Biotechnology Advances Have Improved R&D Success Rates, According to Tufts Center for the Study of Drug Development.BOSTON -- Advances in biotechnology R&D, which are driving new product development and improving success rates, will result in nearly 50 new biotech medicines receiving market approval from the U.S. Food and Drug Administration (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. ), 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 study released today by the Tufts Center for the Study of Drug Development. Based on its analysis of approval success rates for new biopharmaceuticals, the Tufts Center estimates that of approximately 250 protein-based therapeutic products currently in development worldwide, 33 recombinant protein recombinant protein Molecular biology A protein encoded by recombinant DNA or generated from a recombinant gene. See Recombinant pharmacology. (rDNA) and 16 monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing (mAb) therapeutics are likely to receive market approval from the FDA. "Biotechnology advances made during the late 1980s and the 1990s allowed researchers to design novel products, which have led to an expansion in the number and variety of recombinant products in clinical study and an increase in success rates," noted 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. "Development of mAb therapeutics, particularly those based on human genes, has also progressed significantly, with much higher success rates than murine murine /mu·rine/ (mur´en) pertaining to, derived from, or characteristic of mice or rats. mu·rine adj. , or mouse-based, products." He said the bulk of new biotech product development will focus on treating oncologic, immunological, and cardiovascular/hemostasic diseases. The Tufts Center's analysis, summarized in its March/April Tufts CSDD CSDD Center for the Study of Drug Development (Tufts University) CSDD Celu Satiksmes Drošibas Direkcija (Latvian: Central Department of Traffic Safety) CSDD Computer Software Design Description Impact Report, also found that: * rDNA therapeutics entering clinical study during 1990-97 had success rates of 35%, a 35% increase over success rates for those entering study during 1980-89. * Immunological chimeric chi·mer·ic adj. 1. Relating to a chimera. 2. Composed of parts of different origin. mAbs and humanized mAbs for oncology indications had success rates greater than 30%. * Safety, efficacy, and commercial issues are the primary reasons for termination of protein therapeutics during the clinical phase of development. * Maintaining or improving future success rates of new biotech products will depend on novel molecular engineering, intellectual property protection, and efficient manufacturing. About the Tufts Center for the Study of Drug Development The Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) at Tufts University 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, based in Boston, conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums on related topics, and publishes the Tufts CSDD Impact Report, a bi-monthly newsletter providing analysis and insight into critical drug development issues. |
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