Global Labeling Conference

Cell and Gene Therapies (CGT) are increasingly being used to develop novel treatments for rare diseases. Recently there has been a plethora of guidelines to aid the development of CGT, which ultimately can impact the end-label. Labeling professionals should be aware of these emerging guidelines, as well as the standard labeling guidelines, to optimize the development and life-cycle management of labels for CGTs. Unique situations, challenges, and requirements face CGTs which require the labeling team to engage with a broad stakeholder network during development. Considerations include safety concerns associated with CGTs (including benefit-risk considerations for specific populations), the types of nonclinical studies to be performed to support clinical trials, the study expectations and design elements, alternative endpoints/data sets informing the label, traceability, and planning of long-term follow-up requirements and supply chain. This session will focus on some case studies, examples, and considerations where factoring in these broader elements of labeling to successfully optimize the use of CGTs products in rare disease.