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Author Spotlight: Advancements in CAR-T Cell Manufacturing and Gene Therapy Production
Published on: August 18, 2023
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The Cell and Gene Therapy Consortium's Perspective on Harmonizing Data Collection for Patient Enrollment, Therapy
Alexandra Mora1, Linda Barnes2, Clint Divine3
1Accenture, San Francisco, California.
Transplantation and Cellular Therapy
|August 21, 2023
Summary
The Cell and Gene Therapy (CGT) Consortium aims to standardize processes for cell and gene therapies. This initiative addresses the growing complexity of manufacturer-specific portals to reduce risks and costs for healthcare professionals.
Area of Science:
- Biotechnology
- Healthcare Management
- Regulatory Science
Background:
- The cell and gene therapy (CGT) field is rapidly expanding, leading to a proliferation of manufacturer-specific processes and data portals.
- This fragmentation creates significant burdens and inefficiencies for healthcare providers, increasing complexity, risk, cost, and time in patient treatment coordination.
- Stakeholders recognize the unsustainability of multiple, disparate systems for managing CGT programs.
Purpose of the Study:
- To establish alignment among key Cell and Gene Therapy (CGT) stakeholders on process definitions, terminology, challenges, and standardization opportunities.
- To develop a framework for standardizing CGT program start-up, patient enrollment, and therapy administration.
- To streamline communication and data exchange between manufacturers and healthcare organizations from the end-user perspective.
Main Methods:
- Convening the Cell and Gene Therapy (CGT) Consortium with diverse stakeholders including manufacturers, treatment centers, regulators, and service providers.
- Conducting extensive discussions, stakeholder meetings, and interviews to identify challenges and opportunities.
- Developing a manuscript to report on consortium activities, conclusions, and proposed standardization framework.
Main Results:
- A framework for common principles, terminology, and user experiences for patient enrollment, therapy ordering, and starting material collection has been delineated.
- Identified opportunities to streamline communications between CGT manufacturers and healthcare organizations.
- Highlighted the need for standardization to mitigate the increasing burden on healthcare professionals.
Conclusions:
- Standardization of processes and data is crucial for the sustainable scaling of cell and gene therapies.
- A unified approach to CGT program management will reduce complexity, cost, and time for healthcare providers.
- The proposed framework offers a pathway to improve efficiency and support the growing CGT ecosystem.
