|Terry Gregg, DexCom President & CEO|
Q: Share with me a brief history of DexCom and some of the important milestones of the company.
A: Dexcom designs, develops, and commercializes continuous glucose monitoring systems for managing diabetes. The company was really founded in 1999. The premise of that original founding was to develop a fully implanted subcutaneous sensor that would reside in place, in the abdomen, for upwards of a year, maybe 18 months. At the time, reliable, home-based continuous glucose monitors had yet to hit the market.
But by the mid 2000s, it was clear that the opportunity for a home based continuous glucose monitor that provided real-time values to the patient was going to be big.
Around 2003, it became apparent to the company that the amount of resources, capital, etc., in order to commercialize that product, would be more than the company could raise. But they took the lessons learned and the knowledge and then converted the product into an ambulatory one, for use at home.
A three-day sensor was approved by the FDA in March 2006. About a year later, June in 2007, the product was then extended to seven days. That became what we call the Seven System. In March 2009, the next generation, the Seven Plus System was approved by the FDA. That’s a product we have on the market today. The fourth generation sensor is currently pending PMA review by the FDA.
Q: You spent most of your career with Medtronic before retiring. What brought you out of retirement to join DexCom?
I have, personally, been pursuing a hospital glucose sensor since around 1997. One of the reasons I came out of retirement to join DexCom was that I believed that they had a sensor that would be adequate for that intensive care environment. Studies show that when a patient's blood glucose level is high for prolonged periods, recovery from surgery takes longer and the risk of infection increases. Currently, tight glycemic control is achieved by obtaining samples every 30 to 60 minutes, however this testing practice may be too intermittent and cumbersome. So, we developed a blood-dwelling sensor that goes into a peripheral vein for continuous glucose monitoring and we licensed that technology in co-development to Edwards Lifesciences for the ICU. It is pending before the FDA although it has received CE marks in Europe.
Q: What other work has been going on at DexCom?
A: We’ve engaged in two relationships with pump companies, one being J&J Animus (that product will go into the FDA at the end of this year) and the second relationship is with Insulet Corp., which has a disposable insulin infusion system called the Omnipod. That product is actually pending review before the FDA now.
Q: What would you like to call attention to when it comes to diabetes?
A: I think that the most compelling thing that one can do now is to encourage patients to take on their own responsibility for the treatment of their disease. If you look at what the future holds, we’re not going to be able to adequately afford the care that patients will need. Unfortunately, diabetes is growing at a rate that we can’t stop it. We have to educate patients and patients have to be more demanding.
Q: Given what we know and how much work has left to be done, how far are we from an artificial pancreas? One that can monitor blood glucose levels in real-time and respond to them by releasing insulin just as a normal pancreas would?
A: I would say we’re in the five- to 10-year horizon to get to a semi-closed loop system. We’re also unfortunately dealing with a regulatory arena that is more restricted than we’ve seen in a long time. I think two things are going to happen. There will be delays in development in the U.S. And, at the same time, we’re all looking outside the U.S. as fertile ground to move our newer technology. But reimbursement is a concern. It’s an interesting dynamic that we are going to struggle with at least for the next four years, in my opinion.
Q: DexCom recently worked with the FDA on changes sought by the agency in the way DexCom labels certain glucose monitoring devices. Any advice for companies going through similar issues?
A: Read all the guidance documents you can and interpret them in the most conservative way you can. I think the second thing is be very proactive but cooperative with the agency. Working to a joint conclusion that is in the best interest of the patient is really what the FDA wants. I think companies want that as well. Certainly we continue to have what I consider to be a fabulous relationship with the agency. Even in spite of the warning letter, there was no interruption of the review of our files.
Q: What are you doing when you’re not in the office?
A: This isn’t a job; this is a passion. I get to do this. Certainly, I have fun. We have adult children and two grandkids that live in San Diego County. We have a beautiful sailboat that I get down to once in awhile. Certainly, I am blessed in that I have been remunerated more than I ever should be. My wife and I are strong philanthropists. To date, I think we’ve given over $2 million to diabetes research and we will continue to do things of that nature. It’s something we believe very strongly in. When you are blessed like that you should give back.
CHI-Advancing California biomedical research and innovation