Operational Complexity in Cell and Gene Therapy Trials
Applied Clinical Trials
As advanced therapy technology and manufacturing evolve, there are three key operational challenges to address unique to these products.
Advanced therapies (ATs) such as cell therapy, gene therapy, and tissue engineering represent a groundbreaking force in medicine and research. Whereas traditional therapies may use small molecule chemical or biologic products to treat disease, ATs use cells with specifically modified DNA or RNA components to systemically control a disease, replace an aberrant gene, or repair defective tissue. These cellular investigational products have the potential to cure a disease. It is this potential of eliminating disease that could make ATs so revolutionary.