Accelerating All Aspects of Drug and Device Development for those Living with Type 1 Diabetes [Interview][Transcript]

Dr_Henry_Anhalt_T1D_ExchangeGuest: Dr. Henry Anhalt
Presenter: Neal Howard
Guest Bio: Henry Anhalt, DO, is a renowned pediatric endocrinologist with deep clinical and industry experience related to type 1 diabetes. As Chief Medical Officer for T1D Exchange, a nonprofit organization that has created a new paradigm fostering collaboration among patients, physicians, researchers and industry to speed discovery of better therapies for type 1 diabetes.

Segment overview: Type 1 Diabetes (T1D) Exchange is a unique ecosystem of Type 1 diabetes clinicians, researchers, patients and families united in the belief that improving outcomes in type 1 diabetes (T1D) requires a new approach—one that helps researchers conduct better research faster.one that helps researchers conduct better research faster.

Transcription
Health Professional Radio – Living with Type 1 Diabetes

Neal Howard: Hello and welcome to Health Professional Radio, I’m your host Neal Howard for this health supplier segment. Our guest in studio Dr. Henry Anhalt, Chief Medical officer with T1D Exchange the type 1 Diabetes Exchange, a non-profit organization that’s fostering collaboration among patients, patients, physicians, researchers and industry in order to speed discovery of better therapies for type 1 Diabetes. Hello and welcome Dr. Anhalt.

Dr. Henry Anhalt: Thanks so much for having me on the show Neal.

N: The T1D Exchange, you are the Chief Medical Officer. How long has the Type 1 Diabetes Exchange been in existence?

A: The T1D Exchange Neal has been in existence for approximately 6 years and I’ve had the pleasure of serving as their Chief Medical Officer for just about a year now.

N: Okay. In reading some of your information, the Exchange is sort of a very unique ecosystem. Explain how an ecosystem of T1D diabetes clinicians, researchers, patients and families all coexist, how does that happen?

A: Neal, since 1921 when insulin was discovered, unfortunately we’ve made some pretty great advances and developed into technology and drugs. However, insulin remains the main stay of therapy. And so we’ve been unable to cure this disease and with that recognition it was important to understand the gaps that exist around research and advancing therapies that could inch us a bit closer to a cure and while that’s going on understand the unmet needs that patients have by not only doing clinical research but by listening to the voices of patients which drives everything that we do at T1D Exchange. So if you would indulge me I’ll speak to you a couple of programs that we have at the T1D Exchange.

N: Absolutely.

A: And through those examples perhaps highlight how it is that we are filling that gap.

N: Excellent.

A: Okay, so let’s take a look first at our clinical trial network. Our clinical trial network exists of approximately 75 sites that have expertise and care for individuals with type 1 diabetes both adult and pediatric and are in a variety of different environments including private practice and institutions. These sites serve under a master service agreement to efficiently recruit and execute on clinical trials. One of the biggest obstacles in engaging at clinical research is site identification and there are companies or clinical research organizations that do that, however having a master service agreement with 75 qualified sites would engage in clinical research that we can tap into allows us to efficiently identify those sites. But furthermore recruitment of patients remains an obstacle, so if I’ve got a great idea and I’d like to study patients but I only have 10 or 15 patients with the kind of problem that I’m trying to address, I’m stuck at being able to complete that kind of research. So we have a patient registry with over twenty-seven thousand well-characterized individuals with type 1 diabetes that have allowed us to have access to their contact information. So we know lots of information about these folks, we have a way of contacting them and we become trusted custodians of their contact information. So if we go back to the situation of the physician who has an idea but can’t efficiently execute because he doesn’t have enough patients or doesn’t have enough support of additional sites, here we have the ability thru our T1D Exchange to provide identified sites that are qualified and quickly recruit because we have the contact information at our trusted custodians of that information with patients willing to participate in research and allowing us to reach out to them.

N: But how do researchers get involved? What’s the criteria for being able to take advantage of the Exchange?

A: So there are two ways to site I think that are report to highlight Neal. The first is how does this site become a T1D Exchange clinical trial site and we have as I mentioned 75 sites that are carefully vetted by their previous history, the engaging in clinical research, their competencies around having the facilities to engage in clinical research and having the patient population that will allow them to execute on those clinical trials. So becoming a clinical trial site there is a process of vetting and ensuring that they are high quality sites capable of in fact engaging. But I think in addition we work with scientists, clinicians, industry and other stakeholders who are interested in engaging with us to do clinical research and for those we carefully vet each and every study to ensure that’s in line with our vision and strategy of creating a life that’s better for people with type 1 diabetes and to ensure that the kinds of studies that we do will ultimately, hopefully lead to transformative interventions and improvement to the lives for those.

N: Does the efficiency of your model include a cost effective aspect, are we talking better affordability as well as speedy research?

A: Well when it comes to cost effectiveness most certainly working with the T1D Exchange executed on clinical trials is a cost effective way to do studies. In fact a good use case at this is a company called Bosinia, it is a Canadian company that had a novel and transformative treatment that is called rescue glucagon and for people with type 1 diabetes they are at risk 24/7 of experiencing a life threatening low blood sugar reaction that can result in serious complications up to and including death. They have this compound but they didn’t have the resources to be able to do the clinical trials to identify the sites, recruit the patients to do it at relatively low cost and to bring that product to a stage of development that would make it appropriate for the FDA and other regulators to approve the product for use. And in record breaking speed, we were able to work with that team recognizing the transformative nature of this intervention, work with that team for protocol development until ultimately acquisition by…to further develop that hopefully commercialize this product within 18 months, unheard of (crosstalk) in today’s drug development environment. So from that standpoint, efficiency and cost effectiveness for Bosinia was clear and the benefits of the patients for this transformative therapy were also quite clear. Now, the data that we generate, we hope also provides fuel or if you will evidence that the kinds of therapies that we study will have ultimately a reduction in complications that require hospitalizations that increase the cost of health care…So we look at health resource utilization and health economics when it’s appropriate in certain studies.

N: What percentage would you say of your patient data base consists of pediatric patients?

A: So we have 2 data bases Neal but I think…important to highlight. One is the clinical trial registry that I’ve spent some time discussing with you until this…and the age spans from a year of age to over 80 years with the duration of diabetes anywhere from a year to greater than 40 years, it’s a very rich population of individuals and we…individuals with type 1, with in the pediatric age group, excuse me, than…old age. But we also have a separate cohort and data base called Glu and this community is a community that we recruit by word of mouth directly and through social media that there is no limit registry per se but these are individuals who come to us again as trusted custodians of their information that we study, we generate theories and hypothesis that we test by deploying questions of the day that lead us to understanding unmet needs, help drive research and create market for smaller companies to seek solutions that these patients raised. And that patient population, the demographics are a bit different with an average age being older and closer to the third to fourth or fourth to fifth decade.

N: Now where can our listeners go online and get more information about the T1D Exchange?

A: Well www.t1dexchange.org or I can direct people for information on Glu, our patients’ support community and engagement platform and clinical research tool at www.myglu.org.

N: Thank you so much. You’ve been listening to Health Professional Radio, I’m your host Neal Howard. And we’ve been in studio today talking with Dr. Henry Anhalt, Pediatric Endocrinologist and Chief Medical Officer of the T1D Exchange, a non-profit that fosters a model of collaboration between researchers, physicians, patients and industries as well in the fight against T1D. It’s been great having you here with us today Doctor.

A: Thank so much for the opportunity Neal.

N: Thank you. Transcripts and audio of this program are available at healthprofessionalradio.com.au and also at hpr.fm and you can subscribe to this podcast on iTunes.

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