Pharmaceutical Expert Available to Comment On: Sharp Rise in Number of Clinical Drug Trials and Patients' Exposure to Experimental Drugs.
PALO ALTO Palo Alto, city, California
Palo Alto (păl`ō ăl`tō), city (1990 pop. 55,900), Santa Clara co., W Calif.; inc. 1894. Although primarily residential, Palo Alto has aerospace, electronics, and advanced research industries. , Calif.--(BW HealthWire)--Aug. 3, 1998--The trade association that represents the U.S. pharmaceutical and biotechnology industries recently reported that the average number of clinical trials per New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) has more than doubled -- from 30 to 68 -- from 1981-84 to 1994-95. During this same time period, the average number of patients participating in clinical evaluation clinical evaluation Medtalk An evaluation of whether a Pt has symptoms of a disease, is responding to treatment, or is having adverse reactions to therapy of an experimental drug has risen from 1,321 to a staggering 4,237. These increases can be partially attributed to the growing complexity of new drug compounds and increasing regulatory guidelines guidelines,
n.pl a set of standards, criteria, or specifications to be used or followed in the performance of certain tasks. .
In its 1998 Industry Report, the Pharmaceutical Research and Manufacturers of America Pharmaceutical Research and Manufacturers of America (PhRMA) is an industry trade group representing the pharmaceutical research and biotechnology companies in the United States. (PhRMA) estimates that pharmaceutical companies will invest more than $20 billion in research and development this, a 10% increase from 1997. Currently, it costs about $500 million and 15 years to bring a new drug to market, with clinical trials accounting for approximately one-half of the time and one-third of the cost required. In an effort to streamline the number of clinical trials -- and reduce the number of patients exposed to experimental drugs during these trials, pharmaceutical and biotech bi·o·tech
short for biotechnology
Noun 1. companies are turning to the high-tech world of computer simulation for help.
Stuart Koretz, MD, PhD, vice president of medical affairs and business development, for Pharsight is available to comment on the R&D challenges pharmaceutical and biotechnology industries are facing. Dr. Koretz has more than 15 years of experience in drug development across a broad range of therapeutic areas. He was previously vice president, new products discovery, at ALZA Corporation, where he focused on utilizing advanced delivery systems to improve the performance of drugs.
Pharsight Corporation, located in the midst Adv. 1. in the midst - the middle or central part or point; "in the midst of the forest"; "could he walk out in the midst of his piece?"
midmost of Silicon Valley and Biotech Bay, provides drug companies with computer-assisted trial design (CATD CATD Confederación Auténtica de Trabajadores Democráticos (Authentic Confederation of Democratic Workers, Costa Rica)
CATD Corrective Action Tracking Document
CATD Combat Aviation Test Division ) software to design better, and eventually fewer, clinical trials. Pharsight's Trial Designer technology allows researchers to assess proposed clinical studies and determine which will be the most effective and least costly trial. By designing more efficient trials, Pharsight's technology can reduce the number of clinical studies performed per NDA and lessen the number of patients' exposed to experimental drugs. Glaxo Wellcome and Parke Davis are currently using Pharsight's software.
To schedule an interview with Dr. Koretz, please contact Laura Koziol or Gavin Skillman at Schwartz Communications, Inc., at 415/512-0770.
CONTACT: Schwartz Communications, Inc. Laura Koziol or Gavin Skillman, 415/512-0770