Charles a.k.a. "Chip" Zimliki is a biologist who works at FDA. He's an important person for all PWDs to know about in that he has a key role in developing the technology that will one day become a functioning Artificial Pancreas. Chip came to FDA as a grad student on fellowship doing pancreatic beta cell research for diabetes, which was always "near and dear to my heart," he says, as a long-time type 1 diabetic himself, diagnosed as a teenager. We're honored to have Chip join us today to talk about his work and what life looks like from the inside of FDA, pushing for improved diabetes solutions.
"Do people think there's something glaringly wrong? Let us know. You might have insights we weren't familiar with. Every comment is taken as seriously as the others.'"
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— Chip Zimliki, on the call for public comments on Artificial Pancreas guidance (click here to participate)
DM) Chip, you are the team leader of diabetes affairs at FDA, and also director of the FDA's "critical pathway initiative for the artificial pancreas." What does your job entail?
CZ) My day-to-day job is to work with a group of experts at the various FDA Centers -- the Center for Drug Evaluation and Research Organization, the Center for Biologics Evaluation and Research, the Office of Device Evaluation and the Office of In Vitro Diagnostics, which deals with continuous glucose monitors, for example. They all have diabetes experts within them.
The issue is trying to find ways to expedite the process of bringing concepts from the translational research stage to an approved product.
How exactly does that work? And what successes have you had?
It is a complicated process, with so many entities involved. But the FDA Center of Management says it wants to be as transparent as possible about how it's working ensure patient safety and allow these devices to go to market.
Our accomplishments so far include exploring computational modeling in research, which can be used in place of animal models in some cases, and also implementing a new interactive review process in which we get the developers in for a meeting or on the phone, and actually walk them through what is need to obtain the necessary IDE (Investigational Device Exemption) to complete their research.
Any group — academia, industry, or small business — needs an IDE for their proposal to be evaluated by FDA.
At the end of each guidance document we publish, the critical elements for IDE submission are laid out. But groups still struggled with this in the past. Now with our new interactive review process, we have a 'review clock' of just 30 days, which is the fastest in FDA history.
For example, we now have over 20 ongoing investigations for Artificial Pancreas technology. Over half of the IDE applications were approved in the first round.
How many other people at FDA are focused specifically on diabetes, and what are their roles?
It's a huge group. We're talking at least 20 people, probably more because they're spread across the different centers mentioned — the Center for Biologics and Drugs, in stem cell therapy, in vitro technology, and device evaluation, which is responsible for all manner of infusion therapy.
How is patient representation handled exactly?
That's handled by the Office of Special Health Issues (OHSI), within the office of the commissioner.
We do have some patient representatives who sit on panels. We also seek out and welcome interaction at professional society meetings, like the ADA Conference, DTS (Diabetes Technology Society), and CWD (Children with Diabetes events). We do public outreach through these presentations, resulting in bunch of personal communications.
That sounds a little haphazard. What about patients who can't attend those society events?
We're not trying to exclude anyone. We publish guidance documents and there are official mechanisms to submit comments, plus we also encourage direct feedback. Anyone at FDA is ready to go the extra mile to interact with patients who have relevant information for us. Our individual contact information is listed on guidance documents, and we encourage anyone who has comments to reach out to us.
FDA has now issued its guidance on both the low-glucose suspend (LGS) and the larger development of an Artificial Pancreas system. What happens next?
This is currently in draft form, and NOW is the time for comments — the public comment period ends in the beginning of March. We encourage everyone to submit their feedback (click here).
What kind of feedback exactly?
All feedback is welcome — are there known problems with pumps or sensor performance? Problems with the way the guidance is written? Do people think there's something glaringly wrong? Let us know. You might have insights we weren't familiar with. Every comment is taken as seriously as the others.
Once we have this feedback and integrate it, we will create the final, formal guidance document. This will give the industry a clear path forward for device approvals.
What's the timeframe for finalizing Artificial Pancreas guidance?
We want to get this document finalized by the end of 2012. That's a pretty big deal, especially if comments explode the day before the deadline the way they usually do. Then we have to go through them methodologically and make appropriate responses to every question.
FDA certainly appeared to be overly cautious in 2011, but then very recently approved a whole host of new diabetes devices: the iBGStar meter, Tandem's t:slim pump, the iGlucose BG meter reader, and Medtronic's iPro CGM and mySentry remote. Does this flurry of activity indicate a new direction or philosophy at FDA?
I don't think it represents any new philosophy. We're talking about a couple of different offices here. These approvals were the result of a lot of hard work. It was just like the perfect storm of device approvals for diabetes devices recently.
What other major milestones in diabetes technology, if any, do you expect to see met in 2012?
I'd like to move these guidance documents beyond draft form, and highlight areas where academia and industry can mitigate risks. It's my hope that we can get to the stage of outpatient studies (transitional studies) within this calendar year. It's my hope that we can even get a system supporting LGS (low glucose suspend) approved for market this year.
Finally, we have to ask: How does being a long-time type 1 diabetic yourself affect your work? Was there ever any concern that you are "too close personally" to the topic?
Funny, but no one's ever asked me that before! I've had diabetes for 27 years, and what I believe is that every person around it is affected too. Diabetes doesn't just affect the patient, but the entire family.
People affected want to do everything in their power to help the person who has diabetes. Look at Jeffrey Brewer, CEO of JDRF, who has a child with type 1; or Jeff Hitchcock of Children with Diabetes; or David Panzirer of the Helmsley Trust, who also has a child with type 1. Are they 'too close' to the topic? I don't think so. They're passionate about it.
Here at FDA, I'm an engineer first, evaluating the safety and effectiveness of these sytems. But as person with diabetes, I also understand the urgency to get this stuff out as soon as humanly possible.
Thank you, Chip. We're glad to have you on our side!