ArticleMolecular therapy. Methods & clinical development2018
Challenges in Advanced Therapy Medicinal Product Development: A Survey among Companies in Europe.
Article in Molecular therapy. Methods & clinical development, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers, 1 of them a synthesis that pooled it.
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
48 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Clinical manufacturing of adipose-derived stem cells for therapeutic use: current technologies, quality systems and production challenges.Regenerative medicinePooled it
- Engineering high-fidelity bone organoids: Operational classification, multilineage crosstalk, biofabrication evidence, and translational validation.Materials today. Bio · 2026Article
- Advanced therapy medicinal products (ATMPs) - An analysis of the global regulatory status.British journal of clinical pharmacology · 2026Article
- A decade of innovation in healthcare: Automation, bio-printing and digital twin technologies for personalized therapies.International journal of pharmaceutics: X · 2026Review
- The complex price setting and reimbursement of non-industrial advanced therapy medicinal products.Health economics review · 2026Article
- Securing raw materials, reagents, and consumable supplies in the academic bioproduction UNITC network: because the chain is only as strong as its weakest link.Bone marrow transplantation · 2026Article
- Developing and validating a regulatory science competency framework for immune cell therapy: a mixed-methods study.Frontiers in medicine · 2026Article
- Why advanced therapy medicinal products struggle in clinical translation: an in-depth analysis of developmental challenges in the EU.Frontiers in medicine · 2026Review
- Current challenges and future directions of ATMPs in regenerative medicine.Regenerative therapy · 2025Review
- The clinical quality management system of advanced therapy medicinal products in the hospital setting: A scoping review.Molecular therapy. Methods & clinical development · 2025Review
- Article
- The Role and Challenges of Investigator-Initiated Trials in the Cell and Gene Therapy Products Boom in Mainland China.Clinical and translational science · 2025Article
- Impact of regulatory measures on the approval timelines of advanced therapy medicinal products by the European Medicines Agency.Frontiers in medicine · 2025Article
- Challenges in the Patent and Legal Environment for Cell Therapies.Advances in experimental medicine and biology · 2025Review
- Mesenchymal stromal cell therapies for traumatic neurological injuries.Journal of translational medicine · 2024Review
- Bioengineering breakthroughs: The impact of stem cell models on advanced therapy medicinal product development.World journal of stem cells · 2024Review
- Synthesizing regulatory guidance for demonstrating preclinical efficacy and translating promising cell therapies to early phase clinical trials: a scoping review.BMC medicine · 2024Article
- Developing Advanced Chimeric Cell Therapy for Duchenne Muscular Dystrophy.International journal of molecular sciences · 2024Article
- Robotics-Driven Manufacturing of Cartilaginous Microtissues for Skeletal Tissue Engineering Applications.Stem cells translational medicine · 2024Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Advanced therapy medicinal products (ATMPs) hold promise as treatments for previously untreatable and high-burden diseases. Expectations are high and active company pipelines are observed, yet only 10 market authorizations were approved in Europe. Our aim was to identify challenges experienced in European ATMP clinical development by companies. A survey-based cohort study was conducted among commercial ATMP developers. Respondents shared challenges experienced during various development phases, as well as developer and product characteristics. Descriptions of challenges were grouped in domains (clinical, financial, human resource management, regulatory, scientific, technical, other) and further categorized using thematic content analysis. A descriptive analysis was performed. We invited 271 commercial ATMP developers, of which 68 responded providing 243 challenges. Of products in development, 72% were in early clinical development and 40% were gene therapies. Most developers were small- or medium-sized enterprises (65%). The most often mentioned challenges were related to country-specific requirements (16%), manufacturing (15%), and clinical trial design (8%). The European ATMP field is still in its early stages, and developers experience challenges on many levels. Challenges are multifactorial and a mix of ATMP-specific and generic development aspects, such as new and orphan indications, novel technologies, and inexperience, adding complexity to development efforts.
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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.