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Shubha Ghosh, TCLC Help a Scientist Bring a Diagnostic Innovation to Market
In 2000, when she was awarded a Fulbright Scholarship to travel from Colombia to study genetic engineering at the University of Arkansas, Magnolia Ariza-Nieto says she thought she had won the lottery. But with that elation came a sense of responsibility. “When you are on a Fulbright scholarship, you feel you have a moral imperative to pay something back for the benefit of mankind,” she says.
Now, thanks to Shubha Ghosh and the College of Law Technology and Commercialization Law Center (TCLC) that he leads as director, Ariza-Nieto is poised to put her more than 35 years of discovery to practical use with the creation of a diagnostic epigentic kit and complementary precision medicine service that she calls epiWELL.
“epiWELL is a diagnostic kit for healthcare providers to monitor changes in a person’s epigenome, to help with prevention and treatment strategies for a host of diseases, including obesity, Type 2 diabetes, and Alzheimer’s disease,” explains Ariza-Nieto. “Epigenetics is concerned with the function of genes and their role in metabolic disorders. In my opinion, even aging can be considered an epigenetic disease. When people who are aging well say ‘I have good genes,’ they are essentially correct. In aging, some genes are getting turned off and some turned on, causing the diseases of old age. Having a diagnostic kit to prevent these comorbidities is greatly desired.”
Ariza-Nieto’s path from molecular biologist and genetic engineer to medical industry entrepreneur passed through Cornell University, where she has been a researcher for more than a decade. “Originally, I was interested in plant genetics and how GMO plants might affect human health,” she explains. “I joined Cornell University’s biofortification project, which was looking at the nutritional improvement of plants and how that impacts the quality of the food matrix. That’s when I became interested both in epigenetics and the use of in vitro modeling to study the function of genes and genetic biomarkers.”
However, there was a problem with the in vitro methods being used at Cornell University, explains Ariza-Nieto, especially for a researcher looking at how the human epigenome is affected by real-world “biotic and abiotic” stressors. “My research is about creating ways to measure the benefits of physical and cognitive fitness, diet and happiness,” she explains. Existing in vitro models were using cancer cell lines for their models, “but I couldn’t use those for epigenetics because they are compromised cells, so I wanted to develop a cell line using uncompromised cells.”
The use of liver cells for in vitro models looked promising, but Ariza-Nieto says there was still the problem of finding biomarkers for disease. She then realized that to study how genes function in the human body, she should use actual human subjects. “My idea was to use human subjects to investigate epigenetic changes caused by exercise, diet, recreational drugs and medication.” When the large National Institutes of Health grant Ariza-Nieto was working on ended in 2015, she decided to develop her discoveries, methods and data into a diagnostic tool for healthcare providers by licensing her invention and forming her own company.
Ariza-Nieto’s first engagement with the College of Law’s technology commercialization expertise came at a 2016 Cornell University PreSeed Workshop, where a team from the college’s New York State Science and Technology Law Center (NYSSTLC) reviewed her epiWELL concept. “We evaluated the technology at an early stage,” explains Molly Zimmerman, NYSSTLC Associate Director. “PreSeed workshops look at the issues that help make an early ‘go/no-go’ decision. Our team met with Magnolia for two days and provided research and information on key issues, including potential purchasers, distribution channels, the size of the opportunity, competitors and a value proposition.”
The evaluation allowed Ariza-Nieto to pursue her innovation, but she was soon faced with a complex problem—how to start her own business, publish her research and file a patent while at the same time licensing technology and datasets from her former employer and satisfying her medical industry collaborator. “I didn’t know how to balance all the issues, so the business advisor I was working with suggested I return to the College of Law and meet with Professor Ghosh,” recalls Ariza-Nieto.
“Dr. Ariza-Nieto has made significant discoveries about the behavior of specific biomarkers that will have great importance for diagnostics and drug testing,” says Ghosh. “Her story in procuring patent rights through Cornell University is a typical one for an innovator who develops an invention while employed by a university and while collaborating with another entity, in this case Guthrie Health, which assisted her research with human subjects.”
“Professor Ghosh began to help me with the patent, licensing agreement and more,” says Ariza-Nieto. “In the end, we decided that EpiWell and Cornell University would share the patent 50/50. I was so glad to meet Shubha. When I started, I didn’t understand the legal language being used, and it seemed scary. Shubha helped with IP issues and licensing and now I’m learning.”
Together, Ghosh and Ithaca, New York, Small Business Development Center advisor Chuck Schwerin successfully negotiated with Cornell University to move Ariza-Nieto’s patent application forward while preserving her rights to publish and to patent. “My research paper is ready to be published in Endocrine Connections once my probational patent is filed,” says Ariza-Nieto. “After that I will look for grant money and venture capital for my company.”
“I’ve had some good mentors in my life,” continues Ariza-Nieto, including her late father Uriel Ariza-Pardo, a professor of Agriculture and Human Health at the Instituto Colombiano Agropecuario, and professors Michael Shuler and Ross Welch, a biomedical engineer and a plant physiologist, respectively, at Cornell University. “When you get a Fulbright Scholarship, you discover a network of support from professors and researchers, and now, thanks to NYSSTLC and Professor Ghosh, I have found one in the business world.”