DRIFocus Fall 2023

DRIFocus

Introducing Our New CEO: A Champion for the Cure The Diabetes Research Institute Foundation (DRIF) is thrilled to introduce our new CEO, Michael J. Burton. With over 30 years of experience in the philanthropic sector, Burton is an accomplished nonprofit leader and a dedicated advocate for groundbreaking medical research. Under his leadership, the Foundation is poised to reach new heights in our mission to cure diabetes.

Prior to joining DRIF, Burton made significant contributions at prestigious institutions including Princeton University, The Pew Charitable Trusts, and the American Association for Cancer Research. He most recently served as President and CEO of Gateway for Cancer Research, a nonprofit dedicated to advancing early-phase clinical research in oncology.

Burton’s decision to transition from the world of cancer to diabetes research is motivated, in part, by his personal connection to the cause. He witnessed firsthand the significant impact that diabetes had on the lives of both his mother and his daughter’s lifelong friend, and thus shares our profound desire to improve the lives of those affected by the disease.

“I really believe the Diabetes Research Institute is prepared to advance the goal of curing diabetes like no other organization,”

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Diabetes Research Institute Foundation Fall 2023

“I really believe the Diabetes Research Institute is prepared to advance the goal of curing diabetes like no other organization”

By Nicole Mlynaryk said Burton. “I’m in the enviable position of helping to make a strong institution even stronger.”

Looking ahead, the CEO will focus on strengthening the Foundation’s engagement with donors, expanding its reach, and establishing strategic partnerships with organizations across the diabetes community.

“My mission is to build a strong base of support for this institute,” Burton said. “We’re inviting the public to get more involved, keep up-to-date on our progress, and be as inspired by this work as we are.”

Burton’s appointment follows the recent naming of worldrenowned immunologist Matthias von Herrath as the Institute’s new Scientific Director. Their partnership will usher in a transformative era for the Foundation and its affiliated research institute.

“This is an organization on the move,” Burton said. “I believe the history of the cure for diabetes will be written someday, and when that day comes, I know the Diabetes Research Institute will play a leading role.”

WAYS TO GIVE

We truly admire Tim and his numerous passion driven accomplishments and will always be grateful for his generous and steadfast support today and in the future.

Tim Choate:

Driven by Passion to Make a Difference

Arthur (Tim) Choate has led a colorful and vibrant life, full of unique experiences. At the age of 7, while on vacation hunting for gems in the desert, he was diagnosed with type 1 diabetes (T1D). Following his parents’ divorce, he and his mother relocated from New York to Islamorada in the Florida Keys. That is where Tim’s love for fishing began. Tim’s passion for extraordinary billfishing expeditions in unexplored waters led to him winning tournaments in every corner of the world including the Caribbean, South America, Australia, and Hawaii. These amazing life experiences are testament to the fact that he has never let T1D stand in his way or slow him down.

When he moved to Florida, Tim began seeing Dr Daniel Mintz, the Diabetes Research Institute’s (DRI) founder and first scientific director. Tim remains a devoted supporter of the DRI, he closely follows research progress, and is optimistic about what the future holds for people with T1D. Tim attended the University of Miami and became an attorney with the Florida State Attorney’s Office. He later joined a private law practice led by a retired 3rd district court of appeals judge.

As an enthusiastic angler with a deep concern for marine life and ocean conservation, Tim left the legal field behind and led several companies including Artmarina, a sport fishing enterprise he developed which specialized in fishing lodge resorts and charter fishing operations in Costa Rica, Guatemala, Brazil, and the Galapagos Islands.

use of circle hooks to enhance the survival of released billfish.

As a conservationist, he also worked diligently for years to encourage governments and conservation groups to validate the contributions that recreational fishing provides to tourism, pointing out the higher value of sport fishing to a region over commercial fishing.

Tim has received numerous awards and prestigious recognition including the 2013 International Game Fish Association Conservation Award for his key role in the passage of the Billfish Conservation Act of 2012. This act outlawed commercial sales of marlin and sailfish from the Pacific in the US mainland. He also served as chairman of Wild Oceans, the oldest saltwater fishing conservation group in the US, from 2011 to 2022. Following in her Dad’s footsteps, his daughter, Stephanie Osgood Choate Oppenheimer is the current Wild Ocean co-chairman.

Tim has always been an enterprising and visionary individual. He developed a thoughtful and taxwise estate plan and included the people and charitable organizations that are meaningful to him. To ensure that the DRI’s cure-focused research continues until a cure has been discovered and is available to all, he has provided for the DRI Foundation (DRIF) in two ways. In addition to a bequest, Tim has established a charitable remainder trust. This trust provides income for life to a loved one. After their passing, the remaining funds in the trust will support the DRIF and other charitable causes.

We truly admire Tim and his numerous passion driven accomplishments and will always be grateful for his generous and steadfast support today and in the future.

As one of the founders of the Billfish Foundation, Tim actively promoted the catch and release philosophy and included the

Spotlight on Your Philanthropy As year-end approaches many of us are thinking about the causes that are important to us and ways that we can make an impact while taking advantage of tax benefits. You may want to consider one of the following strategies this year:

Donate appreciated securities instead of cash

Generally, you can eliminate the capital gains tax you would otherwise incur from selling securities (as long as you have held them for more than one year) and claim a charitable deduction for the full fair market value of the securities.

Bunching your charitable contributions in one tax year

If your annual tax deductions are below the standard deduction amount, you can combine two years’ worth of charitable contributions into a single tax year and return to the standard deduction on the following year’s tax return. This allows you to itemize the deductions on your tax return for that year and possibly receive a larger tax deduction than you would have received, by claiming the standard deduction for two years.

Fulfill your IRA Required Minimum Distribution (RMD) though a QCD

Strategic Planning Pointer: Many people use charitable remainder trusts (CRTs) to increase their income, save taxes, and benefit charities. A CRT lets you convert highly appreciated assets like stocks or real estate into lifetime income for you or a beneficiary of your choice.

Contact us to learn more.

To learn more visit: DiabetesResearch.org/Ways-to-Give

One way to trim your tax bill and support the DRI Foundation is to make a qualified charitable distribution (QCD) from your individual retirement account (IRA) directly to our organization. Individuals who are 70.5 years and older can direct up to $100,000 per year (up to $200,000 per year for married couples filing jointly) from their IRA accounts. You will not pay income tax on the distribution, and it will not count toward your adjusted income for tax purposes. This is beneficial because adjusted gross income can impact your tax bracket and trigger several additional expenses, including hikes in Medicare costs.

In 2023 new legislation made it possible for individuals to make a one-time QCD of up to $50,000 to create a gift that will pay you or your spouse income for life. Additional details are available on making this type of gift.

To learn more about these and other tax savvy year-end giving strategies, contact: Jill Shapiro Miller: (954) 674-3205 or jshapiro@drif.org, or your professional advisor.

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AROUND THE DRI DRI team: Alice Tomei, Grisell Gonzalez, Aaron Stock, Joel Szust, Yielena Gadea, and Greycy Vega working on the first transplant of conformally coated islets in a model of T1D pre-implanted with Sernova’s pre-vascularized cell pouch.

Dr Alice Tomei and Sernova Alliance brings us

One Step Closer To A Cure In a groundbreaking development, Dr Alice Tomei, the Director of the Islet Immunoengineering Laboratory at the DRI , is set to unveil her pioneering work in pursuit of a cure for T1D in a new collaboration with Sernova Corporation at the upcoming 2023 Joint Congress of The International Pancreas and Islet Transplant Association (IPTA), the International Xenotransplantation Association (IXA), and the Cell Transplant and Regenerative Medicine Society (CTRMS) in San Diego, (October 26 to 29).

Preclinical studies conducted at the DRI, in tandem with Sernova, have yielded promising results. Conformally coated islets, when transplanted into the pre-vascularized Cell Pouch, achieved normal blood glucose control, and reversed the effects of T1D in a model of T1D. These islets also exhibited normal responsiveness to glucose and fully regulated insulin production when transplanted in the Cell Pouch. Ultimately, the treatment group achieved full insulin independence, marking a significant advancement in T1D treatment.

This partnership with Dr Tomei will enable Sernova, a clinicalstage leader in cell therapeutics, to advance its exclusively licensed conformal coating immune protection technology in combination with the Cell Pouch™. The primary goal of this innovative technology is to eliminate the lifelong use of conventional immunosuppressive medications, a current requirement for preventing graft rejection in Sernova’s flagship cell therapy program for the treatment of T1D). Harsh immunosuppressive treatment is currently needed because of the patient’s immune response to cell transplantation therapy.

Dr Tomei’s collaboration with Sernova is focused on reducing and possibly eliminating this negative patient impact.

Furthermore, optimization studies in T1D models have shown that treatment with a single selective immune response agent led to sustained, normalized blood glucose levels during the study period. These findings support the potential to eliminate the need for the immunosuppressive cocktail of medication which is typically used following transplantation, and which is often associated with toxic side effects.

Dr Tomei has emphasized the success achieved in preclinical safety and efficacy studies including developing optimal conditions for conformally coated islets within the Cell Pouch and developing the release criteria essential for the clinical manufacturing process. Together with Sernova, she has optimized the manufacturing process and is currently scaling up the Good Manufacturing Practice (GMP) production of the conformally coated islets, which is a critical step in advancing this technology and making it available for all patients with T1D. “I am pleased with the technical advancements we have made in collaboration with the Sernova scientific team,” said Dr Tomei.

“These elements are critical to advancing the conformal coating technology into the clinic for the potential treatment of all patients with T1D..”

These are exciting times for islet transplantation for T1D. The upcoming 2023 IPITA-IXA-CTRMS Joint Congress promises to be a pivotal event where Dr. Alice Tomei will unveil her work with Sernova that brings us one more critically important step closer to a cure.

iTolerance: Pioneering the Fight Against Diabetes We are excited to announce that iTolerance, a highly innovative medicine company at the forefront of the battle against T1D, has formed a strategic partnership with the DRI, combining iTolerance’s groundbreaking technology with DRI’s scientific expertise to create a synergy that holds immense promise for patients with T1D. Revolutionizing T1D Treatment iTolerance is a biotech startup dedicated to developing regenerative medicine solutions that eliminate the need for lifelong immunosuppression during tissue, organoid, or cell therapy. Their patented technology, known as SA-FasL microgel, has the potential to transform the way that we approach T1D treatment. This substance causes the T cells that would attack the transplanted islets to self-destruct. It can also turn the area into an “immune privileged site”, allowing the islet cells to do their work unmolested by the patient’s immune cells.

Meet iTOL-102: A Potential T1D Cure The flagship program at iTolerance iTOL-102 is a beacon of hope for those affected by T1D. This program involves the use of allogeneic stem cell-derived pancreatic islets, capable of secreting insulin in response to glucose, in the same manner as native pancreatic cells. What sets iTOL-102 apart is the application of the SA-FasL microgel platform, which creates localized immune tolerance, “tricking the immune system to accept the transplanted cells as their own.” The hope is that this will work without the need for any general immunosuppression, enabling the long-term survival and function of these implanted cells.

Addressing a Critical Unmet Need iTolerance’s innovative approach offers hope for the future treatment of T1D by providing a potential cure without the need for lifelong immunosuppression. This advance could lead to

an inexhaustible supply of insulin-producing cells and greatly enhance the quality of life for those affected by T1D. The iTolerance approach relies on a breakthrough technology that was developed by the DRI Team led by Dr Camillo Ricordi: the BioHUB project. This unprecedented research resulted in the successful clinical translation of a method to bioengineer an endocrine pancreas within a biodegradable biologic scaffold, placed onto the omentum (a large flat adipose tissue layer on the surface of the intra-peritoneal organs). This advancement resulted in the first-in-human successful islet transplants into an extrahepatic site, which was showcased by the DRI team in the New England Journal of Medicine.

The BioHUB strategy was developed to combine the novel bioengineering technology with strategies to avoid anti-rejection drugs, eventually applying them to an unlimited source of insulin producing cells. Parallel clinical trials are being conducted at the DRI and other centers in North America and Europe, with such stem cell derived islets.

Camillo Ricordi, Director of the Cell Transplant Center and Director Emeritus of the DRI said, “I am very pleased to see that the three pillars of the DRI BioHUB strategy, namely development of a novel transplant site (omentum), transplantation without immunosuppression and unlimited sources of stem cell derived islets, are entering the final stage of clinical translation and rigorous scientific validation, representing the convergence of over two decades of pioneering work at the DRI, which has now been integrated into iTolerance’s SA-FasL microgel technology”. iTolerance and DRI are on the brink of initiating their first clinical trial to test iTOL-102. This marks a significant milestone in the fight against T1D, as we move research into real-world applications that brings us closer to a cure.

Phase contrast image of islets of model conformally coated with polyethylene glycol (PEG) for transplantation in Sernova’s pre-vascularized cell pouch. iTOL-100 platform technology comprises a chimeric fusion protein of streptavidin-FasL which is combined with a biotin-PEG microgel (SA-FasL microgel) to induce local immune tolerance. Fas Ligand (FasL) is a naturally occurring protein, that is present in all mammals allowing the establishment of local immune tolerance.

Ordinarily, activated T-cells will reject foreign tissue, such as an islet transplant.

That is why current implantation of cells or organs requires life-long immunosuppression of the recipients to prevent organ rejection. Mixing iTOL-100 with the pancreatic islets, and implanting the combination it into the body, results in the binding of FasL to the Fas receptor (FasR) on activated T-cells that arrive to the site of islet transplantation to attack them. Rejection is prevented and tolerance induction without continuous recipient immunosuppression results from the elimination of the attacking immune cells by the FasL, through a process called apoptosis (or programmed cell death). In parallel, T-regulatory cells are generated creating long-term localized immune tolerance that protects the implanted insulin producing cells.

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SPOTLIGHT ON SUPPORTERS

EVENTS

Labor of Love: North America’s Building Trades Unions Over 250 people gathered in Williamsburg, Virginia for the North America’s Building Trades Unions (NABTU) annual Labor of Love Event to benefit the DRI. The three-day event included golf, gaming, a Texas Hold’em tournament, a fishing tournament, and the spirit of friendship and philanthropy for which NABTU and its affiliated partners are well known.

This year over $800,000 was raised, bringing NABTU’s generous total to benefit the DRI more than $75,000,000 since the NABTU/DRIF relationship began.

The Hamptons Garden Gala hosted by National Board Director Roger Silverstein and his wife, Patricia, was an unforgettable night of fun and inspiration. They welcomed over 150 guests to their home in the Hamptons to experience the excitement, conviviality, and intimacy of a premier summer event. We are proud to share that the event raised nearly $270,000 for the cure-focused research at the DRI! Pictured: Patricia and Roger Silverstein

The DRI was recognized as one of the charity recipients of the annual Blue Dream Gala hosted by the Dormition of the Virgin Mary – Greek Orthodox Church of the Hamptons. The event took place on the church grounds, with the esteemed Co-Chairs Amanda Shemesh Goldberg and Denise Goldberg representing the Diabetes Research Institute, and Greek-Americans Carli Pantelidis and Mariana Pantelidis representing Project Purple. The event contributed $175,000 to the DRI. Pictured: John Catsimatidis, Father Constine Lazarakis, Amanda Shemesh Goldberg

Thanks to tremendous local community support and spirit, the annual Walk, Run, or Ride event on September 9th at Cedar Creek Park in Long Island, New York raised over $97,000 to help the DRI find a cure. Special thanks to John Carrion and the committee for their unwavering commitment to the event and mission.

Pictured: Event Participants

Inserra Supermarkets Once again collected donations from shoppers who made donations and received paper “Snoopys” to acknowledge their contributions throughout the month of June. Under the leadership of DRIF Board Member Lindsey Inserra, the stores also organized various fund-raising events including a diabetes education component which took place within the communities served by their stores. Out heartfelt thanks to Lindsey and the Inserra family for their continued parternership and support.

Visit us at DiabetesResearch.org

The 2023 Donaldson Organization Golf Outing held on October 2nd at New York’s renowned Winged Foot Golf Club in Westchester County, was nothing short of remarkable!

Thanks to the Donaldson family, committee and 216 dedicated golfers hitting the course, this year’s outing achieved an impressive milestone by raising over $630,000 towards our mission. Participants came together to celebrate the strides made in diabetes research and to help fuel the next chapter in DRI research toward a cure. Pictured: Bob, Matt, Ty, and Doug Donaldson

To learn more about upcoming events, visit DiabetesResearch.org/Events ­­­

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DRIFocus

Non-Profit Org. US Postage PAID Diabetes Research Institute Foundation

Diabetes Research Institute Foundation National Office 200 South Park Road Suite 100 Hollywood, FL 33021 address service requested

EVENTS CALENDAR

2023

2024

For more information about our upcoming events and registering to attend, visit DiabetesResearch.org/Events NOVEMBER 14

NOVEMBER 16

NOV. 30 - DEC. 2

DECEMBER 13

World Diabetes Day

C3 – Collaborate, Celebrate, Cure Galal NEW YORK

Champions for Charity NEW YORK

The Empire Ball NEW YORK

APRIL 7

APRIL 15

MAY 1

Out of the Kitchen SOUTH FLORIDA

Out of the Kitchen NEW YORK

39th Annual Don Strock Diabetes Golf Outing MIAMI

Join Us at an Event and Be Part of the Cure!

The Diabetes Research Institute and Foundation were created for one reason – to cure diabetes – which is and will continue to be the singular focus until that goal is reached. For the millions of children and adults affected by diabetes, the Diabetes Research Institute is the best hope for a cure. Learn more at DiabetesResearch.org, or contact us directly at 800-321-3437 or info@drif.org.

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