Drug tolerance (DT) is a critical attribute of anti-drug antibody (ADA) assays for assessing clinical immunogenicity. We present a unique situation where a previously approved commercial product, atezolizumab, required re-assessment of the assay DT to meet an increased drug exposure demand arising from a new route of administration (subcutaneous) and align with updated health authority (HA) regulations. Rather than redevelop t...

Bevacizumab is a humanized monoclonal antibody (mAb) approved to treat various cancers in adults and was investigated in pediatric patients. While the drug development of small molecules in pediatrics has greatly benefited from the use of physiologically-based pharmacokinetic (PBPK) modeling for pharmacokinetic (PK) extrapolation, such application remains relatively limited in mAbs. In this study, our objective was to evaluate...

Model-based meta-analysis (MBMA) is a quantitative approach that leverages published summary data along with internal data and can be applied to inform key drug development decisions, including the benefit-risk assessment of a treatment under investigation. These risk–benefit assessments may involve determining an optimal dose compared against historic external comparators of a particular disease indication. MBMA can provide a...

Purpose Fenebrutinib (GDC-0853), a Bruton’s tyrosine kinase (BTK) inhibitor was investigated in a Phase 2 clinical trial in patients with rheumatoid arthritis (RA). Our aim was to apply a model-informed drug development (MIDD) approach to examine the totality of available clinical efficacy data. Methods Population pharmacokinetics (popPK) modeling, exposure-response (E-R) analysis, and model-based meta-analysis (MBMA) of feneb...