PDA Letter Article

Strategic Application of Advanced Analytics for CGT Development

by Jennifer Chadwick, PhD, BioAnalytix


Complex biologic therapies, particularly gene and cell therapies, have the potential to provide long-term therapeutic efficacy, or even cures for serious and congenital diseases, but their development is both risky and highly cost intensive. Strategic application of advanced analytical techniques can help improve selection of candidates and guide development decisions, leading to a greater number of safer, more efficacious cell and gene therapies successfully completing development and entering the market.