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Executive Summary

FDA plans to divide the Division of Biological INDs into three working groups: blood and thrombolytic products; vaccines, allergenics and test kits; and cytokine products. The division's acting director Donald Burlington, MD, reported on the organizational changes during a presentation to the annual meeting of the Regulatory Affairs Professionals Society on Sept. 28. The new organization is designed to facilitate communications with sponsors, Burlington explained. "By breaking things into a little finer structure we can [put] you more directly in contact with the individuals who will be handling the applications on a day-to-day basis." Burlington added that the clarification of duties in the IND division may also improve contact with the other FDA biologic activities. "It will also facilitate coordination between the IND, Product Certification Division, and the research divisions," he said. Three medical officers in the biological IND division have been designated as group leaders of the subunits, Burlington said. Curtis Scribner, MD, will head the group that will handle IND applications for blood and thrombolytic products. The group dealing with cytokine IND applications will be led by Freddie Hoffman, MD. The division's Deputy Director Janet Woodcock, MD, will be in charge of the unit handling INDs for vaccines, allergenic products, and test kits. In addition, CBER's Product Certification Division also will be divided into two subgroups, Burlington reported. One group, which will deal with product license applications for blood products and test kits, will be led by Mary Gustafson, a consumer safety officer. The other section will oversee product license applications for cytokines, vaccines and allergenics. It will be headed by consumer safety officer Sharon Risso. The separation of responsibilities within the IND and product applications group is still at the proposal stage at FDA. The plan must be approved by the Center for Biologics Evaluation and Research Director Paul Parkman, MD. In response to the increasing level of biotech product applications being submitted to the agency, the two divisions will attempt to recruit three to four more staffers each, Burlington noted. Each division currently has about 20 staff members. The current figures represent a doubling in staff manpower over the last two years. Burlington projects that the Center for Biologics Evaluation and Research (CBER) will review 30 to 40 product license applications for biological products over the next three to four years. The expected number of product license applications is an indication of the fact that FDA has approved "two or three major new therapeutic products per year over the last five years or so," Burlington pointed out. FDA calculates that more than 120 biological products for therapeutic use are being actively investigated by companies. Burlington noted that among monoclonal antibodies alone there are about "1,000 discernable products currently under clinical study," and 50 or so of these represent products actively being pursued by sponsors. Some of these in vivo products are patient-specific monoclonal antibodies, which account for the large number in clinicals," Burlington said. The influx of biotech applications is causing the newly formed Division of Cytokine Biology to project a 40% increase in its current staff of 34 scientists over the next few years, the division director Kathryn Zoon, PhD, said. She noted that the division is "currently recruiting in both the area of cytokines and growth factors."

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