Biopharmaceutical Product Approval Times Dropped 21% since the 1980s, According to Tufts Center for the Study of Drug Development.Business Editors/Health/Medical Writers BOSTON--(BUSINESS WIRE)--March 11, 2003 Biopharmaceutical products are taking less time to win FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval, but longer to complete required pre-market studies, according to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. a recent analysis released today by the Tufts Center for the Study of Drug Development. According to the Tufts Center, mean approval time for new biopharmaceuticals dropped by 21% -- from 24.9 to 19.7 months -- between 1982-89 and 2000-02. During the same time, however, average clinical phase times for new biopharmaceuticals increased by 137% -- from 31.2 to 74.0 months. "The net result is that the average combined clinical and approval time for biopharmaceutical products that received FDA approval in 2000-02 was three years longer than it was in the 1980s," said Tufts Center Director Kenneth I Kenneth I (Kenneth mac Alpin), d. 858, traditional founder of the kingdom of Scotland. He succeeded his father, Alpin, as king of Dalriada (the kingdom of the Gaelic Scots in W Scotland) and c. Kaitin. On average, combined clinical and approval time for recently approved new biopharmaceuticals took 7.8 years, compared to 4.7 in the 1980s. Lengthening development times for biopharmaceutical products, Kaitin said, are due in part to the fact that development programs have become more complicated and challenging: "Two decades ago, the biotechnology industry focused on the development of products thought most likely to succeed." According to Janice M. Reichert, lead investigator on the study, more complex and innovative substances are being developed and tested today. "The majority of biopharmaceuticals approved during the 1980s were biological proteins with well-understood functions, such as Factor VIII factor VIII n. A factor in the clotting of blood, a deficiency of which is associated with hemophilia A. Also called antihemophilic factor, antihemophilic globulin, antihemophilic globulin A, , or recombinant versions, such as insulin and human growth hormone human growth hormone (HGH): see growth hormone. ," she said. Kaitin added, "Now the major challenge for the industry is to stop or, better yet, reverse the relentless trend toward longer clinical phase times." Longer development times have translated into more expensive drug development programs. According to the Tufts Center, the average drug costs $802 million to develop and bring to market. Other key findings from the Tufts Center analysis: -- Recombinant proteins Since human recombinants have replaced the animal version in human therapeutics, the prefix of "rh" for "human recombinant" appears less and less in the literature Human recombinants that replaced animal or harvested from human types -- Mean clinical phase time for recombinant DNA recombinant DNA n. Genetically engineered DNA prepared by transplanting or splicing one or more segments of DNA into the chromosomes of an organism from a different species. Such DNA becomes part of the host's genetic makeup and is replicated. (rDNA) products was 19% shorter than for monoclonal antibodies This is a list of monoclonal antibodies, antibodies which are clones of a single parent cell. When used as medications, the generic names end in -mab (see "Nomenclature of monoclonal antibodies"). (mAbs), but 13% longer than for biologics. -- Mean approval phase time for rDNA products was 72% longer than for mAbs, but 75% of mAbs were priority reviewed, whereas only 12% of rDNA products had a priority rating. About the Tufts Center for the Study of Drug Development Based in Boston, Mass., and affiliated with Tufts University Tufts University, main campus at Medford, Mass.; coeducational; chartered 1852 by Universalists as a college for men. It became a university in 1955. Jackson College, formerly a coordinate undergraduate college for women, merged with the College of Liberal Arts in , the Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. The Tufts Center conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums on related topics. |
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