Lauren Stevenson

American College of Physician Executives — United States

Immunology and Microbiology · Life Sciences

21h-index3.8kcitations61works3.72yr avg
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Research Topics

Biosimilars and Bioanalytical Methods(34), Advanced Biosensing Techniques and Applications(23), Monoclonal and Polyclonal Antibodies Research(11), Systemic Lupus Erythematosus Research(6), Statistical Methods in Clinical Trials(6)

Publications61 total

Best practices in the application of parallelism for biomarker assay validation
The AAPS Journal·2026
Why is Biomarker Assay Validation Different from that of Pharmacokinetic Assays?
The AAPS Journal·2025· 1 citedOpen Access
Assessment of Neutralizing Antibody Activity in Clinical Studies: Use of Surrogate Measurements Instead of Stand-alone Assays
The AAPS Journal·2025· 1 citedOpen Access
Special consideration: commentary on the 2025 FDA Bioanalytical Method Validation for Biomarkers
Bioanalysis·2025
Re-thinking the current paradigm for clinical immunogenicity assessment: an update from the discussion in the European Bioanalysis Forum
Bioanalysis·2024· 13 citedOpen Access
Protean Career Orientation and Career Success: On the Roles of Proactive Career Process During the School-To-Work Transition
Journal of Career Assessment·2024· 7 cited
Development of a Highly Sensitive Neurofilament Light Chain Assay on an Automated Immunoassay Platform
Frontiers in Neurology·2022· 41 citedOpen Access
Development of a Highly Sensitive Serum Neurofilament Light Chain Assay on an Automated Immunoassay Platform
2022· 2 citedOpen Access
Best practices for the development and fit-for-purpose validation of biomarker methods: a conference report
AAPS Open·2022· 11 citedOpen Access
Additional file 1 of Best practices for the development and fit-for-purpose validation of biomarker methods: a conference report
Figshare·2022Open Access
Update to the European Bioanalysis Forum Recommendation on Biomarkers Assays; Bringing Context of Use Into Practice
Bioanalysis·2020· 21 cited
A clinical population pharmacokinetic/pharmacodynamic model for BIIB059, a monoclonal antibody for the treatment of systemic and cutaneous lupus erythematosus
Journal of Pharmacokinetics and Pharmacodynamics·2020· 10 cited
2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs ( <u>Part 2</u> – Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity)
Bioanalysis·2019· 31 citedOpen Access
Well-Developed Ligand-Binding Assays Demonstrate Robust Performance Using Singlet Analysis
Bioanalysis·2019· 4 cited
Immunogenicity for Antisense Oligonucleotides: A Risk-Based Assessment
Bioanalysis·2019· 26 citedOpen Access
Evolving Our Thinking on Biomarker Assay Validation: Are we Ready for the Next Leap?
Bioanalysis·2019· 10 citedOpen Access
Perspectives on Gender Parity in Bioanalysis: An Interview with Lauren Stevenson
Bioanalysis·2019· 1 citedOpen Access
Monoclonal antibody targeting BDCA2 ameliorates skin lesions in systemic lupus erythematosus
Journal of Clinical Investigation·2019· 286 citedOpen Access
2018 White Paper on Recent Issues in Bioanalysis: Focus on Flow Cytometry, Gene Therapy, Cut Points and Key Clarifications on Bav (Part 3 – Lba/Cell-Based Assays: Immunogenicity, Biomarkers and Pk Assays)
Bioanalysis·2018· 53 citedOpen Access
FRI0315 Safety, tolerability, pharmacokinetic and pharmacodynamic effects of biib059, a monoclonal antibody targeting bdca2 following intravenous (IV) and subcutaneous (SC) single or multiple doses administration in healthy volounteers (HV) and subjects with active systemic lupus erythematosus (SLE)
Annals of the Rheumatic Diseases·2018· 1 citedOpen Access
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Frequent Co-authors

Lakshmi Amaravadi(10), Sam Haidar(10), Fabio Garofolo(9), Binodh DeSilva(7), Boris Gorovits(7), Eric Woolf(7), Dania Rabah(6), Mark E. Arnold(6), Richard B. Hayes(6), Marian Kelley(6), Jan Welink(6), Heather Myler(6), Catherine Barbey(5), Nathalie Franchimont(5), Brian Booth(5), Eric Fluhler(5), Steve Lowes(5), Isabelle Dumont(5), Surendra K. Bansal(5), Mark Ma(5)