Epigenomic changes are a hallmark of aging, and DNA methylation (DNAm) has emerged as the most reliable molecular marker of an individual's age. Genome‐wide patterns of age‐associated hypo‐ and hypermethylation have been applied to generate predictive models (i.e., “epigenetic clocks”) capable of estimating chronological age in an increasingly diverse set of species including many mammals, a few birds, a reptile, and several b...

In February of 2024, the Product Quality Research Institute held a virtual workshop entitled “Model-Informed Drug Development (MIDD) Approaches in Pediatric Formulation Development.” The workshop covered a range of topics related to pediatric formulation development and testing, including dissolution testing and applications to modeling drug absorption in developing pediatric patients. Workshop speakers reviewed the progress t...

Genetic diversity is the foundation of biodiversity, and preserving it is therefore fundamental to conservation practice. However, global conservation efforts face significant challenges integrating genetic and genomic approaches into applied management and policy. As collaborative partnerships are increasingly recognized as key components of successful conservation efforts, we explore their role and relevance in the Australia...

Genetically modified (GM) organisms and crops have been a feature of food production for over 30 years. Despite extensive science-based risk assessment, the public and many politicians remain concerned with the genetic manipulation of crops, particularly food crops. Many governments have addressed public concern through biosafety legislation and regulatory frameworks that identify and regulate risks to ensure human health and...

Genome editing in agriculture and food is leading to new, improved crops and other products. Depending on the regulatory approach taken in each country or region, commercialization of these crops and products may or may not require approval from the respective regulatory authorities. This paper describes the regulatory landscape governing genome edited agriculture and food products in a selection of countries and regions.