Open AccessModel‐Based Discovery and Development of Biopharmaceuticals: A Case Study of Mavrilimumab
Author(s) -
Wang Bing,
Wu ChiYuan,
Jin Denise,
Vicini Paolo,
Roskos Lorin
Publication year - 2018
Publication title -
cpt: pharmacometrics and systems pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 37
ISSN - 2163-8306
DOI - 10.1002/psp4.12245
Subject(s) - drug development , process development , biopharmaceutical , drug discovery , computational biology , monoclonal antibody , clinical efficacy , medicine , drug , computer science , pharmacology , bioinformatics , biology , engineering , immunology , antibody , microbiology and biotechnology , process management
Drug development is a lengthy, costly process with low probability of success. Biopharmaceuticals are highly specific molecules, with efficacy and safety closely tied to target biology and pharmacology. The “learning−predicting−confirming” continuum by translational and clinical modeling and simulation (M&S) was implemented at every decision point for mavrilimumab, a human monoclonal antibody in development for rheumatoid arthritis (RA). This tutorial uses mavrilimumab as an example to demonstrate rational discovery, preclinical development, clinical study design, and dose selection of biotherapeutics by M&S.