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. 2024 Jun 2;16(11):505-517.
doi: 10.1080/17576180.2024.2342691. Epub 2024 Jun 12.

16th GCC Closed Forum: ICH M10 implementation; NGS, qPCR/dPCR, flow cytometry validation; tissue biomarkers; IS response; immunogenicity harmonization; bioanalytical industry status

Jennifer Zimmer  1 , Amanda Hays  2 , Todd Lester  2 , Manisha Diaz  3 , Eric Thomas  4 , Mark O'Dell  4 , Elizabeth Hyer  5 , Shabnam Tangri  6 , Naveen Dakappagari  6 , Moucun Yuan  7 , Amy Lavelle  7 , Shane Karnik  8 , Aihua Liu  9 , Bin Xu  10 , Kurt Sales  11 , Shashank Gorityala  2 , Gregory Reynolds  12 , Tim Sangster  13 , Dean Franckaert  14 , Iain Love  15 , Vimal Patel  16 , Martin Roberge  17 , Jenny Lin  18 , Erik Jerks  19 , Tao Xu  20 , Wei Garofolo  21 , Sankeetha Nadarajah  21 , Robert Kernstock  22 , Dawn Dufield  23 , David Ambrose  23 , Dominic Warrino  23 , Marsha Luna  23 , Chantal Di Marco  24 , Ariana Tudoroniu  25 , Adriana Iordachescu  25 , Mitesh Sanghvi  26 , Hollie Barton  7 , Michael Brown  27 , Brian Hoffpauir  28 , Agostinho Rocha  29 , Kelly Dong  30 , Jim Yamashita  31
Affiliations

16th GCC Closed Forum: ICH M10 implementation; NGS, qPCR/dPCR, flow cytometry validation; tissue biomarkers; IS response; immunogenicity harmonization; bioanalytical industry status

Jennifer Zimmer et al. Bioanalysis. .

Abstract

The 16th GCC Closed Forum was held in Orlando, FL, USA, on 23 June 2023. Representatives from international bioanalytical Contract Research Organizations were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at the meeting included: IS response, flow cytometry, changes to the bioanalytical industry, NGS assays, biomarker assay for tissues, dPCR validation, immunogenicity harmonization and ICH M10 implementation. Conclusions and consensus from discussions of these topics are included in this article.

Keywords: CRO; ICH M10; IS response; NGS assay; bioanalysis; biomarker assay; dPCR validation; flow cytometry; immunogenicity harmonization.

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Conflict of interest statement

The authors have no competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, stock ownership or options and expert testimony.

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