Cell and gene therapies (CGTs) are revolutionizing the treatment landscape by offering potential cures for previously untreatable conditions. With numerous CGTs entering markets globally, patients with rare and complex diseases now have expanded treatment options. Challenges including scalable manufacturing, high development costs, and equitable patient access continue to be obstacles as the field progresses. Elizabeth (Betty) Woo, Vice President of Cell, Gene, and Advanced Therapies at Thermo Fisher Scientific, highlights the progress in CGTs, recent FDA approvals for milestone treatments like Casgevy and Lyfgenia for sickle cell disease, and the potential of over 30 FDA-approved therapies targeting conditions with limited treatment options.
Woo emphasizes the need for automation and standardization in manufacturing processes to increase efficiency, reduce errors, and lower costs. Collaboration across various stakeholders, including academia, biopharma innovators, manufacturers, regulators, and service providers, is crucial to expedite the development, approval, and access of CGTs. She predicts ongoing advancements in autoimmune diseases and solid tumors, as well as regulatory bodies’ dedication to supporting the CGT pipeline for faster approvals.
Looking ahead, Woo anticipates continued investments in rare diseases and cancer treatments, expansion into new therapeutic indications, and improvements in global regulatory standards to ensure uniform quality and safety. As the CGT industry evolves, collaboration and adoption of standardized practices will be essential for delivering innovative therapies to patients efficiently and broadly.
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