CGT molecular bioanalysis safety requirements for IND filing

CGT Summit 2026 -- Cell and gene therapies (CGTs) are revolutionizing the field of medicine with their ability to target underlying diseases at the genetic and cellular level. CGT products mediate an expression of transferred genetic materials or specifically alter the target genome of the cells. FDA-required safety assessments for CGTs include preclinical assessment, gene expression, vector safety, vector shedding, and biodistribution and persistence analysis.