The US Food and Drug Administration (FDA) mandates product-specific education and training to ensure the safe use of CAR T-cell therapies.¹⁰⁴ This is delivered through the Risk Evaluation Mitigation Strategies (REMS) program, which involves manufacturers evaluating and monitoring treatment sites to ensure compliance.¹⁰⁴ As the number of approved CAR T-cell therapies increases, treatment centers will face a growing inspection burden involving qualification, ongoing auditing and reporting. 

The American Society for Transplantation and Cellular Therapy (ASTCT) launched the 80/20 Initiative to streamline the onboarding and operational processes for clinical centers administering cell therapies.⁹⁸ Recognizing that approximately 80% of the requirements for clinical site onboarding and ongoing operations are common across different manufacturers, the initiative aims to standardize procedures to improve efficiency of onboarding and cost-effectiveness.⁹⁸ 

The 80/20 Task Force convened multi-stakeholder workshops to identify and prioritize common challenges in the onboarding and maintenance of operations at treatment sites, and ways to streamline the process.^98,104 The workshops brought together over 60 stakeholders, including clinicians, regulators, accrediting bodies and manufacturers.^98,104 In the second workshop, they identified key measures that would help simplify the qualification process, minimize duplication of efforts and ensure consistent safety standards across CAR T-cell centers:¹⁰⁴

• Conducting training programs led by treatment centers and/or professional societies to replace manufacturers’ product training.
• Reporting standardized data points into a central, accessible repository for tracking of safety profile trends and identification of new signals.
• Enabling accrediting bodies to attest to programs’ quality and ongoing compliance with field safety expectations to replace initial manufacturer evaluation and ongoing REMS audit.

The Task Force’s recommendations were shared with the FDA at the Cell Therapy Liaison Meeting and in multiple professional society meetings and public forums with regulators, manufacturers, and FDA representatives.104 Recently, the FDA scaled back several of the features of existing CAR T-cell therapy REMS programs redundant to standard clinical practice, including requirements related to manufacturer-created training, product-specific testing of trained staff and data reporting to manufacturers.¹⁰⁴ 

By implementing these strategies, the “80/20 Initiative” aims to find efficiencies in the inspection process for treatment centers and facilitate broader and more equitable access to CAR T-cell therapies.