Concepedia

Vibha Jawa

VJ

Statistics

Publications

10

Citations

315

H-Index

10

Active since

2019

Affiliations

Bristol-Myers Squibb (United States)(Current)

AbbVie (United States)

Janssen (United States)

Pfizer (United States)

United States Military Academy

Vibha Jawa is an author at Bristol-Myers Squibb (United States) specializing in biopharmaceutics, immunology, and bioanalytical methodology.

Publications per year

2019–2025

10

Publications

10

2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)

Steven P. Piccoli, Devangi Mehta, Alessandra Vitaliti et al. · Bioanalysis · 2019 · 95 citations · Full text

Pharmacy, Biomedical Sciences, Biopharmaceutics +13

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 ( <u>Part 3</u> –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 · 2021 · 61 citations · Full text

Veterinary Medicine, Biomedical Sciences, Immunology +17

2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & 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

Preexisting antibody assays for gene therapy: Considerations on patient selection cutoffs and companion diagnostic requirements

Manuela Braun, Claudia Lange, Philipp Schatz et al. · Molecular Therapy — Methods & Clinical Development · 2024 · 25 citations · Full text

Medicine, Molecular Biology, Molecular Medicine +17

Survey Outcome on Immunogenicity Risk Assessment Tools for Biotherapeutics: an Insight into Consensus on Methods, Application, and Utility in Drug Development

Jochem Gokemeijer, Yi Wen, Vibha Jawa et al. · The AAPS Journal · 2023 · 23 citations

Veterinary Medicine, Immunology, Pharmacology +16

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