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Executive Summary

FDA's Center for Biologics Evaluation and Research will gain 50 new reviewers, Commissioner Kessler told center staff at a special March 4 meeting to announce the appointment of Cytokine Biology Division Director Kathryn Zoon, PhD, as director of the agency's biologics center. CBER "intends to begin recruiting immediately 50 new scientific reviewers of biotechnology products," Kessler said. The new personnel will run the gamut from laboratory researchers to medical officers. Observing that "many new products are on the way and this agency must be ready to evaluate them thoroughly and efficiently," Kessler asserted that the agency "will be ready." The addition of 50 new reviewers is "only the beginning," Kessler remarked, noting that "it is all we can get out of the budget right now." Funding for the new recruits is expected to come out of FDA appropriations for biologics, which increased by $13 mil. from $79 mil. in FY 1991 to $92 mil. in FY 1992. FDA already has increased the staffing of the center by almost 13% as called for in the agency's appropriations justifications from last year ("The Pink Sheet" April 29, 1991, T&G-14). The review staff additions proposed by Kessler would increase the number of scientists devoted specifically to biotechnology projects by an estimated 20%. The center plans to attract the new researcher/reviewers through recruitment efforts at universities, journal announcements and professional association meetings. Reportedly, there already exists a pool of scientists interested in working for CBER from which candidates could be readily drawn. Some new reviewers might also come over from the Center for Drug Evaluation & Research. FDA is also looking at expanding its fellowship program for young researchers, FDA Senior Advisor for Science Elkan Blout, PhD, told biotech industry members at the March 5 annual meeting of the Massachusetts Biotechnology Council in Boston. Although fellowships usually are extended to scientists from academia, Blout suggested that young scientists from some of the biotech companies "might benefit from spending a year or two actually working the FDA and seeing how it operates." Kessler, who announced publicly the plan to hire 50 new review scientists at the MBC meeting, cited other steps CBER is taking to facilitate the speedy market approval of biotech products. The FDA commissioner noted that the agency is "hard at work implementing the important proposals" issued by Vice President Quayle's Competitiveness Council last November. He observed that "many of the areas are applicable to products of biotechnology, such as: accelerated drug review; new management reforms and procedures; and innovative use of information systems." The agency broke ground six weeks ago for a new state-of-the- art CBER research facility that will be dedicated to the evaluation of AIDS therapies and biotechnology products, Kessler told the industry group. He also pointed to the new agreement between CBER and CDER to collaborate on reviews that are considered both drugs and biologics. Another example of the agency's efforts to expedite the review process is the recent establishment of an industry/CBER working group "to review various manufacturing and licensing issues." The group met for the first time last month to discuss mechanisms to expedite and streamline the review process. While Kessler publicly announced the appointment of Kathryn Zoon, PhD, as the new director of CBER at the MBC meeting, she was introduced to center staff by FDA Deputy Commissioner for Operations Jane Henney, another relatively recent appointment of Kessler's. Henney told CBER staff that the former cytokine division director "stood out" among other promising candidates for the position. Noting that Zoon had broad support among her peers in the scientific community and industry during the selection process, Henney said that these groups expressed admiration for Zoon's scientific rigor, "her ability to go 'toe-to-toe' with anyone on scientific issues," and her "flexibility and openness in solving problems." In her first address as CBER director, Zoon outlined how she intends to meet the challenges of an increasing number of biotechnology product reviews. "The best way to regulate biological products is establishing and supporting strong scientific programs in which the scientists who are actively involved in the research perform the reviews of these products and participate in the development of policies," Zoon said. "Equally important is to have a strong vital program in pharmacology as well as in clinical trials design and evaluation to accomplish our mission." Within a few weeks, CBER will begin an effort to streamline the center's review process, Zoon announced. "This topic will be the main focus in the upcoming weeks of the CBER listening initiative followed by a senior CBER staff go-away," she said. Listening groups and management retreats have been used by CDER as a means of developing new policy initiatives. At the staff meeting, Kessler thanked former CBER Acting Director Gerald Quinnan, MD, for his contributions to the center and the agency. Kessler highlighted Quinnan's efforts in assuring the safety of the blood supply, his involvement in the development of the National Vaccine Program and his stewardship during the licensing of several important biologic products. The commissioner called Quinnan "the mainstay for [CBER] during a pivotal time of transition." Quinnan was not present to hear Kessler's remarks; he was attending an international vaccine meeting in Russia. Kessler also voiced the agency's appreciation for the role that Janet Woodcock, MD, has played as acting deputy director of the center. Woodcock has been "always a driving force" in policy decisions at CBER, the commissioner noted, and "will continue in various prominent roles at the center." Woodcock's permanent position is that of director of the Biological IND Division, but she is expected to continue to contribute to top management policy-making. Cytokine Biology Division Deputy Director Susan Vargo, PhD, will take over as acting director of the division awaiting the agency's selection of a new director. Potential candidates for that post include the division's current laboratory directors: Teresa Gerrard, MD; Jay Seigal, MD; and Micahel Norcross, MD.

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