ArticleFrontiers in medicine2022
A Regulatory Risk-Based Approach to ATMP/CGT Development: Integrating Scientific Challenges With Current Regulatory Expectations.
Article in Frontiers in medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed.
- Predicting ACI Outcomes with GMP In-Process Control Kinetic Metrics: Initial Chondrocyte Yield and Population Doubling Time as Prognostic Clinical Biomarkers.Life (Basel, Switzerland) · 2026Article
- Recombinant Protein Drugs: A 2025 Update.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Review
- Stem cells in organogenesis and regeneration.Stem cell research & therapy · 2026Review
- Why advanced therapy medicinal products struggle in clinical translation: an in-depth analysis of developmental challenges in the EU.Frontiers in medicine · 2026Review
- Developing and validating a regulatory science competency framework for immune cell therapy: a mixed-methods study.Frontiers in medicine · 2026Article
- Review
- Practice of Cryopreservation of Cellular Starting Materials from the Asia-Pacific Region: An Industrial Perspective.Therapeutic innovation & regulatory science · 2025Review
- Oncolytic Herpes Simplex Virus Therapy: Latest Advances, Core Challenges, and Future Outlook.Vaccines · 2025Review
- Callus organoids reveal distinct cartilage to bone transition mechanisms across donors and a role for biological sex.Bone research · 2025Article
- Genetic engineering frontiers in cell manipulation-based tissue engineering: A comprehensive review.BioImpacts : BI · 2025Review
- Impact of regulatory measures on the approval timelines of advanced therapy medicinal products by the European Medicines Agency.Frontiers in medicine · 2025Article
- Development of Cell and Gene Therapies for Clinical Use in the US and EU: Summary of Regulatory Guidelines.Current gene therapy · 2025Review
- Regulatory Aspects for Approval of Advanced Therapy Medicinal Products in the EU.Handbook of experimental pharmacology · 2024Article
- Article
- Article
- Article
- ATMP development and pre-GMP environment in academia: a safety net for early cell and gene therapy development and manufacturing.Immuno-oncology technology · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Cell and Gene Therapy Products (CGT), regulated as Advanced Therapy Medicinal Products (ATMP) in the European Union (EU), represent a novel and varied group of biotherapeutics developed to treat specific conditions for which there are limited or no effective treatments. The novelty and complexity of this product modality demands a regulatory risk-based approach to define a sound development plan, particularly, as most developers aim to target more than one market area simultaneously for clinical development and registration. This regulatory strategy should be built on solid scientific data that also addresses general regulatory recommendations to enable a benefit:risk analysis that is aligned with the particularities of each CGT product. This risk-based approach is especially helpful when no detailed product-specific regulatory guidelines are available. The goal of this article is to orient developers on how to build a combined EU/US regulatory strategy through the assessment of commonly understood quality (CMC), non-clinical, and clinical regulatory risks faced by ATMP/CGT.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.