Biotechnology Manufacturing Set to Realize Dramatic Improvements, According to Tufts Center for the Study of Drug Development.Business Editors/Health/Medical Writers BOSTON--(BUSINESS WIRE)--Jan. 23, 2003 Biotechnology manufacturing is set to realize dramatic improvements as new facilities go online, easing the bottleneck in production capability, 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. the Tufts Center for the Study of Drug Development. 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 said that approval success rates are likely to increase and clinical development times likely to decrease as additional information from genomics and proteomics provides more target compounds. "Better screening technologies will enable biotech companies to identify promising molecules earlier in the R&D cycle and weed out those that are unlikely to bear fruit," Kaitin said. "These advances will allow biotech companies to be more selective about which products to take into clinical development." Kaitin made his comments in connection with the Tufts Center's newly released Outlook 2003 briefing on major expected, near-term pharmaceutical industry trends. He also noted that although major legislative initiatives in recent years have helped reduce approval times for biopharmaceuticals, "Firms still need to work closely with the 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. to shorten clinical development times." According to the Tufts Center's Outlook 2003 report: -- Short-term delays in biologics license application approvals might occur as FDA review of therapeutic biopharmaceutical products shifts from the FDA's Center for Biologics Evaluation and Research The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the Food and Drug Administration, which is in the United States Department of Health and Human Services. to its Center for Drug Evaluation and Research The Center for Drug Evaluation and Research is a division of the FDA that deals with the approval of drugs. CDER reviews New Drug Applications to ensure that the drugs are safe and effective. It is one of five Centers at the United States Food and Drug Administration. (CDER CDER Center for Drug Evaluation and Research (US FDA) CDER Centre de Développement des Energies Renouvelables (French) CDER Client Development and Evaluation Report ). -- CDER's authority over biopharmaceutical reviews will intensify examination of the regulatory and legal framework surrounding generic biologics. Scientific advances associated with proteomics might be the key that unlocks the door to generic biopharmaceutical products. -- Assuming 70% of the products currently in Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA study are successfully completed, CDER can expect 35 additional new applications over the next one to three years. 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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