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.

Cohort profile: the BangladEsh Longitudinal Investigation of Emerging Vascular and nonvascular Events (BELIEVE) cohort study.

Purpose: Bangladesh has experienced a rapid epidemiological transition from communicable to non-communicable diseases (NCDs) in recent decades. There is, however, limited evidence about multidimensional determinants of NCDs in this population. The BangladEsh Longitudinal Investigation of Emerging Vascular and nonvascular Events (BELIEVE) study is a household-based prospective cohort study established to investigate biological, behavioural, environmental and broader determinants of NCDs.

Gait during community ambulation and laboratory-based walking in people with mild traumatic brain injury.

Background: Gait impairments are common in individuals with mild traumatic brain injury (mTBI), presenting in the acute phase and often persisting in subtle ways over time. Despite the prominence of laboratory gait evaluations, a comprehensive understanding of gait deficits post-mTBI necessitates the examination of various gait domains in real-world environments. Assessing gait during a community ambulation task (CAT) may capture real-world challenges and influence focused interventions or rehabilitation in individuals with mTBI.

Ward-Based Staff Perspectives on Their Preparedness to Recognize Patient Deterioration: An Interpretive Description Study.

Background: Despite an overall decline in serious adverse events in hospitalized patients, approximately one third of inpatient mortality continues to relate to adverse events impacting patients on general wards. The preparedness of nurses, midwives, and nursing assistants (collectively referred to as ward-based staff) to recognize patient deterioration is therefore seen as critical.

Purpose: The aim of this study was to explore ward-based staff perspectives regarding their preparedness to recognize patient deterioration.

Surgical Site Infection After Sacral Neuromodulation: Impact of Postoperative Antibiotics.

Importance: There are limited data to guide practices to reduce surgical site infections following sacral neuromodulation; however, many surgeons prescribe prophylactic postoperative antibiotics after device implantation.

Objective: The aim of the study was to compare the proportion of patients with sacral neuromodulation device-associated surgical site infections after use of prophylactic postoperative antibiotics versus none.

Study Design: This was a multicenter retrospective cohort study of patients undergoing sacral neuromodulation device implantation at 11 institutions from January 2014 to December 2023, comparing outcomes in patients who did versus did not receive prophylactic postoperative antibiotic treatment.