ADVISORY/Improving Safety for Gene Therapy Patients.Business Editors ADVISORY... --(BUSINESS WIRE)--March 8, 2000 TOPIC: The Food and Drug Administration and National Institutes of Health recently announced plans to improve the safety of patients in gene therapy trials, CNN.com reported. 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. reportedly is initiating a Gene Therapy Clinical Trial Monitoring Plan, which will provide surveillance and inspections of trial sites. To ensure guidelines guidelines, n.pl a set of standards, criteria, or specifications to be used or followed in the performance of certain tasks. are being followed, the FDA will regularly request monitoring plans from sponsors of gene therapy trials. Meanwhile, the NIH "Not invented here." See digispeak. NIH - The United States National Institutes of Health. has announced it will be hosting a quarterly series of Gene Transfer Symposia sym·po·si·a n. A plural of symposium. where gene therapy researchers can publicly share their medical and scientific data. EXPERTS: ExpertSource can offer several highly qualified experts to comment on this story: Dr. Clague Hodgson, scientific director at Nature Technology Corporation, is a molecular biologist/biotechnologist with expertise in gene vector systems, such as those used in gene therapy. 402/472-6530, hodgson@natx.com Professor Clayton Smith of the Duke University Medical Center is Director of the Molecular Hematology hematology Branch of medicine concerned with the nature, function, and diseases of the blood. It covers the cellular and serum composition of blood, the coagulation process, blood-cell formation, hemoglobin synthesis, and disorders of all these. Program at the hospital's Center for Genetic and Cellular Therapies. He can comment on gene therapy research. 919-681-5255, 919-684-8111 Professor Michael J. Imperiale of the University of Michigan (body, education) University of Michigan - A large cosmopolitan university in the Midwest USA. Over 50000 students are enrolled at the University of Michigan's three campuses. The students come from 50 states and over 100 foreign countries. Medical School and is an expert on viral vectors Viral vectors are a tool commonly used by molecular biologists to deliver genetic material into cells. This process can be performed inside a living organism (in vivo) or in cell culture (in vitro). for gene therapy. 734-763-3531, 734-764-1817 ExpertSource cannot guarantee the immediate availability of these experts or their familiarity with this specific issue. ExpertSource, a collaboration of Business Wire and The Round Table Group, provides academic and industry experts to the media at no charge. Journalists are encouraged to submit queries to ExpertSource when seeking experts on specific subjects. An online registration form is available at the above web address. Business Wire's Media Resource Center provides working journalists many free media services. Please visit the BW Media Resource Center at (www.businesswire.com/media) for more information. |
|
||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion