STEM is no longer just a term pertaining to plant life or slang for a long model-esque leg. STEM is an acronym which refers to the fields of study relating to SCIENCE TECHNOLOGY ENGINEERING and MATH. They are isolated by this abbreviation usually to discuss the unique ramifications which are correlated with the pursuit and development of these fields and faced by those who participate, including underrepresentation of women and minorities, lack of funding for research and academic program development, waning interest in STEM related college programs, etc. etc.
However, STEM should be celebrated as a vital aspect of any modern advancing society. Research and innovation, particularly in the STEM fields is something that is so exciting yet so important for cultivation particularly in female students. As a biomedical researcher, I understand what it’s like to perform in a traditionally male-dominated field of study and face the backwards dinosaur attitudes of some who feel we still should have a glass ceiling preventing us from advancing beyond a certain point. As the child, grandchild, sister, cousin and niece of many decorated doctors and engineers, despite being female it seemed as though STEM was in my DNA. The privilege of watching an idea become a hypothesis, which in turn becomes a theory, which becomes an experiment, and to eventually have it evolve into a viable direct solution which changes lives for the better- that is the beauty of STEM research. It is akin to watching the birth of a baby and observing it go through a life cycle and grow into something beyond expectation. It is the closest thing in reality to transcending time and location as at the same time we are learning, advancing the society, helping the world at large on a global scale and changing the course of scientific history through discovery. Science is fluid and therefore ever-changing, thus it is never a dull moment in STEM- although it is a lot of hard work!
I was the recipient of a very special award, which I was given for my contribution to the development of the world’s first wearable artificial pancreas device. Awarded by biotech firm Pancreum’s brilliant founders CEO Jerry Joseph and CTO Guilherme ‘Gil’ de Paula, former engineers at Medtronic MiniMed (Guardian RT CGMS), Insulet (OmniPod Insulin Delivery System) and Bayer (diagnostics medical devices). I was the only recipient of this award and it was a great feeling to know that as a mere student I had an opportunity to support the development of an exciting technology that would improve the quality of life for millions of patients who suffer from pancreatic-related conditions such as diabetes, insulin disorders and others.
The world of biomedical technology and pharmaceuticals has been widely known to be one that is high-speed and cutthroat as to keep up with the constantly evolving and often-times extremely lucrative world of curing disease. The development of the artificial pancreas has been no different, with many firms working in a fervent race to the finish line in terms of patents and clinical trials, with the eventual goal of being introduced to the market as a full product. With Pancreum, it is mostly brains over brawn- a smaller more humble firm as compared to mega-firms like Medtronic, yet the design itself and the team were what set Pancreum apart- both of equal genius. The design aspect which really jumped out at me was the fact that this device has a dual-pronged feedback mechanism which included both an insulin AND a glucagon input as they are both opposing hormones in the human body. Thus, the metabolic body systems and blood sugar levels are constantly monitored and eliminate the danger of hypoglycemia without the need for needles or injection as the sleek pacemaker-sized design is worn against the skin and hormones are absorbed cutaneously. This device not only solved the problem of blood sugar management for those with pancreatic related disorders, but also did it in a way which does not impede the quality of life for the wearer- if one can wear a watch, they can wear this device and be confident in the knowledge that their conditions are being monitored and treated.
Gil and Jerry have the education, the passion, the creativity, the integrity and the talent to surpass any numbers game and their idea was flawless in theory even before it was ever a prototype. It was for these reasons that I chose to collaborate with Pancreum in support of this device as it was developed quietly and steadily with meticulous attention to detail, over the past few years after I won the award in 2013. Since then, it has been one of the most thrilling experiences of my life and an honor to have witnessed this project come to fruition knowing that I helped these brilliant engineers make it happen. Raising funds, presenting at various conferences, winning awards from respected industry entities such as Diabetes Mine and slowly but carefully perfecting what is now known as the “Genesis” artificial pancreas, the world’s first wearable device, today I am proud to say that Pancreum has finally received the design patents for this project from the United States government!
AS A SPECIAL TREAT JUST FOR MY READERS, A TOP SECRET INSIDER’S LOOK- original transcripts from emails that went out from the wonderful Pancreum co-founders Jerry Joseph and Gil De Paula in 2014 before Pancreum presented at the Diabetes Mine Conference in California! Up until recently such communication was strictly classified and I could not share however I would now like to offer my readers an exclusive firsthand look at the development of an artificial organ! Jerry and Gil have always been wonderful and keep me informed on the latest news with Pancreum and our project no matter where I am in the world.
Pancreum recently was the subject of a very informative article penned by Tim Brand of Diabetes Daily, who interviewed Pancreum CEO Jerry Joseph following the patent approval for the “Genesis” device. Below is the full article, as published in July 2016 on www.DiabetesDaily.com entitled “The Artificial Pancreas You’ve Never Heard Of: ‘Genesis’”:
“Breaking news: an artificial pancreas you haven’t read about during the past few years has actually been working on groundbreaking technology for people with diabetes.
The small company, Pancreum, consists of a team of dedicated engineers working to develop a ‘low-cost drug delivery platform that will lead to an artificial pancreas.’
Pancreum was recently granted patents for their ‘innovative modular design and wireless power technology.’
This development will help propel them into being a viable player in the artificial pancreas market. This big step is intriguing news.
In the fragmented landscape of diabetes research, Pancreum made some big waves in the diabetes community a few years ago.
Through deliberate and intelligent use of social media and product videos on YouTube, they broke on the scene and caught everyone’s attention and imagination with their artificial pancreas called the “Genesis.”
Pancreum’s Genesis technology even won an award for design and innovation from DiabetesMine. That was a few years ago.
Today, your attention has been drawn to other closed-loop “artificial pancreas” diabetes management systems like Ed Damiano’s ‘Bionic Pancreas.’ There are many artificial pancreas research teams working on their own designs, all in the race to bring this technology to the general public.
Meanwhile, Pancreum has been working quietly behind the scene, only bringing attention to their work and making news in diabetes publications a few purposeful times. But a plan has always been in place.
I had a chance to interview Jerry Joseph, the new CEO of Pancreum, and Gil DePaula, Founder & CTO.
Q: What is the new development for Pancreum?
A: We have recently strengthened Pancreum’s intellectual property portfolio by receiving patents for our innovative modular design and wireless power technology. We have also added to our research and development team by bringing on Steve DiIanni who was the former Director of Mechanical Engineering at Insulet Corporation. Steve has over 25 years of experience in the medical industry designing insulin pumps and will now be leading our engineers in finalizing a clinical-ready insulin delivery system.
Q: What will this do for your funding? Does this raise the interest in any venture capitalist you have spoken to?
A: This news validates what we’ve been saying for years – that our innovative modular pump is truly unique and offers solutions that aren’t available with what’s on the market today. This positions us well for firms looking to make an investment in a company that not only has a seasoned team with a clear vision on how to improve the diabetes pump landscape but also has protected intellectual property to stand behind. We have already secured a significant, committed, investment contribution of $200,000, during our friends & family round of funding and are now looking to continue our conversations with investors to secure Series A funding by the end of 2016.
Q: With the patent of the Genesis, when do you envision being able to go into human clinical trials?
A: These patents strengthen Pancreum’s position to secure additional funding. Obtaining additional funding will then enable us to plan and execute the additional validation and verification testing needed to move forward in the process of having a market-ready device. To reduce the time to market, we plan to take a phased approach. Initially, we will focus our efforts on developing a semi-disposable insulin delivery system, which uses our reusable CoreMD and a single-use insulin pump module. Then with this system established, we will then take that same CoreMD and develop our customizable Genesis modular drug-delivery pump platform. Using the same CoreMD controller will substantially reduce the research and development time required to launch Genesis.
Q: What do you need to move into clinical trials?
A: First, we will need to secure additional funding to move forward with the next steps of the design validation and verification testing. We also will need the support of the diabetes community to help articulate their need for new and innovative technologies, like ours, to get to the market. This will help investors realize the market potential and demand for next generation diabetes devices. We would love to hear from the community about their specific diabetes management needs – let us know by tweeting us @Pancreum.
Q: Have you added any more engineers to your team?
A: Yes, we have recently added Steve DiIanni, former Director of Mechanical Engineering at Insulet, to head-up our engineering team. Steve was instrumental in the development of Insulet’s Pod insulin pump. We have also been working with iSense Corporation on integrating a continuous glucose sensor, and with Dr. Haidar at the Clinical Research Institute of Montreal (affiliated with McGill University) to provide guidance based on their dual-hormone research. Additionally, we are now working with Wilson Sonsini Goodrich & Rosati (WSGR), the leading provider of legal services to life sciences growth enterprises worldwide, who will be providing Pancreum, Inc. legal guidance and introductions to investment capital.
Q: Jerry Joseph, JD, CEO? What does this mean for Pancreum?
A: This re-organization allows Gil DePaula, Founder & CTO, to concentrate his efforts in the development of the clinical ready pump and system. We have been and will continue to work together with our unified vision in helping those with diabetes and other chronic conditions. Jerry will now focus on further building the team and on making strategic partners, as well as securing additional funding to bring our products to market.
Q: Will the work at UVA and Dr. Edward Damiano help get your product through clinical trials with the FDA quicker?
A: The University of Virginia’s and Dr. Damiano’s work on the artificial (bionic) pancreas help bring awareness to what we have been working on for the last 5 years and what we will be working on in the next several years, to make managing and treating diabetes a little easier. Dr. Damiano and others have shown that a dual-hormone closed-loop system is feasible. Our approach is to meet the diabetes community’s need and offer a low-cost, compact, integrated device that has fewer wearable components.
Q: What is the main advantage to your product, why does it stand out?
A: Pancreum is working on a phased development approach of two delivery systems. Phase 1 will consist of a reusable/rechargeable CoreMD processor with a disposable insulin pump. Phase 2 will consist of modular disposable wedges (sensors and pumps) that are controlled by the reusable CoreMD.
Q: Can you give us more detail about the CoreMD wedge concept?
A: Our system and overall concept has several inherent advantages over current systems on the market. Primarily, our modular design and semi-disposable concept allows users to customize the functionality of our product to their needs while keeping the costs as low as possible. Our design may be easily adapted to incorporate newer technology. That is, currently most insulin pump companies refrain from quickly adapting new technologies because of the tremendous amount of time and cost they would need to spend in order to incorporate new technology. These companies would have to redesign their product from the ground up each time. On the other hand, Pancreum’s modular design allows new technology to be easily integrated to the existing system by redesigning only one of the system’s modules, thereby reducing the time and costs associated with adapting to new and upcoming technologies.
The brains of our system (the CoreMD) is designed to be able to communicate with and control a variety of disposable sensor and drug delivery ‘wedges’ as our single-use modules are called. These disposable wedges attach to the rechargeable CoreMD in various configurations based on each user’s needs.
That is, in a first configuration, the same CoreMD may attach to an insulin delivery wedge to function as an insulin pump system. In a second configuration, the same CoreMD may attach to a glucose sensing wedge to function as a continuous glucose monitoring system (CGM). In a third configuration, the same CoreMD may attach to both an insulin delivery wedge and a glucagon delivery wedge, to function as a dual-hormone therapy device. In a fourth configuration, the same CoreMD may attach to both an insulin delivery wedge and a glucose sensing wedge, to function as a closed-loop single-hormone system. In a fifth configuration, the same CoreMD may attach to an insulin delivery wedge, a glucagon delivery wedge, and a glucose sensing wedge to function as a closed-loop dual-hormone bionic pancreas. The user controls which configuration he or she desires by attaching the appropriate wedges to the same CoreMD.
The main advantage is that since we have a modular design, we are able to keep the costs as low as possible for people while at the same time allowing people to configure their treatment based on their own individual needs. For instance, the reusable core (CoreMD) can communicate and power an insulin drug delivery device, a glucagon delivery device, and a continuous glucose sensing device. One user may choose to use attach all devices and another user may choose to just attach the insulin delivery device. Our vision is to first introduce a disposable insulin pump that uses the re-usable CoreMD. This CoreMD in this system would also be ready to work with the additional wedges as they get approved and become available in the market.
Q: Are the devices waterproof?
A: Yes, since each wedge and CoreMD will be hermetically sealed. This will allow the wedges and CoreMD to be completely waterproof. The exact depth and duration will be determined after the initial design has been finalized and tested. The modularity and low profile design of our system will allow all users including athletes to use our pump in all types of environments. Our mission is to plan for the unexpected, to over design each and every safety feature to reduce any likelihood of failures and be robust and reliable enough to withstand all types of stresses and impacts.
Q: Which will be the first products to hit the market?
A: Our initial product will be a disposable insulin pumping system within a housing that can receive the re-usable CoreMD. The overall function will be comparable to existing disposable products but will be available at a significantly lower price point due to the CoreMD that includes costly electronics and battery being rechargeable and reusable. Once we have received regulatory approval to market this device, we will then focus on our Genesis system, which will offer additional modules, such as glucagon delivery, dual hormone therapy and a CGM.
Q: How is the closed-loop algorithm effort going?
A: We have been working with McGill University in Montreal, Canada to incorporate a dual-hormone algorithm that has been developed and tested for several years. This will allow our system to safely correct for high and low glucose levels. We are in the development phase and therefore cannot reveal much more about how are algorithm works.
With the press release informing the world they have been granted a patent on their Genesis, Pancreum will be poised for more funding, clinical trials and being back in the artificial pancreas spotlight. Only time will tell if they can get their Genesis to clinical trials and then the market. However, it is apparent they took the steps to be a major player in the artificial pancreas race. Competition drives innovation, and this news will only drive the market further.” (Brand, 2016)
I LOOK FORWARD TO KEEPING YOU ALL UPDATED WITH MORE NEW AND EXCITING UPDATES FROM THIS PROJECT SO STAY TUNED! FOR NOW please enjoy these photos including my award and also a photo of the prototype courtesy of Pancreum.com. THANK YOU SO MUCH TO PANCREUM CO-FOUNDERS, CEO JERRY JOSEPH AND CTO GIL DE PAULA FOR THE PRIVILEGE OF BEING AT THE FOREFRONT OF THE DEVELOPMENT OF THIS LIFE-CHANGING TECHNOLOGY & TO TIM BRAND FOR THE VERY INFORMATIVE INTERVIEW WHICH I HAVE REPOSTED IN THE ARTICLE.