A BioPhorum member survey aimed to gather initial industry benchmarking data and interest in defining an industry position on visible particulate control strategy for cell and gene therapies.
Regulatory Strategy
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Feedback on revised chapter 5.14 leading to EDQM Pharmeuropa monograph 34.3 gene therapy products for human use, chapter 5.34 and chapter 5.2.12Â
Sep 2022 | Cell & Gene Therapy, Deliverable, Deliverables Report, Feedback to agency, Regulatory Strategy
BioPhorum CGT Regulatory Strategy workstream response to revised chapter 5.14 leading to EDQM Pharmeuropa monograph 34.3 gene therapy products for human use, chapter 5.34 and chapter 5.2.12. This content is available to BioPhorum members only.
Feedback on the WHO draft approach towards development of a global regulatory framework for CGT
Sep 2022 | Cell & Gene Therapy, Deliverable, Deliverables Report, Feedback to agency, Regulatory Strategy
A cross sub-team team of 18 members from 14 companies submitted feedback on WHO Approach towards the development of a global regulatory framework for cell and gene therapy products (document WHO/BS/2022.2424)
Feedback on FDA draft guidance on considerations for the development of CAR-T cell productsÂ
Jun 2022 | Cell & Gene Therapy, Deliverable, Deliverables Report, Feedback to agency, Regulatory Strategy
BioPhorum CGT Regulatory Strategy workstream members provide feedback on the FDA draft guidance on considerations for the development of CAR-T cell products .
Feedback on FDA draft guidance on human gene therapy products incorporating human genome editingÂ
Jun 2022 | Cell & Gene Therapy, Deliverable, Deliverables Report, Feedback to agency, Regulatory Strategy
BioPhorum CGT Regulatory Strategy workstream provided feedback on FDA draft guidance on human gene therapy products incorporating human genome editing .
Feedback on the FDA draft guidance for industry studying multiple versions of a cellular or gene therapy product in an early phase clinical trial
Jan 2022 | Cell & Gene Therapy, Deliverable, Feedback to agency, Regulatory Strategy
This member document summarizes consolidated feedback and recommendations from a collaboration of BioPhorum members on the FDA draft guidance for industry studying multiple versions of a cellular or gene therapy product in an early phase clinical trial consultation.
Feedback on FDA draft guidance for industry studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial
Dec 2021 | Cell & Gene Therapy, Deliverable, Feedback to agency, Regulatory Strategy
BioPhorum members provide feedback on FDA draft guidance for industry studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial.
Feedback on EMA draft toolbox guidance for PRIME marketing authorisation applications
Oct 2021 | Cell & Gene Therapy, Feedback to agency, Regulatory Strategy
Summary BioPhorum member only document detailing feedback and suggested recommendations on EMA draft toolbox guidance for PRIME marketing authorisation applications.
Feedback to FDA: Human gene therapy for neurodegenerative diseases: draft guidance for industry
Oct 2021 | Cell & Gene Therapy, Feedback to agency, Regulatory Strategy
BioPhorum member only summary document providing feedback and recommendations to FDA consultation Human gene therapy for neurodegenerative diseases: draft guidance for industry
Challenges for potency assay development for in vivo and ex vivo gene therapies and the matrix approach
Sep 2021 | Cell & Gene Therapy, High Level Analytics, POI - Cell and Gene Therapy, Publication, Regulatory Strategy
This paper highlights some of the challenges to develop potency assays for gene therapies and promotes a potential solution. It seeks to establish Industry alignment on the benefits of a matrix approach and provides high level guidance on how to adopt this strategy towards potency assay development and validation with examples for in vivo and ex vivo GT processes.