Making the difficult diagnosis

Moving to Commercialization:

Getting the technology out of the labs

RAIG SHIMASAKI, PHD, MBA, is cofounder and CEO of Oklahoma City’s Moleculera labs, a neuroimmunology precision medicine company focused on diagnosing neuropsychiatric and behavioral disorders triggered by autoimmune response.

Dr. Shimasaki is a serial entrepreneur, and scientist and is responsible for co-founding nine companies. He was involved in raising over $30 million for these companies and participated in taking five companies public in the U.S. and Canadian stock markets. His research and development work includes searching for an HIV vaccine, genetic breast cancer risk prediction, a rapid flu test, and therapeutic and biologic products for infectious diseases and neuropsychiatric disorders. He has led multiple products through the FDA approval process and is a co-inventor on several patents. He is also an adjunct professor at the University of Oklahoma Price School of Business and has written several books on biotech entrepreneurship. He is an expert at taking products to commercialization in an industry that sometimes struggles to get technology out of the labs. “You need to be able to recognize the challenges of science, but you can have the greatest discovery in the world and if you don’t really know how to actually take that into a process for a business and get it through regulatory approval and development it doesn’t really do a lot of good for a lot of people,” said Dr. Shimasaki. It was the desire to help people, especially children, that led Dr. Shimasaki to co-found Moleculera Labs with Dr. Madeleine Cunningham in 2011. They did this in response to receiving numerous calls from parents needing testing and treatment for their children following the end of a clinical study performed at the University of Oklahoma in conjunction with the National Institute of Mental Health.

The study looked at antibodies in children that were triggering neuropsychiatric and behavioral disorders. They found that treating the specific antibodies made the patients well.

Now, Moleculera has clinical labs where they focus on testing and treating for autoimmune neuropsychiatric disorders through precision medicine, which refers to actually testing patients before you give them treatments, so they are directed to the correct treatment instead of trial and error or general treatments. This allows them to focus on the root of the issue rather than treating symptoms.

Testing involves the Cunnigham Panel™, named for Dr. Cunningham, who had decades of research into strep, immunology for rheumatic fever and Sydenham’s chorea. The panel looks at the blood of patients who have sudden onset of symptoms related to Obsessive Compulsive Disorder, anxiety, separation anxiety, chronic depression, or potentially even mental illness, autism, or schizophrenia. The patients were previously normal and then had an infection.

The Cunnigham Panel identifies in the blood whether they have these antibodies. If they have the antibodies, they can be treated for the infection in the immune system rather than using psychiatric drugs to treat the symptoms. As a result, patients have shown to get rapidly well.

Common infections can trigger these disorders through molecular mimicry. A molecule on an organism has the same sequence as part of our proteins in the body.

“With strep, what happens is a part of that organism is common to some of the proteins in the brain that cause these normal functions for the brain like cognition and movement. But if an antibody is made against that part of the organism, then it will also cross react and recognize a part of the brain and interrupt that normal functioning. We call that autoimmunity,” said Dr. Shimasaki.

Moleculera Labs have tested and treated more than 13,000 patients in 50 different countries. This certainly shows a need for the testing, however the next step is to be able to raise capital to expand and scale, as well as add new products.

This is where Dr. Shimasaki’s entrepreneurship experience is helpful. He got his start in 1983 in San Francisco with Genentech, one of the first biotech companies in the world. It was here he learned how scientific discoveries were being translated into medicines, tests, and treatments.

Dr. Shimasaki has authored multiple books on the business of bioscience, but he says it was not his goal to write books. He was only trying to chronical everything he began to learn through his career.

“One of my favorite adages is ‘Learn from the mistakes of others because you never live long enough to make them all yourself,’ so I kept a lot of them. I realized after the second or third company, there are concepts that keep showing up,” said Dr. Shimasaki.

Oklahoma has been home for Dr. Shimasaki for more than 30 years. He has seen the growth of the biotech sector in Oklahoma and has worked with the Oklahoma Center for the Advancement of Science and Technology (OCAST), from whom he has been awarded seed capital funding as well as applied research grants. He sees OCAST as an integral part of the success for many of the biotech companies in Oklahoma. He says the OCAST funding allows a researcher to take an idea and move it forward far enough that investors could become interested in it. He references the large gap between research and commercialization. If that gap can be filled, then there are more opportunities Dr. Craig Shimasaki - Moleculera Labs for enterprises to develop in Oklahoma. According to Dr. Shimasaki, “Oklahoma is absolutely a great place for biotech. There are challenges just because of the biotech field, but Oklahoma has an entrepreneurial culture and a group of people who will help each other regardless of if there’s anything in it for them. You can’t import over that type of culture from somewhere else.”

YOU CAN HAVE THE GREATEST DISCOVERY IN THE WORLD BUT IF YOU DON’T KNOW HOW TO TAKE THAT INTO A PROCESS FOR A BUSINESS AND GET IT THROUGH REGULATORY APPROVAL AND DEVELOPMENT IT DOESN’T DO A LOT OF GOOD FOR A LOT OF PEOPLE. ”

www.ocast.ok.gov