Compared with small molecules and other biopharmaceuticals, advanced therapies typically have more complex mechanisms of action and therefore more complex testing requirements. These requirements also change over time as innovators, testing organizations, and regulators apply recent learnings to current projects.
When developing a novel cell or gene therapy it is therefore crucial to have a robust, flexible plan for testing your drug. This plan must be sufficient for proving that your drug meets safety standards and other benchmarks, and ultimately, for gaining regulatory approval.
This article presents the challenges involved with regulatory testing for cell and gene therapies such as the complexity of regulatory requirements, short timelines, and capacity limitations. It also describes how innovators and testing organizations can address these challenges when taking a drug from bench to clinic, citing the viewpoints of regulatory and testing experts from WuXi Advanced Therapies, a company which offers integrated platforms to transform the discovery, development, testing, manufacturing, and commercialization of cell and gene therapies to worldwide customers.
Just fill out the form below to read the full article.