2024 White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation - Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics Immunogenicity Assessment & Clinical Relevance - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies).

The 18 Workshop on Recent Issues in Bioanalysis (18 WRIB) took place in San Antonio, TX, USA on May 6-10, 2024. Over 1100 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 18 WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.

2024 White paper on recent issues in bioanalysis: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA ( - Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA) - Regulatory Agencies' Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation).

The 18th Workshop on Recent Issues in Bioanalysis (18th WRIB) took place in San Antonio, TX, USA on May 6-10, 2024. Over 1100 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 18th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.

Design and early progress of the Comparison of Anticoagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA) trial.

Background: The usual antithrombotic treatment for symptomatic intracranial atherosclerotic stenosis (ICAS) consists of dual treatment with clopidogrel and aspirin for 90 days followed by aspirin alone but the risk of recurrent stroke remains high up to 12 months. The Comparison of Anticoagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA) trial was designed to determine whether other combinations of dual antithrombotic therapy are superior to clopidogrel and aspirin.

Methods: CAPTIVA is an ongoing, prospective, double-blinded, three-arm clinical trial at over 100 sites in the United States and Canada that will randomize 1683 high-risk subjects with a symptomatic infarct attributed to 70-99% stenosis of a major intracranial artery to 12 months of treatment with (1) ticagrelor (180 mg loading dose, then 90 mg twice daily), (2) low-dose rivaroxaban (2.

BSN Learning Pathways: A Leadership Collaboration to Prepare and Retain New Nurses in Specialized Practice Areas.

Current nursing shortages, particularly in complex practice or specialty areas, coupled with high attrition rates of both seasoned and new graduate nurses, have required nursing leaders to consider creative approaches to recruit, prepare and retain nurses in specialty areas. This article describes a collaborative partnership between post-secondary institutions and health authorities in one province to address the need to prepare and retain nurses in high-priority specialized areas, such as the intensive care unit or the emergency department. This partnership allows for a proactive connection that leverages the strengths and resources of both healthcare and educational institutions.

From Federal Policy to Bedside Care: A Canadian Perspective on Key Considerations for Nurse Executive Action for AI Adoption - A Commentary.

The integration of artificial intelligence (AI) into healthcare represents a paradigm shift with the potential to enhance patient care and streamline clinical operations. This commentary explores the Canadian perspective on key organizational considerations for nurse executives, emphasizing the critical role they play in fostering the establishment of AI governance structures and advancing the front-line adoption of AI in nursing practice. The discussion delves into five domains of consideration, analyzing recent developments and implications for nursing executives.

Commentary: Understanding and Disrupting Whiteness in Nursing.

for the opportunity to provide a commentary on the article, How Whiteness Shapes Nursing in Canada - What Does the Literature Say? A Rapid Review (Walker et al. 2025). I want to begin by congratulating the authors on completing a rapid review on a very important topic.

How Whiteness Shapes Nursing in Canada - What Does the Literature Say? A Rapid Review.

Globally and nationally, there has been growing understanding and acknowledgment of systemic racism and its impact as a structural determinant of health. The profession of nursing has an obligation to carefully self-examine so it does not further contribute to systemic racism. Using the National Collaborating Centre for Methods and Tools' rapid review methodology, this rapid review of the literature seeks to understand how whiteness shapes the Canadian nursing profession.

Organizational Initiatives for the Recruitment, Retention and Advancement of Black Nurses: A Rapid Review.

Introduction: Black nurses are under-represented in the Canadian nursing workforce. A legacy of discrimination and systemic barriers reinforce the under-representation of Black nurses in the nursing workforce throughout the health system.

Objective: The objective of this study was to identify and describe organizational initiatives for the recruitment, retention and advancement of Black nurses in the healthcare system.

Grounded in the Present and Anticipating the Future.

and along with it, the first issue of the () for the year 2025. We begin the year with significant and persistent health and healthcare challenges. Recently released data from the Canadian Institute for Health Information indicate that 5.

Sexual Orientation Disclosure and Strategic Navigation of Interpersonal Invisibility.

People with concealable stigmatized identities may strategically share or hide cues to their identity. They may likewise seek or avoid interpersonal invisibility (i.e.

Association between body mass index, obesity, and vulvar cancer recurrence.

Objective: The objective of this paper is to study the association between obesity and tumor recurrence in patients with vulvar cancer.

Methods: This is a retrospective study including vulvar cancer patients from 2003 to 2022. Our primary outcome was progression-free survival (PFS) stratified by status of obesity, defined as body mass index (BMI) >30.

Patterns of Treatment and Real-World Outcomes of Patients With Non-small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations Receiving Mobocertinib: The EXTRACT Study.

Background: Real-world data regarding patients with non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion (ex20ins) mutations receiving mobocertinib are limited. This study describes these patients' characteristics and outcomes.

Methods: A chart review was conducted across three countries (Canada, France, and Hong Kong), abstracting data from eligible patients (NCT05207423).

Caution when using network partners for target identification in drug discovery.

Identifying novel, high-yield drug targets is challenging and often results in a high failure rate. However, recent data indicates that leveraging human genetic evidence to identify and validate these targets significantly increases the likelihood of success in drug development. Two recent papers from Open Targets claimed that around half of FDA-approved drugs had targets with direct human genetic evidence.

Testing for myelin oligodendrocyte glycoprotein antibodies: Who, what, where, when, why, and how.

Testing for myelin oligodendrocyte glycoprotein immunoglobulin G antibodies (MOG-IgG) is essential to the diagnosis of MOG antibody-associated disease (MOGAD). Due to its central role in the evaluation of suspected inflammatory demyelinating disease, the last 5 years has been marked by an abundance of research into MOG-IgG testing ranging from appropriate patient selection, to assay performance, to utility of serum titers as well as cerebrospinal fluid (CSF) testing. In this review, we synthesize current knowledge pertaining to the "who, what, where, when, why, and how" of MOG-IgG testing, with the aim of facilitating accurate MOGAD diagnosis in clinical practice.

Validity of non-traditional measures of obesity compared to total body fat across the life course: A systematic review and meta-analysis.

IntroductionTraditional obesity measures including body mass index, waist circumference, waist-to-hip ratio, and waist-to-height ratio have limitations. The primary objective of this study was to identify and review the validity of non-traditional obesity measures, using measures of total body fat as the reference standard, that have been used across multiple life stages. MethodsWe conducted a systematic review and searched MEDLINE, Embase, and PsycINFO.

Interpretation of COVID-19 Epidemiological Trends in Mexico Through Wastewater Surveillance Using Simple Machine Learning Algorithms for Rapid Decision-Making.

Detection and quantification of disease-related biomarkers in wastewater samples, denominated Wastewater-based Surveillance (WBS), has proven a valuable strategy for studying the prevalence of infectious diseases within populations in a time- and resource-efficient manner, as wastewater samples are representative of all cases within the catchment area, whether they are clinically reported or not. However, analysis and interpretation of WBS datasets for decision-making during public health emergencies, such as the COVID-19 pandemic, remains an area of opportunity. In this article, a database obtained from wastewater sampling at wastewater treatment plants (WWTPs) and university campuses in Monterrey and Mexico City between 2021 and 2022 was used to train simple clustering- and regression-based risk assessment models to allow for informed prevention and control measures in high-affluence facilities, even if working with low-dimensionality datasets and a limited number of observations.

Exploiting the Achilles' Heel of Viral RNA Processing to Develop Novel Antivirals.

Treatment options for viral infections are limited and viruses have proven adept at evolving resistance to many existing therapies, highlighting a significant vulnerability in our defenses. In response to this challenge, we explored the modulation of cellular RNA metabolic processes as an alternative paradigm to antiviral development. Previously, the small molecule 5342191 was identified as a potent inhibitor of HIV-1 replication by altering viral RNA accumulation at doses that minimally affect host gene expression.

Liposomal Formulation of Hydroxychloroquine Can Inhibit Autophagy In Vivo.

Preclinical studies have shown that the anti-malarial drug hydroxychloroquine (HCQ) improves the anti-cancer effects of various therapeutic agents by impairing autophagy. These findings are difficult to translate in vivo as reaching an effective HCQ concentration at the tumor site for extended times is challenging. Previously, we found that free HCQ in combination with gefitinib (Iressa, ZD1839) significantly reduced tumor volume in immunocompromised mice bearing gefitinib-resistant JIMT-1 breast cancer xenografts.

Defensive Mechanisms of Likely Enhance Its Invasiveness as One of the World's Worst Alien Species.

Kunth is native to tropical America and has invaded tropical and subtropical Asia and numerous Pacific Islands. It forms dense thickets and reduces native species diversity and populations in its introduced range. This invasive vine also seriously impacts many agricultural crops and is listed as one of the world's 100 worst invasive alien species.

Combined Impact of Canada Goldenrod Invasion and Soil Microplastic Contamination on Seed Germination and Root Development of Wheat: Evaluating the Legacy of Toxicity.

The concurrent environmental challenges of invasive species and soil microplastic contamination increasingly affect agricultural ecosystems, yet their combined effects remain underexplored. This study investigates the interactive impact of the legacy effects of Canada goldenrod ( L.) invasion and soil microplastic contamination on wheat ( L.

A Review of Food-Related Social Media and Its Relationship to Body Image and Disordered Eating.

Background/objectives: Appearance-related social media, such as "thinspiration" and "fitspiration" posts, have been shown to contribute to poor body image and disordered eating. Food-related social media is becoming increasingly popular; however, far less is known about its relationship to body image and disordered eating.

Methods: The current review searched PsycNet and PubMed (Medline) for all the literature examining food-related social media and its relationship with body image and/or disordered eating outcomes.

Impact of Caffeine Intake on Female Basketball Players' Performance.

Background: This study aimed to analyze the effect of caffeine ingestion on basketball performance in semi-professional female players.

Methods: A double-blind, placebo-controlled, randomized experimental design was conducted, in two different periods separated by a week. Twelve female basketball players ingested 3 mg of caffeine/kg of body mass or a placebo.

Compact Quantum Cascade Laser-Based Noninvasive Glucose Sensor Upgraded with Direct Comb Data-Mining.

Mid-infrared spectral analysis has long been recognized as the most accurate noninvasive blood glucose measurement method, yet no practical compact mid-infrared blood glucose sensor has ever passed the accuracy benchmark set by the USA Food and Drug Administration (FDA): to substitute for the finger-pricking glucometers in the market, a new sensor must first show that 95% of their glucose measurements have errors below 15% of these glucometers. Although recent innovative exploitations of the well-established Fourier-transform infrared (FTIR) spectroscopy have reached such FDA accuracy benchmarks, an FTIR spectrometer is too bulky. The advancements of quantum cascade lasers (QCLs) can lead to FTIR spectrometers of reduced size, but compact QCL-based noninvasive blood glucose sensors are not yet available.

Characterization of RAP Signal Patterns, Temporal Relationships, and Artifact Profiles Derived from Intracranial Pressure Sensors in Acute Traumatic Neural Injury.

Goal: Current methodologies for assessing cerebral compliance using pressure sensor technologies are prone to errors and issues with inter- and intra-observer consistency. RAP, a metric for measuring intracranial compensatory reserve (and therefore compliance), holds promise. It is derived using the moving correlation between intracranial pressure (ICP) and the pulse amplitude of ICP (AMP).