Shannon Harris

2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 &amp; CAR-T Immunogenicity; PCR &amp; Vaccine Assay Performance; ADA Assay Comparability &amp; Cut Point Appropriateness ( <u>Part 3</u> – Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization)

LiNa Loo, Shannon Harris, Mark Milton et al. · Bioanalysis · 2022 · 36 citations · Full text

Medicine, Biomedical Sciences, Biotechnology +16

2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral &amp; Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry ( <u>Part 2</u> – Recommendations on Biomarkers/CDx Assays Development &amp; Validation, Cytometry Validation &amp; Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents &amp; Positive Controls Generation)

Sarah Hersey, Steve Keller, Joel Mathews et al. · Bioanalysis · 2022 · 25 citations · Full text

Pharmacy, Biomedical Sciences, Biopharmaceutics +16

2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles <u>Part 2</u> – Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development &amp; Validation; Emerging Technologies; Critical Reagents Deep Characterization

Giane Sumner, Steve Keller, James W. Huleatt et al. · Bioanalysis · 2023 · 13 citations

Pharmacy, Biomedical Sciences, Biotechnology +17

2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines ( <u>PART 2</u> – Recommendations on Development &amp; Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies)

Olga Kholmanskikh, Yow‐Ming Wang, Sarah Hersey et al. · Bioanalysis · 2024 · 11 citations · Full text

Pharmacy, Biomedical Sciences, Immunology +17