{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T18:32:20Z","timestamp":1786645940538,"version":"build-2736575974"},"reference-count":40,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,8,12]],"date-time":"2026-08-12T00:00:00Z","timestamp":1786492800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,8,12]],"date-time":"2026-08-12T00:00:00Z","timestamp":1786492800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Human Gene Therapy"],"abstract":"<jats:p>\n                    Accurate classification of Genetically Modified Organism (GMO) gene therapies remains a significant challenge to initiating clinical trials in the United Kingdom, often delaying patient access to innovative treatments. Current regulatory processes require separate GMO risk assessments at each National Health Service (NHS) trial location, leading to inconsistent approaches and duplication of effort. This article presents the development of a decision tree designed to streamline GMO classification for Gene Therapy Investigational Medicinal Products (GTIMPs). The proposed tool aims to address key challenges in trial setup by providing a structured and evidence-based approach to GMO classification, clarifying international misalignment in hazard classification and offering practical guidance for the\n                    <jats:italic toggle=\"yes\">in\u00a0vivo<\/jats:italic>\n                    and\n                    <jats:italic toggle=\"yes\">ex vivo<\/jats:italic>\n                    GMO GTIMPs most encountered in clinical practice. By harmonizing decision-making and clarifying containment requirements, the adoption of the decision tree across NHS organizations could reduce variability, accelerate trial setup, and strengthen the United Kingdom\u2019s position as a competitive destination for GTIMP clinical trials.\n                  <\/jats:p>","DOI":"10.1177\/10430342261473434","type":"journal-article","created":{"date-parts":[[2026,8,12]],"date-time":"2026-08-12T08:52:36Z","timestamp":1786524756000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Streamlining Genetically Modified Organism Regulatory Classification in UK Gene Therapy Clinical Trials: A UK Pharmacy Perspective"],"prefix":"10.1177","author":[{"ORCID":"https:\/\/orcid.org\/0009-0001-9583-8628","authenticated-orcid":false,"given":"Annalisa","family":"Del Prete","sequence":"first","affiliation":[{"name":"Pharmacy Department, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beatriz","family":"Duran Jimenez","sequence":"additional","affiliation":[{"name":"Pharmacy Department, Manchester University NHS Foundation Trust, Manchester, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne","family":"Black","sequence":"additional","affiliation":[{"name":"NHS Specialist Pharmacy Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, United Kingdom."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,8,12]]},"reference":[{"key":"e_1_3_4_2_1","unstructured":"1.UK Government. Advanced therapy medicinal products: Regulation and licensing in the UK. GOV.UK: London. Available from: https:\/\/www.gov.uk\/guidance\/advanced-therapy-medicinal-products-regulation-and-licensing [Last accessed: February12 2026]."},{"key":"e_1_3_4_3_1","unstructured":"2.U.S. Food and Drug Administration. Regulation of human cells tissues and cellular and tissue-based products (HCT\/Ps): Small entity compliance guide. Guidance for industry. FDA: Silver Spring (MD); 2022. Available from: https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/regulation-human-cells-tissues-and-cellular-and-tissue-based-products-hctps-small-entity-compliance [Last accessed: February12 2026]."},{"key":"e_1_3_4_4_1","unstructured":"3.Code of Federal Regulations. Title. 21 Part 1271: Human cells tissues and cellular and tissue-based products. U.S. Government Publishing Office: Washington (DC). Available from: https:\/\/www.ecfr.gov\/current\/title-21\/part-1271 [Last accessed: February12 2026]."},{"key":"e_1_3_4_5_1","unstructured":"4.Health and Safety Executive. The Genetically Modified Organisms (Contained Use) Regulations 2014. HSE: London. Available from: https:\/\/www.hse.gov.uk\/pubns\/books\/l29.htm [Last accessed: Nov20 2025]."},{"key":"e_1_3_4_6_1","doi-asserted-by":"publisher","DOI":"10.18609\/cgti.2024.153"},{"key":"e_1_3_4_7_1","unstructured":"6.Pan UK Pharmacy Working Group for ATMPs. Requirements for governance and preparation of gene therapy. Specialist Pharmacy Service: London. Available from: https:\/\/www.sps.nhs.uk\/articles\/requirements-for-governance-and-preparation-of-gene-therapy\/ [Last accessed: Nov20 2025]."},{"key":"e_1_3_4_8_1","unstructured":"7.Pan UK Pharmacy Working Group for ATMPs. In-vivo GMO gene therapy medicinal products. Specialist Pharmacy Service: London. Available from: https:\/\/www.sps.nhs.uk\/articles\/in-vivo-gmo-gene-therapy-medicinal-products\/ [Last accessed: Dec8 2025]."},{"key":"e_1_3_4_9_1","unstructured":"8.Pan UK Pharmacy Working Group for ATMPs. Ex-vivo (cell based) GMO gene therapy medicinal products. Specialist Pharmacy Service: London. Available from: https:\/\/www.sps.nhs.uk\/articles\/ex-vivo-gmo-gene-therapy-medicinal-products\/ [Last accessed: Dec8 2025]."},{"key":"e_1_3_4_10_1","unstructured":"9.Pan UK Pharmacy Working Group for ATMPs. In-vivo non-GMO gene therapy medicinal products. Specialist Pharmacy Service: London. Available from: https:\/\/www.sps.nhs.uk\/articles\/in-vivo-non-gmo-gene-therapy-medicinal-products\/ [Last accessed: Dec20 2025]."},{"key":"e_1_3_4_11_1","unstructured":"10.Pan UK Pharmacy Working Group for ATMPs. Ex-vivo non-GMO gene therapy medicinal products. Specialist Pharmacy Service: London. Available from: https:\/\/www.sps.nhs.uk\/articles\/ex-vivo-non-gmo-gene-therapy-medicinal-products\/ [Last accessed: Dec20 2025]."},{"key":"e_1_3_4_12_1","unstructured":"11.Health and Safety Executive. The SACGM compendium of guidance: Part 2. Risk assessment of genetically modified microorganisms (other than those associated with plants). HSE: London. Available from: https:\/\/www.hse.gov.uk\/biosafety\/gmo\/acgm\/acgmcomp [Last accessed: Dec8 2025]."},{"key":"e_1_3_4_13_1","unstructured":"12.Health and Safety Executive. The SACGM compendium of guidance: Part 6. Guidance on the use of genetically modified microorganisms in a clinical setting. HSE: London. Available from: https:\/\/www.hse.gov.uk\/biosafety\/gmo\/acgm\/acgmcomp [Last accessed: Dec8 2025]."},{"key":"e_1_3_4_14_1","unstructured":"13.Cell and Gene Therapy Catapult. UK ATMP clinical trials database. CGT Catapult: London; 2025. Available from: https:\/\/ct.catapult.org.uk\/resources\/clinical-trials-database [Last accessed: February21 2026]."},{"key":"e_1_3_4_15_1","unstructured":"14.UK Government. Genetically Modified Organisms (Deliberate Release) Regulations 2002. The Stationery Office: London. Available from: https:\/\/www.legislation.gov.uk\/uksi\/2002\/2443\/contents [Last accessed: Dec10 2025]."},{"key":"e_1_3_4_16_1","unstructured":"15.UK Government. Environmental Protection Act 1990. The Stationery Office: London. Available from: https:\/\/www.legislation.gov.uk\/ukpga\/1990\/43\/contents [Last accessed: Dec10 2025]."},{"key":"e_1_3_4_17_1","unstructured":"16.Health and Safety Executive. Control of Substances Hazardous to Health Regulations 2002. HSE: London. Available from: https:\/\/www.hse.gov.uk\/cleaning\/topics\/coshh.htm [Last accessed: Dec15 2025]."},{"key":"e_1_3_4_18_1","unstructured":"17.Health and Safety Executive. The approved list of biological agents: Advisory Committee on Dangerous Pathogens 2023. HSE: London. Available from: https:\/\/www.hse.gov.uk\/pubns\/misc208.htm [Last accessed: Dec15 2025]."},{"key":"e_1_3_4_19_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-1-0716-0146-4_4"},{"key":"e_1_3_4_20_1","doi-asserted-by":"publisher","DOI":"10.1038\/mto.2016.15"},{"key":"e_1_3_4_21_1","unstructured":"20.University College London. Genetic Modification Safety Committee guidance: Classifying GM activity with lentiviral vectors. UCL: London. Available from: https:\/\/www.ucl.ac.uk\/safety-services\/sites\/safety-services\/files\/lentiviral-guidance.pdf [Last accessed: Dec20 2025]."},{"key":"e_1_3_4_22_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms26178282"},{"key":"e_1_3_4_23_1","article-title":"Lentivirus for CAR-T and other cell therapy products: A microbiological and biosafety perspective","author":"Rivero-Jimenez RA","year":"2025","unstructured":"22.Rivero-Jimenez RA, , Rivero-Navea G, , Adukkadukkam D, et al. Lentivirus for CAR-T and other cell therapy products: A microbiological and biosafety perspective. 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Good practice on the assessment of GMO-related aspects in the context of clinical trials with AAV clinical vectors. European Commission: Brussels; 2022. Available from: https:\/\/health.ec.europa.eu\/system\/files\/2022-01\/aavs_gp_en.pdf [Last accessed: February24 2026]."},{"key":"e_1_3_4_38_1","unstructured":"37.U.S. Food and Drug Administration. Testing of retroviral vector-based human gene therapy products for replication-competent retrovirus during product manufacture and patient follow-up: Guidance for industry. FDA: Silver Spring (MD); 2020. Available from: https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/testing-retroviral-vector-based-human-gene-therapy-products-replication-competent-retrovirus-during [Last accessed: Jan5 2026]."},{"key":"e_1_3_4_39_1","unstructured":"38.European Medicines Agency Committee for Medicinal Products for Human Use. Guideline on development and manufacture of lentiviral vectors. EMA: Amsterdam. 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