Opportunities and insights from pharmaceutical companies on the current use of new approach methodologies in nonclinical safety assessment.

Sharing New Approach Methodology (NAM)-based regulatory experiences is crucial for improving human risk assessment and reducing animal use in drug safety testing. To foster broader adoption, the Biotechnology Innovation Organization surveyed companies about NAM usage and collected case studies showcasing NAM-based regulatory filings for biotherapeutics, where NAMs replaced large animal studies for safety assessment. These scientifically justified approaches were generally accepted by global health authorities, particularly in the context of species relevance limitations, prior target modulation experience, and/or when addressing severe disease.

A Randomized Controlled Trial of Ergonomic Risk in Pediatric Adenotonsillectomy.

Objective: This study aims to compare the intraoperative ergonomics of tonsillectomies and adenoidectomies performed in seated versus standing positions for pediatric otolaryngology residents and attending physicians.

Study Design: A randomized controlled trial.

Setting: A tertiary care center.

PRO-based Stratification Improves Model Prediction for Toxicity and Survival of Head and Neck Cancer Patients.

Patient-Reported Outcomes (PRO) consist of information provided directly by the patients about their health status including symptom ratings. PROs are commonly used in clinical practice to support clinical decisionmaking and have recently been incorporated into machine learning models to improve risk prediction. In this work, we aim to evaluate whether the inclusion of a patient stratification based on 12-month post-treatment predicted Patient Reported Outcomes improves risk prediction of radiationinduced toxicity and overall survival for head and neck cancer patients.

Evaluation of a comprehensive set of normal tissue complication probability models for patients with head and neck cancer in an international cohort.

Background/purpose: Normal tissue complication probability (NTCP) models can be used to guide radiation therapy (RT) decisions by estimating side-effect risks pretreatment to minimize (late) side-effects. Recently, a comprehensive individual toxicity risk (CITOR) profile of NTCP models addressing common side-effects in head and neck cancer (HNC) patients was developed. This study investigates the generalizability of these models in an international setting, with different treatment approaches and side-effect assessments, promoting their integration into more widespread clinical practice.

Assessing the impact and risk of immunomodulatory compounds on pregnancy.

There have been remarkable advancements in understanding the complex and dynamic immune biological processes engaged during all stages of pregnancy. Exquisite control of immune processes is critical to successful outcome in all stages of pregnancy from ovulation to birth. There are many immunomodulatory therapeutics that may offer beneficial treatment options for a variety of diseases (e.