Elizabeth Donley: Autism avenger is Executive of Year

When Elizabeth Donley left the Wisconsin Alumni Research Foundation to establish her own biotechnology firm, she made the transition from stem cell research advocate to stem cell science practitioner.

That transition led to Donley’s selection as the In Business Executive of the Year, as chosen from a panel of judges that includes Deb Archer, president and CEO of the Greater Madison Chamber of Commerce, retired UW–Madison Director of Athletics Pat Richter, and Mark Bakken, founder of Nordic LLC and HealthX Ventures.

Donley, CEO of Stemina Biomarker Discovery, leads a company that has developed and is now commercializing a test, known as devTOX, for screening drug candidates and chemical compounds for their potential to cause birth defects, and therefore autism, during pregnancy.

The emphasis on using human cells to predict human response to toxic compounds has made Stemina a leader in the cause of finding alternatives to animal testing. Moreover, the work of Donley and her staff has led to what some call revolutionary progress in the way autism is diagnosed and treated.

Keeping tabs on metabolism

One in 68 American children are now diagnosed with autism and the average age of diagnosis is 4.5 years. In essence, Stemina’s birth-defect screening test provides a prediction of the potential for drugs and chemicals to cause birth defects. Stemina, founded in November 2006, provides the test to an assortment of markets, including pharmaceutical, chemical, agricultural, cosmetics, and consumer-product companies, as well as government agencies such as the Environmental Protection Agency and the U.S. Army.

Elizabeth Donley

The EPA is Stemina’s strongest market because of its $10.6 million contract with the agency to screen pharmaceuticals, chemicals, and environmental toxins for their potential to cause birth defects. Donley also has secured nearly $8 million in federal and state grants to fund research and development of these important tests. The commercial activity involving devTOX enables Stemina to reduce what it has to raise in terms of angel and venture capital.

Perhaps Donley’s most important accomplishment as a business executive is her ability to remain in Wisconsin when coastal investors keep trying to lure her away with the promise of much-needed venture capital, but that’s only a partial answer. “One of the primary things that I would say is the ability to continue to grow the company in the face of difficult economic times and in the face of not being the center of the universe for funding for this kind of endeavor,” she says. “We’ve been very creative in being able to continue to grow our company from a variety of different funding sources, including angel investors and federal grants.

“So probably my biggest accomplishment is the ability to survive against some adverse conditions, but I would also say that bringing together a very strong team of bright people who are super hard-working, and getting everyone rolling in the same direction, is equally as important.”

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Stemina’s primary focus is metabolomics, which is the study of metabolism, with the goal of more precisely identifying diagnostic biomarkers that allow medical practitioners to not only to diagnose autism sooner and more precisely, but also to inform more personalized treatments.

Stemina is also developing a test to diagnose autism from a blood sample that could allow physicians to make personalized treatment recommendations based on patient’s biochemistry. The company has surveyed 495 patient blood samples from two different institutions, the Mind Institute at the University of California–Davis and the Arkansas Children’s Hospital Research Institute. From that research, it has learned that autism is a spectrum disorder not just from a cognitive and behavioral perspective, but also from a metabolic standpoint.

“We say that will revolutionize the diagnosis and treatment of autism because for the first time we are able to see biochemical differences across the spectrum that show that one child with autism is not the same as others,” Donley says. “Intuitively, we know this because people sort of use a shotgun approach to figuring out what will help the child. When parents get a diagnosis of autism, they go to the Internet and maybe research and find that modified diet might work, or dietary supplements, or certain kinds of attention-deficit medicine, or behavioral therapy, and they start doing everything without any precision about who is a likely responder to what therapy.

“What our diagnostic tools are going to allow us to do is to not only diagnose more precisely and sooner, but also try to inform more individualized treatment for patients.”

Donley says this opportunity is much like the early days of phenylketonuria or PKU, a rare disorder of metabolism that causes an amino acid called phenylalanine to build up in the body. PKU is caused by a defect in the gene that helps create the enzyme needed to break down phenylalanine. Without the necessary enzyme, an unhealthy buildup can develop when a person with PKU eats foods high in protein. “In a generation gone by, children were cognitively impaired if their diet wasn’t changed in the first year of life, and now it’s part of every newborn screen,” Donley notes.

Under Donley’s direction, Stemina has secured a BrightStar Foundation investment, received a Wisconsin Innovation Award, and was awarded $3.9 million in federal grants from the National Institutes of Health to fund the Children’s Autism Metabolome Project, or CAMP, along with the development of a new cardio-toxicity test for drugs. The project is a clinical study to validate its test for diagnosis and individualized treatment so that some day the parents of autistic kids won’t have to trying everything from modified diets to behavioral therapy.

CAMP, which will be conducted at six sites around the country over the next 18 to 24 months, is the largest study ever conducted into the metabolism of children with autism. “We say this test will revolutionize the diagnosis and treatment of autism because for the first time we are able to see biochemical differences across the spectrum that show that one child with autism is not the same as others,” Donley explains.

Globetrotting evangelist

Donley has also co-authored papers on metabolomics in toxicology and preclinical research, as well as autism diagnosis. As the result of Stemina’s research, Donley’s phone lit up with calls for major national and international speaking engagements with the International Society for Autism Research and Autism Investment Conference. From Brazil to Stockholm to San Francisco, she has spoken on new findings to ensure that researchers and scientists are aware of Stemina’s advancements.

As a scientist, Donley has an interest in presenting information about Stemina’s product breakthroughs to the global scientific community, but her international travels also aid commercialization. “What we do is so extraordinarily technical, and the purchasers of these tests are physicians and Ph.D.-level scientists, so it’s critically important to present at scientific meetings and publish in peer-reviewed journals,” she says. “We do that regularly because it really lends all the important scientific credibility that’s required in order for anyone to use our test.

“It isn’t enough to have nice marketing materials. You have to be integrated in the community and each of our presentations at these scientific meetings must go through a peer-reviewed process before we’re invited to speak or present or post.”

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