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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: tangri s. Bioanalysis. 2024;16(8):179-220. doi: 10.1080/17576180.2024.2340961. Epub 2024 May 22. Bioanalysis. 2024. PMID: 38899739
16th GCC Closed Forum: ICH M10 implementation; NGS, qPCR/dPCR, flow cytometry validation; tissue biomarkers; IS response; immunogenicity harmonization; bioanalytical industry status.
Zimmer J, Hays A, Lester T, Diaz M, Thomas E, O'Dell M, Hyer E, Tangri S, Dakappagari N, Yuan M, Lavelle A, Karnik S, Liu A, Xu B, Sales K, Gorityala S, Reynolds G, Sangster T, Franckaert D, Love I, Patel V, Roberge M, Lin J, Jerks E, Xu T, Garofolo W, Nadarajah S, Kernstock R, Dufield D, Ambrose D, Warrino D, Luna M, Marco CD, Tudoroniu A, Iordachescu A, Sanghvi M, Barton H, Brown M, Hoffpauir B, Rocha A, Dong K, Yamashita J. Zimmer J, et al. Among authors: tangri s. Bioanalysis. 2024 Jun 2;16(11):505-517. doi: 10.1080/17576180.2024.2342691. Epub 2024 Jun 12. Bioanalysis. 2024. PMID: 38864397
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: tangri s. Bioanalysis. 2022 Jun;14(11):737-793. doi: 10.4155/bio-2022-0081. Epub 2022 May 17. Bioanalysis. 2022. PMID: 35578991
Effectiveness of therapeutic heparin versus prophylactic heparin on death, mechanical ventilation, or intensive care unit admission in moderately ill patients with covid-19 admitted to hospital: RAPID randomised clinical trial.
Sholzberg M, Tang GH, Rahhal H, AlHamzah M, Kreuziger LB, Áinle FN, Alomran F, Alayed K, Alsheef M, AlSumait F, Pompilio CE, Sperlich C, Tangri S, Tang T, Jaksa P, Suryanarayan D, Almarshoodi M, Castellucci LA, James PD, Lillicrap D, Carrier M, Beckett A, Colovos C, Jayakar J, Arsenault MP, Wu C, Doyon K, Andreou ER, Dounaevskaia V, Tseng EK, Lim G, Fralick M, Middeldorp S, Lee AYY, Zuo F, da Costa BR, Thorpe KE, Negri EM, Cushman M, Jüni P; RAPID trial investigators. Sholzberg M, et al. Among authors: tangri s. BMJ. 2021 Oct 14;375:n2400. doi: 10.1136/bmj.n2400. BMJ. 2021. PMID: 34649864 Free PMC article. Clinical Trial.
Heparin for Moderately Ill Patients with Covid-19.
Sholzberg M, Tang GH, Rahhal H, AlHamzah M, Kreuziger LB, Ní Áinle F, Alomran F, Alayed K, Alsheef M, AlSumait F, Pompilio CE, Sperlich C, Tangri S, Tang T, Jaksa P, Suryanarayan D, Almarshoodi M, Castellucci L, James PD, Lillicrap D, Carrier M, Beckett A, Colovos C, Jayakar J, Arsenault MP, Wu C, Doyon K, Andreou ER, Dounaevskaia V, Tseng EK, Lim G, Fralick M, Middeldorp S, Lee AYY, Zuo F, da Costa BR, Thorpe KE, Negri EM, Cushman M, Jüni P; RAPID Trial investigators. Sholzberg M, et al. Among authors: tangri s. medRxiv [Preprint]. 2021 Jul 12:2021.07.08.21259351. doi: 10.1101/2021.07.08.21259351. medRxiv. 2021. Update in: BMJ. 2021 Oct 14;375:n2400. doi: 10.1136/bmj.n2400 PMID: 34268513 Free PMC article. Updated. Preprint.
2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A - Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Spitz S, Zhang Y, Fischer S, McGuire K, Sommer U, Amaravadi L, Bandukwala A, Eck S, Garofolo F, Islam R, Jordan G, King L, Saito Y, Sumner G, Terry L, Vitaliti A, Wang YM, Grimaldi C, Joyce A, Palmer R, Andisik M, Araya M, Azadeh M, Baltrukonis D, Elliott R, Haidar S, Kumar S, Mayer A, Neff F, Palackal N, Peng K, Abhari MR, Satterwhite C, Savoie N, Soo C, Vinter S, Welink J, Yan W, Maher K, Lanham D, Bertholet S, Dakappagari N, Gonneau C, Green C, Junker F, Kar S, Patti-Diaz L, Sarikonda S, McCausland M, Teixeira PC, Decman V, Estevam J, Hedrick M, Robert AH, Hopkins G, Nuti S, Tangri S, Wnek R, Dandamudi S, Dasgupta A, Edmison A, Faustino P, McGuinness M, Lima Santos GM, Mirza T, Shakleya D, Stojdl S, Tampal N, Zhang J, Cherry E, Cludts I, Exley A, Ishii-Watabe A, Kirshner S, Pedras-Vasconcelos J, Shen M, Siggers R, Solstad T, Verthelyi D, Yan H, Zhang L. Spitz S, et al. Among authors: tangri s. Bioanalysis. 2021 Mar;13(5):295-361. doi: 10.4155/bio-2021-0005. Epub 2021 Jan 29. Bioanalysis. 2021. PMID: 33511867
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: tangri s. 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.
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