USP invites qualified candidates to apply to serve as scientific experts on the Adeno-associated virus (AAV) Gene Therapy Expert Panel (EP). The purpose of this EP is to develop a new greater than <1000> General Chapter with best-practice guidelines on AAV vector design, manufacturing, quality control and regulatory considerations. The EP will also investigate suitable physical Reference Standards that would accelerate therapy development by industry and academic laboratories. There are currently two AAV-based gene therapies approved in the United States but hundreds in development. Documentary guidelines and reference standards would be a great benefit to developers.
The EP will make recommendations to and work under the direction of the Biologics and Biotechnology 5 Monographs – Advanced Therapies Expert Committee chaired by Dr. Mehrshid Alai. Candidates interested in sharing their time and expertise should have in-depth knowledge concerning the development of AAV-based therapeutics. Applicants’ curricula vitae should refer to specific examples of relevant work in these areas.
EP members will be expected to actively contribute to the writing of sections of the general chapter based on their expertise and to actively editing other sections. EP members will share current practices and review inter-laboratory study data during the development of physical reference standards. The EP is expected to meet primarily via a series of monthly teleconferences. There will also likely be a face-to-face meeting in Rockville, MD during the time span of the EP.
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