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Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. Planning common next steps. A workshop Report.
Viviani L, Reid K, Gastineau T, Milne C, Smith D, Levis R, Lei D, van Ooij M, Gilbert PA, Vandeputte J, Xie J, Madhuri L, Shaid S, Kubiak V, Suri R, Mizukami T, Shirasaki Y, Li X, Zhou YY, Trapkova A, Goel S, Prakash J, Subagio AA, Suwarni E, Jung KJ, Sanyal G, Das P, Coppens E, Wright D, Peng Z, Northeved H, Jungbäck C, Kirpitchenok T, Del Pace L, Seo B, Poojary B, Ottoni A. Viviani L, et al. Among authors: gastineau t. Biologicals. 2022 Jul;78:17-26. doi: 10.1016/j.biologicals.2022.06.003. Epub 2022 Jul 12. Biologicals. 2022. PMID: 35840492 Free PMC article.
What can vaccines learn from aviation?
Gastineau T. Gastineau T. Vaccine. 2020 Jul 14;38(33):5082-5084. doi: 10.1016/j.vaccine.2020.06.027. Epub 2020 Jun 18. Vaccine. 2020. PMID: 32565341 Free PMC article.
How to accelerate the supply of vaccines to all populations worldwide? Part I: Initial industry lessons learned and practical overarching proposals leveraging the COVID-19 situation.
McGoldrick M, Gastineau T, Wilkinson D, Campa C, Clercq N, Mallia-Milanes A, Germay O, Krishnan J, Van Ooij M, Thien MP, Mlynarczyk PJ, Saltus E, Juvin P, Clenet D, Basso A, Dellepiane N, Pagliusi S, de Moraes Stávale MC, Sivaramakrishnan VH, Desai S. McGoldrick M, et al. Among authors: gastineau t. Vaccine. 2022 Feb 23;40(9):1215-1222. doi: 10.1016/j.vaccine.2021.11.098. Vaccine. 2022. PMID: 35180993 Free PMC article. Review.
How to accelerate the supply of vaccines to all populations worldwide? Part II: Initial industry lessons learned and detailed technical reflections leveraging the COVID-19 situation.
McGoldrick M, Gastineau T, Wilkinson D, Campa C, De Clercq N, Mallia-Milanes A, Germay O, Krishnan J, Van Ooij M, Thien MP, Mlynarczyk PJ, Saltus E, Wauters F, Juvin P, Clenet D, Basso A, Dellepiane N, Pagliusi S, Collaço de Moraes Stávale M, Sivaramakrishnan VH, Desai S. McGoldrick M, et al. Among authors: gastineau t. Vaccine. 2022 Feb 23;40(9):1223-1230. doi: 10.1016/j.vaccine.2021.12.038. Vaccine. 2022. PMID: 35180994 Free PMC article. Review.
Addressing vaccine supply challenges in Europe: Expert industry perspective and recommendations.
Pasté M, Stoffel M, Bardone C, Baron-Papillon F, Czwarno A, Galbraith H, Gastineau T, Germay O, Gonzo D, Juvin P, Kissane J, Laigle V, Mlynarczyk P, van Hoof P, Wettendorff M, Quilici S. Pasté M, et al. Among authors: gastineau t. Health Policy. 2022 Jan;126(1):35-42. doi: 10.1016/j.healthpol.2021.11.006. Epub 2021 Nov 28. Health Policy. 2022. PMID: 34887101 Free article. Review.
Alignment in post-approval changes (PAC) guidelines in emerging countries may increase timely access to vaccines: An illustrative assessment by manufacturers.
Dellepiane N, Pagliusi S, Akut P, Comellas S, De Clercq N, Ghadge S, Gastineau T, McGoldrick M, Nurnaeni I, Scheppler L; Regulatory Experts Working Group. Dellepiane N, et al. Among authors: gastineau t. Vaccine X. 2020 Aug 25;6:100075. doi: 10.1016/j.jvacx.2020.100075. eCollection 2020 Dec 11. Vaccine X. 2020. PMID: 32995745 Free PMC article.
Path Forward to Optimise Post-approval Change Management and Facilitate Continuous Supply of Medicines and Vaccines of High Quality Worldwide : Joint Position from EFPIA, IFPMA and Vaccines Europe.
Deavin A, Adam S, Ausborn S, Nielsen ASB, Cappellini S, Colmagne-Poulard I, Gastineau T, Gonzalez-Martinez A, Meillerais S, Mortazavi C. Deavin A, et al. Among authors: gastineau t. Ther Innov Regul Sci. 2023 Jan;57(1):7-11. doi: 10.1007/s43441-022-00426-9. Epub 2022 Aug 2. Ther Innov Regul Sci. 2023. PMID: 35917091 Free PMC article.