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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: andisik m. Bioanalysis. 2022 Jun;14(11):737-793. doi: 10.4155/bio-2022-0081. Epub 2022 May 17. Bioanalysis. 2022. PMID: 35578991
2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (Part 2 - Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity).
Booth B, Stevenson L, Pillutla R, Buonarati M, Beaver C, Fraier D, Garofolo F, Haidar S, Islam R, James C, Kadavil J, Kavetska O, Li F, Satterwhite C, Savoie N, Subramaniam S, Tampal N, Thway T, Woolf E, Blaye OL, Andisik M, Briscoe C, Cape S, Dasgupta A, Fischer S, Haidar S, Hayes R, Kamerud J, Lima Santos GM, Nehls C, Soo C, Vinter S, Whale E, Xu K, Cho SJ, Edmison A, Kassim S, Rocha TC, Welink J, Amur S, Bandukwala A, Cherry E, Hopper S, Ishii-Watabe A, Kirshner S, Maher K, Pedras-Vasconcelos J, Saito Y, Saunders TS, Skibeli V, Verthelyi D, Wang YM, Yan H. Booth B, et al. Among authors: andisik m. Bioanalysis. 2019 Dec;11(23):2099-2132. doi: 10.4155/bio-2019-0270. Epub 2019 Dec 9. Bioanalysis. 2019. PMID: 31833782
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: andisik m. Bioanalysis. 2021 Mar;13(5):295-361. doi: 10.4155/bio-2021-0005. Epub 2021 Jan 29. Bioanalysis. 2021. PMID: 33511867
2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach).
Pan L, Mora J, Walravens K, Wagner L, Hopper S, Loo L, Bettoun D, Bond S, Dessy F, Downing S, Garofolo F, Gupta S, Henderson N, Irwin C, Ishii-Watabe A, Kar S, Jawa V, Joseph J, Malvaux L, Marshall JC, McDevitt J, Mohapatra S, Seitzer J, Smith J, Solstad T, Sugimoto H, Tounekti O, Wu B, Wu Y, Xu Y, Xu J, Yamamoto T, Yang L, Torri A, Kirshner S, Maxfield K, Vasconcelos JP, Abhari MR, Verthelyi D, Brodsky E, Carrasco-Triguero M, Kamerud J, Andisik M, Baltrukonis D, Bivi N, Cludts I, Coble K, Gorovits B, Gunn GR, Gupta S, Millner AH, Joyce A, Kubiak RJ, Kumar S, Liao K, Manangeeswaran M, Partridge M, Pine S, Poetzl J, Rajadhyaksha M, Rasamoelisolo M, Richards S, Song Y, Swanson S, Thacker S, Wadhwa M, Wolf A, Zhang L, Zhou L. Pan L, et al. Among authors: andisik m. Bioanalysis. 2023 Jul;15(14):773-814. doi: 10.4155/bio-2023-0135. Epub 2023 Aug 1. Bioanalysis. 2023. PMID: 37526071
12 results