Krystal Haynes, Senior Director of Business Development, ICS, at Cencora, outlines the challenges facing cell and gene therapy manufacturers as they attempt to move products from clinical development to commercial availability.
Sponsored by Cencora
The commercialization of cell and gene therapies presents significant barriers, with only 3% of the more than 4,000 therapies currently in the pipeline achieving full FDA or EMA approval. Reimbursement remains one of the most formidable obstacles, as therapies priced between $100,000 and $3 million per treatment lack a standardized global framework, creating disparate payer and government-led models across different countries. Logistics and regulatory compliance add further complexity, requiring precise supply chain coordination and careful navigation of FDA requirements around labeling, serialization, cold chain packaging, and serialization exemptions. Krystal Haynes, Senior Director of Business Development, ICS, at Cencora explains how they have positioned themselves to address these challenges through a globally integrated infrastructure spanning 100 countries and more than 1,100 offices. They pursue early engagement with manufacturers to anticipate regulatory hurdles and provide fit-for-purpose logistics support across both clinical and commercial stages of development.
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