Effects of narrow linear clearings on movement and habitat use in a boreal forest mammal community during winter.

Linear clearings for human activities cause internal fragmentation of otherwise intact native forest, with many potential impacts on wildlife. Across a boreal forest region of some 4,000 km2, we investigated how movements and habitat use of ecologically different mammal species are affected by narrow (about eight m) seismic line (SL) clearings associated with fossil fuel extraction, which form extensive networks many kilometers long. We conducted nine repeat snow track surveys during three winters at 14 pairs of one-kilometer transects, each comprising one transect along the SL and a second running perpendicular into adjacent forest. Data for 13 individually-analyzed mammal taxa (species or sets of closely related species) and five mammal groups, categorized based on body size-diet combinations, showed that movements across transects were either unaffected by SL clearings (relative to continuous forest) or restricted only slightly. However, these clearings were favored for linear travel by most species and body size-diet groups (excepting small mammals). The strength of this preference varied in a manner consistent with species' differing needs to move long distances (associated with their energetic requirements): large predators > large herbivores > mid-sized predators > mid-sized herbivores > small mammals. In terms of overall habitat use, large-bodied predators (e.g., wolves and coyotes) strongly selected SL clearings over forest, medium-sized predators (e.g., mustelids) and medium-sized herbivores (e.g., hares and squirrels) preferred forest, and neither large herbivores nor small mammals had a clear habitat preference. Consequently, there was a net shift in both species and trophic composition within the SL, in favor of large predators and away from medium-sized predators and herbivores. Given the high regional SL density (1.9 km/km2) such shifts are likely to have complex ecological consequences, of currently unknown magnitude.

9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks.

The 9th GCCClosed Forum was held just prior to the 2015 Workshop on Recent Issues in Bioanalysis (WRIB) in Miami, FL, USA on 13 April 2015. In attendance were 58 senior-level participants, from eight countries, representing 38 CRO companies offering bioanalytical services. The objective of this meeting was for CRO bioanalytical representatives to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues selected at this year's closed forum include CAPA, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, and ELNs. A summary of the industry's best practices and the conclusions from the discussion of these topics is included in this meeting report.

Recommendations on biomarker bioanalytical method validation by GCC.

The 5th GCC in Barcelona (Spain) and 6th GCC in San Antonio (TX, USA) events provided a unique opportunity for CRO leaders to openly share opinions and perspectives, and to agree upon recommendations on biomarker bioanalytical method validation.

Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC).

An open letter written by the Global CRO Council for Bioanalysis (GCC) describing the GCC survey results on stability data from co-administered and co-formulated drugs was sent to multiple regulatory authorities on 14 December 2011. This letter and further discussions at different GCC meetings led to subsequent recommendations on this topic of widespread interest within the bioanalytical community over the past 2 years.