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PK/PD and Bioanalytical Considerations of AAV-Based Gene Therapies: an IQ Consortium Industry Position Paper.
Kavita U, Sun K, Braun M, Lembke W, Mody H, Kamerud J, Yang TY, Braun IV, Fang X, Gao W, Gupta S, Hofer M, Liao MZ, Loo L, McBlane F, Menochet K, Stubenrauch KG, Upreti VV, Vigil A, Wiethoff CM, Xia CQ, Zhu X, Jawa V, Chemuturi N. Kavita U, et al. Among authors: jawa v. AAPS J. 2023 Jul 31;25(5):78. doi: 10.1208/s12248-023-00842-1. AAPS J. 2023. PMID: 37523051 Review.
2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity,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: jawa v. Bioanalysis. 2023 Jul;15(14):773-814. doi: 10.4155/bio-2023-0135. Epub 2023 Aug 1. Bioanalysis. 2023. PMID: 37526071 Free article.
Preexisting antibody assays for gene therapy: Considerations on patient selection cutoffs and companion diagnostic requirements.
Braun M, Lange C, Schatz P, Long B, Stanta J, Gorovits B, Tarcsa E, Jawa V, Yang TY, Lembke W, Miller N, McBlane F, Christodoulou L, Yuill D, Milton M. Braun M, et al. Among authors: jawa v. Mol Ther Methods Clin Dev. 2024 Feb 20;32(1):101217. doi: 10.1016/j.omtm.2024.101217. eCollection 2024 Mar 14. Mol Ther Methods Clin Dev. 2024. PMID: 38496304 Free PMC article. Review.
A High Threshold of Biotherapeutic Aggregate Numbers is Needed to Induce an Immunogenic Response In Vitro, In Vivo, and in the Clinic.
Cohen JR, Brych SR, Prabhu S, Bi V, Elbaradei A, Tokuda JM, Xiang C, Hokom M, Cui X, Ly C, Amos N, Sun J, Calamba D, Herskovitz J, Capili A, Nourbakhsh K, Merlo A, Carreon J, Wypych J, Narhi LO, Jawa V, Joubert MK. Cohen JR, et al. Among authors: jawa v. Pharm Res. 2024 Apr;41(4):651-672. doi: 10.1007/s11095-024-03678-2. Epub 2024 Mar 22. Pharm Res. 2024. PMID: 38519817
An IQ Consortium Perspective on Best Practices for Bioanalytical and Immunogenicity Assessment Aspects of CAR-T and TCR-T Cellular Therapies Development.
Gokemeijer J, Balasubramanian N, Ogasawara K, Grudzinska-Goebel J, Upreti VV, Mody H, Kasar S, Vepachedu VR, Xu W, Gupta S, Tarcsa E, Dodge R, Herr K, Yang TY, Tourdot S, Jawa V. Gokemeijer J, et al. Among authors: jawa v. Clin Pharmacol Ther. 2024 Feb;115(2):188-200. doi: 10.1002/cpt.3111. Epub 2023 Dec 17. Clin Pharmacol Ther. 2024. PMID: 37983584 Review.
Best Practices and Considerations for Clinical Pharmacology and Pharmacometric Aspects for Optimal Development of CAR-T and TCR-T Cell Therapies: An Industry Perspective.
Mody H, Ogasawara K, Zhu X, Miles D, Shastri PN, Gokemeijer J, Liao MZ, Kasichayanula S, Yang TY, Chemuturi N, Gupta S, Jawa V, Upreti VV. Mody H, et al. Among authors: jawa v. Clin Pharmacol Ther. 2023 Sep;114(3):530-557. doi: 10.1002/cpt.2986. Epub 2023 Jul 26. Clin Pharmacol Ther. 2023. PMID: 37393588 Review.
Survey Outcome on Immunogenicity Risk Assessment Tools for Biotherapeutics: an Insight into Consensus on Methods, Application, and Utility in Drug Development.
Gokemeijer J, Wen Y, Jawa V, Mitra-Kaushik S, Chung S, Goggins A, Kumar S, Lamberth K, Liao K, Lill J, Phung Q, Walsh R, Roberts BJ, Swanson M, Singh I, Tourdot S, Kroenke MA, Rup B, Goletz TJ, Gupta S, Malherbe L, Pattijn S. Gokemeijer J, et al. Among authors: jawa v. AAPS J. 2023 Jun 2;25(4):55. doi: 10.1208/s12248-023-00820-7. AAPS J. 2023. PMID: 37266912
64 results