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Achieving a Culture of Quality by Design

Achieving a Culture of Quality by Design – Quality Quarterly Issue 7

PDF Version In this spring issue of Quality Quarterly, I explore the idea that the philosophical underpinnings of a “Quality by Design” (QbD) framework for pharmaceutical product development can be applied to achieving a “Culture of…

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…

Interview with Kaitlyn Barago

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

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…

Helping Organizations Address Employee Absenteeism, Disengagement & Rising Health Care Costs

In this interview, Nancy describes the origins of her business called Life Quality by Design and its initial focus on employee well-being and organizational wellness programs. Since this 2018 interview, Nancy has merged her biotech consulting…