Meet The Disruptors: How Dr. Michael Shuler & Hesperos Are Shaking Up The Pharmaceutical Industry

Flexibility. In research or business, adjusting to unforeseen problems and being flexible when results don’t turn out as planned is important. You always need to ask yourself, “If this one approach does not work, is there another approach that can still achieve your end goal?”

As a part of our series about business leaders who are shaking things up in their industry, I had the pleasure of interviewing Michael Shuler.

Michael Shuler, Ph.D., is president & chief executive officer of Hesperos Inc., a biotech company developing a novel technology to accelerate drug discovery and development through its “Human-on-a-Chip” platform. He was the founding chair for the Department of Biomedical Engineering at Cornell University and has been a faculty member for nearly 50 years. He has published over 300 journal articles on his research in pharmacology and toxicology, and won numerous scientific awards including the Lush Prize for Science and elected as a member into the American Academy of Arts and Sciences and National Academy of Engineering.

Thank you so much for doing this with us! Before we dig in, our readers would like to get to know you a bit more. Can you tell us a bit about your “backstory”? What led you to this particular career path?

Ever since I can remember, I’ve always been fascinated with science. While most 13-year-old children don’t know what they want to be when they grew up, at that age I knew I wanted to be a chemical engineer. To show how passionate I was, I went on to get my Ph.D. in chemical engineering with a focus on integrating biology and physiology, and haven’t looked back since.

Fast forward to the early 1990s, I realized that the conventional road to getting a therapeutic drug approved and into patients was completely flawed. It can take an astonishing 15 years and $3 billion from start to finish for one drug because most of the time and money is spent on drug candidates that fail. The standard procedure is to test a drug on animals first and then on humans. The problem is that not only are humans very different from animals, but all humans are different from each other, as well. As a result, many drugs that work very well in mice do not work well in people, and a drug that works well for me may not work for you.

While I set out on this journey of finding a novel approach, I was also caring for my daughter who has Down syndrome. She was really the motivating factor behind pursuing this career path. People with Down syndrome are at much higher risk of certain diseases, such as Alzheimer’s disease and a wide variety of heart defects. In addition, it is difficult to test drugs on this population and their unique genetic makeup increases the chance that a drug may work differently for them than for others.

As I pondered all of these complications related to drug development, I thought to myself, “There has to be a better way!”

After working in my own chemical engineering lab trying to design better modeling tools for drug development, I teamed up with nanoscience and cell culture systems expert James J. Hickman and launched Hesperos in 2015 to change how the pharmaceutical industry conducted drug development. A year later, we partnered with researchers at the University of Central Florida through the Florida High Tech Corridor’s Matching Grants Research Program to further improve our devices used in the Human-on-a-Chip technology. Since then, the technology has continued to evolve and advance into what it is today.

Can you tell our readers what it is about the work you’re doing that’s disruptive?

At Hesperos, our mission is to revolutionize the drug development process so it is done faster and at a fraction of the cost of traditional methods. We believe that this can be done if we reduce, and ultimately, eliminate preclinical animal testing and replace it with the technology we’ve developed known as Human-on-a-Chip.

Drug testing on animals has been the mainstay approach for ensuring safety and efficacy of a therapeutic. However, it is clear that animals are poor predictors of human response. Out of every 50 drugs that are deemed safe in animals, only one will actually be safe in humans. And this one safe drug may not even be effective in treating disease. Then it’s back to the drawing board. This is why drug development costs so much and takes a long time.

We have developed a microphysiological system known as Human-on-a-Chip that can mimic how the human body will react to drug treatments. Our platform comprises human-based cell models of interconnected organs, such as the heart and liver, all incubated on a chip about the size of a credit card. We can then measure toxicological and efficacy responses after drug exposure of each organ system, similar to animal testing. However, unlike animal models, we can easily scale up our systems and produce results faster, cheaper and more relevant to predicting human outcomes.

Can you share a story about the funniest mistake you made when you were first starting? Can you tell us what lesson you learned from that?

James and I were just starting to work together when we landed a meeting with a major pharmaceutical company to discuss our technology. This was a big moment for us and we thought we were ready for any question they could throw at us. We spent hours figuring out the best way to present how our system works and what the advantages were over the traditional methods.

Turns out, we weren’t as prepared as we thought.

After we presented everything and convinced the pharma company that we could potentially improve their drug development process significantly, they asked us how much our service would cost. Of course this was the one thing we did not discuss beforehand! We panicked and gave them a random number off the top of our heads. Because we didn’t do the research to justify a reasonable cost for our new service, the price we threw at them ended up killing the deal. Although at the time it didn’t seem very funny, when I look back on that experience now and how far we’ve come since then, it makes me laugh. Even at the start, you need to be fully prepared or you may lose out on something big.

We all need a little help along the journey. Who have been some of your mentors? Can you share a story about how they made an impact?

Henry Tuschiya was one of my Ph.D. advisers who influenced how I’ve built my scientific career. He taught me that there will be situations when you need to reformulate your strategy and goals to take advantage of new possibilities. Sometimes, taking a step back and looking at challenges from another point-of-view can help you achieve the most impactful outcome.

Another one of my mentors is Kramer Luks, a faculty member who was at Notre Dame. When I was an undergraduate, I did decently academically my first two years, but it was by no means impressive. During one of our chats, Kramer told me that I needed to have more confidence in my ability. That was all it took for me. I started to get better grades my last two years of undergrad, which then allowed me to enter a highly ranked Ph.D. program.

Kramer’s support also laid the foundation for believing that I could make my ideas work in any environment.

In today’s parlance, being disruptive is usually a positive adjective. But is disrupting always good? When do we say the converse that a system or structure has ‘withstood the test of time’? Can you articulate to our readers when disrupting an industry is positive, and when disrupting an industry is ‘not so positive’? Can you share some examples of what you mean?

We have set out on a journey to change the drug development process for the better so patients can get the treatments they desperately need and not have to wait years for them to become available.

However, the same stakeholders that we want to collaborate with are also working under a strongly regulated system where failure to block a drug from entering the market due to significant harmful side effects is catastrophic. Because of this, many regulatory agencies and drug developers don’t want to disrupt the status quo. And so people will argue that being disruptive is not necessarily the way to go.

To accept a new method to predict safety and efficacy of a drug is a significant challenge and there has to be substantial data to support that a new method has distinct advantages over existing approaches. While we are confident that our systems will prove to be superior to traditional animal models to predict human response, this hypothesis remains to be fully validated for approval to move a drug from preclinical studies into human clinical trials. We believe there are special opportunities to test drugs that will treat diseases where no good animal model exists, such as many rare diseases.

Can you share 3 of the best words of advice you’ve gotten along your journey? Please give a story or example for each.

Confidence. Have confidence in your abilities and the decisions that you make. It took confidence to launch Hesperos, but I believed that there were new and improved techniques that could get more effective and safer drugs to patients.

Flexibility. In research or business, adjusting to unforeseen problems and being flexible when results don’t turn out as planned is important. You always need to ask yourself, “If this one approach does not work, is there another approach that can still achieve your end goal?”

Persistence. This is a trait I had early on that was encouraged by my parents and reinforced throughout my academic studies and experiences. Persistence derives in part from both confidence and flexibility. I have taken on a lot of challenges that others have said are difficult, if not impossible, to solve. But that has always motivated me to remain steadfast in my pursuit no matter what the problem. This will always lead to the highest payout.

We are sure you aren’t done. How are you going to shake things up next?

Since we are a service company, we are currently working with our collaborators on a project-by-project basis. But what we want in the future is to have our system be fully recognized as a suitable and reliable replacement for animal testing by drug regulatory agencies. Our goal is to work closely with developers to get a drug approved that is largely based on our technology with little to no animal testing.

Do you have a book, podcast, or talk that’s had a deep impact on your thinking? Can you share a story with us? Can you explain why it was so resonant with you?

One book that really resonates with me is The Soul of a New Machine by Tracy Kidder. It’s a fast-paced story that follows a group of researchers trying to build a new type of computer. What I love most about this book is that it shows that it’s not enough to develop a new technology. You need to “ship product” to make it real. You can love the technology, but it doesn’t make a positive difference unless you can get it in front of customers.

Can you please give us your favorite “Life Lesson Quote”? Can you share how that was relevant to you in your life?

“Do unto others as you would have them do unto you.” I have been lucky enough to work with many brilliant people, and it’s clear that a good leader will show respect and empathy to each and every colleague. By treating others how you want to be treated, you can keep the people you work with motivated and determined.

You are a person of great influence. If you could inspire a movement that would bring the most amount of good to the most amount of people, what would that be? You never know what your idea can trigger. :-)

I am motivated by our company’s mission of bringing better and more effective therapies to patients faster than ever imaginable. If academic institutions and pharmaceutical companies worldwide can move away from using animal models and adopt other validated research methods, it will save a tremendous amount of time, money and resources. Ultimately, I believe that our innovative solution could save millions of lives.

How can our readers follow you online?

You can follow Hesperos and its progress through our website or connect with me on LinkedIn.

This was very inspiring. Thank you so much for joining us!