Jeffrey Brewer discusses Bigfoot Biomedical’s Automated Insulin Delivery System

On Tuesday, September 29 we will be live-streaming an interview with Jeffrey Brewer about Bigfoot Biomedical’s Automated Insulin Delivery System, hosted by TuDiabetes Community Manager Emily Coles. TuDiabetes members in attendance will be welcome to ask questions!

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Jeffrey Brewer is a Founder and CEO of Bigfoot Biomedical, a Silicon Valley company developing the world’s first automated system for the treatment of T1D. For the past thirteen years, since his son’s T1D diagnosis at age seven, Jeffrey has been a thought leader and influencer across the T1D community. As a volunteer, donor, and International Board Member for JDRF, he launched the JDRF Artificial Pancreas Project in 2005, and later served as CEO of JDRF. In the role of CEO, Jeffrey forged financial partnerships with industry to drive research and development of insulin delivery and glucose monitoring technologies. He spearheaded US regulatory reform in the area of automated insulin delivery, and elevated the organization’s strategic priorities to include health care policy, reimbursement, and access to technology for people with T1D. Prior to his work in T1D, Jeffrey founded two successful technology start-ups – CitySearch and Overture / GoTo.com – both of which later became publicly traded companies. Jeffrey served as CEO of Overture which was acquired by Yahoo! in 2002.

Bigfoot Biomedical has developed a fully functioning, automated insulin delivery solution for the treatment of Type 1 Diabetes (T1D). By integrating its FDA-approved insulin pump and the leading continuous glucose monitor (CGM) with a smartphone app and a comprehensive, cloud-based data platform, Bigfoot enables a safer and less costly way to treat the millions of people living with T1D. Founded by proven entrepreneurs with track records of innovation and value creation, Bigfoot is creating a durable business of scale, and meeting an important unmet health need. Bigfoot’s roots were chronicled in Wired Magazine and its prototype system, which has been used in the real-world for the past two years, was described poignantly in this blog post by the wife of Bigfoot’s co-founder Bryan Mazlish. Bigfoot was also recently featured in the WSJ.

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This event is starting in just a few minutes, at TuDiabetes.org/live. Join us!

Watching this on replay in the Google hangout. The line about wanting their devices to “fit into the way you live, not have you have to live your life according to how devices work” gets huge applause points from me. No wonder these were the guys who picked up the ball dropped when Assante went belly up. Yay Bigfoot!

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I completely agree, @DrBB. I found Jeffrey’s approach and perspective really exciting!

Good news about the FDA being much more collaborative and supportive too.

Don’t have time to watch the replay right now, which may answer my probably stupid question: how is this different from the “bionic pancreas”?

As I understand it, it’s going to be a closed loop system in the sense that the CGM will be allowed to directly control the pump, but (though I don’t think this was covered in the talk) it doesn’t administer both glucagon and insulin, just insulin. One of the co-founders is using the DIY closed-loop system that was posted about here on TUD a couple of weeks back. I’ll see if I can find the link. I was impressed at the time because the system as proposed would occupy an important niche between a full-blown AP like the iLet and others, which I think are going to be extremely expensive and difficult to obtain for a lot of us, and a more limited solution that would nevertheless be a huge improvement over the standard pumps we have now.

Two things stood out. One is that they aren’t just trying to make a new gadget; rather they are looking at the whole business model of how these things are distributed and resupplied from top to bottom. They are trying to make that system more streamlined and affordable–kind of a subscription service model (could be good or bad–a lot depends on the details. But they seem to be approaching it from the right mindset–which leads to the other standout for me, which is that these are the guys who have acquired all of Asante’s assets, including the Snap insulin pump, and plan to build on that as the core of their physical device. So those of us orphaned when Assante was shuttered may have another chance at a pump that incorporates the Snap and takes it to the next level. I had one for about 4 months this year, and loved it. It still had drawbacks but it was far more user-centered in its design than virtually all of the others, and Bigfoot seems to embrace a similar outlook–much more in tune with what we expect from the rest of the digital ecology these days. I just hope they can avoid whatever crevasse did in Assante.

On edit: Here’s the TUD discussion: Are the DIY Artificial Pancreas Folks Outlaws?

And here’s the article that prompted it (which I just noticed is actually quite a bit older–June 2014):

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How can you have a closed-loop pump if you use today’s insulins which last 4-5 hours? Actually, you can’t.

Was there any mention of a revolutionary new insulin? I didn’t watch the presentation.

Which prompts my next suggestive question for @EmilyC . How about setting up one of your interviews with someone from the FDA who can discuss how the approval program works for devices and/or drugs? This process always continues to baffle me.

Perhaps I’ll end up even more baffled and less informed after hearing someone from the government talk around a question rather than answer it. But, hey, what the heck? If it could be arranged it might be worth doing? Possibly? Perhaps? At least we could then say, “Well, we tried”. :blush:

LOL! I think we can make that happen, @irrational_John :slight_smile: Great suggestion! I think I had someone from FDA on a couple years ago, along with another presenter, but I can’t for the life of me remember who it was and what specific topic they discussed (a condition runs on my family that we call CRS, which stands for “can’t remember s***”. I seem to be having a flare-up ;)). @MarieB, do you remember that interview?

I’ll check my rolodex for folks in FDA…

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That was my understanding, too. It’s a single hormone system, rather than the dual hormone system of, say, the bionic pancreas.

+1,000. I felt like Asante was the first pump company that actually considered itself to be beholden to its customers, rather than the other way around. I had fervently hoped their business model would shame other companies into following suit! Now I hope Bigfoot does…

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Great idea @irrational_John. FYI for anyone who didn’t get a chance to listen to the interview: he spoke quite a bit about his own change of perspective on the FDA and how that came about, essentially because Bigfoot took the astonishing step of–gasp!–contacting the agency to explain what they were trying to do and engaging with them collaboratively to make it happen, which the regulators were perfectly willing to do. He also said the reason we see so much of this “Why is this pump available in Europe [or Australia or whoever] but not here!?” phenomenon is a deliberate choice the other big manufacturers make, not something necessitated by FDA intransigence or slowness, and that Bigfoot was committed to releasing their products here first. I thought that whole discussion was really interesting as well.

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you and @askmanny had a little chat about this
https://forum.tudiabetes.org/t/fda-outlines-flexible-approaches-for-artificial-pancreas-system-clinical-trials-product-approvals/10497

there was also someone from the FDA at 2014 MasterLab

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I don’t know how Asante orphans like me (T2D) will fit in, but I’d jump to Bigfoot in a heartbeat given the chance! Like the Snap very much.

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@Thas, I’ll meet you in SF with our pogo sticks and we can jump down to Sunnyvale together :wink:

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