For over 15 years, academic leaders in clinical research and engineering worked with funders, patient groups and industry to support the advancement of AID.
In 2002, Bigfoot Biomedical CEO Jeffrey Brewer’s technology career was flourishing, having founded two successful startup dot-coms that later became publicly traded companies. He had just moved his family from Silicon Valley to New York City, and was ready for new challenges. But when his young son received a devastating diagnosis just weeks after the family settled into their new home, Brewer found himself unable to focus on anything else. Stunned by the lack of information, high risk of error and antiquated devices available to help manage his son’s type 1 diabetes, Brewer began laying the groundwork for his most important technology project to date: automated insulin delivery (AID).
Fifteen years, millions of dollars and many challenges later, the type 1 diabetes community is anxiously awaiting the release of Medtronic’s MiniMed 670g, the world’s first hybrid closed-loop AID system, while Bigfoot, Insulet and others follow closely behind. But how did one man, often called “the Father of the Artificial Pancreas,” navigate the regulatory, medical and business challenges of this innovation to have such an impact? He didn’t do it alone. By aligning with JDRF and partnering with the Helmsley Charitable Trust, T1D Exchange and others, Brewer’s vision for better diabetes technology is now a reality, thanks to this unique and unprecedented strategic collaboration.
Tools from the Dark Ages
When seven-year-old Sean Brewer was hospitalized and diagnosed with type 1 diabetes, his father knew almost nothing about the chronic illness. “I was told he would need insulin for the rest of his life, and was given a few vials of the drug, needles and a hand-written diagram,” said Brewer. “That was it.”
He recalls being told that he and his wife would have to be very careful about how much insulin to dose, or it would have very dangerous consequences.
“I was appalled at the lack of tools available to help us. I had just come out of the technology industry, where we thought we were changing the world,” said Brewer. “I couldn’t believe health care was still in the dark ages.”
From the beginning, Brewer refused to accept the burdensome, manual process of carbohydrate counting and dosing using existing technology. He was driven to find a better solution.
“It was the most important thing for the care of my son,” he said. “It didn’t seem good enough.”
No Time to Waste
Just two weeks after his son’s diagnosis, Brewer attended a local meeting of the Diabetes Technology Society, a young non-profit studying innovation and technology for those living with diabetes. He learned everything he could about blood glucose sensors, continuous glucose monitors (CGMs), insulin pumps and the current device landscape, including a closed-loop, or AID, system.
“There were folks working on it — testing it out on dogs, for example. It seemed pretty exciting.”
But when Brewer asked when such a system would be available to buy, there was no answer. Through conversations with others and his own research, he learned there were a number of problems in making AID available to consumers. For one, the Food & Drug Administration (FDA) had no idea how to regulate such a system. Companies like Medtronic and Johnson & Johnson/Animas were afraid it would be too expensive and they’d lose money. Doctors thought it was too difficult to program and weren’t interested in prescribing it, and insurance companies wouldn’t cover them.
“There were too many challenges in the ecosystem. It seemed broken,” stated Brewer. “And there was no investment to fix it.”
A New Focus
As a long-time philanthropist, Brewer seized the opportunity to fund development work and studies that would help solve these challenges. Like so many in the type 1 diabetes community, he turned to JDRF, the type 1 diabetes-focused research foundation whose funding at the time was directed primarily on finding a biological cure for the disease. In 2004 he made an initial gift of $1 million, restricting it for short-term improvements to help people manage their type 1 diabetes today. His investment was eventually leveraged into more than $120 million over the course of the next decade, and led to years of work on JDRF’s Artificial Pancreas (AP) project as a volunteer, donor, member of the International Board of Directors and, from 2011-2014, CEO.
In 2005, not long after Brewer’s initial investment, he met Aaron Kowalski, a newly hired JDRF employee and long-time type 1 diabetes patient with an interest in technology. Brewer and Kowalski (now Chief Mission Officer) became close partners in the AP program, developing studies, testing algorithms, educating the FDA on why innovation was needed in the diabetes space, and supporting trials to prove the safety and reliability of CGM. They also joined forces with DirecNet (Diabetes Research in Children Network), who had already begun studying diabetes technology with modest funding from the National Institute of Health (NIH), to form the AP Consortium.
But for all of the work they did proving the need for and viability of this type of technology, Brewer hit major roadblocks when trying to engage the big pharmaceutical companies. It appeared that only a large company like Medtronic, Roche, or Johnson & Johnson/Animas could invest in integrating the necessary technology needed to bring the AID system forward. But they were slow to act and weren’t convinced that a system was possible.
“They weren’t committed to the disruptive technologies that were needed to change the game.”
Brewer was frustrated that the initiative he had led to drive resources to industry didn’t have the payoff he had hoped. But in 2008, after several years of intense research and development, he and his colleagues found another way.
Coming Together for a Common Goal
That year, a new organization, The Leona M. and Harry B. Helmsley Charitable Trust, was quickly becoming one of the nation’s largest private foundations, following the death of Leona Helmsley a year earlier. Prominent real estate developers Leona and Harry Helmsley had left their estate to the Helmsley Charitable Trust and named her grandson David Panzirer one of the Trustees. Panzirer began building a type 1 diabetes program and hired Dana Ball, a long-time T1D advocate and philanthropy executive, to direct the program with him. Together, Panzirer and Ball met with Brewer and Kowalski to discuss the need for new diabetes technology as short-term solutions while a T1D cure remained undiscovered.
“From that very first conversation, I saw the passion, the plan and the promise of investing in this technology,” said Ball, whose work at Helmsley pre-dated his creation of T1D Exchange in 2012. “Up until then, my work was focused on therapies and approaches to finding a cure. They made a very powerful first impression.”
Helmsley saw the promise of the developing JDRF AP Program and provided an initial grant of $2.3 million to build out the AP team. With those funds, JDRF was able to hire four staff members with clinical, regulatory and business expertise. Brewer recalls how critical that support was when sitting down with regulators.
“This stuff is just very, very hard. It requires a lot of work and money,” he said. “That first Helmsley grant was critical in getting the right resources in place, so we could play that game.”
Ball added that the partnership was just as beneficial for his work at Helmsley. “I got to invest in their work at JDRF, to benefit from their research and information. It created a platform for JDRF and Helmsley to collaborate, based on a common strategy between the two organizations.”
Helmsley’s initial investment in JDRF was the beginning of an important and unique collaboration between non-profits – not only with Helmsley’s financial support of AID research and development, but in working together to provide updates, discuss challenges and jointly advance the field of automating insulin delivery.
Two years later, NIH began funding research projects through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Suddenly, there were more financial resources to drive this important work forward, and there were signs that the collective work was de-risking AID innovation. The group focused on identifying studies that would create more awareness for AID systems and would create a body of evidence to support patients’ needs for such a device. These studies provided the data they needed when meeting with regulators and payors.
“It’s easy to have vision, but the majority of people depend on solid data,” said Ball, who worked closely with the Helmsley Charitable Trust to create T1D Exchange to conduct research and provide much-needed data to the business, medical, academic and non-profit communities working in type 1 diabetes. The T1D Exchange Registry, consisting of health information and self-reported data on more than 30,000 patients with T1D, as well as observational studies conducted through T1D Exchange’s clinic network, helped provide the evidence needed to better understand the burden of device use and create a value proposition for AID.
“When you’re able to collect that kind of data – including the doctors treating them, the kind of measures they need to have in place – you can put it all into the payor’s perspective,” said Brewer. “That’s what makes it all come together.”
Not Your Average Medical Device Company
In 2014, it was time for Brewer to step out of research and into development, by creating a company that would manufacture an AID device. Brewer stepped down as CEO of JDRF, co-founding his third technology startup, Bigfoot Biomedical, to develop the Bigfoot smartloop™ system. He teamed up with Bryan Mazlish, the original “Bigfoot,” a computer science and complex mathematics expert who had successfully hacked an insulin pump and a continuous glucose monitor to create his own AID system using a smartphone. They were later joined by Lane Desborough, co-creator of Nightscout, a free, open-source CGM remote monitoring system, now used by thousands. The Bigfoot team is now nearly 50-strong, with roughly 40% of the staff living with or caring for someone with type 1 diabetes.
Brewer’s team continues to use data from T1D Exchange’s clinic to inform their work in modeling insulin delivery and blood glucose variation. Registry data also helped the science team create a complex, human endocrine system simulation which is used in their development process.
And just last month, Ball continued his long-standing financial support of Brewer’s work in AID system research and development, with a multi-million dollar investment in Bigfoot Biomedical. This investment, part of the T1D Exchange AID Initiative aimed at advancing systems and components that support AID, is yet another example of how their work, and the work of other non-profits, can have a dramatic effect on breakthrough technologies and therapies for people with diabetes.
“There are not a lot of examples of this kind of collaboration between non-profits,” Brewer said of his long-standing relationship with JDRF, Helmsley, T1D Exchange and others who have since joined forces to push this technology forward. “I’m very proud of what we’ve been able to accomplish together.”
Bigfoot, and Others, are Coming
While Brewer says he is in no way “done,” he can now focus his attention on the Bigfoot smartloop™ system, which completed its first human clinical trial at three U.S. clinics in late 2016. Bigfoot plans to submit their system for Pre-Market Approval to the FDA in 2018. This would allow them to sell the system to consumers.
As excitement builds for the release of the MiniMed 670g and other systems like Bigfoot’s, some patients worry they will be priced out of the market. Brewer and his team are committed to making the Bigfoot system accessible. After all, cost was one of the key roadblocks to developing this technology when he began this work in 2002.
“The AP system cannot be a rich man’s toy. If that’s the case, it will never come to market, because there aren’t enough rich people to buy it, and it simply can’t cost the system more money. Preventing that cost is in everyone’s best interest, and it’s my commitment,” he said. “In a way, it’s a social justice issue.”
As researchers continue to work tirelessly to understand type 1 diabetes and research biological therapies, a cure is still many years away. But Sean Brewer, now 22, will soon have access to this life-changing technology that his father and others envisioned all those years ago…thanks to the collective power of JDRF, the Helmsley Charitable Trust and T1D Exchange working together to improve the lives of all who are touched by type 1 diabetes.
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