Blog

Investigating Unforeseen Outcomes in a Culture of Quality

June 15, 2023

A willingness to investigate unwelcome results is integral to building and maintaining a culture of quality. My first two Quality Quarterly issues focused on bioassays and total analytical error. I chose these topics because the resolving…

AAPS Keynote Philadelphia

Presentations and Panels

September 26, 2021

In this presentation, Nancy describes how %CV is an often used, but poor metric for relating assay performance, reported value measurement uncertainty and fitness-for-purpose. She presents a biomarker case study to show how assay suitability…

CHI podcast The Chain Interview June 2021

Interviews

June 1, 2021

In this interview, Nancy describes her unconventional journey to becoming a scientist and how her early childhood experiences influenced her recent decision to expand the scope of her business. She gives her insights into the quality challenges…

Cell & Gene Therapy Analytics Conference Virtual Biotherapeutics Analytical Series

Dose Escalation Studies: How to Deal with Variability in Vector Dose Measurements

Presentations and Panels

March 23, 2021

In this presentation, Nancy explains that pre-clinical and clinical trials involving dose escalation assume that the assigned dose values are comparable across studies. However, dose assays for vectors often have high variability. Nancy discusses…

Defining Therapeutic Window for Viral Vectors: A Statistical Framework to Improve Consistency in Assigning Product Dose Values

Publications

October 1, 2020

This open access article was co-authored with my statistical consultant colleague of 30+ years. In it we propose using an equivalence approach for lot release testing of vector products. Because dose related toxicity is a concern, dose assays…

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Phone: 703-727-9195

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