By Amy Schneider
Five team members stood before the vice president of research and development for a major pharmaceutical company to encourage the development of Sytia, a new drug to control Type 2 diabetes while preventing hypoglycemia, a costly and dangerous side effect sometimes associated with currently marketed drugs.
From initial research through clinical testing to production and marketing, the team estimated the cost at more than $500 million.
After the presentation, team members fielded tough questions from the company executives and fellow researchers. Would using a placebo put the control group at risk? Is the drug intended to be more effective than existing drugs? Would a twice-daily dose be an obstacle for elderly patients, who often struggle to keep up with their medications?
Despite the team’s thorough and persuasive answers, Sytia will not be hitting the market anytime soon. That’s because the drug and the presentation about it were a role-playing exercise as part of a two-week “boot camp” that introduces students from three universities — Georgia Tech, Emory and Georgia State — to the complex process of drug development in the pharmaceutical industry.
The team members were students giving their final presentation in June, and the “vice president of research and development” was the teaching team of Mark Prausnitz and Andreas Bommarius, faculty members in Georgia Tech’s School of Chemical & Biomolecular Engineering, as well as Nina Urban from the Georgia Research Alliance.
Prausnitz said the biennial course, which was offered this summer for only the second time, is designed to put the science that the students are learning in context and to give them an overview of how it is applied in actual pharmaceutical-development situations.
“This course is a unique opportunity for students to learn — in a very short time — about the operation of a pharmaceutical company directly from the people in the industry,” he said. “It’s a unique, comprehensive and practical approach that helps the students connect what they learn in classrooms and labs with the expectations in the workplace.”
The Sytia team — ChBE graduate students Samantha Au and Andrew Tadros; ChBE postdoctoral fellow and pharmacist Yasmine Gomaa; Eirini Christodoulaki, a Tech graduate student in industrial engineering; and Taran Lundgren, a doctoral student in pharmacology at Emory — was one of five teams, each of which was charged with developing and defending the science behind a different drug to treat a particular disease.
Each team initially was provided with a detailed research article describing the early-stage development of a drug and was charged with designing an R&D program to bring that drug to market, including drug formulation, manufacturing, preclinical studies, clinical trials and even marketing.
Each day of the two-week course, a different representative of a pharmaceutical company spoke to the students in the morning about one stage of the pharmaceutical development process. During the afternoon, the student groups designed that stage of the development process for their drugs, and the company representative acted as a consultant and guide.
“The industry presenters said the day they spent here with these students was one of the most fun they have had in years,” Bommarius said. “Many of them remarked on how unusual it is for a course to cover everything from drug design to marketing, and they were impressed by the students as they talked with them about their projects.”
The students also found the class eye-opening and rewarding. Students rated it 4.7 out of 5 on a post-course survey.
In addition to teaching students the “real-world” process of pharmaceutical development, the course brought together researchers from a dozen disciplines at three universities. This interdisciplinary structure not only created a rich environment for team discussions but also built new connections among pharmaceutical researchers in metro Atlanta.