Strategies for derisking translational processes for biomedical technologies
Abstract
Inefficient translational processes for technology-oriented biomedical research have led to some prominent and frequent failures in the development of many leading drug candidates, several designated investigational drugs, and some medical devices, as well as documented patient harm and postmarket product withdrawals. Derisking this process, particularly in the early stages, should increase translational efficiency and streamline resource utilization, especially in an academic setting. In this opinion article, we identify a 12-step guideline for reducing risks typically associated with translating medical technologies as they move toward prototypes, preclinical proof of concept, and possible clinical testing. Integrating the described 12-step process should prove valuable for improving how early-stage academic biomedical concepts are cultivated, culled, and manicured toward intended clinical applications.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Full GMP compliance is required for Phase I clinical trials in the European Union, which could be cumbersome for academic developments.
“Full GMP compliance is required for Phase I clinical trials which could be cumbersome for academic developments (134).”
From Scalable Manufacturing of CAR T Cells for Cancer Immunotherapy (2021) · cites this paper as [134]
No citation lists for this paper
No citation lists for this paper yet — checked again daily.
References 41 · Cited by 36
- Authors
- Abou-El-Enein, M., Duda, G. N., Gruskin, E. A., & Grainger, D. W.
- Affiliations
- Berlin-Brandenburger Centrum für Regenerative Therapien (DE)
- University of Utah (US)
- Venue
- Trends in Biotechnology
- Publisher
- Elsevier BV
- Published
- 2017-02
- Volume
- 35
- Issue
- 2
- Pages
- 100-108
- ISSN
- 0167-7799 (ISSN-L)
- OpenAlex
- W2481191654
- Cited by
- 36
- References
- 41
- Citations by year
- 2026: 2 · 2025: 3 · 2024: 3 · 2023: 2 · 2022: 2 · 2021: 6 · 2020: 4 · 2019: 5 · 2018: 5 · 2017: 2 · 2016: 2
- FWCI
- 0.69
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Trends in biotechnology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Health and Medical Research Impacts
- Physical Sciences › Engineering › Safety, Risk, Reliability and Quality › Technology Assessment and Management
- Health Sciences › Veterinary › Small Animals › Animal testing and alternatives
- Keywords
- translational research, de-risking, drug development failure, medical device development, academic research, clinical testing, prototype development
- MeSH terms
- Algorithms, Biotechnology, Equipment Design, Risk Management, Drug Design, Models, Organizational, Drug Approval, Device Approval, Equipment Failure Analysis, Translational Research, Biomedical
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
