Blog

Total Analytical Error (TAE) from Concept to Calculations

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…
Nancy Sajjadi

Developments in Bioassays

For over 30 years, I have been involved in the quality control of experimental biologics and have witnessed both incredible outcomes and tragic disappointments in addressing many different unmet clinical needs. I recently attended a conference…

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…