miami Medical campus. The DRI team served UM Kendall Department of Medicine clinic through May 2017 but the decision was made to discontinue offering this service as it was not economically feasible to continue once its endocrinologists moved from Kendall to the new Lennar Center. Once clinics have begun at Lennar Center, the DRI team will investigate the feasibility of extending services to that location.

Of those served, approximately 50 percent fall into the category in which there is no available reimbursement for education services; this includes patients who are uninsured or insured through Medicare/Medicaid. With this financial burden, the DRI Education Department would certainly suffer from fiscal instability without the generous support of donors. The contributions made by these philanthropists provide individual patient scholarships and subsidies to the DRI Education Program that ensure adequate staff to accomplish its goal of providing comprehensive diabetes self-management education to all persons in the community regardless of financial means.

• The DRI team continues to be involved in professional and community outreach initiatives, including but not limited to: • UM campus and community health services, including expansion sites throughout South Florida • Provide lectures for UM Medical Students, Residents, and Fellows about diabetes education principles and practices; importance of multidisciplinary team in management of patients with type 1 and type 2 diabetes • Local professional presentations through American Diabetes Association and American Association of Diabetes Educators of Florida • University of Miami Grand Rounds • Diabetes Research Institute Foundation – PEP (Parents Empowering Parents) Squad and ‘Top Tips’ articles • Newspaper and television interviews for The Miami Herald, Univision, Today’s Dietitian, US News & World Report and more.

• The DRI Diabetes Education and Nutrition Service also coordinated two clinical experience

training programs during the past year which involved up-skilling industry representatives on the medical and education standards for diabetes care. A total of 35 representatives attended, with outstanding program satisfaction ratings across all programs offered.

In the coming year, the DRI Diabetes Education and Nutrition Service will continue to update its very successful educational curriculum to continue the current class schedule (e.g., Healthy Me, Diabetes Made Simple, Pump Training and the highly acclaimed Mastering Your Diabetes program). Mastering Your Diabetes (MYD) continues to incorporate continuous glucose monitoring into the program so that every participant has the opportunity to wear a diagnostic CGM throughout the program. In addition, a new session has been added to help patients understand how to use this dynamic form of diabetes monitoring to better “think like a pancreas.” The team also developed and successfully completed one “Transitions” program for teens exiting pediatric care/parental care to adult care/ self-management responsibilities, i.e., a high school to college/working life paradigm to better facilitate these young people as they move into this next, and more independent, phase of their lives.

To learn more about the DRI’s education and nutrition services, visit diabetesresearch.org/diabetes-classes.

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faculty & staff [diabetes research institute foundation]

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FACULTY Dr. Camillo Ricordi Stacy Joy Goodman Professor of Surgery Distinguished Professor of Medicine Professor of Biomedical Engineering, Microbiology, and Immunology Director, Diabetes Research Institute and Cellular Transplantation Dr. Midhat Abdulreda Assistant Professor of Surgery Dr. Ashutosh Agarwal Assistant Professor of Biomedical Engineering Dr. Rodolfo Alejandro Professor of Medicine Director, Clinical Cell Transplant Program (CCTP) Dr. David Baidal Assistant Professor of Medicine Dr. Allison Bayer Research Assistant Professor of Microbiology and Immunology Dr. Per-Olof Berggren Mary Lou Held Visiting Scientist Adjunct Professor of Surgery Director, Rolf Luft Research Center Stockholm, Sweden Dr. Dora Berman-Weinberg Research Associate Professor of Surgery Dr. Ernesto Bernal-Mizrachi Professor of Medicine Chief, Division Endocrinology, Diabetes, and Metabolism Deputy Director of Beta Cell Biology and Signal Transduction Dr. Peter Buchwald Associate Professor of Molecular & Cellular Pharmacology Director, Drug Discovery Program Dr. Juan Dominguez-Bendala Research Associate Professor of Surgery Director, Stem Cell Development for Translational Research

23 [2018 annual report]

Dr. Diego Correa Research Assistant Professor, Dept. of Orthopaedics, Division of Sports Medicine Diabetes Research Institute, Cell Transplant Center Dr. Chris Fraker Research Assistant Professor of Surgery Dr. Hermes Florez Professor of Public Health Sciences and Medicine Director, Division of Epidemiology and Population Health GRECC Director, Miami VA Healthcare System Dr. Ronald Goldberg Professor of Medicine Director, Diabetes Prevention Program (DPP) Dr. Norma S. Kenyon Martin Kleiman Professor of Surgery Director, Wallace H. Coulter Center for Translational Research Chief Innovation Officer, University of Miami Deputy Director, Diabetes Research Institute

Dr. Shari Messinger Cayetano Associate Professor of Biostatistics Director, Biostatistics Dr. Bresta Miranda Assistant Professor of Medicine Interim-Director, Eleanor and Joseph Kosow Diabetes Treatment Center Dr. Ricardo Pastori Research Professor of Medicine Director, Molecular Biology Laboratory Dr. Maria Del Pilar Solano Assistant Professor of Medicine Dr. Alberto Pugliese Professor of Medicine Director, Immunogenetics Deputy Director of Immune Tolerance Dr. Lisa Rafkin Mervis Research Assistant Professor of Medicine Dr. Paolo Serafini Assistant Professor Dr. Jay Skyler Professor of Medicine Deputy Director of Clinical Research and Academic Programs

Dr. Giacomo Lanzoni Research Assistant Professor, Biochemistry & Molecular Biology

Dr. Alice Tomei Assistant Professor of Biomedical Engineering

Dr. Wei Li Research Associate Professor

VOLUNTARY DRI PROFESSORS

Dr. Elina Linetsky Research Assistant Professor of Surgery

Dr. Sara Farnetti Voluntary Assistant Professor of Surgery

Dr. Thomas Malek Professor of Microbiology and Immunology Interim Chair of Microbiology and Immunology

Dr. Daniel Mintz Voluntary Professor of Medicine

Dr. Armando Mendez Research Associate Professor of Medicine Director, Advanced Technology Platforms Director, Clinical Chemistry Lab

Dr. Cherie Stabler Adjunct Associate Professor of Biomedical Engineering

Dr. Barry Sears Voluntary Assistant Professor of Surgery

Dr. Collin Weber Voluntary Assistant Professor of Surgery

ADMINISTRATIVE Dr. Mitra Zehtab, MBA, Deputy Director and Chief Operating Officer Dora Cardenal, Director, Accounting Angie Arzani, Sr. Manager, Finance Sabrina Boulazreg, Sr. Manager, Business Operations Juan Perez-Scholz, Manager, Sponsored Programs Mabel Luis, Executive Assistant Grace Perez, Sr. Buyer Ligia Delgado, Sr. Accounting Assistant Ilvis Torres, Senior Administrative Assistant Edmundo Caldera, Administrative Assistant

BIOMEDICAL ENGINEERING

DIABETES PREVENTION PROGRAM (DPP) Dr. Ronald Goldberg, Professor of Medicine, Director Juliet Sanguily, Nurse Specialist Research Jeanette Gonzalez-Calles, Research Associate 2 Bertha Veciana, Sr. Medical Assistant

DRUG DISCOVERY PROGRAM Dr. Peter Buchwald, Associate Professor of Molecular and Cellular Pharmacology, Director Oscar Alcazar, Sr. Research Associate 1 Damir Bojadzic, Research Assistant

Dr. Chris Fraker, Research Assistant Professor of Surgery Dr. Mohammad Tootoonchi, Post-Doctoral Associate

ELEANOR AND JOSEPH KOSOW DIABETES TREATMENT CENTER

CLINICAL CHEMISTRY LAB

Dr. Rodolfo Alejandro, Professor of Medicine Dr David Baidal, Assistant Professor of Medicine Dr. Ronald B. Goldberg, Professor of Medicine Dr. Maria Del Pilar Solano, Assistant Professor of Clinical of Medicine Dr. Jay Sosenko, Professor of Medicine Dr. Jay S. Skyler, Professor of Medicine

Dr. Armando Mendez, Research Associate Professor of Medicine, Director Rosa Hernandez, Supervisor Medical Technology Elsa Cribeiro, Sr. Research Assistant

CLINICAL CELL TRANSPLANT PROGRAM (CCTP) Dr. Rodolfo Alejandro, Professor of Medicine, Director Dr. David Baidal, Assistant Professor of Medicine Ana Alvarez Gil, ARNP Dr. Nathalia Padilla Tellez, Post-Doctoral Associate Allison De Oliveira, Patient Access Representative

CLINICAL RESEARCH CENTER Dr. Bresta Miranda, Assistant Professor of Medicine, Interim-Director Burlett Masters, Research Support Specialist Ada Konwai, Sr. Research Assistant

FACULTY

DRI EDUCATION PROGRAM Della Matheson, Director Jacqueline Colon, Dietitian Mercy Molina, Dietitian Dina Mesa, Supervisor, Patient Access

FLOW CYTOMETRY LAB Dr. Oliver Umland, Scientist

FAST TRACK PROGRAM Dr. Camillo Ricordi, Stacy Joy Goodman Professor of Surgery, Director Dr. Diego Correa, Research Assistant Professor Xiumin Xu, Director, DRI-China, Collaborative Human Cell Transplant Program

HISTOLOGY Kevin Johnson, Sr. Research Associate 3

HUMAN CELL PROCESSING (CGMP) FACILITY Dr. Camillo Ricordi, Stacy Joy Goodman Professor of Surgery Dr. Armando Mendez, Research Associate Professor of Medicine, Director Dr. Elina Linetsky, Research Assistant Professor of Surgery Dr. Raj Hirani, Director of Regulatory Support Dr. Alejandro Alvarez-Garcia, Associate Scientist Dr. Xiaojing Wang, Associate Scientist Luis Roque, Quality Assurance Auditor Carmen Castillo, Sr. Research Assistant

IMAGE ANALYSIS FACILITY Dr. Maria Bulina, Sr. Manager Research Support

IMMUNOBIOLOGY OF ISLET TRANSPLANTATION Dr. Giacomo Lanzoni, Research Assistant Professor

IMMUNOGENETICS PROGRAM Dr. Alberto Pugliese, Research Professor of Medicine, Director Dr. Isaac Snowhite, Scientist Dr. Alessia Zoso, Scientist Dr. Sirlene Cechin, Associate Scientist Gloria Allende, Sr. Research Associate 2 Alex Arevalo, Data Entry Clerk

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ISLET PHYSIOLOGY Dr. Per Olof-Berggren, Adjunct Professor of Surgery, Director Dr. Midhat Abdulreda, Assistant Professor of Surgery Dr. Luis Hernandez Rodriguez, Research Associate 3 Ashley Tschiggfrie, Research Assistant

MICROBIOLOGY & IMMUNE TOLERANCE Dr. Allison Bayer, Assistant Professor of Microbiology and Immunology Cecilia Cabello Kindelan, Supervisor Research Lab Nathalia Arenas, Research Assistant Vanessa Teixeira, Research Assistant

PRE-CLINICAL CELL PROCESSING & TRANSLATIONAL MODELS Dr. Armando Mendez, Research Associate Professor of Medicine, Director Dr. Joel Szust, Scientist and Core Director Yelena Gadea, Supervisor Research Lab Greycy Vega, Research Assistant

PRE-CLINICAL RESEARCH Dr. Norma Sue Kenyon, Martin Kleiman Professor of Surgery, Director Dr. Dora Berman-Weinberg, Research Associate Professor Waldo Diaz, Sr. Manager, Research Support Melissa Willman, Sr. Manager, Research Support Alex Rabassa, Sr. Research Associate 3 James Geary, Sr. Veterinary Tech

STEM CELL DEVELOPMENT FOR TRANSLATIONAL RESEARCH & MOLECULAR BIOLOGY Dr. Juan Dominguez-Bendala, Research Associate Professor of Surgery, Director Dr. Ricardo Pastori, Professor of Medicine Dr. Dagmar Klein, Scientist Silvia Alvarez Cubela, Manager, Research Laboratory

25 [2018 annual report]

TISSUE ENGINEERING & ENCAPSULATION TECHNOLOGIES Dr. Alice Tomei, Assistant Professor of Biomedical Engineering, Director Dr. Diana Velluto, Associate Scientist Bernard Wasserlauf, Research Associate 3 Michael Lupp, Research Associate 2

DIABETES TRIALNET Dr. David Baidal, UM Site Principal Investigator Dr. Jay Sosenko, Associate Chair of Ethics and Epidemiology Dr. Lisa Rafkin-Mervis, Associate Chair of Clinical Coordination Della Matheson, Trial Coordinator Dr. Carlos Blaschke, Trial Coordinator Dr. Natalia Sanders Branca, Research Associate 1 Irene Santiago, Sr. Administrative Assistant

DRIF Chairman’s Message [diabetes research institute foundation]

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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 are relatively 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.

The reasons for this are multifold, but we truly believe that three differentiators set the DRI and DRI Foundation apart – and reinforce our belief that we have invested our time and resources in the right place:

in the nonprofit, legal and corporate sectors. She will help guide the Foundation into an exciting era for those living with this disease. I, together with our Board colleagues, look forward to Alice’s leadership.

1. From the day this organization was founded, we have been solely focused on finding a biological cure for diabetes. The DRI leads the world in cure-focused research. As one of the largest and most comprehensive research centers dedicated to curing diabetes, the DRI is working aggressively to achieve its vision – a world without diabetes. The DRI Foundation exists solely to fund the DRI and its search for the cure. We want to cure diabetes now.

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 ask ourselves: how do you take something that is clearly special and make it better?

That is precisely what we are charged with doing, in the interest of our loved ones, each of you, and the millions of people living with diabetes.

2. W e leverage donor dollars and global collaborations to accelerate the path to a cure. Through our annual support of the DRI, the Foundation provides seed funding for promising research. This funding allows DRI research teams to gather data and show initial success so they can compete for funding from the National Institutes of Health (NIH) and other public and private agencies. Between fiscal year 2012 and 2016, the DRI Foundation provided $35M to the DRI. During that same time, the DRI was awarded $41.3M in additional funding.

Many of these awards were made possible because of the DRI Foundation’s initial seed funding to launch the research.

Additionally, the DRI Federation has daily impact on the effort to find a cure. Scientific collaboration is the cornerstone of the DRI’s research philosophy, and the DRI is the hub of the DRI Federation, the global alliance of scientists working together to accelerate progress, share ideas and strategies, and overcome significant barriers that we could not tackle on our own. It is also an integral component of the DRI’s ability to identify and accelerate promising research from the lab bench to the patient bedside, ensuring the DRI is pursuing the most promising research ideas that can lead to a cure.

3. Our research model continues to center around the DRI BioHub strategy, a comprehensive, three-pronged approach to curing diabetes: Site, Sustain and Supply. The BioHub builds upon decades of cure-focused research and addresses major research challenges that stand in the way of a biological cure for diabetes.

And now, the research conducted through our BioHub strategy has led to five clinical trials, either underway or on the path to launching in the near future. The ability to advance this work to the clinical setting represents a significant step in the path toward a cure. We are proud that our financial support has helped to make this possible as well as so many vital research projects, just some of which are described in this report.

While this past year has been one of significant advances, it was also a year of transition as we undertook a search for a new Chief Executive Officer. I’m pleased to announce that we just recently appointed Alice Rodd O’Rourke as the new CEO. Alice comes to the DRIF with an exceptional decades-long track record in achieving results and providing innovative leadership

27 [2018 annual report]

Because there is so much exciting and highly promising work being done by Dr. Camillo Ricordi and his entire team, the need to raise the significant amount of money required to fuel their research is critically essential. Many of the members of our DRI family gave generously, renewed their commitments, and helped to provide the resources necessary for moving the science forward. Significant support was provided through the estates of generous individuals, like Roger E. Jones, Ruth Einhorn Plaks, and others, who not only provided for the DRI during their lifetime but made the selfless decision to help find a cure for generations to come by supporting the DRIF through their estate plans.

We are grateful to one of our most long-standing and loyal supporters, North America’s Building Trades Unions (NABTU), and to its president, Sean McGarvey, and all of the hard-working men and women of the building trades for this extraordinary commitment. Their impact on and friendship to the DRI and Foundation over more than four decades cannot be overstated.

We’d like to extend special thanks to the Inserra Family for their considerable, ongoing generosity. That exemplary support combines with major gifts from The Batchelor Foundation, Ricardo Puente, Rick and Margarita Tonkinson, the Diabetes Research & Wellness Foundation, and so many others. Add in funds raised at our events, many of which are pictured on the following pages, together with the inspiring efforts of our DRI Diplomats, and we can count thousands who have helped to provide meaningful resources to our DRI scientists.

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 everyone living with diabetes. The progress has been wonderful, but 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, William J. Fishlinger Chairman

financial summary 2018 [diabetes research institute foundation]

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Research Funding is Critical The mission of the Diabetes Research Institute Foundation — to provide the DRI with the funding necessary to cure diabetes now — is a testament to the belief that tomorrow is not soon enough to cure this disease.

Funding from the DRIF — your donations — is critical for ensuring that DRI scientists can jump-start new ideas, leverage philanthropic dollars into significant grant awards, and continue innovative research projects that remain focused on a cure.

DIABETES RESEARCH INSTITUTE FOUNDATION Statement of Activities for Fiscal Year 2018

DIABETES RESEARCH INSTITUTE Statement of Activities for Fiscal Year 2018

Support and Revenue

Support and Revenue

Contributions Reimbursement Contracts Special Events, net of expenses Investment Income

8,062,935 213,192 2,566,209 801,861 11,644,197

Expenses and Fund Balances Program Services Research (provided to the Diabetes Research Institute) Community Education

5,996,723 906,518 6,903,241

Support Services Administration and General Fundraising

1,339,926 1,788,229 3,128,155

Change in Net Assets

1,612,801

Net Assets, Begining of Year

27,234,622

Net Assets, End of Year

28,847,423

Fundraising Percentage Fundraising Expenses as a Percentage of Support and Revenue

29 [2018 annual report]

15%

Diabetes Research Institute Foundation National Institutes of Health Corporate Grants JDRF University of Miami Kosow Center American Diabetes Association/ American Heart Assocation Grants

5,996,723 3,549,547 1,409,939 1,638,788 1,467,960 474,999 95,541 14,633,497

Expenditures Research Grants Research and Clinical Support

13,516,823 1,116,674 14,633,497

financial summary 2017 [diabetes research institute foundation]

30

“With every new discovery, we are further energized to ensure that the DRI has the funding necessary to achieve its mission. Without your support, this extraordinary progress would simply not be possible.�

DIABETES RESEARCH INSTITUTE FOUNDATION Statement of Activities for Fiscal Year 2017

DIABETES RESEARCH INSTITUTE Statement of Activities for Fiscal Year 2017

Support and Revenue

Support and Revenue

Contributions Reimbursement Contracts Special Events, net of expenses Investment Income

5,448,163 335,377 2,362,067 1,223,418 9,369,025

Expenses and Fund Balances Program Services Research (provided to the Diabetes Research Institute) Community Education

6,287,390 916,902 7,204,292

Support Services Administration and General Fundraising

885,814 1,523,654 2,409,468

Change in Net Assets

(244,735)

Net Assets, Begining of Year

27,479,357

Net Assets, End of Year

27,234,622

Fundraising Percentage Fundraising Expenses as a Percentage of Support and Revenue

31 [2018 annual report]

16%

Diabetes Research Institute Foundation National Institutes of Health Corporate Grants JDRF University of Miami Kosow Center American Diabetes Association/ American Heart Assocation Grants

6,287,390 3,538,715 1,788,106 1,375,445 1,339,180 437,745 143,399 14,909,980

Expenditures Research Grants Research and Clinical Support

13,859,421 1,050,559 14,909,980

to our donors

to our donors... [diabetes research institute foundation]

32

...with our deepest gratitude.

We wish to gratefully acknowledge all of our donors whose continued support has allowed DRI scientists to pioneer new cell-based therapies, advance promising research to patients, and discover new, groundbreaking pathways for Engineering a Cure.

Our entire DRI family is extraordinary and your passionate commitment to cure this disease inspires us to forge ahead to fulfill our shared mission. Through your generous contributions and tireless efforts, you help make our life-changing work possible. Thank you!!

33 [2018 annual report]

“While I haven’t let diabetes hold me back, a day doesn’t go by that I don’t dream of finding a cure. And I believe that the Diabetes Research Institute is the best hope for a cure.”

- Jennifer Ross, Honoree, Dreams in the City

“

[diabetes research institute foundation]

34

“

35 [2018 annual report]

“My family fully supports the Diabetes Research Institute because we know they will find a cure for our precious granddaughter, Brooke.”

- Natalie Olstein, Co-Chair, Gift of Love,

Gift of Hope Luncheon

heritage society [diabetes research institute foundation]

36

Leaving a Legacy 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 trust 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 legacy and perpetuate their philanthropic goals for all those affected by diabetes.

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

“I know that lifetime giving is great but a planned gift from my estate will help ensure that the DRI can continue its meaningful research.

The DRI is truly the best hope for a cure!”

— Gale Goldstein Tucker

“I’ve heard it said, ‘Don’t give to be blessed; feel blessed to be giving,’ and that’s a philosophy I believe in.”

— Bob Dooley

37 [2018 annual report]

National Board of Directors Chairman

William J. Fishlinger

Immediate Past Chairman Harold G. Doran, Jr.

Vice Chair

Bonnie Inserra

Treasurer

John C. Doscas

Secretary

Bruce A. Siegel

Chief Executive Officer Alice Rodd O’Rourke

Directors Marlene Berg Ronald Maurice Darling, Jr. Piero Gandini Marc S. Goldfarb Esther Goodman Marc S. Goodman Lindsey Inserra-Hughes Eleanor Kosow Sandra Levy Sean F. McGarvey Ramon Poo Charles Rizzo Stephen Rizzo Ricardo Salmon Tom Santiago David Sherr Richard Tonkinson Jill Viner Bruce Waller

[diabetes research institute foundation]

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Regional Board of Directors FLORIDA REGION

NORTHEAST REGION

Chairman

Chairman

Barbara Singer

John Carrion**

Directors

Executive Committee

Sari Addicott Crystal Blaylock John Calles Florence Elbaz Bruce Fishbein Sabrina Gallo Amy Greenwald Scott Greenwald Andria Holtz Arianna Lamosa Sandra Levy* Steve Klein Tammy Klein Rosa Schechter Marco Selva James Sensale Miriam Sensale Doug Tannehill Jim Tomsula Julie Tomsula Richard Tonkinson*

William J. Fishlinger* Marc S. Goldfarb* Marc S. Goodman* Barbara Hatz Bonnie Inserra* Meryl R. Lieberman John R. Luebs Allan L. Pashcow Charles Rizzo* Bruce A. Siegel*

Directors Samantha Shanken Baker Diane L. Cohen Delia DeRiggi-Whitton Peter L. DiCapua Douglas R. Donaldson Iris Feldman Joan Fishlinger Lindsey Inserra-Hughes* Ricardo Salmon* Jonathan Tepper Bruce Waller* Roberta Waller Wendy Waller

* Also member of National Board of Directors * * Also member of Northeast Board Executive Committee

39 [2018 annual report]

Honorary Board Lynne and Martin Baron Diane and Bernard Beber, M.D. Barbara Berman Juan Elias Calles Ambassador 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 Robert Leichtung Charlotte Milgram Martha Mishcon Marge Kleiman Mintz Stephen Muss Judy and John P. Newell, III Edward James Olmos Allan L. Pashcow Michelle Robinson Blanche Rosenblatt Donna Shalala Kathy Simkins Serena Simkins Oscar Sotolongo Ferne and Daniel Toccin Dottie and Jack S. Weiss Lenny Wolfe

[diabetes research institute foundation]

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DRIF Staff National Staff Alice Rodd O’Rourke Chief Executive Officer Kelly Dunphy Chief Operating Officer Lisa Keitges Chief Development Officer Jeffrey Young Chief Financial Officer Tom Karlya Senior Vice President, Community Development Jill Shapiro Miller Senior Vice President, Development Lori Weintraub, APR Senior Vice President, Marketing and Communications Lauren Schreier Senior Director of Marketing and Communications Shaby Rosales Director of Human Resources Jill Salter Senior Manager, Development Jessica DeBlois Development Manager Karen Paraboo Operations Manager

41 [2018 annual report]

Yashie Vindell Community Development Coordinator Oneida Osuna Staff Accountant Jan Ileto Development Assistant Marisol McKay Accounting Assistant

Florida Regional Staff Nicole Otto Major Gift Officer Kit Wills Major Gift Officer Sheryl Sulkin Director of Events Dena Prior Events Manager Sarah Mehan Events Coordinator

Northeast Staff Amy Epstein Director of Events Jill Salter Senior Manager, Development DeirdrĂŠ Hector Events Manager

National Office/Florida Region 200 S. Park Road, Suite 100 Hollywood, FL 33021 T: (800) 321-3437 P: (954) 964-4040 F: (954) 964-7036 New York Office/Northeast Region 259 West 30th Street, Suite 402 New York, NY 10001 P: (212) 888-2217 F: (212) 888-2219 The Diabetes Research Institute Foundation is an independent 501(c)(3) not-for-profit corporation.

DiabetesResearch.org