06.27.23 -- Optimizing Digitalization To Accelerate Your R&D

Drug/therapy development has made significant leaps in innovation in recent years, but common issues that hinder progress still exist. Are you harnessing and optimizing your data for speedier drug development and quicker launch timescales? This article shares important recommendations.

An important step in the gene therapy development process is assembling biodistribution data in suitable animals in relation to the intended clinical population. Developing an accurate biodistribution profile is influenced by factors such as the route of administration, dose level(s), dosing regimen, and the animal immune response to the gene therapy product. The FDA adopted this ICH guidance in May 2023, and the EMA plans to adopt it in September 2023.