Alignment of practices for data harmonization across multi-center cell therapy trials: a report from the Consortium for Pediatric Cellular Immunotherapy

Abdel‐Azim, Hisham; Dave, Hema; Jordan, Kimberly R.; Rawlings‐Rhea, Stephanie D.; Luong, Annie; Wilson, Ashley

doi:10.1016/j.jcyt.2021.08.007

Cited by 2 publications

(1 citation statement)

References 112 publications

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“…Data harmonization of production processes, quality management system, validation, and analytical QC methods strategies will reduce product variability, increase reproducibility, and enable site-to-site comparison. 42 Secondly, DARE-NL aims to create a biologics and technology hub that supports development of innovative technologies that support ATMP production, such as availability of GMP-grade materials and viral vectors for academic use and future outlook to new technological advancement applicable for ATMP manufacturing. Using the DARE-NL platform, we aim to strengthen the connection towards policy makers in The Netherlands and across EU pertaining to regulatory issues, health technology assessment, market authorization, and reimbursement program, as well as a patient outreach program to improve patient access.…”

Section: Expanding the Networkmentioning

confidence: 99%

Basics of advanced therapy medicinal product development in academic pharma and the role of a GMP simulation unit

Johanna,

Daudeij,

Devina

et al. 2023

Immuno-Oncology and Technology

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Section: Expanding the Networkmentioning

confidence: 99%

Basics of advanced therapy medicinal product development in academic pharma and the role of a GMP simulation unit

Johanna,

Daudeij,

Devina

et al. 2023

Immuno-Oncology and Technology

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Cellular Therapy for Children with Central Nervous System Tumors: Mining and Mapping the Correlative Data

et al. 2023

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Purpose of Review Correlative studies should leverage clinical trial frameworks to conduct biospecimen analyses that provide insight into the bioactivity of the intervention and facilitate iteration toward future trials that further improve patient outcomes. In pediatric cellular immunotherapy trials, correlative studies enable deeper understanding of T cell mobilization, durability of immune activation, patterns of toxicity, and early detection of treatment response. Here, we review the correlative science in adoptive cell therapy (ACT) for childhood central nervous system (CNS) tumors, with a focus on existing chimeric antigen receptor (CAR) and T cell receptor (TCR)-expressing T cell therapies. Recent Findings We highlight long-standing and more recently understood challenges for effective alignment of correlative data and offer practical considerations for current and future approaches to multi-omic analysis of serial tumor, serum, and cerebrospinal fluid (CSF) biospecimens. We highlight the preliminary success in collecting serial cytokine and proteomics from patients with CNS tumors on ACT clinical trials.

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Alignment of practices for data harmonization across multi-center cell therapy trials: a report from the Consortium for Pediatric Cellular Immunotherapy

Cited by 2 publications

References 112 publications

Basics of advanced therapy medicinal product development in academic pharma and the role of a GMP simulation unit

Basics of advanced therapy medicinal product development in academic pharma and the role of a GMP simulation unit

Cellular Therapy for Children with Central Nervous System Tumors: Mining and Mapping the Correlative Data

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