Bioanalytical Pharmacokinetics (PK) methods are designed for robust performance under rigorous regulatory compliance requirements to ensure the generated data is reliable and maintains integrity. In a phase 1 dose-finding clinical study, aberrant PK profiles of two co-administered biologics drugs were observed. Unexpectedly, we discovered high fill levels in collection tubes from the majority of samples. This led to the hypoth...

Urbanization in temperate climates often advances the beginning and peak of biological events due to multiple factors, especially urban heat islands. However, the effect of urbanization on insect phenology remains understudied in more tropical areas, where temperature may be a weaker phenological cue. We surveyed moths across an urban gradient in a subtropical city weekly for a year to test how impervious surface and canopy co...

Immunogenicity evaluation is a critical part of drug development. Regulatory guidelines from multiple health agencies provide recommendations for the development and validation of anti-drug antibody (ADA) assays to assess immunogenicity in clinical trials. These recommendations primarily describe an ADA method run in one bioanalytical laboratory supporting a biotherapeutic molecule; however, there are increasing instances that...

Recent work has shown the decline of insect abundance, diversity and biomass, with potential implications for ecosystem services. These declines are especially pronounced in regions with high human activity, and urbanization is emerging as a significant contributing factor. However, the scale of these declines and the traits that determine variation in species‐specific responses remain less well understood, especially in subtr...

RO7297089, an anti-B-cell maturation antigen (BCMA)/CD16A bispecific tetravalent antibody, is being developed as a multiple myeloma (MM) therapeutic. This study characterized nonclinical pharmacokinetics (PK), pharmacodynamics (PD), soluble BCMA (sBCMA), and soluble CD16 (sCD16) changes following administration of RO7297089 to support clinical trials. Unbound and total RO7297089 concentrations were measured in cynomolgus monke...

Purpose of Review “I can’t breathe” were the last words spoken by Eric Garner (July 17, 2014), Javier Ambler (March 28, 2019), Elijah McClain (August 30, 2019), Manuel Ellis (March 3, 2020), and George Floyd (May 25, 2020). These were all African American men who died at the hands of police in the United States. Recently, police brutality has gained critical and overdue attention as one clear manifestation of systemic racism....

A year‐long acoustic survey for critically endangered North Atlantic right whales was conducted at two sites on the central and western Scotian Shelf. Autonomous hydrophones recorded sound continuously from July 2004 to August 2005. Right whale contact calls (upcalls) were identified using automatic recognition software, and the resulting detections were checked manually. Substantial numbers of hours with upcalls were observed...

The patterns and mechanistic controls of fine root production and mortality in a 19-year-old longleaf pine (Pinus palustris Miller) plantation were assessed using minirhizotrons in a complete factorial design experiment that manipulated root carbon source and sink strengths. Carbon source strength to roots was manipulated through foliar scorching, carbon sink strength in roots was altered via nitrogen fertilization, and carbon...