The Johns Hopkins Gazette: December 9, 2002
December 9, 2002
VOL. 32, NO. 14


Master's Program in Biotechnology Adds Concentration in Regulatory Affairs

Johns Hopkins Gazette Online Edition

The Krieger School of Arts and Sciences master's degree program in biotechnology has added a concentration in regulatory affairs, meeting demand from industry and government for staff with expertise in federal oversight and governance of the biotechnology and pharmaceutical industries.

The concentration, designed for professionals who need in-depth knowledge, focuses on the procedures and regulations that govern the manufacturing, testing and sale of new biotechnology products like drugs, vaccines, diagnostic and therapeutic technologies, and genetically engineered plants and animals.

"Federal agencies and biotech companies have made clear to us that, as the discovery phase of the biotechnology boom matures, both government and industry need experts who are well-versed in the legal, business and societal challenges of bringing discoveries to market," said Deborah Cebula, assistant dean of Arts and Sciences, who heads the school's Advanced Academic Programs.

"The fruits of biotechnology will benefit the public only when products are safely delivered to the shelves of pharmacies and supermarkets," Cebula said. "Our program is one of the first of its kind committed to educating bioscience professionals, starting from the research bench through the regulation, manufacturing and commercialization of biotechnology products."

The new concentration is the third in the Johns Hopkins master of science in biotechnology program. The others are biotechnology enterprise (business) and bioinformatics.

Lynn Johnson Langer, associate program chair, said, "The biotechnology industry is growing very rapidly, and it's commercializing many new products that must go through the regulatory system of the Food and Drug Administration. Bottlenecks in the approval process are literally costing the industry billions of dollars," she said. "In order to speed up the approval process for new therapies and diagnostics, both industry and the FDA are demanding better-trained people who fully understand the regulatory process."

In addition to Johns Hopkins faculty, instructors for the new concentration have been recruited from both industry and the government, Langer said.

"Our instructors are coming from cutting-edge research groups both at Johns Hopkins and at outside institutions like the FDA, NIH, the U.S. Defense Department, and private and public companies," Langer said.

"This program was designed based on the needs of the government and industry," Langer said. "It is a unique program, grounded in the sciences yet providing industry-relevant courses that allow students to focus on the aspects of biotechnology most important to them, with over 40 electives from which to select."

Courses are offered evenings and weekends, primarily at the Homewood campus, the Montgomery County Campus in Rockville, Md., and the Washington Center. For more information, go to or call the Office of Advanced Academic Programs at 410-516-6057 or 800-847-3330.