Blog

Total Analytical Error (TAE) from Concept to Calculations

March 1, 2023

Do you struggle with understanding statistical concepts applicable to your role and responsibilities in the development of biologics? Are you aware of the trend toward Bayesian statistical inference and the shift away from the frequentist…

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…

Interview with Kaitlyn Barago

Interviews

October 15, 2019

In this short interview, Nancy reviews her education and experience in the development of cell and gene therapy products. She provides insights into how the complexity of biologics make bioassay design, development, and validation of assays…

The Positive Value of Employee Attachment

Interviews

April 19, 2019

In this interview by Cecile Alper-Leroux, VP of products and innovation at UKG Ultimate Software, a developer of human analytics, Nancy describes how the uniquely human capacity to develop deep bonds is the outcome of very complex brain biochemistry…

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Phone: 703-727-9195

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