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CBER MAb WORKSHOP WILL DISCUSS RETROVIRAL CONTAMINATION

Executive Summary

CBER MAb WORKSHOP WILL DISCUSS RETROVIRAL CONTAMINATION, center director Gerald Quinnan announced at a May 15 session of the Association of Biotechnology Companies' annual meeting in Washington, D.C. Reporting on activities being sponsored by the Center for Biologics Evaluation and Research, Quinnan said that an early autumn workshop on monoclonal antibodies "definitely" will address as one topic "the relevance and the degree of the appropriate testing for retroviruses and validation procedures for retrovirus removal." The workshop will analyze ways to "facilitate product development by modifying the tortuous testing" companies are currently doing, Quinnan said. Proceedings from the workshop will be used to revise the current points to consider for monoclonal antibodies. A full agenda for the meeting, which will be cosponsored by the National Cancer Institute, has yet to be set, Quinnan reported. CBER increasingly has been using workshops as vehicles to revise points to consider documents. In March, the center cosponsored an international workshop on continuous cell lines with the National Institutes of Health. CBER is incorporating recommendations made by the conference subcommittees in an update of the 1987 continuous cell lines points to consider. Quinnan said the revised document should be available in a couple of months. A workshop on gene therapy also is being planned for late this year, although Quinnan noted that the meeting could be moved back to early in 1992. New points to consider on gene therapy are to be issued by FDA in June. In other areas, CBER plans to broaden its surveillance of promotional activities for biological products, Quinnan indicated. "One of the things we will be doing in the very near future is enhancing our capabilities on promotional advertising." Promotion will be monitored by CBER's Office of Compliance and Office of Product Certification. The center recently sent one of its first regulatory letters on promotional activities: to Lederle-Praxis for the advertising of Praxis' HibTITER Haemophilus b vaccine ("The Pink Sheet" April 1, T&G-9). Commenting on the center's ability to handle increasing regulatory responsibilities in an environment of no staffing increases, Viagene VP-Clinical Development and Regulatory Affairs Bruce Merchant, MD, noted at the meeting that, consistent with recommendations made by the Edwards Committee for FDA in general (see stories this issue, the center for biologics must prioritize its activities. Efficient surveillance of existing products and expedited review of new products, particularly for life-threatening diseases, were among the highest priorities identified by Merchant. "Indepth regulatory training for scientific review staff," should be incorporated into CBER practice, Merchant said, noting that during his 10 years at FDA he was offered only three training sessions, all unrelated to scientific review. Merchant urged that PLA and establishment licensing application reviews be streamlined to reduce the turnaround time. In addition, there should be accountability and recognition for scientific review activities, and scientific research programs should be targeted to regulatory issues, he maintained. CBER needs to de-emphasize certain areas in order to devote resources to its priorities, Merchant remarked and one area of diminishing emphasis should be non-commercial INDs. "This is a luxury that probably can no longer be enjoyed either by the public or the agency," Merchant said. He commented that non-commercial INDs have an impact on largely local populations and therefore should be reviewed by local Institutional Review Boards. Similarly, certain Phase I commercial INDs "should be handled by local IRBs that are >specilly constituted to have adequate competence in toxicology and manufacturing considerations," Merchant maintained. The Viagene exec estimated that CBER spends "probably 50%-60%" of its time on non-commercial INDs and Phase I commercial INDs, "about 50% of which never go anywhere." Lot- release testing should also be reduced, Merchant said.
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