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2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (Part 3 - Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays).
Corsaro B, Yang TY, Murphy R, Sonderegger I, Exley A, Bertholet S, Dakappagari N, Dessy F, Garofolo F, Kierstead L, Koch H, Sarikonda G, Savoie N, Siggers R, Solstad T, Lu Y, Milton M, Marshall JC, DelCarpini J, Gorovits B, Gupta S, Jesaitis L, Kamerud J, Kromminga A, Ma A, McNally J, Yan H, Wu B, Verthelyi D, Kirshner S, Pedras-Vasconcelos J, Rajadhyaksha M, Staack RF, Cherry E, Cludts I, Dahlbäck M, Gunn GR, Ishii-Watabe A, Jawa V, Kubiak R, Partridge M, Petrillo M, Pine SO, Poetzl J, Song S, Stebbins C, Wu Y, Zhang L, Kar S, Liang M, Abhari MR, Schweighardt B, Stubenrauch K, Xu Y. Corsaro B, et al. Among authors: kamerud j. Bioanalysis. 2021 Mar;13(6):415-463. doi: 10.4155/bio-2021-0007. Epub 2021 Feb 3. Bioanalysis. 2021. PMID: 33533276
Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis.
Lowes S, Jersey J, Shoup R, Garofolo F, Savoie N, Mortz E, Needham S, Caturla MC, Steffen R, Sheldon C, Hayes R, Samuels T, Di Donato L, Kamerud J, Michael S, Lin ZJ, Hillier J, Moussallie M, de Souza Teixeira L, Rocci M, Buonarati M, Truog J, Hussain S, Lundberg R, Breau A, Zhang T, Jonker J, Berger N, Gagnon-Carignan S, Nehls C, Nicholson R, Hilhorst M, Karnik S, de Boer T, Houghton R, Smith K, Cojocaru L, Allen M, Harter T, Fatmi S, Sayyarpour F, Vija J, Malone M, Heller D. Lowes S, et al. Among authors: kamerud j. Bioanalysis. 2011 Jun;3(12):1323-32. doi: 10.4155/bio.11.135. Bioanalysis. 2011. PMID: 21679026
Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC).
Lowes S, Boterman M, Doig M, Breda M, Jersey J, Lelacheur R, Shoup R, Garofolo F, Dumont I, Martinez S, Needham S, Zimmer J, Caturla MC, Couerbe P, Maltas J, Steffen R, Petrilla J, Safavi A, Awaiye K, Bhatti M, Sheldon C, Schiebl C, Struwe P, Turk D, Sangster T, Pattison C, Fast D, Goodwin L, Kamerud J, Dinan A, Mamelak D, Islam R, Segers R, Lin ZJ, Hillier J, Garofolo W, Folguera L, Zimmer D, Zimmermann T, Pawula M, Moussallie M, de Souza Teixeira L, Rocha T, Allinson J, Jardieu P, Tang D, Gouty D, Wright L, Truog J, Lin J, Yamashita Y, Khan M, Liu Y, Xu A, Lundberg R, Cox C, Breau A, Hayes R, Bigogno C, Schoutsen D, Dilger C, Jonker J, Bouhajib M, Levesque A, Gagnon-Carignan S, Harman J, Nicholson R, Jenkins R, Warren M, Lin MH, Karnik S, De Boer T, Houghton R, Green R, Demaio W, Sable R, Smith K, Siethoff C, Cojocaru L, Allen M, Reuschel S, Gonzalez P, Harter T, Fatmi S, Rock M, Vija J, Sayyarpour F, Malone M, Nowatzke W, Best S, Fang X. Lowes S, et al. Among authors: kamerud j. Bioanalysis. 2012 Sep;4(17):2117-26. doi: 10.4155/bio.12.192. Bioanalysis. 2012. PMID: 23013394
Recommendations on incurred sample stability (ISS) by GCC.
Lowes S, LeLacheur R, Shoup R, Garofolo F, Dumont I, Martinez S, Zimmer J, Caturla MC, Couerbe P, Awaiye K, Fatmi S, Farmen R, Sheldon C, Bower J, Fiscella M, Fast D, Cape S, Hulse J, Kamerud J, Zhang T, Pasas-Farmer S, Garofolo W, Moussallie M, Rocci M, Allinson J, Gouty D, Buonarati M, Boudreau N, Pellerin B, Lin J, Xu A, Hayes R, Bouhajib M, Stipancic M, Nicholson R, Nehls C, Warren M, Karnik S, Houghton R, Stovold C, Reuschel S, Cojocaru L, Marcelletti J, Fang X, Smith I, Watson A. Lowes S, et al. Among authors: kamerud j. Bioanalysis. 2014 Sep;6(18):2385-90. doi: 10.4155/bio.14.155. Bioanalysis. 2014. PMID: 25384591
8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation.
Bower J, Fast D, Garofolo F, Gouty D, Hayes R, Lowes S, Nicholson R, LeLacheur R, Bravo J, Shoup R, Dumont I, Carbone M, Zimmer J, Ortuno J, Caturla MC, Datin J, Lansing T, Fatmi S, Struwe P, Sheldon C, Islam R, Yu M, Hulse J, Kamerud J, Lin J, Doughty J, Kurylak K, Tang D, Buonarati M, Blanchette A, Levesque A, Gagnon-Carignan S, Lin J, Ray G, Liu Y, Khan M, Xu A, El-Sulayman G, DiMarco C, Bouhajib M, Tacey D, Jenkins R, der Strate Bv, Briscoe C, Karnik S, Rhyne P, Garofolo W, Schultz G, Roberts A, Redrup M, DuBey I, Conliffe P, Pekol T, Hantash J, Cojocaru L, Allen M, Reuschel S, Watson A, Farrell C, Groeber E, Malone M, Nowatzke W, Fang X. Bower J, et al. Among authors: kamerud j. Bioanalysis. 2014;6(22):2957-63. doi: 10.4155/bio.14.287. Bioanalysis. 2014. PMID: 25496252
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3--LBA, biomarkers and immunogenicity).
Amaravadi L, Song A, Myler H, Thway T, Kirshner S, Devanarayan V, Ni YG, Garofolo F, Birnboeck H, Richards S, Gupta S, Luo L, Kingsley C, Salazar-Fontana L, Fraser S, Gorovits B, Allinson J, Barger T, Chilewski S, Fjording MS, Haidar S, Islam R, Jaitner B, Kamerud J, Katori N, Krinos-Fiorotti C, Lanham D, Ma M, McNally J, Morimoto A, Mytych D, Nogueira da Costa A, Papadimitriou A, Pillutla R, Ray S, Safavi A, Savoie N, Schaefer M, Shih J, Smeraglia J, Skelly MF, Spond J, Staack RF, Stouffer B, Tampal N, Torri A, Welink J, Yang TY, Zoghbi J. Amaravadi L, et al. Among authors: kamerud j. Bioanalysis. 2015 Dec;7(24):3107-24. doi: 10.4155/bio.15.226. Epub 2015 Dec 4. Bioanalysis. 2015. PMID: 26635247
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity).
Richards S, Amaravadi L, Pillutla R, Birnboeck H, Torri A, Cowan KJ, Papadimitriou A, Garofolo F, Satterwhite C, Piccoli S, Wu B, Krinos-Fiorotti C, Allinson J, Berisha F, Cocea L, Croft S, Fraser S, Galliccia F, Gorovits B, Gupta S, Gupta V, Haidar S, Hottenstein C, Ishii-Watabe A, Jani D, Kadavil J, Kamerud J, Kramer D, Litwin V, Lima Santos GM, Nelson R, Ni Y, Pedras-Vasconcelos J, Qiu Y, Rhyne P, Safavi A, Saito Y, Savoie N, Scheibner K, Schick E, Siguenza PY, Smeraglia J, Staack RF, Subramanyam M, Sumner G, Thway T, Uhlinger D, Ullmann M, Vitaliti A, Welink J, Whiting CC, Xue L, Zeng R. Richards S, et al. Among authors: kamerud j. Bioanalysis. 2016 Dec;8(23):2475-2496. doi: 10.4155/bio-2016-4989. Bioanalysis. 2016. PMID: 27855512
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: kamerud j. Bioanalysis. 2017 Apr;9(7):505-516. doi: 10.4155/bio-2017-5000. Epub 2017 Mar 24. Bioanalysis. 2017. PMID: 28339299
2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays).
Gupta S, Richards S, Amaravadi L, Piccoli S, Desilva B, Pillutla R, Stevenson L, Mehta D, Carrasco-Triguero M, Neely R, Partridge M, Staack RF, Zhao X, Gorovits B, Kolaitis G, Sumner G, Stubenrauch KG, Zou L, Amur S, Beaver C, Berger I, Berisha F, Birnboeck H, Bower J, Cho SJ, Cludts I, Cocea L, Donato LD, Fischer S, Fraser S, Garofolo F, Haidar S, Haulenbeek J, Hottenstein C, Hu J, Ishii-Watabe A, Islam R, Jani D, Kadavil J, Kamerud J, Kramer D, Kurki P, MacMannis S, McNally J, Mullan A, Papadimitriou A, Pedras-Vasconcelos J, Ray S, Safavi A, Saito Y, Savoie N, Fjording MS, Scheibner K, Smeraglia J, Song A, Stouffer B, Tampal N, der Strate BV, Verch T, Welink J, Xu Y, Yang TY, Yengi L, Zeng J, Zhang Y, Zhang Y, Zoog S. Gupta S, et al. Among authors: kamerud j. Bioanalysis. 2017 Dec;9(24):1967-1996. doi: 10.4155/bio-2017-4974. Epub 2017 Dec 5. Bioanalysis. 2017. PMID: 29205064
36 results