IQ Survey Results on Current Industry Practices-Part 1: Immunogenicity Risk Assessment.

An immunogenicity risk assessment (IRA) is a relatively new expectation of health authorities that is increasingly incorporated into the drug development process across the pharmaceutical/biotech industry. The guiding principle for an IRA includes a comprehensive evaluation of product- and patient-related factors that may influence the immunogenic potential of a biotherapeutic drug and a potential action plan. The Immunogenicity Working Group from the IQ Consortium (Clinical Pharmacology Leadership Group) has conducted a survey to understand the current practices for conducting IRAs and relevant aspects of bioanalysis.

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.

Effect of lactation feeder design on sow and litter performance, feeder cleaning criteria, and economic return.

A total of 557 mixed parity sows (PIC 1050) were used to evaluate the effect of lactation feeder design on sow farrowing performance, litter growth performance, feeder cleaning criteria, and economics. The experiment was conducted during the summer of 2023 at a commercial sow farm located in northwest Texas. The study used two sequential farrowing groups with approximately 279 sows per group.

The effects of dacitic (rhyolitic) tuff breccia and corn distillers' dried grains with solubles (DDGS) inclusion on pellet mill electrical efficiency, production rate, and subsequent pellet quality.

Two experiments were conducted to evaluate the effect of Azomite (AZO) and 30% distillers' dried grains with solubles (DDGS) on pellet mill (PM) electrical consumption (kWh/MT), production rate, and pellet quality. Experiment 1 was conducted as a 2 × 2 × 2 factorial with main effects of diet formulation (0% or 30% DDGS), PM (1 or 2), and AZO (0% or 0.25%) with 4 replications per treatment.

The Provision and Utilization of Telehealth within Academic Mental Health Clinics in North America during the COVID-19 Pandemic.

Objective: To document the experience of 14 academic child and adolescent psychiatry programs in transitioning to and managing telehealth services during the COVID-19 pandemic. The goal was to understand how programs adopted and sustained telehealth during the pandemic. Telehealth was defined as services delivered via videoconferencing and telephony.