TAMEST Member Profile: Mary Pat Moyer, Ph.D. (NAE), INCELL Corporation, LLC

When the pandemic hit, TAMEST Member Mary Pat Moyer, Ph.D. (NAE), Founder, CEO and Chief Science Officer of INCELL, immediately knew her biomedical product manufacturing business in San Antonio had to pivot to develop new COVID-19 related products. Though a definite risk, she says her blue-collar upbringing instilled her with a moral compass to do what is right and help people when and how you can.

No stranger to hard work and ambition, Dr. Moyer has held jobs since she was just eight. By 14, she was working two jobs while going to school to support herself and her family. She credits these early hardships for her understanding of time management, discipline, and knowledge that good things come to those who work hard.

Dr. Moyer received her Ph.D. in Microbiology from The University of Texas at Austin and spent twenty-years breaking glass ceilings at UT Health San Antonio. At the time she was hired, Dr. Moyer served as the Department of Surgery’s first woman on faculty with a Ph.D. By the time she was tenured in 1989, she was one of just four female faculty members at UT Health San Antonio to hold the distinction.

Today, Dr. Moyer’s thriving biopharmaceutical company utilizes its broad range of capabilities to manufacture products based on a range of solutions, reagents, vaccines, test materials and more. Still a relatively small company, Dr. Moyer says they are essentially self-funded, further setting them apart in an industry largely supported by venture capitalists. In 2019, she was inducted into the National Academy of Engineering, and became a member of TAMEST, for her “entrepreneurship and development of cell lines, cell media and testing technologies for regenerative medicine and biopharma products.”

TAMEST connected with Dr. Moyer to hear more about her life, work, and the shift to develop a vaccine and an at-home COVID-19 diagnostic kit.

Tell us about yourself and what inspired your career in bioscience.

I always loved biology and nature. As a child, I would climb trees, ride giant wild land tortoises, and visit a dock near my childhood home in Florida to fish and watch sea turtles come onto the beach and lay their eggs. I remember being amazed when I first looked through a microscope at a slide of pond water with its moving and teeming microorganisms and plants. That’s what sparked it for me.

My parents clearly conveyed that if I ever wanted to go to college, I would need to find my own way to pay for it. Thus, I had major life goals: to be the first in my family to go to college and study biology. I kept my grades up, was in the top 1 percent of my high school class and did my last year of high school while in my first year at Stetson University in Deland, Florida, where I had a full scholarship and was selected as an assistant for the biology labs.

However, when my dad, who had served in both World War II and Korea, was called to serve in Vietnam, I had to come home to help my mom, and ended up in a circuitous education path without a scholarship. To finish my degree, I found a closer school, took out student loans, had an off-campus job, and completed my B.S. and M.S. degrees in biology. During my lab assistant job to wash glassware, I learned everyone else’s tasks, from animal studies to microbiology and cell culture, and found that I loved it all!

You went on to receive your Ph.D. and had a long career as Research Division Head and Professor of Surgery at UT Health San Antonio for more than 20 years. What inspired you to pivot your academic career to found and lead the INCELL Corporation?

I have been a biomedical researcher for my whole career, and I love seeing something nobody has seen before. Academia provided me a scientific foundation to pursue discovery, give a competitive challenge, offer a special camaraderie shared by scientists, and offer me an opportunity to teach young minds and to provide service to my profession.

However, from my work, industry collaborations and clinical research, I realized that I needed to integrate bioengineering, manufacturing and packaging to bring products developed by me and my collaborators for clinical use. The impetus for my founding INCELL Corporation LLC in 1993 were early 1990s events. I got divorced, government and private research funds were getting more difficult to obtain, and my department chairman was going to retire.

Thus, I was stimulated to “re-invent” myself as a scientist-entrepreneur by founding INCELL as a path to take care of my children and my staff, who all depended on me. I got my first SBIR grant and a 50%-time commitment was required, so I gave up my tenure, and went part-time at the university. Gradually, I decreased my percentage of time at UT Health San Antonio as grants and contracts closed out in 2001. It was a gamble, but I passionately believed INCELL could succeed.

Unlike most other early-stage companies, I had a collaborative business model with many research entities and believed that our team could develop and use unique platforms and bioengineering technologies in the areas of regenerative medicine, cancer and infectious diseases to make new products. Twenty-eight years later, there have been many challenges, with ups and downs, but I made the right decision for me.

Talk about INCELL’s work during this pandemic. How soon did your company switch gears and focus on vaccine and other microbiological products?

It was clear in January and February that a pandemic was coming and that we needed to prepare to bring out our RediVax™ rapid response vaccine platforms of cells, viral vectors, non-needle delivery and testing capabilities to explore making a vaccine, and toward developing other COVID-19 products.

Those platforms were developed in the early- to mid-2000s with Department of Defense support and the expectation that they would be available for a readiness response to a virus or other biological threat. Thus, we had years of developing extensive data and materials that were foundational to our planned approach and could be combined with the newly available COVID-19 genes and reagents.

I had deep concerns about the volatile political landscape, so I decided that INCELL would self-fund, not seek grants or contract funding and not publicize our initial work. Challenged by the PPE and other shortages we validated re-use of materials, new sourcing, etc. and collectively defined “Plan B” strategies that would not compromise quality or operations.

What goes into vaccine development and tell us what exciting discoveries you have uncovered.

Vaccine development for a safe and effective product is very multi-faceted. It involves not only the science of the vaccine “active ingredient,” but also the many steps for labeling, packaging, storing, stability assessments and other quality testing in vitro and in vivo.

INCELL has integrated the ever-evolving work by others with our own knowledge and capabilities. We focused on our design, manufacturing and scaled-up production of a vaccine that builds on our existing platform technologies, has commercial potential, and could be self-administered in an emergency and made available for people worldwide.

It is packaged for non-needle delivery, stimulates persistence of immune memory cells, requires only a single immunization day, is safe, effective, reasonably priced, stable, easily distributed, and stored no colder than refrigeration. Similarly, we have been exploring “at-home” ease-of-use visual diagnostic kits, that share the same requirements for our vaccine. There are many challenges, of course, increased insurance and operations costs, and a sense of responsibility.

Some vaccines being discussed in the media are described as ultra-cold storage. The vaccine you are developing isn’t. What is the difference and why is that important?

Ultra-cold storage generally means keeping a product at or below -70°C. This results in much greater costs for storage, shipping and logistics when compared to storage at room temperature or in a refrigerator. An improperly stored vaccine would likely have reduced or no efficacy.

In a distribution plan to store large numbers of vaccine units long-term, specialized facilities and high electrical use ultra-cold freezers are required. These needs are expensive, have limited availability in most hospital settings and are not available in standard pharmacies or doctors’ offices. Also, these add to overall costs beyond just the cost of each vaccine unit.

What makes you the most passionate about what you do?

Because I was trained as a virologist, since January I have been staying abreast of the literature and working in the laboratory six to 12 hours a day to lead the COVID-19 vaccine development and other initiatives, including diagnostics.

This has been a personal renewal of my passion for the adventure of scientific discovery with the goal to develop new COVID-relevant products. The same is true for our products in regenerative medicine, cancer and cell or tissue therapies. This includes personalized medicine therapies for various diseases, such as neural diseases, and the culture and storage of a patient’s cancer and white blood cells.

For me personally, my staff initiated the cultures of my surgically removed breast cancer cells, which I have cryostored, cultured and characterized. However, I had to delay my irradiation treatment to fight and find a way to collect and store my apheresed white blood cells post-surgery, so I could have unirradiated cells cryostored and ready for potential immune therapy if and when I need them. I am passionate about this on-going foundational work in personalized medicine that hopefully can also be developed for use by other cancer patients.

I am also very passionate about public education in science and medicine and have been active in many venues, including doing my best in hot-button areas of science such as HIV and AIDS, stem cells, regulatory challenges, and interacting with elected and government officials and teachers at the local, state and federal levels. I have been a passionate activist in this because I think scientists, engineers and technology business leaders have a responsibility to bring education to the public.

Is there anything else you’d like to add?

My background and experiences have taught me about the vital attributes that each individual scientist-entrepreneur should have: the ability to accept failure as well as success, self-reliance, hard work, respect for all people, honesty, critical thinking, patriotism, courage, promoting community activism, taking responsibility, being your own boss, speaking truth to power, fighting when you need to, bridling ego, supporting your team, helping those who follow you, keeping your word, taking action for the underdog, giving a hand up, teaming, strategizing, reading for fun and for knowledge, loving and being loved, thinking out of the box and being impatient with the status quo.

My Guidance Quote: “Be honest, hire good people, keep a spiritual center and sense of humor, love and be loved, and never, never give up!”