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What We Need to Learn from Failures in COVID-19 Testing

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Description

The COVID-19 pandemic has not only disrupted our lives on all fronts, but it has also exposed our need to focus on the highest quality and safety in testing. With insufficient testing and false-negative results, COVID-19 testing has shown how devastating insufficient testing can be for our community on a global scale. However, experiencing oversight of the importance of safety testing is not a new occurrence. Bioanalysis, due to its critical nature in drug development has seen its fair share of devastating testing failures. Taking the lessons learned from this current health crisis, let’s come together to understand the following: why this happened; areas of risk in our own industry; and how we can apply these lessons to our own systems and processes to avoid similar failures.

Contributors

  • Stephanie Pasas-Farmer, Ph.D.

    Stephanie Pasas-Farmer is a recognized bioanalytical expert in in the areas of discovery and regulated bioanalysis for pharmaceutical, biologics and hybrid technologies, including antibody-drug conjugate technology. Relying on insights gained over a 20-year career focused on bioanalytical operations across global biopharmaceutical companies, contract research organizations and consulting, Stephanie founded Ariadne Software in 2018 and led development of Red Thread, guiding it from inception to production as an artificial intelligence (AI)-enabled solution for common challenges in bioanalytical data review.

    Prior to Ariadne Software, Stephanie created BioData Solutions, a scientific advisor firm whose aim is to help sponsors advance early stage molecules into potential new drug candidates with bioanalysis support and regulatory compliance planning. Before founding BioData Solutions, she led a team of scientists at a global bioanalytical laboratory focused on the support of large molecule and antibody drug conjugate programs using LBA, LC‐MS/MS, and cell-based assays. Earlier career roles included management responsibility for quality control functions of bioanalytical laboratory operations, in addition to business development and research scientist positions.

    Stephanie earned her Ph.D. and MSc degrees with honors in pharmaceutical chemistry from the University of Kansas. She received a BS degree in chemistry from St. Mary’s College of Notre Dame.