Northeastern’s graduate
programs in biotechnology experienced remarkable growth
in the first decade of the 21st century. A key part
of this growth was the launch, with support from the
Sloan Foundation, of Professional Science Master’s
(PSM) programs in bioinformatics, biotechnology, and,
in 2010, biopharmaceutical regulatory science.
Regulatory science encompasses the scientific and
technological basis for production, regulatory approval,
and subsequent monitoring of biopharmaceutical substances.
The discipline is different from regulatory affairs,
which is concerned with the development and enforcement
of regulations through clearly defined administrative
protocols. It is also distinctive from the research
and development that supports drug discovery and development.
Students study protein and carbohydrate chemistry,
bioprocess engineering, immunology and immunogenicity,
and analysis and characterization methodologies in
both classroom and laboratory settings. These technical
courses are augmented with business courses in regulatory
issues, business, communications, and how to succeed
in a regulated workplace. Students acquire the core
competencies necessary to prepare them for highly valued
positions in the biotech and pharmaceutical industries
and in government agencies such as the FDA. |