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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. Bioanalysis. 2022 Jun;14(11):737-793. doi: 10.4155/bio-2022-0081. Epub 2022 May 17. Bioanalysis. 2022. PMID: 35578991 Free article.
Immunogenicity assessment of AAV-based gene therapies: An IQ consortium industry white paper.
Yang TY, Braun M, Lembke W, McBlane F, Kamerud J, DeWall S, Tarcsa E, Fang X, Hofer L, Kavita U, Upreti VV, Gupta S, Loo L, Johnson AJ, Chandode RK, Stubenrauch KG, Vinzing M, Xia CQ, Jawa V. Yang TY, et al. Among authors: loo l. Mol Ther Methods Clin Dev. 2022 Aug 2;26:471-494. doi: 10.1016/j.omtm.2022.07.018. eCollection 2022 Sep 8. Mol Ther Methods Clin Dev. 2022. PMID: 36092368 Free PMC article. 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2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity,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: loo l. Bioanalysis. 2023 Jul;15(14):773-814. doi: 10.4155/bio-2023-0135. Epub 2023 Aug 1. Bioanalysis. 2023. PMID: 37526071 Free article.
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: loo l. AAPS J. 2023 Jul 31;25(5):78. doi: 10.1208/s12248-023-00842-1. AAPS J. 2023. PMID: 37523051 Review.
Spatial omics techniques and data analysis for cancer immunotherapy applications.
Zhang Y, Lee RY, Tan CW, Guo X, Yim WW, Lim JC, Wee FY, Yang WU, Kharbanda M, Lee JJ, Ngo NT, Leow WQ, Loo LH, Lim TK, Sobota RM, Lau MC, Davis MJ, Yeong J. Zhang Y, et al. Among authors: loo lh. Curr Opin Biotechnol. 2024 Mar 22;87:103111. doi: 10.1016/j.copbio.2024.103111. Online ahead of print. Curr Opin Biotechnol. 2024. PMID: 38520821 Review.
CRISPR activation screens: navigating technologies and applications.
Clark T, Waller MA, Loo L, Moreno CL, Denes CE, Neely GG. Clark T, et al. Among authors: loo l. Trends Biotechnol. 2024 Mar 15:S0167-7799(24)00036-2. doi: 10.1016/j.tibtech.2024.02.007. Online ahead of print. Trends Biotechnol. 2024. PMID: 38493051 Free article. Review.
Epigenome-wide association study of total nicotine equivalents in multiethnic current smokers from three prospective cohorts.
Huang BZ, Binder AM, Quon B, Patel YM, Lum-Jones A, Tiirikainen M, Murphy SE, Loo L, Maunakea AK, Haiman CA, Wilkens LR, Koh WP, Cai Q, Aldrich MC, Siegmund KD, Hecht SS, Yuan JM, Blot WJ, Stram DO, Le Marchand L, Park SL. Huang BZ, et al. Among authors: loo l. Am J Hum Genet. 2024 Mar 7;111(3):456-472. doi: 10.1016/j.ajhg.2024.01.012. Epub 2024 Feb 16. Am J Hum Genet. 2024. PMID: 38367619
Pneumonia outbreaks due to re-emergence of Mycoplasma pneumoniae.
Meyer Sauteur PM, Beeton ML; European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Study Group for Mycoplasma and Chlamydia Infections (ESGMAC), and the ESGMAC Mycoplasma pneumoniae Surveillance (MAPS) study group. Meyer Sauteur PM, et al. Lancet Microbe. 2024 Feb 8:S2666-5247(23)00406-8. doi: 10.1016/S2666-5247(23)00406-8. Online ahead of print. Lancet Microbe. 2024. PMID: 38342111 Free article. No abstract available.
Relative deficiency in interferon-γ-secreting CD4+ T cells is strongly associated with poorer COVID-19 vaccination responses in older adults.
Ho VWT, Boon LH, Cui J, Juequn Z, Shunmuganathan B, Gupta R, Tan NYJ, Qian X, Purushotorman K; SCOPE Cohort Study Group; Fong SW, Renia L, Ng LFP, Angeli V, Chen J, Kennedy BK, Ong CWM, Macary PA. Ho VWT, et al. Aging Cell. 2024 Apr;23(4):e14099. doi: 10.1111/acel.14099. Epub 2024 Feb 5. Aging Cell. 2024. PMID: 38317404 Free PMC article.
Efficacy and safety of the orthopaedic manipulation techniques of the Lin School of Lingnan Region in the treatment of adolescent idiopathic scoliosis: protocol of a participant-and-assessor-blinded randomized controlled study.
Hung HY, Kong WC, Tam TH, Leung PC, Zheng Y, Wong AYL, Lin Z, Yao F, Tian Q, Mok TL, Loo LE, Chung KL. Hung HY, et al. Among authors: loo le. BMC Musculoskelet Disord. 2024 Jan 4;25(1):32. doi: 10.1186/s12891-023-07152-9. BMC Musculoskelet Disord. 2024. PMID: 38178051 Free PMC article.
340 results