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I am a US-based consultant with over a decade of hands-on experience developing, validating, and applying analytical methods including: NAMs for toxicology assessments, immunogenicity/PK/biomarker assays for both preclinical and clinical bioanalysis, and complex cell-based and tissue-based assays.

  • North Carolina State University, Immunology Ph.D.

  • Diplomate of the American Board of Toxicology (DABT) 2017-2022

  • PI at multiple CROs leading preclinical and clinical bioanalysis including PK, biomarker, and immunogenicity

  • Lead investigator for development and application of New Approach Methodologies including benchmarking to in vivo results for toxicology assessments

  • Study Director for in vivo preclinical assays at a GLP-regulated CRO

  • Deep technical expertise across a variety of methods including immunoassays (ECL/ELISA), ELISpot, Flow Cytometry, enzymatic assays, cell-based reporter/proliferation/expression assays, etc.

Scientific Thought Leadership

Recent Webinars:

Example Publications:

  • Williams, W. T., Lindley, K., Liao, H., Kamen, L., Miller, M., et.al. (2024). Development of a validated novel bead extraction method for the detection of anti-PEG antibodies in human serum. Bioanalysis, 17(1), 7–15.

  • Butala-Flores E, Nguyen T, Selvan N, Armstrong L, Miller M, et .al. Validation of Anti-Adeno Associated Virus Serotype rh10 (AAVrh.10) Total and Neutralizing Antibody Immunogenicity Assays. Pharm Res. 2023 Oct; 40 (10): 2383-2397.

  • Starks CM, Miller MM, et.al. Optimization and qualification of an assay that demonstrates that a FimH vaccine induces functional antibody responses in women with histories of urinary tract infections. Hum Vacc Immuno. 2021 Jan 2; 17(1): 283-292.

  • Miller MM, McMullen PD, Andersen ME, Clewell RA. Multiple receptors shape the estrogen response pathway and are critical considerations for the future of in vitro-based risk assessment efforts. Crit Rev Toxicol. 2017 Aug; 47(7): 564-580.

  • Miller MM, Alyea RA, Le Sommer C, et.al. Development of an in vitro assay measuring estrogenic responses for use in chemical safety assessment.  Toxicol Sci. 2016 Aug 7.