Blog

Co-chair panel Bioassays and statistics FAQs to FACTS

In this session, Nancy Sajjadi and Steve Walfish introduce 4 speakers and posit several questions to address hot topics in bioassay design, development and validation:  Generating and evaluating the standard curve, establishing equivalence…

AAPS Keynote Philadelphia

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

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

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

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…