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Type 1

Jeffrey Brewer Highlights JDRF’s New Direction, Thoughts on the Cure, and Progress on the Artificial Pancreas Project

by adam brown, joseph shivers, and kelly close

We were honored to sit down recently with Jeffrey Brewer, the new President and CEO of the Juvenile Diabetes Research Foundation (JDRF). Mr. Brewer is the founder of two highly successful online businesses: Overture Services (acquired by Yahoo), where he served as CEO; and CitySearch (now a division of USA Interactive), where he was Chief Technology Officer. From 2003 to 2010, Mr. Brewer served as Executive Chairman of KickStart International, an award-winning non-profit organization helping poverty-stricken populations in East Africa. He became actively involved with JDRF soon after his son, Sean, was diagnosed with type 1 diabetes in 2002.

During our interview, Mr. Brewer discussed how his unique background in both the private and non-profit sectors has prepared him well for his new job. Although he took over for outgoing CEO Alan Lewis only in June, he has wasted no time making big changes at JDRF. He highlighted JDRF’s new direction during our discussion, which includes more focus on the treatment side of diabetes, embracing the adult type 1 population, and going beyond academic research as JDRF’s sole focus. One of Mr. Brewer’s primary motivators is to push for tools that can help make diabetes safer to live with than it is today. He also discussed his pragmatic approach to the cure, his frustration with the FDA, and the current state of the artificial pancreas. As the father of a son with type 1 diabetes, Mr. Brewer has a patient-focused outlook, and we expect big changes and exciting developments from JDRF in the coming years as a result of his taking over the leadership of the organization.

jeffrey brewer's background

Kelly Close: We were really excited when we heard you were being named president of JDRF this past June. I remember very well meeting you in 2002 at the Diabetes Technology Society meeting; your son Sean had just been diagnosed with type 1. How did you find out about that meeting and did you consider that the start of your journey into the field?

Jeffrey Brewer: That was about three weeks after my son’s diagnosis. I remember vividly being in the hospital and the staff showed us the sliding scale for insulin dosing. It seemed pretty crude to me at the time. I asked about technologies for diabetes and they said, “There are devices called insulin pumps, but you’re not ready for that. You need to stay with injections.” Of course, this was back in 2002; they didn’t think about putting a newly diagnosed child on a pump. Now, we know that that’s probably the best thing to do in terms of preserving beta cell function and extending the honeymoon period.

I got online and soon learned about insulin pumps and the early-stage research on continuous glucose monitors. I said to myself, “Why can’t we have a computer program that will basically take what comes out of one and then drive the other and automate this crude and simplistic procedure that I have for administering insulin to my son?” In doing research online, I found the Diabetes Technology Society meeting and then saw that there were going to be some presentations on the topic of what was being called an artificial pancreas.

To top things off, I had just moved to New York City with the idea of starting a career in philanthropy. I started a couple of companies that worked out pretty well and provided me with a foundation to focus on philanthropy and on some causes that were interesting to me. And at the very moment that I was launching that phase in my life, this cause picked me rather than me picking it.

a period of transition at jdrf

Adam Brown: As head of the organization, how will you leverage the JDRF’s strengths and address weaknesses?

Jeffrey: I think about where our biggest opportunities are during a very transitional period in our history. There are three aspects of the transition that you could view as relative weaknesses of our previous strategy. However, as we move forward and execute, I think these will turn out to be very powerful strengths.

The first very big transition is we’re moving away from the over reliance on the cure as the central part of our message and funding. This does not mean JDRF is any less committed in its focus to find a cure, but we have some work to do in order to get there. And in the meantime, there are many people who will live with diabetes for a relatively long period of time. We have a responsibility and an opportunity to help them live better, healthier, longer, and less stressful lives. And so one of the big changes that we’re undergoing is focusing on improving the lives of people living with diabetes on a day-to-day basis.

This expanded mission will also develop into an emphasis on prevention.

There are certainly some exciting opportunities to slow down or completely prevent the progression of diabetes. In slowing down its progression, we can improve people’s ability to live with diabetes and reduce the probability of getting complications over time.

Kelly: When you say prevention, do you mean prevention of type 1 diabetes, prevention of diabetes complications, or both?

Jeffrey: Both. Prevention means two things for JDRF. It means slowing the progress of or preventing the disease entirely, and that’s what I was talking about earlier. But, as you mention, prevention also means prevention of complications, which would include developing better treatments to eliminate or lessen the burden of the devastating complications that all too often result from living with type 1 diabetes. And JDRF is focused on this as well.

Earlier I was referring to prevention in the first sense: identifying people who are at risk for type 1 diabetes and devising ways to delay the onset of the disease or preventing it from developing entirely. These people might have developed multiple antibodies already, may have glucose intolerance, or might be pre-symptomatic, but are well on the way to developing type 1 diabetes.

Given what we understand about type 1 diabetes, we know it develops over a very long period of time in many cases. There are markers for the development of the disease that we need to start testing for. For instance, there might be an opportunity to use GLP-1 (e.g., Byetta or Victoza) on people when they have a few antibodies and some hints of glucose intolerance. These treatments might be protectors of beta cell mass in a way that would be very impactful powerful in slowing the progression of diabetes and complications over time.

In addition, it’s not just about moving the curve, but changing the slope of the curve. We hope to get to a point where diabetes takes longer to develop and develops at a much slower rate. We now know that if you could get people through adolescence, a challenging time for those living with type 1 diabetes, you would likely protect them from the damage that teens unknowingly do to their bodies during these years.

Kelly: Is the JDRF contemplating any other changes?

Jeffrey: The second big change at JDRF is moving away from an exclusive focus on children and also embracing the adult type 1 diabetes audience. At the end of the day, at least 85% of the people living with diabetes are adults, not children. We’re no less committed to improving the lives of children, but there are a lot of people out there who have lived with this disease for a very long time. And what’s really important to them is an improvement in their life today, whether that’s managing blood sugar better on a daily basis, preventing complications, or screening their kids for diabetes.

These first two big changes are mutually reinforcing. Embracing treatment and prevention is going to help us be more relevant to the type 1 diabetes adult crowd. If the cure is five years away, then by all means let’s double down, let’s go for the cure, and treatment is not important. But if the cure is farther out than that, then we’ve got to really focus on helping people live with diabetes. And that’s where JDRF is going.

Kelly: That sounds like a very realistic approach, and from a patient perspective, really exciting. Can you tell us about the third major change at JDRF?

Jeffrey: The third big change at JDRF is a commitment to going beyond academic research as our sole focus. We’re still funding academics primarily today, but with much more focus on translational research and on efforts to move developments from the laboratory into companies. At the end of the day, companies will deliver the therapeutics for our loved ones, whether they develop devices or drugs. JDRF is an enabler in this process. We’re the only organization, the only entity in the whole equation that is exclusively focused on benefiting the lives of people with type 1 diabetes. JDRF is not going to develop intellectual property. We’re not going to do laboratory work. We’re not going to do clinical trials. We’re not going to sell drugs or devices. We’re not going to prescribe drugs or devices. We just want to help all those things happen more effectively and more efficiently than otherwise would, and to have this sooner than we otherwise would.

When we look at how and what has to happen, JDRF will be intervening across the entire pipeline. This will occur at the laboratory level with the academic researchers; at the company level where development and clinical trials occur; at the FDA level where regulation and approval take place; at the reimbursement level to make sure that treatments are covered by insurance companies; and at the level of the clinician in helping make sure that they’re paid for the time that they spend with patients and that they’re educated about treatment options.

Treatments that address the underlying disease, immune therapies and cell therapies like encapsulated beta cells are going to have huge regulatory challenges. They’re going to have big reimbursement challenges. And they’re going to have huge clinical delivery challenges. JDRF needs to be helping across that entire pipeline.

Kelly: The new project surrounding diabetic retinopathy sounds exciting. Can you tell us a little bit about it?

Jeffrey: Yes, it is very exciting. We foresee that there’s an opportunity to have a cross-functional project around retinopathy similar to the Artificial Pancreas Project. As you know, the Artificial Pancreas Project has really covered a large gamut of activities in the organization. That is to say, it’s funding research, but equally as important, it’s also supporting the efforts of companies, working with the regulatory agencies, working with insurance companies, and working with clinicians to encourage adoption of CGM. It’s been a hugely cross-functional effort and points to the future of how JDRF is going to work. I think that the retinopathy opportunity will also allow us to leverage resources across the organization. We now have a revolutionary treatment proved to not only stop the progression of retinopathy, but to actually reverse it and improve vision from where a person began treatment.

It’s really an exciting opportunity, but we’re not satisfied until patients have access to it and are able to utilize it. And a lot needs to happen in order to make that the case. We need to make sure that the insurance companies are going to cover it and that there’s a business model that incentivizes the company to promote this drug and make it widely available. We also need to work with clinicians to enhance their ability to deliver this therapy and encourage early detection so that we can treat patients as soon as possible.

This might also lead us to working with diagnostic and device companies to provide clinicians with the tools needed to diagnose retinopathy in its early stages. The concept of remote diagnosis of retinopathy is also emerging. A device takes a picture of the retina and the result is downloaded to some central location where the analysis is performed.

Kelly: Can you tell us how JDRF is engaging with the type 2 diabetes audience?

Jeffrey: Actually, much of what we do in terms of research and funding is applicable to people with type 2 diabetes. We look at science and fund beta cell replacement and regeneration. Our efforts are also very applicable in terms of glucose control and the artificial pancreas. Additionally, the same complications apply to patients with either type 1 or type 2 diabetes. It’s in our DNA that we are a type 1- focused organization; our mission is to improve the lives of people with type 1 diabetes. However, we certainly want to leverage the opportunity to appeal to the broader type 2 diabetes field.

We hope to encourage more competition and more innovation in the field, which will ultimately benefit all people with diabetes.

Adam: What, in your opinion, is the biggest struggle patients with diabetes face? How is JDRF addressing this?

Jeffrey: The biggest struggle is that diabetes is 24-7. There is no rest from the disease. People with type 1 diabetes have to think about the disease when they get up in the morning, when they go to sleep at night, when they eat a meal or a snack, when they skip a meal or a snack, when they exercise, when they are sick, when they are stressed … pretty much all the time. This is why I’m really excited about the artificial pancreas. Automated insulin delivery will enable those living with the disease to think less about it.

Adam: Every patient has good and bad days with glucose control. What would you say to patients on those bad days?

Jeffrey: Diabetes is a hard disease to live with. The cognitive burden of living with the disease – the fact that you have to think pretty much all the time about it – is completely underappreciated. I have a teenage son who doesn’t want to have diabetes, and sometimes acts as if he doesn’t, which as you can imagine doesn’t work very well for him or for the family. Teenagers aren’t the best at embracing such a huge responsibility and thinking about long-term consequences of not managing type 1 diabetes well. I’m sure I don’t tell my son enough, but I think people with type 1 diabetes should generally give themselves a great deal of credit for having to accept more responsibility for maintaining their own health than everyone else.

thoughts on the cure

Adam: As we have many patients in our readership, and as Kelly and I both have type 1 diabetes ourselves, we have to ask for your thoughts in this realm - what in your opinion constitutes a cure and how has that evolved?

Jeffrey: That’s a hard discussion. I think the cure is different things to different people at different stages of diabetes. I think the only complete cure at the end of the day is you never get diabetes to begin with – it’s probably prevention. Polio is a good analogy. There’s no cure for polio, but people never get it anymore in the developed world. If you actually get polio, then there’s a treatment for it. But the cure for it is the vaccine that prevents it. When I think of the concept of the cure for people already diagnosed with type 1, it should mean insulin independence, freedom from complications and not having to think much, if at all, about their condition. Maybe a cure is taking two pills a day: one pill stems the autoimmune attack and the other pill regenerates beta cells. If that meant insulin independence and freedom from complications, that’d be pretty good, right?

Whether that’s enough to say we’ve reached a cure is entirely debatable , but some might argue it’s pretty close. That would be one vision for what a cure is. Short of that might be encapsulated pig islets that would need to be implanted in the subcutaneous tissues in your forearm and replaced every two years. That sounds a little less like a cure, but if you’re completely insulin independent, that’s pretty great too, right? It certainly doesn’t feel as final or as complete as we might imagine a cure, but it’s still pretty good.

The cure I think is a very inspirational concept because it represents finality. It represents a hope that everybody can say, “Let’s do that. Let it be done. When can we get there?” It’s very motivational and it is what we are all committed to, but at the end of the day, we’re just going to make progress towards improving people’s lives through better treatments that will one day begin to look more like cures. And then, at some point, we’re going to have a new problem of people arguing whether or not we have reached the cure. I look forward to the day when we are arguing about whether we’ve reached the cure.  Being in a place to have that argument will represent enormous progress against JDRF’s mission.

Kelly: How is JDRF prioritizing the cure going forward?

Jeffrey: As I said, we’re moving towards a 50-50 split of activities and funding between cure and glucose control/complications. I think that there are good opportunities in both areas and we will continue to push forward on both fronts. I believe both are wanted and needed and demanded by the constituency that we serve and by the way, are naturally reinforcing. One of the things that Bruce Buckingham did was put recently diagnosed patients on closed-loop therapy. Who knows? We might get as much benefit in terms of preserving beta cell mass and function as we get on some immune therapy treatments. These different areas at some point are very much overlapping, and that’s really exciting.

the artificial pancreas (closed-loop)

Kelly: You were involved with JDRF’s Artificial Pancreas Project from the beginning. Can you give us your latest thinking on it?

Jeffrey: Back in 2002, I had a pretty simplistic view on the artificial pancreas – it’s a lot more complicated than I had originally thought! But still, my basic hunch was right, which is that this could and should exist. And furthermore, it only doesn’t exist because of a lack of resources to make it happen. Now we have resources. Of course, there are still some challenges to solve and it’s going to be a stepwise approach to automating insulin delivery. But we’re very excited about our partnership with Animas, which we believe will be a big step in terms of improving people’s ability to manage diabetes. I believe that the current generations of technology in insulin pumps and in CGM will support some automation of insulin delivery that will be hugely beneficial in terms of changing the way people live with diabetes, especially kids.

The scenario where my son forgets to bolus for lunch and he has a blood sugar of 500 mg/dl when he comes home from school just shouldn’t happen. If he’s wearing a CGM, the system can give him a little extra insulin once he has reached 250 mg/dl or 300 mg/dl. This never has to happen, and my son also shouldn’t go into a seizure because his insulin pump keeps pumping insulin even though he’s hypoglycemic. We had a scary episode this year where my son did a sloppy bolus late at night and then went to sleep. As teenagers do, they’ll sleep late in the mornings sometimes. For some reason, my wife knew that something wasn’t right. She tried to check on him, but his door was locked. She couldn’t get him to wake up. So she called the New York City Fire Department and they came with the axe and broke down the door. He was in his room unconscious. He was taken to the intensive care unit at the hospital for a day and a half. When he woke up, he couldn’t even remember his name. In the end, fortunately, everything was all right - the neurologist tested him and everything came back, but it was pretty scary, and that doesn’t need to happen.

Kelly: It’s especially frustrating when this technology is currently available but isn’t FDA-approved. That’s the irony.

Jeffrey: Well this is the problem. The FDA has a very limited and narrow view concerning safety. In other words, they’re looking at a very small slice of the safety picture. We need to remember that diabetes is still a very unsafe condition to live with today. What we need to do is look at ways to make it safer to live with. The benefit that you would get from saving people from hypoglycemia and seizures in the middle of the night with low-glucose suspend systems that shut off when blood sugar readings go below a certain level, for example, could be life saving in some cases. And the only consequence is that occasionally you may be a little high in the morning because your insulin pump shut off when your CGM indicated you were in danger of becoming hypoglycemic. But that’s a really good tradeoff.

So the FDA has the wrong picture. They have a narrow picture of safety, and JDRF is trying to help the FDA understand how to make diabetes safer to live with than it is today. This example of automatic shutoff during hypoglycemia is just a no-brainer. It’s an absolute no-brainer. The fact that we have to go through tens of millions of dollars of clinical trials in order to prove to the FDA that that’s a good thing is really a shame.

When I refer to the closed loop or artificial pancreas, I want to be very clear that I mean the progression of products. The first evolution will be an automatic shutoff of insulin when the patient does not respond to a hypoglycemia alarm from their CGM. Pretty simple. This technology exists and should already be approved. The next step is to turn off insulin based on a predicted low glucose. Along the same lines, the system should infuse slightly more insulin if the blood sugar is trending too high. In this hybrid system, you would still be doing meal-time boluses and setting basal rates, but it would be better than what we have now. And then at some point, we’ll be able to narrow the system’s target range to say, 80-120 mg/dl. Finally, maybe we’ll add another hormone like glucagon, Symlin (pramlintide), or leptin to the system. The goal is to have a device that can basically mimic the control of the pancreas.

Kelly: Can you tell us about the control-to-range trial? How is the research progressing?

Jeffrey: We’ve tested a number of algorithmic approaches but are just beginning the control-to-range studies. Inpatient control-to range-studies have begun in Europe, and will begin soon in the U.S.  It takes longer to get approval in the United States for these inpatient studies, where the patient is in a hospital bed and the nurse is testing the blood sugar every 15 minutes. It’s totally inconceivable that a person could be exposed to ANY danger under these conditions. But approval from the FDA to proceed with those inpatient studies can take months.  As a result, I’m worried about the progress we’re going to be able to make in the outpatient setting.

Kelly: How has JDRF approached the FDA?

Jeffrey: We meet with the FDA every three months. I was down there with the team recently. We have active discussions with them and it’s still hard, but we’ve only just begun. We’re working with a broad community of researchers, clinicians, and people affected by type 1 to bring the best scientific data and information about the needs of patients to the FDA. Frustration in the community is growing, and we and others will step up our advocacy for clear and reasonable FDA guidelines.

Kelly: It seems like JDRF has placed more focus on faster insulin recently. Can you tell us how this developed?

We’re going to have smaller, more accurate, better pumps. We’re going to have subsequent generations of CGM that should be more accurate, perhaps through a combination of sensors, redundant sensors, and/or different types of sensors. The one thing needed for the artificial pancreas that is not on anybody’s radar today is fast-acting insulin.

Jeffrey: We looked at what’s needed to get to a fully automated artificial pancreas and what components are in place today or will be in place in the coming years. We’re going to have smaller, more accurate, better pumps. We’re going to have subsequent generations of CGM that should be more accurate, perhaps through a combination of sensors, redundant sensors, and/or different types of sensors. The one thing needed for the artificial pancreas that is not on anybody’s radar today is fast-acting insulin. Even the fastest insulin still takes 20 minutes to start working and 90 minutes to peak. That’s not how the pancreas works – the pancreas secretes insulin with instantaneous action.

We need to get closer to that instantaneous effect. There are a couple of different ways you can do that. You can have a different chemical compound that gets into the bloodstream faster and becomes active faster. You can have a device that delivers the insulin to the different parts of the body or facilitates the uptake of the insulin. We realized that this was a serious gap that needed to be filled. We went to a bunch of the insulin and device companies and said, “What can we do to help spur development of faster-acting insulin?” Hence, we have this partnership with BD around the microneedle. This is really interesting technology that delivers insulin intradermally, which has much faster uptake.

final thoughts

Adam: What advice would you give to parents who have children with diabetes? 

Jeffrey: Make sure you get to know and interact with other parents of kids with type 1. It seems so hard and overwhelming, especially at the time of diagnosis, but also when kids hit adolescence and become more independent. However hard it seems in your family, you are definitely not alone. The story has played out millions of times in millions of families. But it gets easier. The kids grow up and find their way. The prospects for living a healthy life with this disease are very good now, and only getting better. And the tools will be making it much easier to live with over time. There is much exciting progress on the horizon.

Kelly: Any final thoughts for our readers?

Jeffrey: I would like to emphasize the important changes happening at JDRF. There’s an evolution happening and it’s happening pretty fast. We’re trying to make sure that our public identity catches up with what we’re doing. It’s certainly a big challenge, but it’s the right way to do things. A lot of organizations try to change their marketing messages and then hastily change what they do in order to accord with those messages. We’re doing something new and exciting now and our challenge is just to communicate that to the public.

Kelly: Jeffrey, we so appreciate you taking the time to speak with us. Thank you so much for your leadership in diabetes and for pushing us all to do as well as we can.

Jeffrey: I enjoyed it. Thank you very much as well and for working so hard on diaTribe. It’s been great to watch diaTribe grow – thank you so much for all the wonderful education for people with diabetes.