“This is not a sustainable model.”

Healthcare Providers call for sector-wide standards & collaboration to solve widespread cell & gene therapy challenges at hospitals and sites of care

Cell and gene therapies (CGTs) are on the cutting edge of medicine, but their current production and delivery complexity is pushing many Healthcare Providers to a breaking point. CGT operational systems and processes are so numerous and unnecessarily varied that the growth of the field is at risk. At a recent advisory council attended by 16 leading cell and gene therapy healthcare professionals, providers and administrators voiced an urgent need for standards and simplicity to make the growth of CGT sustainable. Among the greatest challenges – workflows and systems that are not standardized; large amounts of uncompensated time lost to data entry and system trainings; low staff morale and high attrition risk due to the need to prioritize processes and training over time with patients; IT and cybersecurity vulnerabilities related to the proliferation of too many portals and digital systems; and excessive operational variability and training requirements for CGT clinical trials that may only enroll a limited number of patients per site. These challenges arise from many different types of CGT products, in all phases of development. Healthcare professionals stated that these operational challenges will limit CGT’s ability to scale, may prevent some medical centers from taking on new CGT clinical studies, and will likely become unsustainable as the field provides therapies for more common diseases with larger patient populations. Collaboration among the entire sector, with a special emphasis on the needs of Healthcare Providers and the patients they serve, is urgently required to develop necessary standards and harmonized approaches – and reduce complexity.

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