From Cell Cultures to Mass Markets

"These are not projects you can start the night before they are due." 

This is advice Mike Lynch gives to students in his design course, Biotech Design 1 & 2. And he intends for his words to be taken literally: When it comes to growing cells for his design projects, you have to measure time in days and weeks rather than hours before a deadline. 

Lynch, an assistant professor of biomedical engineering at Duke University, started his biotech design course in 2014, the same year he arrived at Duke after launching a successful company, OPX Biotechnologies. Recognizing that many students wanted wet-lab experience, Lynch created the course to allow students to design novel molecular compounds while experimenting with the standard design process. 

“Biotech design is a lot different than medical device design or other two-semester design courses. We’re making drugs that will affect a broad group of patients and will take significant time and investment for development,” says Lynch. “So in addition to learning what their drug will need to do functionally, my students need to learn about commercial requirements for their products, and they’re doing all that while learning how to design, build, test and then repeat as needed.”

While the wet lab component alone distinguishes his course from other design offerings, Lynch also challenges his students to approach solutions with an entrepreneurial mindset. 

After selecting a project, students spend the first semester of the course researching commercial opportunities for their new drug, therapy or diagnostic. During this time they assess the potential market size for their product, examine the competitive landscape, and study the patent application process to learn whether their idea warrants patent protection. 

The approach can yield real-world results, as for the team of juniors and seniors whose “CBTEch” project sought to demonstrate a cheaper and more effective way to create medical cannabi-noids using E. coli.

They didn't complete their project before the year ended, but ended up being the first to demonstrate the biosynthesis of a key intermediate in cannabinoid production in E. coli,” says Lynch. “And that had a very good business model, so there’s a push to continue that project in the future.”

Other student projects have included a rapid HIV diagnostic test and a drug developed with Duke gastroenterologists that could help maintain ammonia levels in the blood to prevent he-patic encephalopathy in patients with liver failure.

While those projects could follow a more traditional commercial route, some students find that their designs––while useful––don’t support a viable business model. 

One group attempted to create a gel-like depot that would slowly release drugs for tuberculosis af-ter being injected into a patient’s arm. Many TB patients in the developing world have issues com-pleting their medications––some simply stop tak-ing the treatment once they begin to feel better, while others don’t have consistent access to treatment. Both issues can lead to resistant forms of the bacte-ria and rebound infections. By creating a depot to slowly dispense TB drugs over a month, the students hoped to simplify the treatment process. 

“This team quickly learned that there wasn’t a good business model for their design, so instead they went back and looked at philanthropic opportunities in the global health sphere because they felt strongly that this was a project worth exploring,” says Lynch. 

As the course attracts more students, Lynch is looking forward to growing the program to best serve the BME design community. 

“The entrepreneurial aspect of the course makes it more difficult and time-consuming, but I think it’s also more rewarding,” says Lynch. “These students get into the design process from day one, and there are always new and exciting projects, which makes it fun to teach and a great experience for students.”