Center for Advanced Regulatory Analysis
The Barnett Institute has established a new Center for Advanced Regulatory Analysis (CARA), which was created through a recent generous gift from the Barnett family. CARA has a mandate to invent, implement and train – all in the context of US and international biotech drug regulations, with a focus on assisting in the development and distribution of safe and effective protein based therapeutics. The technical staff of CARA include pioneers of the industry. Supported by this staff and state-of-the-art analytical instrumentation in the areas of separation sciences, mass spec- trometry and NMR, the program is indeed a center of excellence and well positioned to execute its mandate.
The training initiatives of CARA were originally based on a Memorandum of Understanding with the US-FDA where CARA is developing training modules for the agency in the area of Chemistry, Manufacturing and Control related to glycoprotein characterization. This is an exciting opportunity to help train FDA reviewers in state-of-the-art analytical technology and therefore aid in the evaluation of products produced by the biotech industry.
The specific analytical needs of the biotech industry and the agency that regulates this industry are daunting. Unlike small molecule drugs, protein based products represent highly heterogeneous and complex chemical entities to the point where the control and elucidation of drug structure represents a significant challenge to sponsors and regulators alike.
Regarding implementation, CARA operates through collaborative service agreements using a single portal into the Barnett Institute, which facilitates giving access to the broad base of skills, experience and instrumentation that exists within the organization. CARA will operate within the Barnett Institute and will also establish a core facility for collaboration and service of academic and industrial groups.
The Barnett Institute has always adapted to changing societal needs. The creation of CARA is a natural evolution of the Institute, which will continue to have as its core competence the advancement and implementation of analytical technology, as well as the training of students to produce the next generation of analytical chemists. CARA will join and collaborate with the Institute's fundamental NIH sponsored research, which remains very active.
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