Hope for the Battle against Type 1 Diabetes

Ed Damiano (middle) in his lab with members of his new medical device company, Beta Bionics; (left to right) Raj Setty and Rob LeBourdais, design engineers; Firas El-Khatib, senior engineer; Ed Raskin, vice president for benefit development and corporate strategy; Serafina Raskin, vice president and general counsel; Gibb Clarke, chief operating officer. Beta Bionics’ mission is to improve the health of people with type 1 diabetes. Photo by Michael D. Spencer

Ed Damiano, a Boston University professor of biomedical engineering and the father of a 16-year-old boy with type 1 diabetes, has been racing for nearly 13 years to develop an artificial, or bionic, pancreas that could transform the lives of millions of people who have the same disease as his son, freeing them from the round-the-clock burden of managing a potentially life-threatening disorder themselves. Damiano’s device, which regulates blood sugar levels by automatically delivering precisely calibrated doses of insulin and glucagon, will start the final round of Food and Drug Administration-approved human clinical trials in the first half of 2017.

Most academics would have long since turned their invention over to industry to push it through the cumbersome regulatory and commercialization maze. Instead, Damiano and BU senior research scientist Firas El-Khatib have started an unorthodox, socially minded medical device company to bring their bionic pancreas through final clinical trials and regulatory approval and into the hands of the people with type 1 diabetes who have been eagerly awaiting this kind of breakthrough tool. Damiano says his team moves faster, more efficiently, and more aggressively than has been seen in the medical device industry.

Eli Lilly and Company, the pharmaceutical giant that in 1923 first commercialized the lifesaving insulin hormone for patients with diabetes, is betting on Damiano. Lilly invested $5 million in the new company, Beta Bionics, Inc., at the end of 2015 and Deirdre Ibsen, Lilly Diabetes’ global brand development leader, holds a seat on the Beta Bionics’ board.

“I’m so impressed with Ed’s passion, but also with his pragmatism, his creativity in moving this forward,” says Enrique A. Conterno, president of Lilly Diabetes. “We thought for us it was a great investment.”

Damiano’s lab is one of a half dozen teams working on various kinds of artificial pancreases or closed-loop, automated insulin delivery systems, which are expected to become commercially available over the next few years. While most other systems automate only the delivery of insulin, Damiano’s device, which has moved through nearly eight years of successful clinical trials, has a bihormonal pump that supplies both insulin and glucagon. “We are a huge believer that glucagon will be a very important part of the artificial pancreas,” says Conterno. “That’s how, physiologically, the human body works.” Describing Damiano’s device as “the most advanced,” Conterno adds, “he had incredible data. It’s pretty clear that his algorithms and his systems are delivering better outcomes.”

Beta Bionics is a public benefit corporation. If you’ve heard of Patagonia and Kickstarter, you know something about this new kind of company. Unlike traditional companies, which are all about maximizing profits, these new corporations are for-profit entities that are also dedicated to social responsibility and a public benefit mission. The first public benefit corporation was launched in 2010 and Massachusetts is now among 30 states that allow this business model. In its corporate charter, Beta Bionics defines its broad public benefit as improving human health.

“Our mission is to act always in the best possible interest of the type 1 diabetes community,” says Damiano, who is president of Beta Bionics and holds a seat on the board, but will remain at BU as a professor and researcher. “We have no desire to flip the company for a quick return on investment. In fact, I think that would be the surest way to undermine the mission of Beta Bionics. I believe that if Beta Bionics remains faithful to our convictions and to our core values, it will lead to the best possible products—products that will thrive in the marketplace and change the paradigm of type 1 diabetes management.”

Beta Bionics appears to be the first medical device company to enter the public benefit realm.

“Traditional corporations may make decisions based on a short-term horizon,” says Mike Pratt, interim managing director of BU’s Technology Development office, whose team helped Damiano navigate the mountain of licensing and intellectual property agreements required to start the company (BU holds a 5 percent equity stake in Beta Bionics and owns the patents). “Venture capitalists want to see returns on their investments fast. Ed recognizes that he has to generate some profit in order to be sustainable, but the public benefit corporation structure gives Beta Bionics some flexibility that other companies don’t have—to put the people who need the device first. Bottom line: Ed wants to put extra focus on a really safe, effective product.”

Damiano gives a hypothetical example of how the public benefit model could protect the bionic pancreas: A large medical device company makes a lucrative offer to acquire Beta Bionics. If Damiano and his board conclude that the company will shelve their potentially disruptive device in order to keep drawing revenue on their existing products, Beta Bionics can—and it will, Damiano says—legally turn down the offer because it’s not in the best interest of the type 1 diabetes community. A traditional corporation would be required to accept the offer.

Type 1 diabetes, which affects about two million people in the United States, is an autoimmune disease that destroys the pancreatic beta cells that normally produce insulin, which allows the body to convert carbohydrates to energy. If treated poorly over the years, the disease can damage organs such as the kidneys and eyes, as well as blood vessels and nerves. The bionic pancreas mimics the efficiency of the natural pancreas, which fine-tunes the body’s glucose level both by lowering it (with minute amounts of insulin) and by raising it (with tiny doses of glucagon).

In keeping with his public benefit mission, Damiano founded Beta Bionics with a group of parents of children with type 1 diabetes—Orange County, Calif., attorneys Edward B. and Serafina Raskin, whose 10-year-old son Max was diagnosed with type 1 diabetes at age 7; and Jeff Hitchcock, whose 28-year-old daughter was diagnosed at 24 months and who founded the non-profit Children with Diabetes, an online community that promotes understanding of the care and treatment of the disease. These corporate founders have bonded over the round-the-clock management required to keep their children healthy—monitoring blood sugar levels, calculating insulin doses, counting carbohydrate grams—and the constant worrying about long-term complications. They all know the fear of “dead-in-bed” syndrome, which can occur if blood sugar levels go too low while a person with type 1 diabetes is sleeping.

“My daughter is perfectly healthy, but to get there has been an extraordinary amount of work,” says Hitchcock, who is the Beta Bionics public benefit director and holds a seat on the board.

Hitchcock met Damiano at a diabetes technology conference in 2006. “I heard for the first time someone talking about a technological solution that I knew would work,” says Hitchcock. “He spoke with passion and with the conviction of a scientist—not that touchy-feely hope kind of thing, but with ‘I know how to do this and I’m not going to stop until I solve it.’”

“When we ask our families ‘How often do you think about type 1 diabetes,’ the answer for some is ‘about every five minutes,’” Hitchcock says. As Hitchcock explains, about 10 percent of people in the US who have the disease—including David Damiano and Max Raskin—wear continuous glucose monitors, which are tiny sensors that give blood sugar readings every five minutes. David and Max also wear insulin pumps, which deliver relatively precise injections of insulin under the skin.

With its patented algorithms, Damiano’s bionic pancreas, which is called the iLet and is about the size of an iPhone 3, does all the calculating, adjusting, and dosing autonomously and automatically. The only information that users have to enter is their weight.

“All that constant worry goes away,” says Hitchcock. “The bionic pancreas never gets tired. It’s always there.”

With parents following his progress on the bionic pancreas for more than a decade now, Damiano has attained rock star status in the type 1 diabetes community. Two years ago, a few months after his son had been diagnosed, Ed Raskin connected online with Damiano. It was 2 a.m. in Orange County, 11 p.m. in Boston. Parents of children with type 1 diabetes don’t get much sleep; they stay up to monitor blood sugar levels.

“When I was in the hospital with Max when he was being diagnosed, that’s when I understood—you mean no one’s invented a way to tell me how much insulin to give my kid?” Raskin recalls. “A machine doesn’t do this? I have an amazing iPhone in my pocket and I have to do all this manually?”

The two fathers ended up talking by phone for a couple of hours that night. Damiano gave Raskin a crash course on the bionic pancreas. Raskin pledged that he and his wife, who are founding partners in a small law firm that handles a lot of health care-related work, would help in any way they could.

Now, in addition to his day job, Ed Raskin is vice president for public benefit development and corporate strategy at Beta Bionics and holds a seat on the board. Serafina Raskin is a vice president, secretary, and general counsel for Beta Bionics. The company’s chief operating officer, Gibb Clarke, is a social entrepreneur who has launched several successful, small medical device companies. Clarke is a longtime friend of the Raskins and the couple says he has watched them grapple with the non-stop management of their son’s disease and wanted to help. Steven J. Russell, an assistant professor of medicine at Harvard Medical School and endocrinologist at the Massachusetts General Hospital (MGH), and Roy Beck, executive director of the nonprofit Jaeb Center for Health Research, serve on Beta Bionics’ scientific advisory board.

After Damiano’s son, David, was diagnosed with type 1 diabetes at 11 months, he set himself a deadline: To get the bionic pancreas on David by the time he heads off to college. David is now a high school junior.

The National Institutes of Health has awarded Damiano $1.5 million for the Bionic Pancreas Bridging Study, which will begin later this year and will be the first home-use trial to test the iLet in adults and children with type 1 diabetes. The final Bionic Pancreas Pivotal Trial is scheduled to begin in 2017.

“It’s a horrible disease,” says Pratt. “Ed is passionate about it. His mission, his vision, is what’s driving him. Why would you not want to help him?”

In 2008, Damiano needed healthy adult volunteers to participate as control subjects at MGH in the first human clinical trials of the bionic pancreas. Pratt volunteered. “I spent 27 hours in bed with IVs in both arms,” he says.

“As an administrator at a university, when you come across a person who’s passionate about something and it’s for a humanitarian purpose—in Ed’s case, something that improves people’s health—that inspires you,” says Pratt. “Sometimes in my group’s meetings, I’ll play Ed’s TEDx talk. I say, ‘Let’s remember why we’re doing this.’ I like to think of the University as a problem solver and Ed’s a perfect example of that.”