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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: gokemeijer j. 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.
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. 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.
The Clinical Development of Taldefgrobep Alfa: An Anti-Myostatin Adnectin for the Treatment of Duchenne Muscular Dystrophy.
Muntoni F, Byrne BJ, McMillan HJ, Ryan MM, Wong BL, Dukart J, Bansal A, Cosson V, Dreghici R, Guridi M, Rabbia M, Staunton H, Tirucherai GS, Yen K, Yuan X, Wagner KR; Taldefgrobep Alfa Study Group. Muntoni F, et al. Neurol Ther. 2024 Feb;13(1):183-219. doi: 10.1007/s40120-023-00570-w. Epub 2024 Jan 8. Neurol Ther. 2024. PMID: 38190001 Free PMC article.
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. AAPS J. 2023 Jun 2;25(4):55. doi: 10.1208/s12248-023-00820-7. AAPS J. 2023. PMID: 37266912
A Quantitative Systems Pharmacology Consortium Approach to Managing Immunogenicity of Therapeutic Proteins.
Kierzek AM, Hickling TP, Figueroa I, Kalvass JC, Nijsen M, Mohan K, Veldman GM, Yamada A, Sayama H, Yokoo S, Gulati A, Dhanikula RS, Gokemeijer J, Leil TA, Thalhauser CJ, Giorgi M, Swat MJ, Chelliah V, Small BG, Benson N, Walker M, Gadkar K, Quarmby V, Deng R, Ferrante A, Dickinson GL, Van Der Walt JS, Zhou L, Chen X, Jones HM, Narula J, Tourdot S, Lavé T, Ribba B, van der Graaf PH. Kierzek AM, et al. Among authors: gokemeijer j. CPT Pharmacometrics Syst Pharmacol. 2019 Nov;8(11):773-776. doi: 10.1002/psp4.12465. Epub 2019 Oct 8. CPT Pharmacometrics Syst Pharmacol. 2019. PMID: 31529677 Free PMC article. No abstract available.
Synthesis and Biologic Evaluation of a Novel 18F-Labeled Adnectin as a PET Radioligand for Imaging PD-L1 Expression.
Donnelly DJ, Smith RA, Morin P, Lipovšek D, Gokemeijer J, Cohen D, Lafont V, Tran T, Cole EL, Wright M, Kim J, Pena A, Kukral D, Dischino DD, Chow P, Gan J, Adelakun O, Wang XT, Cao K, Leung D, Bonacorsi SJ Jr, Hayes W. Donnelly DJ, et al. Among authors: gokemeijer j. J Nucl Med. 2018 Mar;59(3):529-535. doi: 10.2967/jnumed.117.199596. Epub 2017 Oct 12. J Nucl Med. 2018. PMID: 29025984 Free article.
27 results