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2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization Part 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).
Szapacs M, Jian W, Spellman D, Cunliffe J, Verburg E, Kaur S, Kellie J, Li W, Mehl J, Qian M, Qiu X, Sirtori FR, Rosenbaum AI, Sikorski T, Surapaneni S, Wang J, Wilson A, Zhang J, Xue Y, Post N, Huang Y, Goykhman D, Yuan L, Fang K, Casavant E, Chen L, Fu Y, Huang M, Ji A, Johnson J, Lassman M, Li J, Saad O, Sarvaiya H, Tao L, Wang Y, Zheng N, Dasgupta A, Abhari MR, Ishii-Watabe A, Saito Y, Mendes Fernandes DN, Bower J, Burns C, Carleton K, Cho SJ, Du X, Fjording M, Garofolo F, Kar S, Kavetska O, Kossary E, Lu Y, Mayer A, Palackal N, Salha D, Thomas E, Verhaeghe T, Vinter S, Wan K, Wang YM, Williams K, Woolf E, Yang L, Yang E, Bandukwala A, Hopper S, Maher K, Xu J, Brodsky E, Cludts I, Irwin C, Joseph J, Kirshner S, Manangeeswaran M, Maxfield K, Pedras-Vasconcelos J, Solstad T, Thacker S, Tounekti O, Verthelyi D, Wadhwa M, Wagner L, Yamamoto T, Zhang L, Zhou L. Szapacs M, et al. Among authors: thomas e. Bioanalysis. 2023 Aug;15(16):955-1016. doi: 10.4155/bio-2023-0167. Epub 2023 Aug 31. Bioanalysis. 2023. PMID: 37650500
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 - Hybrid LBA/LCMS and input from regulatory agencies).
Song A, Lee A, Garofolo F, Kaur S, Duggan J, Evans C, Palandra J, Donato LD, Xu K, Bauer R, Bustard M, Chen L, Cocea L, Croft S, Galliccia F, Haidar S, Hughes N, Ishii-Watabe A, Islam R, Jones B, Kadavil J, Krantz C, Lima Santos GM, Olah T, Pedras-Vasconcelos J, Staelens L, Saito Y, Savoie N, Scheibner K, Spitz S, Tampal N, Thomas E, Vinter S, Wakelin-Smith J, Welink J, Zeng J, Zhou S. Song A, et al. Among authors: thomas e. Bioanalysis. 2016 Dec;8(23):2457-2474. doi: 10.4155/bio-2016-4988. Bioanalysis. 2016. PMID: 27855509
Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis.
Islam R, Kar S, Ritzén H, Hays A, Tayyem R, Barry C, Keyhani A, Zimmer J, Cruz Caturla M, Couerbe P, Warren M, Khadang A, Bourdage J, Lindley K, Williams D, Hughes N, Sheldon C, Satterwhite C, Vija J, Yu M, Boulay I, Stamatopoulos J, Lin J, Cape S, Estdale S, Thomas E, Dinan A, MacNeill R, Xiao YQ, Garofolo W, Savoie N, Brown M, Rhyne P, Hristopoulos G, Xu A, Goodwin L, Spriggs F, Xu A, Awaiye K, Hayes R, St Charles J, Bouhajib M, DiMarco C, DiMarco L, Savu SR, Bennett P, Kakkanaiah V, Nehls C, Stouffer B, Tabler E, Briscoe C, Karnik S, DuBey I, Kulagina N, Lindsay J, Beaver C, Williard C, Wang H, Feng H, Malone M, Wells E, Fang X, Moussallie M. Islam R, et al. Among authors: thomas e. Bioanalysis. 2019 Apr;11(7):645-653. doi: 10.4155/bio-2019-0072. Epub 2019 Apr 17. Bioanalysis. 2019. PMID: 30993999
12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity.
Briscoe C, Hughes N, Hayes R, Islam R, Bennett P, Stouffer B, Cape S, Rhyne P, Beaver C, Charles JS, Kakkanaiah V, Xu A, Caturla MC, Spriggs F, Tayyem R, Barry C, Keyhani A, Zimmer J, Couerbe P, Warren M, Khadang A, Bourdage J, Lindley K, Williams D, Sheldon C, Satterwhite C, Vija J, Yu M, Boulay I, Stamatopoulos J, Lin J, Estdale S, Thomas E, Dinan A, MacNeill R, Xiao YQ, Matassa L, Garofolo W, Savoie N, Hristopoulos G, Xu A, Goodwin L, Awaiye K, Ritzén H, Bouhajib M, Marco CD, Savu SR, Nehls C, Tabler E, Hays A, Karnik S, Brown M, Lowes S, DuBey I, Kulagina N, Lindsay J, Williard C, Wang H, Malone M, Wells E, Fang X, Moussallie M. Briscoe C, et al. Among authors: thomas e. Bioanalysis. 2019 Jun;11(12):1129-1138. doi: 10.4155/bio-2019-0131. Epub 2019 Jul 19. Bioanalysis. 2019. PMID: 31319683
16th GCC Closed Forum: ICH M10 implementation; NGS, qPCR/dPCR, flow cytometry validation; tissue biomarkers; IS response; immunogenicity harmonization; bioanalytical industry status.
Zimmer J, Hays A, Lester T, Diaz M, Thomas E, O'Dell M, Hyer E, Tangri S, Dakappagari N, Yuan M, Lavelle A, Karnik S, Liu A, Xu B, Sales K, Gorityala S, Reynolds G, Sangster T, Franckaert D, Love I, Patel V, Roberge M, Lin J, Jerks E, Xu T, Garofolo W, Nadarajah S, Kernstock R, Dufield D, Ambrose D, Warrino D, Luna M, Marco CD, Tudoroniu A, Iordachescu A, Sanghvi M, Barton H, Brown M, Hoffpauir B, Rocha A, Dong K, Yamashita J. Zimmer J, et al. Among authors: thomas e. Bioanalysis. 2024 Jun 2;16(11):505-517. doi: 10.1080/17576180.2024.2342691. Epub 2024 Jun 12. Bioanalysis. 2024. PMID: 38864397
The 10th GCC Closed Forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and counteracting fraud.
Cape S, Islam R, Nehls C, Allinson J, Safavi A, Bennett P, Hulse J, Beaver C, Khan M, Karnik S, Caturla MC, Lowes S, Iordachescu A, Silvestro L, Tayyem R, Shoup R, Mowery S, Keyhani A, Wakefield A, Li Y, Zimmer J, Torres J, Couerbe P, Khadang A, Bourdage J, Hughes N, Awaiye K, Matthews B, Fatmi S, Johnson R, Satterwhite C, Yu M, Lin J, Cojocaru L, Fiscella M, Thomas E, Kurylak K, Kamerud J, Lin ZJ, Garofolo W, Savoie N, Buonarati M, Boudreau N, Williard C, Liu Y, Warrino D, Kale P, Adcock N, Shekar R, O'Connor E, Ritzen H, Sanchez C, Hayes R, Bouhajib M, Savu SR, Stouffer B, Tabler E, Tu J, Briscoe C, der Strate BV, Rhyne P, Conliffe P, DuBey I, Yamashita J, Tang D, Groeber E, Vija J, Malone M, Osman M. Cape S, et al. Among authors: thomas e. Bioanalysis. 2017 Apr;9(7):505-516. doi: 10.4155/bio-2017-5000. Epub 2017 Mar 24. Bioanalysis. 2017. PMID: 28339299
Considerations for Cell Type Heterogeneity in Pediatric Salivary DNA Methylation Analyses: Comparison of Reference Panels & Stratification by Estimated Cell Type Proportion.
Chan MH, Meijer M, Merrill SM, Fu MPY, Lin D, MacIsaac JL, Riis JL, Granger DA, Thomas EA, Kobor MS. Chan MH, et al. Among authors: thomas ea. bioRxiv [Preprint]. 2024 Nov 11:2024.11.08.621377. doi: 10.1101/2024.11.08.621377. bioRxiv. 2024. PMID: 39605421 Free PMC article. Preprint.
5,364 results