Pratik Patel, Michael Parlato, and Kevin Colbert are the co-founders of Glyscend.
Interview by Lawrence Jones
Which division of the University did you all graduate from?
Whiting School of Engineering, Department of Biomedical Engineering, Center for Bioengineering Innovation & Design
Please describe your current position(s) and your roles in Glyscend.
Michael Parlato is Chief Executive Officer and responsible for developing overall strategy and attracting private funding. Pratik Patel is Chief Technology Officer and is responsible for research and development of the core technology through benchtop and animal experimentation. Kevin Colbert is Chief Operating Officer and is responsible for logistical execution of contracts and partnerships with outside collaborators.
How has your JHU training prepared you for the path you have chosen?
Our training at the Center for Bioengineering Innovation & Design (CBID) prepared us specifically for the work we are carrying out at Glyscend. As engineering students, CBID placed us in operating rooms and clinics with physicians and patients. From this unique perspective, we were able to develop a nuanced understanding of the problems facing patients with type 2 diabetes. In addition, we had incredible opportunities to practice lean development within CBID, identifying and testing key risks with our technology from the outset. There were also very practical experiences at JHU that in retrospect could not have been more on point. For instance, even as students, we found ourselves in Silver Spring at FDA headquarters, pitching our technology and preclinical testing strategy to the Center for Devices and Radiological Health in a mock pre-submission meeting, just as a medtech company would do. Two years later, we find ourselves planning similar meetings with the FDA as a startup. In retrospect, the value of those experiences cannot be overstated.
Why did diabetes research top your list for creating Glyscend?
When we came to Johns Hopkins, the three of us had similar mindsets: we want to leave this program with a startup that can maximally impact patient health. In addition, we recognized that, while cost effective as a treatment for type 2 diabetes, Roux-en-y gastric bypass is widely unavailable to many patients. While there are fewer than 50,000 surgeries annually for type 2 diabetes, more than 25 million Americans now suffer from the disease. We decided that, if we could mimic some aspect of the surgery noninvasively (duodenal nutrient exclusion, in our case), we could extend the therapeutic benefits to a much wider patient population. Thus, our observations of bariatric surgeries and interactions with patients, surgeons, and endocrinologists at Hopkins hospitals were key to the conception of Glyscend.
How important has mentorship been for you team in the beginning, now, and the
We have been fortunate to have a diverse group of mentors with expertise in clinical practice, business development, regulatory affairs, and product development. In addition to the three of us, Glyscend’s cofounders include Dr. Pankaj (Jay) Pasricha and Dr. Ashish Nimgaonkar. Despite their full time commitments as Clinicians and Professors at Johns Hopkins (Jay – Vice Chair of Innovation at School of Medicine & Professor of Neurosciences & Gastroenterology, Ashish – Assistant Professor of Medicine and Medical Director at the CBID program), Jay & Ashish continue to advise the three of us on a regular basis. In fact, the genesis of the project stems from Jay and Ashish teaming up with as when we were students and allowing us to use many of their resources (with Jay granting access to his lab resources and Ashish offering us mentorship along the Biodesign process). In addition, our graduate advisory committee consisted of professors from the School of Medicine & the Whiting School of Engineering, industrial experts from companies such as Johnson & Johnson and Medtronic, as well as regulatory experts from FDA. Upon forming Glyscend, Inc. four months after graduation, the team recruited advisors from around the country with expertise in the diabetes market, drug delivery, and startup formation, to name a few. Mentorship continues to be an important factor in our success: one of our priorities now is expanding that advisory board. When evaluating an advisor, we look not only at the network and reputation that person brings to the table, but more importantly what hands on mentorship they bring.
What was a key and pivotal step in getting Glyscend to this stage (scientifically and financially) where you are?
Financially, the most significant step Glyscend has taken to date is the National Science Foundation Small Business Technology Transfer (STTR) grant. The STTR is a partnership with Hopkins, so we have the school’s name to thank in part for that funding. It was that grant, coupled with the Maryland Innovation Initiative Phase 1 grant from the state of Maryland that really enable us to pursue Glyscend full time after graduating. Scientifically, the early data we were able to gather at Hopkins was pivotal in convincing granting agencies early on that we had something exciting. So again, the access provided through CBID, which sits in between the schools of engineering and medicine, was crucial. Without that connection to mentors and PIs within SOM, we wouldn’t have been able to collect that early animal data. Glyscend is currently engaged in raising its first round of private financing. This will enable the team to complete key experiments and get closer to an FDA IDE submission and start clinical trials in late 2017.
If any of our readers reading are interested in creating a biotech company do you have any preliminary suggestion?
If someone has an interest in creating a company, and they know what product or service they want to provide, the best advice we can give is to validate the market need for that product or service as early and cheaply as possible. Prove that someone is willing to part with their money in exchange for what you offer. It could be through interviews, surveys, or actual advertisements – but find some way to validate the need.
In addition, we’ve recently decided to start a blog recounting our experiences, with the aim of helping other would-be-entrepreneurs find their way through the minefield of life science startup creation (as well as sharing some or our more entertaining and sometimes embarrassing experiences). For more information, readers can sign up at www.glyscend.com/blog.
What do you consider is fundamentally different about the biotech industry landscape for diabetes therapeutics from when you first conceived of Glyscend a few years ago compared to now?
The biggest difference from when we started the project is the scientific and industry consensus around using insights from bariatric surgery to treat type 2 diabetes. When we started the project in 2013, there was only one major play in the market trying to bring surgically inspired treatment for type 2 diabetes to market. In just three, close to $150 million have been invested in companies trying to emulate the effects of surgery. We were recently at the Diabetes Surgery Summit in London, where basic scientists and practicing physicians presented compelling evidence suggesting that surgery should be considered earlier in the treatment algorithm. Even large multinational corporations, such as Johnson & Johnson, attended the meeting in London in order to keep up with the new scientific insights. In short, the intersection of bariatric surgery and its effect on type 2 diabetes is ripe for innovation and Glyscend is at the forefront.
Can you tell our readers the number of biotech companies working in the space of developing alternatives to bariatric surgery, with a specific focus on treating type 2 diabetes?
In the last decade, at least six startups have proposed less invasive alternatives to bariatric surgery. Several of these startups have shifted their primary focus from treating obesity to treating type 2 diabetes. This shift is primarily motivated by the the lower regulatory burden associated with demonstrating improvements in glycemic control rather than achieving weight loss. These startups can be separated into two groups: 1) those that require endoscopy and a medical specialist and 2) those that can be prescribed by primary physicians and be taken at home like a pharmaceutical drug. Endoscopic alternatives are further in development, but will require new medical specialists, primarily gastroenterologists, to treat a patient population that they currently do not treat. The latter group of therapies, which Glyscend’s approach falls under, is better positioned for clinical adoption because it preserves the existing care pathway. Due to the heterogeneity of type 2 diabetes, we believe the future will have a spectrum of therapies, each offering its own unique risk-benefit paradigm that clinicians will discuss with their patients to prioritize treatment options.
Johns Hopkins has traditionally been a leader in medical innovation, what is your perspective of the future of JHU entrepreneurial biotech/bioengineering innovation’s momentum in the upcoming years?
As master’s students in 2013 – 2014, we came to Hopkins at the height of the push for innovation. We remember when the report came out of President Daniel’s office regarding the staggering disparity between research funding and venture capital being put into Hopkins startups. For us, it was a perfect storm – so many stakeholders in the area were eager to help young entrepreneurs like ourselves. We hope to continue riding the rising tide of innovation in the Mid Atlantic (evidenced by the biotech tax credit, TEDCO granting options, expansion of incubators like FastForward, etc.).