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: 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.

The Current Applications of Metabolomics in Understanding Endometriosis: A Systematic Review.

Endometriosis is a common gynecological disease that affects approximately 10-15% of reproductive-aged women worldwide. This debilitating disease has a negative impact on the quality of life of those affected. Despite this condition being very common, the pathogenesis is not well understood.

Optimising investigative pathways in military medicine: operational impact of a military cardiopulmonary exercise testing clinic.

Introduction: Abnormal cardiorespiratory symptoms and investigative findings in service personnel typically result in prolonged investigation and occupational restriction. This analysis aimed to assess the impact of the xford ilitary Cardiopulmonary xercise Testing linic (OMEC), which investigates such symptoms and findings, on occupational recommendations.

Methods: A service evaluation was conducted on all OMEC attendances over a 5-year period.

A comprehensive review of clinical experiences and extracurricular activities for US premedical students applying to osteopathic medical schools.

Context: The healthcare industry faces a critical shortage of qualified physicians. To address this growing concern, medical schools nationwide are increasing their efforts to recruit and train premedical students to fill this gap. Those efforts include adequately preparing premedical students with the competencies and skills to meet the application requirements and gain acceptance to the medical school of their choosing.