Preparing for the future of precision medicine: synthetic cell drug regulation.

Synthetic cells are a novel class of cell-like bioreactors, offering the potential for unique advancements in synthetic biology and biomedicine. To realize the potential of those technologies, synthetic cell-based drugs need to go through the drug approval pipeline. Here, we discussed several regulatory challenges, both unique to synthetic cells, as well as challenges typical for any new biomedical technology. Overcoming those difficulties could bring transformative therapies to the market and will create a path to the development and approval of cutting-edge synthetic biology therapies. Graphical Abstract.

"It could bring down Greek life as a whole": Greek life members' perspectives on party culture, safety, responsibilities and consequences.

OBJECTIVE: Describe Greek life students' perspectives of party culture, safety, and College Sexual Violence (CSV) prevention. PARTICIPANTS: 27 US undergraduates: 5 fraternity underclassmen, 6 fraternity upperclassmen, 10 sorority underclassmen, 6 sorority upperclassmen. METHODS: Students participated in one of four focus groups, separately by gender and academic year. Facilitation guide addressed partying, sexual violence, and safety. RESULTS: Greek life members described partying preferences, perceived safety threats, and actions they took to party safely. University efforts to support safe partying were not universally viewed as helpful. CONCLUSIONS: Although Greek life students strive to create safe partying environments, there remain missed opportunities to mitigate risks related to CSV. The responsibility to ensure safe partying falls too heavily on students, resulting in universities missing opportunities to provide measures that promote safety while mitigating risks and potentially serious harms.

Case Report: Infant With Congenital Adrenal Hyperplasia and 47,XXY.

Congenital adrenal hyperplasia is a group of autosomal recessive disorders in which enzymes in the cortisol biosynthesis pathways are disrupted by gene mutations. The most common form of congenital adrenal hyperplasia, caused by 21-hydroxylase deficiency, is characterized by decreased cortisol and aldosterone synthesis and excessive androgen production. Adult height is often compromised in affected patients. Intellectual capability remains intact in patients with congenital adrenal hyperplasia caused by 21-hydroxylase deficiency, based on previous studies. 47,XXY (KS) is a sex chromosomal aneuploidy that manifests with hypergonadotropic hypogonadism, tall stature, and variable intellectual and behavioral dysfunction. This clinical report describes an infant with 21-hydroxylase deficiency congenital adrenal hyperplasia and 47,XXY. The results of his neurodevelopmental, endocrine, neurological, and physical therapy evaluations during his first 22 months are included and were normal. This is the first published case investigating the neurodevelopmental profile of a patient with the combination of these two genetic disorders.