The Cell and Gene Therapy Consortium's Perspective on Harmonizing Data Collection for Patient Enrollment, Therapy Ordering and Scheduling, and Cell Collection.

Autor: Mora A; Accenture, San Francisco, California. Electronic address: alexandra.r.mora@accenture.com., Barnes L; Association for the Advancement of Blood & Biotherapies, Bethesda, MD., Divine C; The University of Kansas Cancer Center, Westwood, Kansas., Frey N; University of Pennsylvania and the Abramson Cancer Center, Philadelphia, Pennsylvania., Fuchs C; Genentech, South San Francisco, California., Hayes B; Accenture, San Francisco, California., Henke D; Standards Coordinating Body, Gaithersburg, Maryland., Holman P; ArsenalBio, South San Francisco, California., Liu H; H. Lee Moffitt Cancer Center, University of South Florida Morsani College of Medicine, Tampa, Florida., Porter D; University of Pennsylvania and the Abramson Cancer Center, Philadelphia, Pennsylvania., Powel K; Talaris Therapeutics, Union Bridge, Maryland., Srivastava S; Accenture, New York, New York.
Jazyk: angličtina
Zdroj: Transplantation and cellular therapy [Transplant Cell Ther] 2023 Nov; Vol. 29 (11), pp. 653-665. Date of Electronic Publication: 2023 Aug 19.
DOI: 10.1016/j.jtct.2023.08.011
Abstrakt: Established in October 2021, the Cell and Gene Therapy (CGT) Consortium convened with the goal to bring together key CGT stakeholders - manufacturers, treatment centers, regulators, services providers, and ecosystem partners - to gain alignment on process definitions, terminology, challenges, and opportunities for process and data standardization from CGT program start-up and patient enrollment to therapy administration. With the recognition that the number of investigational and commercial cell and gene therapies will scale over the next several years, so will the number of manufacturer-specific processes and solutions (e.g., portals). As a result, this will increase the burden on academic medical centers, community hospitals, standalone clinics, collection facilities, and labs. Healthcare professionals (HCPs) and other industry stakeholders agree that a multiplicity of manufacturer portals with varying data requirements and nomenclature is unsustainable and adds unnecessary complexity - risk, cost, and time - in coordinating patient treatment. Following extensive discussions and multiple stakeholder meetings and interviews, we have developed a manuscript reporting on our activities and conclusions. Through the course of the manuscript, we delineate a framework for defining common principles, terminology, and user experiences for enrolling patients, ordering therapies, and collecting starting material in a standardized way. We also provide substantial background information on opportunities to streamline communications between manufacturing and healthcare organizations from the HCP end-user's perspective.
(Copyright © 2023 The American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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