ISSX 2011, Poster 170

ISSX 2011, Poster 170

Published:  14 September 2011

Temporal changes in CYP3A4 mRNA and activity following treatment of cultured human hepatocytes with interleukin-6 (IL-6): Implications for study design and endpoint selection

In recent years the focus of pharmaceutical drug development (once dominated by small molecule (NCE) therapies) has shifted and is now shared with a significant number of new therapies emerging from biological (New Biological Entities or NBE's) development. Since the approval of the first biological treatment in the United States (recombinant insulin, 1982), more than 250 biologics have reached the market, representing roughly one-quarter of all new drugs approved by U.S. and European Union authorities (Trusheim et al, 2010). Biologics include a broad range of therapies including (but not limited to) vaccines, cell or gene therapies, therapeutic protein hormones, cytokines and tissue growth factors, and monoclonal antibodies.