Validation of an LC-MS/MS method for assessment of fenbendazole sulfone drug residue in northern bobwhite liver.

The Northern Bobwhite (Colinus virginianus) is an economically important game bird within the Rolling Plains Ecoregion. Within this region, bobwhite is experiencing extreme cyclic population fluctuations which are resulting in a net decline in total population. It is suspected that within this region two helminth parasites, an eyeworm (Oxyspirura petrowi) and a cecal worm (Aulonocephalus pennula), are contributing to this phenomenon. However, this has been difficult to study as the primary mode of investigation would be the deployment of anthelmintic treatment. Unfortunately, no registered treatments for wild bobwhite currently exist. Thus, utilizing an anthelmintictreatment for wild bobwhite would require registration of that treatment with the U.S. Food and Drug Administration (FDA). As bobwhite are game birds that are hunted, they are considered food-producing animals to the FDA, and as such require the assessment for the withdrawal of the drug residues to be assessed for human food safety. In this study, we optimized and validated a bioanalytical method for the quantification of fenbendazole sulfone in bobwhite following the U.S. FDA Center for Veterinary Medicine Guidance for Industry #208 [VICH GL 49 (R)] for assessment of fenbendazole sulfone drug residue in Northern bobwhite liver. The official method for quantifying fenbendazole sulfone in domestic chicken (Gallus gallus) was adapted for use in bobwhite. The validated method quantitation range is 2.5-30 ng/mL for fenbendazole with an average recovery of 89.9% in bobwhite liver.

Cardiac Resynchronization Therapy: US Trends and Disparities in Utilization and Outcomes.

BACKGROUND: The use of cardiac resynchronization therapy (CRT) has increased significantly since its initial approval in 2001 for use in patients with advanced heart failure. However, trends in utilization of CRT have not been systematically characterized. METHODS AND RESULTS: We used the Nationwide Inpatient Sample database to identify all patients with CRT implantation during 2002 to 2010. The overall trends in CRT device implantation, patient characteristics, and outcomes were examined in detail and compared among demographic subgroups. During 2002 to 2010, a total of 374,202 CRT procedures were recorded. Significant and persistent gender and racial disparities favoring men (71.4%) and white (79.6%), respectively, were noted in all years. The highest number of CRT devices were implanted in the 65- to 84-year age group (64.6%), with significant increase in number of CRT implants in older patients ≥ 85 years over the years (P = 0.02). The CRT-associated in-hospital mortality improved from 1.08% in 2003 to 0.70% in 2010 (P = 0.03). The correlates of higher mortality included males (0.93% versus 0.71% in females; P = 0.04) and older age (age ≥ 85 years had 1.5% mortality versus 0.8% for age < 85 year; P < 0.001). The mean hospital length of stay for CRT decreased, while mean CRT-associated hospital charges increased progressively over the years. Factors associated with higher charges were gender (males > females), older age, and greater comorbidities. CONCLUSIONS: CRT implantation is a relatively safe procedure that has become safer in higher risk patients. However, significant disparities in CRT utilization exist in certain demographic subgroups, and these disparities have persisted across the years.

University - industry collaborations: models, drivers and cultures.

The way academic institutions and pharmaceutical companies have been approaching collaborations has changed significantly in recent years. A multitude of interaction models were tested and critical factors that drive successful collaborations have been proposed. Based on this experience the current consensus in the pharmaceutical industry is to pursue one of two strategies: an open innovation approach to source discoveries wherever they occur, or investing selectively into scientific partnerships that churn out inventions that can be translated from bench to bedside internally. While these strategies may be intuitive, to form and build sustainable relationships between academia and large multinational healthcare enterprises is proving challenging. In this article we explore some of the more testing aspects of these collaborations, approaches that various industrial players have taken and provide our own views on the matter. We found that understanding and respecting each other's organisational culture and combining the intellectual and technological assets to answer big scientific questions accelerates and improves the quality of every collaboration. Upon discussing the prevailing cooperation models in the university - industry domain, we assert that science-driven collaborations where risks and rewards are shared equally without a commercial agenda in mind are the most impactful.