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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: vigil a. AAPS J. 2023 Jul 31;25(5):78. doi: 10.1208/s12248-023-00842-1. AAPS J. 2023. PMID: 37523051 Review.
2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization).
Mora J, Palmer R, Wagner L, Wu B, Partridge M, Meena, Sonderegger I, Smeraglia J, Bivi N, Dakappagari N, Diebold S, Garofolo F, Grimaldi C, Kalina W, Kamerud J, Kar S, Marshall JC, Mayer C, Melton A, Merdek K, Nolan K, Picard S, Shao W, Seitzer J, Tanaka Y, Tounekti O, Vigil A, Walravens K, Xu J, Xu W, Xu Y, Yang L, Zhu L, Verthelyi D, Kubiak RJ, Coble K, Gupta S, Abhari MR, Richards S, Song Y, Ullmann M, Calderon B, Cludts I, Gunn GR, Gupta S, Ishii-Watabe A, Manangeeswaran M, Maxfield K, McCush F, O'Day C, Peng K, Poetzl J, Rasamoelisolo M, Saad OM, Scheibner K, Shubow S, Song S, Thacker S. Mora J, et al. Among authors: vigil a. Bioanalysis. 2024 Apr;16(7):77-119. doi: 10.4155/bio-2024-0024. Epub 2024 Feb 22. Bioanalysis. 2024. PMID: 38389403 Free article.
Nonclinical pharmacokinetics and biodistribution of VSV-GP using methods to decouple input drug disposition and viral replication.
Dambra R, Matter A, Graca K, Akhand SS, Mehta S, Bell-Cohn A, Swenson JM, Abid S, Xin D, Lewis C, Coyle L, Wang M, Bunosso K, Maugiri M, Ruiz R, Cirillo CM, Fogal B, Grimaldi C, Vigil A, Wood C, Ashour J. Dambra R, et al. Among authors: vigil a. Mol Ther Methods Clin Dev. 2022 Dec 28;28:190-207. doi: 10.1016/j.omtm.2022.12.013. eCollection 2023 Mar 9. Mol Ther Methods Clin Dev. 2022. PMID: 36700123 Free PMC article.
Assessment of the Immunogenicity Potential for Oligonucleotide-Based Drugs.
Henry SP, Arfvidsson C, Arrington J, Canadi J, Crowe D, Gupta S, Lohmann S, Massonnet B, Mytych D, Rogers T, Rogers H, Stebbins C, Stovold C, Verthelyi D, Vigil A, Xuan C, Xu Y, Yu R, Klem T. Henry SP, et al. Among authors: vigil a. Nucleic Acid Ther. 2022 Oct;32(5):369-377. doi: 10.1089/nat.2021.0112. Epub 2022 Sep 29. Nucleic Acid Ther. 2022. PMID: 36178478
A Compound that Inhibits Glycolysis in Prostate Cancer Controls Growth of Advanced Prostate Cancer.
Uo T, Ojo KK, Sprenger CCT, Soriano Epilepsia K, Perera BGK, Damodarasamy M, Sun S, Kim S, Hogan HH, Hulverson MA, Choi R, Whitman GR, Barrett LK, Michaels SA, Xu LH, Sun VL, Arnold SLM, Pang HJ, Nguyen MM, Vigil ABG, Kamat V, Sullivan LB, Sweet IR, Vidadala R, Maly DJ, Van Voorhis WC, Plymate SR. Uo T, et al. Among authors: vigil abg. Mol Cancer Ther. 2024 Mar 20. doi: 10.1158/1535-7163.MCT-23-0540. Online ahead of print. Mol Cancer Ther. 2024. PMID: 38507737
A Compound that Inhibits Glycolysis in Prostate Cancer Controls Growth of Advanced Prostate Cancer.
Uo T, Ojo KK, Sprenger CC, Epilepsia KS, Perera BGK, Damodarasamy M, Sun S, Kim S, Hogan HH, Hulverson MA, Choi R, Whitman GR, Barrett LK, Michaels SA, Xu LH, Sun VL, Arnold SLM, Pang HJ, Nguyen MM, Vigil ABG, Kamat V, Sullivan LB, Sweet IR, Vidadala R, Maly DJ, Van Voorhis WC, Plymate SR. Uo T, et al. Among authors: vigil abg. bioRxiv [Preprint]. 2024 Feb 13:2023.07.01.547355. doi: 10.1101/2023.07.01.547355. bioRxiv. 2024. PMID: 37461469 Free PMC article. Updated. Preprint.
95 results