Moleculera Labs: Creating Hope Through Innovation with Dr. Shimasaki

Moleculera Labs is dedicated to improving the lives of children and adults impacted by infection-induced autoimmune diseases.

As a co-founder of nine entrepreneurial ventures, four in Oklahoma, Craig Shimasaki, Ph.D., wrote the book on entrepreneurship. No, literally wrote the book. Dr. Shimasaki, co-founder and CEO of Oklahoma City-based Moleculera Labs, has authored three books on biotechnology entrepreneurship, beginning with his first title back in 2009, “The Business of Bioscience: What Goes into Making a Biotechnology Product.”

Along the way, he’s co-founded and led multiple biotech-related ventures, mentored teams in statewide collegiate business plan competitions, now serves as Senior Entrepreneur-in-Residence at the University of Oklahoma Price College of Business, and was a founding member of the Oklahoma Entrepreneurship Mentoring Program.

“Throughout my life I’ve had a curiosity for medicine, science and business,” Dr. Shimasaki told me in a recent interview. “I used to take apart my mother’s toaster and iron to understand how they worked.” A California native, he earned his undergraduate degree in biochemistry at the University of California-Davis before going to work in South San Francisco with pharmaceutical giant Genentech. His interest in business led him to earn his MBA at the Kellogg School of Management at Northwestern University.

“Having a desire and a passion to help people who are suffering from chronic diseases and disorders, and then gaining a good understanding of business, I found myself moving into the area of biotech entrepreneurship,” he said. 

Dr. Shimasaki’s journey into entrepreneurship began in 1987 when a former Genentech colleague lured him to Oklahoma to help start up a new biotech company. “That offered me the opportunity to finish my Ph.D. at the University of Tulsa in Molecular Biology and Biotechnology,” Dr. Shimasaki said. “And it was an opportunity for me to see Oklahoma, its people and its culture.”

He never left.

Today, he’s leading a company—Moleculera Labs—that provides next-generation antibody tests that detect whether an autoimmune reaction is causing neurologic or psychiatric symptoms. The company is dedicated to improving the lives of children and adults impacted by infection-induced autoimmune diseases. The research that sparked the precision medicine company was developed by Madeleine Cunningham, Ph.D., a George Lynn Cross Research Professor at the OU Health Sciences Center, who is a co-founder and chief scientific officer of Moleculera Labs. 

Dr. Cunningham’s initial research led to what became known as the “Cunningham Panel” as she conducted studies into a disturbing condition in children known as PANDAS, or Pediatric Autoimmune Neuropsychiatric Disorders Associated with Strep. When the clinical study ended, anxious parents continued contacting Dr. Cunningham seeking help for their children.

“That’s when Dr. Cunningham came to me and said, “How can we help these hurting people now that the study is concluded?” Dr. Shimasaki recalled. “And that was when we co-founded the company in 2011.”

PANDAS occurs when the immune system produces antibodies intended to fight an infection but instead the antibodies mistakenly attack healthy tissue in the child’s brain, resulting in inflammation and inducing a sudden onset of movement disorders, neuropsychiatric symptoms and abnormal neurologic behaviors.

“When antibodies attack our joints, we call it rheumatoid arthritis,” Dr. Shimasaki said. “But when they attack our brains, sometimes we call it mental illness or rebellious kids or even just bad parenting—a whole host of things. But if it’s identified and biologic, you can actually treat it.” 

Once PANDAS is identified, parents can seek treatment for the underlying condition with anti-infectives and immune modulators. Dr. Shimasaki recalls one child in particular from years ago, a then 8-year-old boy named Adam.

“He was diagnosed with ADHD, and they thought he had autism,” Dr. Shimasaki said. “His parents considered putting him in a psychiatric hospital because they didn’t know how they could help him. And then they heard about us.” After Adam was diagnosed with PANDAS by his doctor with the aid of Moleculera Labs’ test panel, he was successfully treated for an infection and his immune system dysfunction.  A few months back, his mother sent me his picture,” Dr. Shimasaki said. “He’s now running high school cross country,” she said, “Recovery is possible. He’s 10,000 times better.” 

Moleculera Labs has tested more than 11,000 patients and has expanded the scope of its testing to include many other chronic disorders, including ADHD, autism, schizophrenia, and many others. They are now doing research to include an autoimmune heart panel and a post-COVID autoimmune syndrome panel.

Dr. Shimasaki and his wife, Verna, a realtor, have two adult daughters who both live in California, which sparks a question. What keeps him here in Oklahoma City when he’s a West Coast native? “I would say it’s the great people, openness to innovation and entrepreneurial culture, the quality of life and, of course, the lack of traffic compared to San Francisco or Los Angeles,” he said with a laugh. “All this combines into why Oklahoma is a great place to build a company because there is an entrepreneurial history with the oil booms and the risk-taking mindset to drill holes in the ground and look for oil.”

Dr. Shimasaki cites a passage from one of his books, where he compares the five essential elements of building an entrepreneurial culture to farming: You need good seed, soil, water, fertilizer and an experienced farmer; these equate to innovative ideas, incubators, access to capital, a trained workforce and seasoned entrepreneurs.

Oklahoma City has all of those elements. “This is a very progressive, innovative, entrepreneurial-minded group of people,” he said.