One of the challenges in clinical flow cytometry is limited stability of fresh whole blood samples. It is essential to have sufficient sample stability for flow cytometry analysis in clinical trials, as this allows for transportation of samples from clinical sites to the flow cytometry laboratory, and enables batching of samples, thereby increasing consistency of data and cost-effectiveness of the study.
Clinical studies can contain flow analyses varying from straight-forward cell subset characterization to complex target engagement and intracellular phosflow assays. For late phase clinical studies that require flow cytometry analysis often include shipment of samples from multiple different sites, it is essential to address sample stability during method development and validation of the applied flow cytometry assays. There are several techniques and methods available for extending stability of flow cytometry samples including availability of fixative-containing commercial blood collection tubes, freezing whole blood and applying lyse/fix and freezing methods after sample collection for storage up to several weeks. These approaches have been successfully implemented in clinical studies, enabling complex but efficient flow cytometry analysis in multi-site clinical studies. This webinar will address several strategies for extending stability of flow cytometry samples, and implementation thereof in clinical studies.
Amanda Hays, Ph.D., Associate Director of Bioanalytical Science, PRA Health Sciences
Amanda is the Associate Director of Bioanalytical Science at PRA Health Sciences. Amanda joined PRA in 2017 and leads a group of scientists in method development and optimization of large molecule bioanalytical techniques including LBA, immunogenicity, biomarkers, flow cytometry and qPCR. Prior to joining PRA, she held leadership positions at other CROs, including senior scientist and Biopharma R&D manager. Amanda received her Ph.D. in pharmacology in 2012 from the University of Kansas Medical Center, where she studied targeting organic anion transporting polypeptides in cancer to improve diagnostics and therapy.Message Presenter
Henko Tadema, Ph.D., Associate Director of Bioanalytical Science, PRA Health Sciences
Henko is an Associate Director of Bioanalytical Science at PRA Health Sciences, based in the Netherlands analytical laboratory. He joined PRA in 2011, briefly after flow cytometry analysis was implemented at PRA. Since then the demand for cellular analysis in clinical studies kept increasing, which has led to the two harmonized flow cytometry laboratories in Lenexa (KS) and Assen (NL). Together with the highly skilled scientists in both laboratories, he focuses on delivering high quality, harmonized flow cytometry analyses in early through late phase global clinical studies. In addition, he works with our sponsors on the optimal choice and design of cellular assays in support of their clinical studies. Henko received his Ph.D. in Immunology in 2011 from the University of Groningen, NL, where he studied mechanisms underlying the development of autoimmune disease.Message Presenter
Who Should Attend?
- Scientists in small, mid and large pharma who develop and validate flow cytometry methods in support of clinical studies (WRIB attendees, CYTO attendees, ICCS attendees)
- Scientists from bioanalytical labs who develop and validate flow cytometry assays in support of clinical studies
- Academic and research scientists who are interested in various techniques for extending flow cytometry sample stability
What You Will Learn
- Understand the challenges of achieving extended stability for flow cytometry samples
- Define several approaches to extending flow cytometry sample stability
PRA Health Sciences
PRA Health Sciences recognizes that the world of drug development is complex and dynamic, and that’s why PRA has designed two laboratories to meet those challenges. PRA offers the highest quality services for pharmacokinetic, immunogenicity, biomarker analysis and CMC analysis, comprising a wide range of platforms for small molecules, large molecules and cell-based entities.
PRA’s Laboratories for Drug Development are managed, staffed, and supported by industry-leading experts who have the scientific knowledge and experience necessary to successfully deliver the most complex of studies.
The GLP & GMP compliant facilities in the USA and the Netherlands adhere to the latest global regulatory guidelines and expectations. PRAs technology investments and innovative service offerings are key components of goals and strategies for developing solutions for clients.
No one understands the daily pressure of tight deadlines better than the colleagues at PRA laboratories, because PRA realizes that behind every sample we analyze, a patient is waiting to be treated.