The use of Paper Analytic Devices (PADs) as low-cost, low-technology tests for screening counterfeit and substandard pharmaceuticals resulted from collaborative efforts between the science departments of Notre Dame and Saint Mary’s College, and now Notre Dame students are in the process of taking this new technology to the market through the entrepreneurial business venture, Imani Health.
Notre Dame senior Sean McGee began research with the PADs project two and a half years ago. This past year, fellow senior Luke Smith joined the project along with ESTEEM student Amanda Miller, who graduated from Saint Mary’s in 2013, and MBA students Chase Lane and Valeriano Lima to create Imani Health.
“On average, I believe the WHO and Interpol estimate that 30 percent of drugs are counterfeit that are sold, and it causes pretty significant problems with human health,” McGee said.
Notre Dame associate professor of chemistry and biochemistry Marya Lieberman and professor of chemistry and physics at Saint Mary’s Toni Barstis continuously work to combat this problem, McGee said, through the creation and improvement of these cheap paper-based devices.
“Hundreds of thousands of people every year are at risk for something like this and also from a monetary perspective, the pharmaceutical industry loses 75 billion dollars in revenue as a result of counterfeiting,” he said.
McGee said the Imani Health business plan began when Smith approached him and suggested submitting the PADs project to the McCloskey Business Plan Competition.
“Imani Health focuses on taking the PAD project and essentially transferring it out of the lab and maturing it into a product that we can get out to the world,” he said. “We’re looking at maturing the PAD itself and also the accompanying software package that would allow it to develop a worldwide database that would basically paint a real-time map of where counterfeiting is happening.”
According to McGee, the software package is currently in development in the lab of professor of computer science and engineering Patrick Flynn.
“He estimates that with one dedicated person it would probably take somewhere close to a year [to develop the software],” he said.
Although certain aspects of the project are still undergoing work, McGee said that in addition to entering the McCloskey Business Plan Competition, Imani Health also entered the OneStart Competition for science entrepreneurs.
“We just applied to get to the final round,” he said. “We submitted our stuff and we’re waiting to hear back if we’ve made it.
“If we do, we will be going to San Francisco on May 22 to compete in the final round, which will entail us trying to win $150,000 in start up money and free lab space for a year at the [GlaxoSmithKline] laboratories in the Bay Area.”
McGee said the results of the OneStart Competition would be released within the next few weeks.
Results of the McCloskey competition were, however, released last week. Although Imani Health made it to the semifinals, which consisted of the top 12 teams from a field of more than 150 applicants, McGee said the team did not win.
McGee said although the loss was unfortunate, there was still room for improvement for the business plan, the most crucial dealing with patent approval.
“The intellectual property doesn’t exist yet because the patents are pending at the USPTO,” McGee said. “The problem is that they have a back log of about three years.”
Although McGee will not see the project completed firsthand due to his graduation at the end of the semester, he said Lieberman and Barstis would continue working on the PADs project. Although the patent is the main missing component at the moment, progress can still occur.
“Right now we’re going to focus on product maturation,” he said.
McGee said quick and easy drug testing might significantly aid certain fields such as work in customs, border patrol and airports.
“They can seize drugs and take them and test them on the spot rather than having to send them to a lab where they have to continue to test it,” he said.
Right now, the facilities that conduct drug testing do not have the resources to keep up with workload.
“Even here, domestically, we can see it being used by various dieticians and urologists because there’s becoming an increasing prevalence of people buying their medications online,” he said.
With such a large counterfeit-drug industry, McGee said an efficient and low-cost method of detecting drug quality is essential.
