Validating Assays in Flow Cytometry: Learn from the creators of CLSI guideline H62
Validation of assays used in flow cytometry requires different analytical method validation approaches in a preclinical and clinical setting. A fit-for-purpose (FFP) strategy allows customization of the level of validation conducted to satisfy the intended use of the assay and its associated regulatory status.
This panel discussion hosted by BD will be conducted by Virginia Litwin, Steve Eck and Nicolas Bailly and moderated by Elena Afonina. The discussion will cover a few aspects of CLSI guidance H62, including the following topics:
- How to setup and standardize flow cytometers
- How to approach analytical method validation for Precision and Detection Capability parameters
The objective is to learn from the authors of this guideline and from BD flow cytometry experts.
Speakers:
Virginia Litwin, PhD, Charles River Laboratories
A leader with over 20 years of experience in translational biomarker applications advancing drug development. She has a long-standing history of advocating for flow cytometry validation and standardization. Most notably, she was the chair of the Document Development Committee for the Validation of Assays Performed by Flow Cytometry. 1st ed. CLSI guideline H62. She has been championing validation in flow cytometry with regulatory agencies and in the flow cytometry community through educational workshops, conference presentations, whitepapers, and publications.
Steve Eck, PhD, AstraZeneca
An experienced leader in the development of pharmacodynamic biomarker assays in drug development across therapeutic areas. Steve is an advocate for global consensus standards for flow cytometry assays for clinical trial applications. He was part of the Document Development Committee for the Validation of Assays Performed by Flow Cytometry. 1st ed. CLSI guideline H62 and he was the team leader of the assay validation chapter.
Nicolas Bailly, BD Biosciences
An accomplished flow cytometry professional with over 15 years of experience in clinical cytometry. He supervised the clinical lab in the Cytometry, Cytology, and Haemostasias department of the University Hospital in Belgium, where he was responsible for the diagnosis of patient samples for Lymphoma & Leukemia and MRD. Currently, he is a Scientific & Technical Specialist in the European Scientific Support team at BD Biosciences and routinely provides extensive customer support on applications of BD flow cytometry platforms.
Moderator:
Elena Afonina, PhD, BD Biosciences
An industry leader with a successful track record of In Vitro Diagnostic (IVD) and pharmaceutical drug development. She is experienced in the development of IVD Flow Cytometry and Hematology Systems and interfacing with regulatory agencies. She was part of the Document Development Committee for the Validation of Assays Performed by Flow Cytometry. 1st ed. CLSI guideline H62.
