The novelty of CGTs has introduced unique supply chain challenges and considerations not seen by chemically synthesized (small molecule) drugs. These complexities increase during the clinical phases, where drug safety and efficacy milestones are still underdeveloped. For example, for autologous therapies such as Chimeric antigen receptor T (CAR-T) therapies, in which the treatment is developed from the patient’s own cells, supply chain management plays an integral role in the chemistry, manufacturing, and control (CMC) processes. Supply chain management requires proactive planning due to the strict cold chain requirements and time sensitivity of CGTs. This research examines strategies and responses to challenges experienced by industry stakeholders (such as sponsors and manufacturers) during the implementation phases of their clinical supply chain management. This research further evaluates the adequacy of the current regulatory framework for distribution and supply chain management of CGTs in the United States (US).