Gene/somatic cell AIDS therapy practicum to be held Sept. 13-14; FDA public workshop on HIV trials Sept. 6-8.
GENE/SOMATIC CELL AIDS THERAPY PRACTICUM TO BE HELD SEPT. 13-14 by a subcommittee of the National Task Force on AIDS Drug Development is designed as a hands-on workshop focusing on how protocols move through the Center for Biologics Evaluation & Research investigational new drug process and through the National Institutes of Health Recombinant DNA Advisory Committee. In addition to CBER and RAC protocol approvals, issues to be discussed during the two-day workshop will include gene therapy and somatic cell therapy, changes in vectors employed in protocols, preclinical efficacy and toxicology testing, trial design and patient follow-up, Good Manufacturing Practices regulations, an overview of the RAC and a series of case studies.
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