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2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization).
Loo L, Harris S, Milton M, Meena, Lembke W, Berisha F, Bertholet S, Dessy F, Dodge R, Fang X, Fiscella M, Garofolo F, Gorovits B, Gupta S, Jawa V, Ishii-Watabe A, Long B, Lu Y, Mack T, McGuire K, Nolan K, Pan L, Potthoff B, Purushothama S, Smith D, Solstad T, Sonderegger I, Taddeo F, Tangri S, Wagner L, Wu B, Xu Y, Kirshner S, Verthelyi D, Yan H, Maxfield K, Pedras-Vasconcelos J, Abhari MR, Gupta S, Wu Y, Rajadhyaksha M, Andisik M, Baltrukonis D, Cherry E, Cludts I, Gunn G, Millner AH, Jordan G, Kar S, Kubiak R, Lotz GP, Palmer R, Peng K, Poetzl J, Richards S, Savoie N, Staack RF, Stubenrauch K, Wadhwa M, Waxenecker G, Yang TY, Zhang L. Loo L, et al. Among authors: smith d. Bioanalysis. 2022 Jun;14(11):737-793. doi: 10.4155/bio-2022-0081. Epub 2022 May 17. Bioanalysis. 2022. PMID: 35578991
2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A - Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC & Part 1B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Kaur S, Alley SC, Szapacs M, Wilson A, Ciccimaro E, Su D, Henderson N, Chen L, Garofolo F, Hengel S, Jian W, Kellie JF, Lee A, Mehl J, Palandra J, Qiu H, Savoie N, Shakleya D, Staelens L, Sugimoto H, Sumner G, Welink J, Wheller R, Xue YJ, Zeng J, Zhang J, Zhou H, Wang J, Summerfield S, Kavetska O, Dillen L, Ramanathan R, Baratta M, Dasgupta A, Edmison A, Ferrari L, Fischer S, Fraier D, Haidar S, Heermeier K, James C, Ji A, Luo L, Lima Santos GM, Post N, Rosenbaum AI, Sporring S, Surapaneni S, Vinter S, Wan K, Woolf E, Kavetska O, Cho SJ, Kossary E, Prior S, Abhari MR, Soo C, Wang YM, Bandukwala A, Cherry E, Cludts I, Ghosh S, Hopper S, Ishii-Watabe A, Kirshner S, Maher K, Maxfield K, Pedras-Vasconcelos J, Saito Y, Smith D, Solstad T, Verthelyi D, Wadhwa M, Wagner L, Waxenecker G, Yan H, Zhang L. Kaur S, et al. Among authors: smith d. Bioanalysis. 2022 May;14(9):505-580. doi: 10.4155/bio-2022-0078. Epub 2022 May 17. Bioanalysis. 2022. PMID: 35578993
An introduction to the Marburg virus vaccine consortium, MARVAC.
Cross RW, Longini IM, Becker S, Bok K, Boucher D, Carroll MW, Díaz JV, Dowling WE, Draghia-Akli R, Duworko JT, Dye JM, Egan MA, Fast P, Finan A, Finch C, Fleming TR, Fusco J, Geisbert TW, Griffiths A, Günther S, Hensley LE, Honko A, Hunegnaw R, Jakubik J, Ledgerwood J, Luhn K, Matassov D, Meshulam J, Nelson EV, Parks CL, Rustomjee R, Safronetz D, Schwartz LM, Smith D, Smock P, Sow Y, Spiropoulou CF, Sullivan NJ, Warfield KL, Wolfe D, Woolsey C, Zahn R, Henao-Restrepo AM, Muñoz-Fontela C, Marzi A. Cross RW, et al. Among authors: smith d. PLoS Pathog. 2022 Oct 13;18(10):e1010805. doi: 10.1371/journal.ppat.1010805. eCollection 2022 Oct. PLoS Pathog. 2022. PMID: 36227853 Free PMC article.
Animal testing for vaccines. Implementing replacement, reduction and refinement: challenges and priorities.
Akkermans A, Chapsal JM, Coccia EM, Depraetere H, Dierick JF, Duangkhae P, Goel S, Halder M, Hendriksen C, Levis R, Pinyosukhee K, Pullirsch D, Sanyal G, Shi L, Sitrin R, Smith D, Stickings P, Terao E, Uhlrich S, Viviani L, Webster J. Akkermans A, et al. Among authors: smith d. Biologicals. 2020 Nov;68:92-107. doi: 10.1016/j.biologicals.2020.07.010. Epub 2020 Oct 8. Biologicals. 2020. PMID: 33041187 Free PMC article.
Modern science for better quality control of medicinal products "Towards global harmonization of 3Rs in biologicals": The report of an EPAA workshop.
Schutte K, Szczepanska A, Halder M, Cussler K, Sauer UG, Stirling C, Uhlrich S, Wilk-Zasadna I, John D, Bopst M, Garbe J, Glansbeek HL, Levis R, Serreyn PJ, Smith D, Stickings P. Schutte K, et al. Among authors: smith d. Biologicals. 2017 Jul;48:55-65. doi: 10.1016/j.biologicals.2017.05.006. Epub 2017 Jun 7. Biologicals. 2017. PMID: 28596049 Free article.
Maintaining the quality of vaccines through the use of standards: Current challenges and future opportunities.
Sajjadi NC, Brady R, Jungbäck C, Mallet L, Milne C, Prior S, Pulle G, Rigsby P, Schofield T, Siggers R, Smith D, Stickings P, Uhlrich S, Van Molle W, Walker A, Wu T, Zhou T, Baca-Estrada M. Sajjadi NC, et al. Among authors: smith d. Biologicals. 2024 May;86:101756. doi: 10.1016/j.biologicals.2024.101756. Epub 2024 Mar 12. Biologicals. 2024. PMID: 38479213
Practice variation in therapeutic hypothermia for hypoxic ischemic encephalopathy among neonates with congenital heart disease in the United States.
Chawla V, Peluso AM, Ball MK, Tabbutt S, Bailly DK, Mueller D, Rao R, Levy PT; Children’s Hospitals Neonatal Consortium Cardiac Focus Group and the Pediatric Cardiac Critical Care Consortium. Chawla V, et al. J Perinatol. 2024 Nov 22. doi: 10.1038/s41372-024-02173-1. Online ahead of print. J Perinatol. 2024. PMID: 39578511 No abstract available.
Early Outcomes of Mental Health Screening Integrated Into Routine HIV Care in Malawi.
Chikuse E, Hagstrom C, Smith D, Banda T, Chimbaka H, Nkhoma Z, Samuko M, Lichenya J, Hoffman R, Njala J, Phiri S, Phiri K, van Oosterhout JJ. Chikuse E, et al. Among authors: smith d. Glob Health Sci Pract. 2024 Nov 22. doi: 10.9745/GHSP-D-23-00517. Online ahead of print. Glob Health Sci Pract. 2024. PMID: 39578095 Free article.
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