Based in Orlando, FL, Hesperos, led by CEO Mike Shuler and Chief Scientist James "J" Hickman, is developing systems and solutions designed to reduce the cost and time it takes to bring a new drug to market. Driven by a genuine desire to help patients and create a company where employees truly have a stake, Shuler and Hickman, both extremely accomplished in their own fields, joined forces in the fall of 2014 to commercialize a revolutionary technology with the potential to completely transform an industry. Shuler and Hickman shared their journey from inception to recipients of a multi-million dollar grant and their eventual goal of widespread adoption of their life-changing technology.
"In layman's terms, we're trying to make the process of bringing a drug to market more effective," Shuler said. "Only one in ten compounds come out of clinical trials as an approved product. By using human-based models, pharmaceutical companies and others will be able to make better predictions on which drugs to send through clinical trials. Our goal is to see if our system will predict certain failures ahead of time, so pharmas won't go so far with a drug that's likely to fail. They make their money by 'killing off' bad drugs early. Our solutions should improve success rates and, as a result, significantly reduce the overall cost and time of drug development."
Hickman added, "Right now, it's about 12 to 15 years to bring a drug to market. We'd like to decrease that timeline dramatically. Many animals are currently used in the pre-clinical trial space. In addition to the ethical concerns, animals contribute to the high failure rate. They're not good predictors. Our approach is much different."
The Journey to Success
Both Shuler and Hickman have a history rich in accomplishments and are widely recognized by colleagues, academic institutions, societies and academies for their ground-breaking research and innovative solutions. Shuler, the founding chair for the Department of Biomedical Engineering at Cornell University, has over 25 years’ experience with Body-on-a-Chip research. He has received numerous research related awards, among his honors is election to the National Academy of Engineering (1989) and the American Academy of Arts and Sciences (1996) and he has published over 300 peer reviewed journal articles of which over 70 focus on in vitro toxicology and pharmacology (Body-on-a-Chip). Shuler graduated with a Ph.D. in Chemical Engineering from the University of Minnesota and a B.S. from the University of Notre Dame.
Hickman published the first serum-free, defined culture system for neuronal systems in 1995. He also pioneered the establishment of functional in vitro systems and was one of the first to report toxicity studies from neurons on microelectrode arrays in a defined system in the 1990s. Hickman received his Ph.D. from the Massachusetts Institute of Technology (Chemistry) and his M.S. and B.A. from Penn State University. He was also elected to the Board of Directors of the American Institute for Medical and Biological Engineers (AIMBE), the premier society for Biomedical Engineering of which he is a Fellow.
Shuler and Hickman shared their impetus for pursuing such a lofty endeavor and some of the challenges they faced along the way. "When we formed Hesperos, we both had our academic jobs, but also had the freedom to develop something else," Shuler said.
Hickman added, "We believed so strongly in what we were setting out to do that we put up our own money, almost a million dollars, to get the company up and running. We wanted the focus to be on helping patients and felt that if we'd taken outside money, we'd risk being dictated by people with profit as their only motive. We also had incredible support from the UCF Incubator Program.They made the entire transition less scary and less unknown. The proximity to The University of Central Florida is also nice. Almost half of our employees are UCF graduates.
Maintaining a Competitive Edge
In terms of challenges, for one, the systems are definitely complicated. Our model is a service based company. Competitors are trying to sell instruments and embed technicians within pharmaceutical companies. We want to remain service-based, while the pharmas want to bring things in-house. We've hit some incredible milestones, but they've gone with competitors because we weren't willing to sell equipment. Trying to find the right mix of people willing to work with a service-based company of our nature has been a challenge. Nevertheless, being challenged with difficult problems has helped us to validate our systems."
Shuler added, "Convincing people it is real is the hardest part at first. Things will get easier when they decide to incorporate our solutions as a standard part of the drug process. That's starting to happen now. With our progress over the past three to four years, we’ve seen increased success in terms of industrial partners, but we're also competing for more federal funds. Getting access to these funds is important because they allow us to develop new aspects of technology that can expand the capabilities of what we can do."
Regardless of the challenges, Shuler and Hickman are determined to see the benefits of their technology reach the masses. According to Shuler, what makes Hesperos so unique is their strength and expertise in multi-organ systems. Many other companies offer single-organ systems, but only a handful can do multi-organ testing. This allows Hesperos to take multiple tissues, hook them all together and test their exposure to various drugs. This expertise is extremely attractive to pharmaceutical companies. It's also attractive to organizations like the National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS), who recently awarded Hesperos with a $4 million three-year NIH Phase IIb Small Business Innovation Research (SBIR) grant.
Shuler and Hickman elaborated on this advantage and other ways Hesperos works to separate itself from competitors. "Our systems produce functional readouts that mimic readouts a doctor would do while interacting with a patient," Hickman said. "Instead of looking at bio-markers, we can measure output directly. This allows us to see if the drug works, what the liver converts the drug into, the toxicity, as well as the therapeutic index, which is a measurement of the spread of concentration for when a drug is effective to when it becomes toxic. We're able to find that window before clinical trials. This will allow us to take a patient's cancer cells and figure out if the therapeutic is effective against that particular cancer and also look at the toxicity. We could determine at what dosages the drug would not be as onerous in terms of side effects but still effective in killing cancer cells."
Shuler added, "Our system is a pumpless self-contained platform, allowing us to do functional measurements, something most other companies can't do. You can hold the system in the palm of your hand. If you look at other competitors, there's a huge box that also goes along with their system to pump fluids and help regulate the system. Ours is very simple. It's low volume and has no pumps or valves. If you ran a multi-organ system but weren't careful about the total volume, you'd dilute the metabolite and not see their effect on other organs. J has also spent a lot of time developing a medium, to replace serum that allows us to know all the components in it."
Hesperos has approximately 18 full-time employees and, according to Shuler and Hickman, has been a very lean operation since the start. Neither Shuler nor Hickman have taken a salary. The majority of their profits have gone into developing their workforce and capabilities. When new employees are hired, they're given stock, something Shuler and Hickman are extremely fond of and proud to offer. According to Shuler, employees are fully committed to making the technology real. They're motivated by producing something that will be of great use and value to society.
Notable community support
In terms of philanthropic activities and how Hesperos gives back to the community, their ultimate goal is to develop a non-profit that feeds back into the company to focus on rare diseases. Even though Florida is not considered a pharmaceutical hub, Hesperos is working on partnerships with Florida-based companies to allow them to use their platform, giving them a competitive advantage. Shuler and Hickman are determined to make the pharmaceutical industry much more prominent in Florida. They cite the low cost of doing business, no state income tax, great weather and access to top talent as reasons why Florida has so much untapped potential.
What it means to be a Florida Companies to Watch Honoree
"The exposure it gives our company is great," Hickman said. "Most people have no idea that this capability is out there and that one of the best companies doing it is right here in Orlando. It helps to get the word out that we're willing to work with pharmaceutical companies. It's great visibility." Shuler added, "It's an incredible recognition and a validation of the concept we're working on."
"In terms of why we were selected, I think it has a lot to do with the uniqueness of our business model," Hickman said. "There are not a lot of visible bio-tech startups in the area. We're also self-funded, which is different than the standard route." Shuler added, "It's a mix of our exiting new technology and our unique and transformative platform. We've had a lot of support along the way. People like Carol Ann Dykes and Tom O'Neal from the UCF Incubator Program have been extremely helpful. The Florida High Tech Corridor Council has also helped us move along some of our technology."
Looking ahead, Shuler and Hickman would like to see the use of their technology become standard in the drug development process of the pharmaceutical industry. Neither founder feels it's unrealistic to see at least one major pharmaceutical company adopt their approach, within three years, as a standard component of their pre-clinical trials. More widespread adoption and regulatory acceptance is their ultimate goal.
Advice for aspiring entrepreneurs
Both Shuler and Hickman offer up some invaluable advice for aspiring entrepreneurs. "Have a long term vision of building something you think is significant and critical," Shuler said. "There will be times when things go well and times when things don't go so well. The key is to believe that what you're doing is important. It's also important to have a vision of something that's going to have a positive impact on society and help lots of people."
Hickman added, "Find your local incubator and utilize their services. The federal government and universities have made a great effort to use incubators to lessen the bar to start your business. They offer so much support. The barriers to start a business have never been lower."