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Biorxiv : the Preprint Server for Biology|November 26, 2025
Insertion of an invading retrovirus regulates a novel color trait in swordtail fishNadia B Haghani, Tristram O Dodge, John J Baczenas, et al.Current Biology : CB|September 26, 2024
Structural genomic variation and behavioral interactions underpin a balanced sexual mimicry polymorphismTristram O Dodge, Bernard Y Kim, John J Baczenas, et al.JAMA Network Open|March 31, 2025
Targeted Normoxemia and Supplemental Oxygen-Free Days in Critically Injured Adults: A Stepped-Wedge Cluster Randomized Clinical TrialDavid J Douin, John D Rice, Erin L Anderson, et al.The AAPS Journal|December 2, 2021
Anti-drug Antibody Validation Testing and Reporting HarmonizationHeather Myler, João Pedras-Vasconcelos, Kelli Phillips, et al.Bioanalysis|February 3, 2021
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)Bart Corsaro, Tong-Yuan Yang, Rocio Murphy, et al.Bioanalysis|February 23, 2024
2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization)Johanna Mora, Rachel Palmer, Leslie Wagner, et al.Bioanalysis|August 1, 2023
2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity,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)Luying Pan, Johanna Mora, Karl Walravens, et al.Pageof 29