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.

Human pluripotent stem cell (hPSC)-derived models for autism spectrum disorder drug discovery.

Introduction: Autism spectrum disorder (ASD) is a prevalent and complex neurodevelopmental disorder (NDD) with genetic and environmental origins. Currently, there are no effective pharmacological treatments targeting core ASD features. This leads to unmet medical needs of individuals with ASD and requires relevant human disease models recapitulating genetic and clinical heterogeneity to better understand underlying mechanisms and identify potential pharmacological therapies.

Young Australian drinkers' awareness, perceptions and behaviours towards low alcohol beverage products.

Young Australian drinkers (aged 18-24 years) are more likely to consume alcohol at risky levels than any other age group. The increased availability and diversity of low alcohol beverages (LAB)s available to Australian consumers presents an opportunity for young drinkers to moderate their drinking behaviours. To explore young risky drinkers' awareness, perceptions and behaviours towards LAB products.

Racial disparities in length of hospitalization and systemic medication utilization in patients with psoriasis.

The growing evidence of chronic inflammation and sequelae caused by psoriasis indicates the need for systemic treatment, including biologics and conventional treatments like methotrexate. However, unconscious racial bias may lead to discrepancies in systemic medication prescription. Racial identity is also suspected to affect comorbidity and hospitalization rates in patients with psoriasis.

Evaluation of dermatologic diagnostic ability on skin of colour in preclinical medical students.

Background: Various studies have revealed that there is a disproportionately low representation of skin of colour (SOC) in medical school dermatologic curriculum and board study resources.

Methods: First-year and second-year medical students were emailed an 18-question survey regarding (1) identifying correct diagnoses of dermatologic conditions on either White skin or SOC and (2) their confidence in identifying dermatologic conditions on SOC.

Results: 15% of the images of dermatologic conditions included in the institutional preclinical curriculum show images of patients with SOC.

Accuracy of reported energy in food and beverages supplied to hospital patients.

Background: Underprovision of food energy within the hospital environment can negatively affect clinical outcomes. Hence, the supply of hospital foods/beverages and the ability to assess their calorie provision is critical. The aim of this study was to directly measure the energy density of foods/beverages supplied to patients by Gold Coast University Hospital (GCUH) foodservice and compare these to caloric values established from nutrition information panels (NIPs) on product packaging.

Trend Analysis of Industry-Sponsored Research Funding and Research Productivity in Orthopaedic Surgery Using the Open Payments Database.

Introduction Orthopedic surgery and industry work together in order to provide optimal patient care. The Open Payments Database (OPD), established in 2013, reports industry payments to physicians. This study analyzes the first five years of industry-sponsored research funding (ISRF) to orthopedic surgeons and examines research productivity's effect on ISRF.

Patient and provider attitudes regarding sudden unexpected death in epilepsy disclosure at a low-resource, minority community health center.

Background: Sudden Unexpected Death in Epilepsy (SUDEP) is a complication of epilepsy responsible for approximately 1 death per 1000 patients. The literature has demonstrated minimal SUDEP disclosure between providers and patients, although patients have consistently reported desire to know about their risk. However, the majority of these studies has been conducted in Caucasian populations which did not seek to include lower socio-economic class individuals.

Nourishing Physical Productivity and Performance On a Warming Planet - Challenges and Nutritional Strategies to Mitigate Exertional Heat Stress.

PURPOSE OF REVIEW: Climate change is predicted to increase the frequency and severity of exposure to hot environments. This can impair health, physical performance, and productivity for active individuals in occupational and athletic settings. This review summarizes current knowledge and recent advancements in nutritional strategies to minimize the impact of exertional-heat stress (EHS).

Association Between Picky Eating, Weight Status, Vegetable, and Fruit Intake in Children and Adolescents: Systematic Review and Meta-Analysis.

Picky eating is a common appetitive trait reported among children and adolescents and may have detrimental effects on their weight, vegetable, and fruit intake, impacting health status. However, an updated systematic review of the literature and summary of effect estimates is required. This study aims to explore the association between picky eating with weight, vegetable and fruit intake, vegetable-only intake, and fruit-only intake.

National Trends in Inpatient Hospital Outcomes of Children with Osteogenesis Imperfecta and the Importance of Extraskeletal Manifestations: A Kids' Inpatient Database Study.

Objective: To investigate the extent of extraskeletal manifestations along with inpatient outcomes and complications associated with osteogenesis imperfecta (OI).

Study Design: This cross-sectional study utilized the Kids' Inpatient Database as a part of the Healthcare Cost and Utilization Project to investigate inpatient hospital outcomes and management in patients with OI from 1997 through 2016. Data regarding hospital characteristics, cost of treatment, inpatient outcomes, and procedures were collected and analyzed.

A simple step to improve fat and energy delivery of human milk delivered via bottle-feeding pump: An experimental study.

Background: Enteral feeding pump systems deliver decreased amounts of macronutrients in human milk to neonates. This study determined the macronutrient loss associated with a bottle-feeding pump system and the effect of manually mixing the human milk during extended feeds.

Methods: Macronutrient content from samples of donor human milk was analyzed after simulated extended feeds with a bottle-feeding pump system, using a human milk analyzer.

Lights, Sirens, and Load: Anticipatory emergency medical treatment planning causes cognitive load during emergency response driving among paramedicine students.

Paramedics face various unconventional and secondary task demands while driving ambulances, leading to significant cognitive load, especially during lights-and-sirens responses. Previous research suggests that high cognitive load negatively affects driving performance, increasing the risk of accidents, particularly for inexperienced drivers. The current study investigated the impact of anticipatory treatment planning on cognitive load during emergency driving, as assessed through the use of a driving simulator.

The Effect of Cannabidiol on Subjective Responses to Endurance Exercise: A Randomised Controlled Trial.

Background: Exercise is known to improve health. However, it can be unpleasant, often inducing negative feelings, or 'affect'. Cannabidiol (CBD), a non-intoxicating constituent of the cannabis plant, has been reported to enhance the subjective experience of exercise; specifically, in trained individuals performing fixed-intensity endurance activity.

Evaluating possible 'next day' impairment in insomnia patients administered an oral medicinal cannabis product by night: a pilot randomized controlled trial.

Cannabis and its major constituents, Δ-tetrahydrocannabinol (THC) and cannabidiol (CBD), are being widely used to treat sleep disturbances. However, THC can cause acute cognitive and psychomotor impairment and there are concerns that driving and workplace safety might be compromised the day after evening use. Here, we examined possible 'next day' impairment following evening administration of a typical medicinal cannabis oil in adults with insomnia disorder, compared to matched placebo.

Nutrition environments in early childhood education: do they align with best practice?

Objective: To assess the comprehensiveness (scope of nutrition guidance) and strength (clarity of written language) of centre-based nutrition policies (CBNP) within early childhood education (ECE) centres. To also consider the applicability of an existing CBNP assessment tool and policy alignment with best practice food provision and feeding practices.

Design: Cross-sectional online study to assess written ECE CNBP using the Wellness Child Care Assessment Tool.

Quality evaluation of nutrition policies in early childhood education and care services in Nerang, QLD.

Issue Addressed: Food environments in early childhood, such as early childhood education and care services, influence the development of dietary patterns and behaviours that traverse into adulthood, where they affect health and longevity. Nutrition policies are mandatory in early childhood education and care services in Australia and can positively or negatively shape the food environment. However, the quality of such nutrition policies is unknown.

Predicting 5-year dementia conversion in veterans with mild cognitive impairment.

Introduction: Identifying mild cognitive impairment (MCI) patients at risk for dementia could facilitate early interventions. Using electronic health records (EHRs), we developed a model to predict MCI to all-cause dementia (ACD) conversion at 5 years.

Methods: Cox proportional hazards model was used to identify predictors of ACD conversion from EHR data in veterans with MCI.

"Honestly, they are just like us": U.S. parents choose middle-class gender and racial ingroup peers for their children.

Children and adolescents benefit from positive intergroup peer interactions, but they are unlikely to have many opportunities for these interactions if their parents are uncomfortable with them. Drawing primarily on social identity theory (SIT), this study investigated how U.S.

Impact of incidental synucleinopathy in mild cognitive impairment due to Alzheimer disease.

Recent evidence suggests that the presence of α-synuclein Lewy bodies (LBs) correlates with accelerated disease progression in patients with Alzheimer disease (AD) but it is unclear whether this effect is also exerted in the mild cognitive impairment (MCI) phase of AD. We sought to determine whether incidental LB pathology in patients with MCI due to AD is associated with a faster rate of cognitive decline compared to MCI controls without LB pathology. We identified patients within the National Alzheimer's Coordinating Center (NACC) database with MCI due to AD and stratified the cohort by the presence or absence of synucleinopathy.