The developers of an app to track symptoms of bipolar disorder knew they had a promising idea, but they realized they needed help navigating the legal and regulatory maze required to bring such a product to market. They turned to Biomedical Development Corporation (BDC) for funding, scientific support, and business expertise.
San Antonio-based BDC has supported the app development for more than seven years, from the underlying research and algorithm development to human clinical trials and approval. The company on Tuesday launched its KIOS Bipolar app, which provides real-time behavioral advice for the changing mental conditions of users with bipolar disorder.
“There’s no way I would have been able to bring forth a product like this,” said Richard Priesmeyer, who created the algorithms powering the app. “It’s a unique team with specialized expertise and a significant management service function that Biomedical provides to get us through the grant and regulatory process.”
BDC helps bring commercially viable biomedical products to market by linking biomedical entrepreneurs with sources of research funding and specialized legal and business expertise.
Priesmeyer, who teaches strategic management in the Greehey School of Business at St. Mary’s University, and Dr. Charles Bowden came to BDC to develop the KIOS Bipolar app. Bowden, a psychiatrist and an expert on bipolar disorder at UT Health San Antonio who retired earlier in 2017, became BDC’s chief science officer. He saw the need for an easy-to-use tool for patients to better manage bipolar symptoms.
Users can access the app to track multiple mental health conditions like anxiety and depression. Over time, the app can detect changes in a users’ mental condition based on how they answers eight questions, such as “Have you felt depressed, sad, or down?” The app’s algorithm then offers users targeted advice based on clinically accepted criteria used by psychiatrists.
Users can try the app for free for a month; it costs $29 a month thereafter.
By tracking changes in mental conditions, the app’s algorithm provides a level of precision not currently available with traditional in-office techniques that doctors use for patient assessments, according to Bowden.
“If you could have simple advice that reminds you of the most common but disruptive experiences a bipolar person is likely to have, you are helping that bipolar person a lot just by their using the app on their phone at times and in places where a psychiatrist cannot be present around the clock,” Bowden said.
Attorney and certified public accountant Phyllis Siegel founded BDC in 1984 as an outgrowth of her law practice, where she had been providing legal and business advice to her clients, many of whom were inventors or scientists.
“We started in the early 1980s before there were angel funds or venture capitalists,” Siegel said. “The cash flow problem for innovators coming in my office evolved over time into scientists looking for grants.”
Since its founding, BDC has received 66 National Institutes of Health (NIH) grants totaling nearly $15 million to support research and development for different biomedical technologies, Siegel said.
Her accounting background and experience in legal regulatory compliance was well suited to helping entrepreneurs looking to navigate the complex world of developing a product or service for biomedical use.
She is anticipating using the KIOS algorithm to develop a web-based app providing behavioral advice for people suffering from disorders stemming from opioid use.
“The model is basically the same,” Priesmeyer said, “[but] with getting a different team together to identify the key variables and advice that can be given to the opioid user.”
The company and its affiliates occupy a 13,000-sq.-ft. facility in the Tobin Hill neighborhood. The formulation lab, a quality control and assurance lab, and a U.S. Food and Drug Administration-compliant on-site manufacturing facility enables BDC to offer everything from product formulation and validation to regulatory submissions and eventual production of biomedical products on location.
The number of employees varies depending on the product being developed and manufactured, but BDC averages about 25 employees. The company has developed other products, such as the IClean mouth rinse, created originally as a solution to sanitize medical equipment, and the Skincerity skin masque, which was developed as a preventive treatment for bed sores but is marketed as having cosmetic benefits.
While Siegel is the corporation’s CEO, her son Gregg writes the grant applications in collaboration with the bioscience or technology professionals with the promising idea.
Reflecting on San Antonio’s evolving network of bioscience companies, Gregg Siegel said, “You now see a community of companies, entrepreneurs, scientists, and specialized consultants that never existed before.”
Cynthia Phelps is a San Antonio-based recovery coach helping people with addictions or in recovery from alcohol, other drugs, codependency, or other addictive behaviors and wants to develop an app to help her clients. As a biomedical entrepreneur, she has found that specialized resources for ideas like hers are essential for product development.
“Startups often don’t have the capital to pay for critical steps such as clinical trials, or negotiating the FDA regulations,” Phelps said. “Having the resources of BDC can ensure that more biomedical apps make it to market.”