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2023 White Paper on Recent Issues in Bioanalysis: Deuterated Drugs; LNP; Tumor/FFPE Biopsy; Targeted Proteomics; Small Molecule Covalent Inhibitors; Chiral Bioanalysis; Remote Regulatory Assessments; Sample Reconciliation/Chain of Custody (PART 1A - Recommendations on Mass Spectrometry, Chromatography, Sample Preparation Latest Developments, Challenges, and Solutions and BMV/Regulated Bioanalysis PART 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/IVD/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).
Baratta M, Jian W, Hengel S, Kaur S, Cunliffe J, Boer J, Hughes N, Kar S, Kellie J, Kim YJ, Lassman M, Mehl J, Morgan L, Palandra J, Sarvaiya H, Zeng J, Zheng N, Wang J, Yuan L, Ji A, Kochansky C, Tao L, Huang Y, Maes E, Barbero L, Contrepois K, Ferrari L, Fu Y, Johnson J, Jones B, Kansal M, Lu Y, Post N, Shen HH, Xue YY, Zhang YC, Biswas G, Cho SJ, Edmison A, Benson K, Abberley L, Azadeh M, Francis J, Garofolo F, Gupta S, Ivanova ID, Ishii-Watabe A, Karnik S, Kassim S, Kavetska O, Keller S, Kossary E, Li W, McCush F, Mendes DN, Abhari MR, Scheibner K, Sikorski T, Staack RF, Tabler E, Tang H, Wan K, Wang YM, Whale E, Yang L, Zimmer J, Bandukwala A, Du X, Kholmanskikh O, Gijsel SK, Wadhwa M, Xu J, Buoninfante A, Cludts I, Diebold S, Maxfield K, Mayer C, Pedras-Vasconcelos J, Abhari MR, Shubow S, Tanaka Y, Tounekti O, Verthelyi D, Wagner L. Baratta M, et al. Among authors: azadeh m. Bioanalysis. 2024;16(9):307-364. doi: 10.1080/17576180.2024.2347153. Epub 2024 May 27. Bioanalysis. 2024. PMID: 38913185
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: azadeh 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: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles Part 2 - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization.
Sumner G, Keller S, Huleatt J, Staack RF, Wagner L, Azadeh M, Bandukwala A, Cao L, Du X, Salinas GF, Garofolo F, Harris S, Hopper S, Irwin C, Ji Q, Joseph J, King L, Kinhikar A, Lu Y, Luo R, Mabrouk O, Malvaux L, Marshall JC, McGuire K, Mikol V, Neely R, Qiu X, Saito Y, Salaun B, Scully I, Smeraglia J, Solstad T, Stoop J, Tang H, Teixeira P, Wang Y, Wright M, Mendez L, Beaver C, Eacret J, Au-Yeung A, Decman V, Dessy F, Eck S, Goihberg P, Alcaide EG, Gonneau C, Grugan K, Hedrick MN, Kar S, Sehra S, Stevens E, Stevens C, Sun Y, McCush F, Williams L, Fischer S, Wu B, Jordan G, Burns C, Cludts I, Coble K, Grimaldi C, Henderson N, Joyce A, Lotz G, Lu Y, Luo L, Neff F, Sperinde G, Stubenrauch KG, Wang Y, Ware M, Xu W. Sumner G, et al. Among authors: azadeh m. Bioanalysis. 2023 Aug;15(15):861-903. doi: 10.4155/bio-2023-0151. Epub 2023 Aug 16. Bioanalysis. 2023. PMID: 37584363
Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development.
Hays A, Wissel M, Colletti K, Soon R, Azadeh M, Smith J, Doddareddy R, Chalfant M, Adamowicz W, Ramaswamy SS, Dholakiya SL, Guelman S, Gullick B, Durham J, Rennier K, Nagilla P, Muruganandham A, Diaz M, Tierney C, John K, Valentine J, Lockman T, Liu HY, Moritz B, Ouedraogo JP, Piche MS, Smet M, Murphy J, Koenig K, Zybura A, Vyhlidal C, Mercier J, Jani N, Kubista M, Birch D, Morse K, Johansson O. Hays A, et al. Among authors: azadeh m. AAPS J. 2024 Feb 5;26(1):24. doi: 10.1208/s12248-023-00880-9. AAPS J. 2024. PMID: 38316745
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: azadeh m. Bioanalysis. 2024;16(8):179-220. doi: 10.1080/17576180.2024.2340961. Epub 2024 May 22. Bioanalysis. 2024. PMID: 38899739
Neutralizing Antibody Sample Testing and Report Harmonization.
Jani D, Gunsior M, Marsden R, Cowan KJ, Irvin SC, Hay LS, Ward B, Armstrong L, Azadeh M, Cao L, Carmean R, DelCarpini J, Dholakiya SL, Hays A, Hosback S, Hu Z, Kulagina N, Kumar S, Lai CH, Lichtfuss M, Liu HY, Liu S, Mozaffari R, Pan L, Pennucci J, Poupart ME, Saini G, Snoeck V, Storey K, Turner A, Vainshtein I, Verthelyi D, Wala I, Yang L, Yang L. Jani D, et al. Among authors: azadeh m. AAPS J. 2024 Jul 12;26(4):80. doi: 10.1208/s12248-024-00955-1. AAPS J. 2024. PMID: 38992280
Anti-drug Antibody Sample Testing and Reporting Harmonization.
Jani D, Marsden R, Gunsior M, Hay LS, Ward B, Cowan KJ, Azadeh M, Barker B, Cao L, Closson KR, Coble K, Dholakiya SL, Dusseault J, Hays A, Herl C, Hodsdon ME, Irvin SC, Kirshner S, Kolaitis G, Kulagina N, Kumar S, Lai CH, Lipari F, Liu S, Merdek KD, Moldovan IR, Mozaffari R, Pan L, Place C, Snoeck V, Manning MS, Stocker D, Tary-Lehmann M, Turner A, Vainshtein I, Verthelyi D, Williams WT, Yan H, Yan W, Yang L, Yang L, Zemo J, Zhong ZD. Jani D, et al. Among authors: azadeh m. AAPS J. 2022 Oct 28;24(6):113. doi: 10.1208/s12248-022-00762-6. AAPS J. 2022. PMID: 36307592
Correction to: Neutralizing Antibody Sample Testing and Report Harmonization.
Jani D, Gunsior M, Marsden R, Cowan KJ, Irvin SC, Hay LS, Ward B, Armstrong L, Azadeh M, Cao L, Carmean R, DelCarpini J, Dholakiya SL, Hays A, Hosback S, Hu Z, Kulagina N, Kumar S, Lai CH, Lichtfuss M, Liu HY, Liu S, Mozaffari R, Pan L, Pennucci J, Poupart ME, Saini G, Snoeck V, Storey K, Turner A, Vainshtein I, Verthelyi D, Wala I, Yang L, Yang L. Jani D, et al. Among authors: azadeh m. AAPS J. 2024 Sep 4;26(5):98. doi: 10.1208/s12248-024-00965-z. AAPS J. 2024. PMID: 39231893 No abstract available.
Evaluation of Cellular Immune Response to Adeno-Associated Virus-Based Gene Therapy.
Gorovits B, Azadeh M, Buchlis G, Fiscella M, Harrison T, Havert M, Janetzki S, Jawa V, Long B, Mahnke YD, McDermott A, Milton M, Nelson R, Vettermann C, Wu B. Gorovits B, et al. Among authors: azadeh m. AAPS J. 2023 Apr 26;25(3):47. doi: 10.1208/s12248-023-00814-5. AAPS J. 2023. PMID: 37101079 Free PMC article. Review.
49 results