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2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines (PART 2 - Recommendations on Development & Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies).
Kholmanskikh O, Wang YM, Hersey S, Wadhwa M, Block K, Bandukwala A, Szapacs M, Weiner R, Awwad K, Dessy F, Downing S, Du X, Garofolo F, Harris S, Hou V, Jones J, Kar S, Kinhikar A, Li M, Mathews J, Meissen J, Sumner GO, Pan L, Sanderink G, Scully I, Stanta J, Tanaka Y, Vauleon S, Wagner L, Wang K, Zhu L, Eck S, Lin YD, Azadeh M, Decman V, Diebold S, Du X, Goihberg P, Alcaide EG, Gonneau C, Hedrick MN, Hopkins G, Kar S, Loschko J, McCausland M, Mendez L, Sehra S, Stevens E, Sun YS, Tangri S, Trampont PC, Cludts I, Dysinger M, Kavita U, Sugimoto H, Chilewski S, Grimaldi C, Jiang Y, Kamerud J, Liu S, Owen C, Palackal N, Petit-Frere C, Pine S, Abhari MR, Scheibner K, Williams L, Xu T, Zhang G. Kholmanskikh O, et al. Among authors: trampont pc. Bioanalysis. 2024;16(8):179-220. doi: 10.1080/17576180.2024.2340961. Epub 2024 May 22. Bioanalysis. 2024. PMID: 38899739
Best practices for the development, analytical validation and clinical implementation of flow cytometric methods for chimeric antigen receptor T cell analyses.
Sarikonda G, Mathieu M, Natalia M, Pahuja A, Xue Q, Pierog PL, Trampont PC, Decman V, Reynolds S, Hanafi LA, Sun YS, Eck S, Hedrick MN, Stewart JJ, Tangri S, Litwin V, Dakappagari N. Sarikonda G, et al. Among authors: trampont pc. Cytometry B Clin Cytom. 2021 Jan;100(1):79-91. doi: 10.1002/cyto.b.21985. Epub 2020 Dec 29. Cytometry B Clin Cytom. 2021. PMID: 33373096 Free article. Review.
2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 - Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62).
Piccoli S, Mehta D, Vitaliti A, Allinson J, Amur S, Eck S, Green C, Hedrick M, Hopper S, Ji A, Joyce A, Litwin V, Maher K, Mathews J, Peng K, Safavi A, Wang YM, Zhang Y, Amaravadi L, Palackal N, Thankamony S, Beaver C, Bame E, Emrich T, Grimaldi C, Haulenbeek J, Joyce A, Kakkanaiah V, Lanham D, Maher K, Mayer A, Trampont PC, Vermet L, Dakappagari N, Fleener C, Garofolo F, Rogers C, Tangri S, Xu Y, Liang M, Rajadhyaksha M, Richards S, Schweighardt B, Purushothama S, Baltrukonis D, Brumm J, Cherry E, Delcarpini J, Gleason C, Kirshner S, Kubiak R, Pan L, Partridge M, Pedras-Vasconcelos J, Qu Q, Skibeli V, Saunders TS, Staack RF, Stubenrauch K, Torri A, Verthelyi D, Yan H, Gorovits B, Palmer R, Milton M, Long B, Corsaro B, Farrokhi V, Fiscella M, Henderson N, Jawa V, McNally J, Murphy R, Waldner H, Yang TY. Piccoli S, et al. Among authors: trampont pc. Bioanalysis. 2019 Dec;11(24):2207-2244. doi: 10.4155/bio-2019-0271. Epub 2019 Dec 10. Bioanalysis. 2019. PMID: 31820675
Cooperation between Noncanonical Ras Network Mutations.
Stites EC, Trampont PC, Haney LB, Walk SF, Ravichandran KS. Stites EC, et al. Among authors: trampont pc. Cell Rep. 2015 Feb 10;10(5):840. doi: 10.1016/j.celrep.2015.01.048. Epub 2015 Feb 11. Cell Rep. 2015. PMID: 30849858 Free article. No abstract available.
Cooperation between Noncanonical Ras Network Mutations.
Stites EC, Trampont PC, Haney LB, Walk SF, Ravichandran KS. Stites EC, et al. Among authors: trampont pc. Cell Rep. 2015 Jan 20;10(3):307-316. doi: 10.1016/j.celrep.2014.12.035. Epub 2015 Jan 15. Cell Rep. 2015. PMID: 25600866 Free PMC article.
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