New Molecular Entity (NME)

Integrating the Drug Discovery Laboratory. ‘Application of a rational approach to workflow automation can increase time for science. One of the many challenges biopharmaceutical companies face is improving the throughput of drug discovery. Despite vast sums of investment, the U.S. FDA in 2005 approved a total of 20 new molecular entities (NME), the same number as in 1974.2 In 2004, R&D spending by members of the Pharmaceutical Research and Manufacturers Association (PhRMA) was 38.8 billion U.S. dollars, an increase of 12.5 percent over 2003, and a sizable leap from the inflation-adjusted $4.1 billion spent in 1974. Based on a study in 2004, approximately 20 percent of discovery chemists’ time is spent in nonproductive activities such as manual data transcription, merging data from various sources for analysis, and writing reports and notebook entries. In essence, the scientist has become the “data integrator,” performing tasks that take time from designing and performing experiments.’

CDER New Molecular Entity (NME) Drug and New Biologic Approvals in Calendar Year 2006

New Molecular Entities: A European Comparison (PDF)

Wikipedia: New chemical entity

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