Navigating CLSI H62, Validation of Assays Performed by Flow Cytometry, 1st edition - On Demand Webinar

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CLSI H62, Validation of Assays Performed by Flow Cytometry

Recorded on: August 18th, 1:00 PM US Eastern time

The Clinical and Laboratory Standards Institute (CLSI) recently released the first edition of CLSI H62, Validation of Assays Performed by Flow Cytometry. This comprehensive document covers all aspects for flow cytometry testing from the installation of the instrument to archiving the results.  The target audience is anyone who touches a flow cytometer.

The objective of this webinar is to provide guidance on how to distill the vast amount of information contained in this 234-page document into practice in the laboratory. Real-life examples of applying the document and practical suggestions will be provided.

In this webinar, you will learn:

  • How to navigate the document;
  • How to plan an analytical method validation and create an assay validation protocol;
  • How to execute an analytical method validation;
  • How to streamline data analysis and report creation;
  • What to do when you have questions about CLSI H62

Speakers:

Dr. Virginia Litwin, PhD
Charles River Laboratories

Dr. Nithianandan Selliah, PhD
Cerba Research

Dr. Virginia Litwin, PhD

Charles River Laboratories

Virginia Litwin is a thought-leader in validation and standardization for flow cytometry. Bringing “Cytometry from Bench-to-Bedside” has been the focus of her professional activities since 1999 when she started working in translational medicine at Bristol-Myers Squibb. 

She co-founded the Flow Cytometry Community within the AAPS. This group published the first papers on flow cytometry method and instrument validation. She was a councilor for the International Society for the Advancement of Cytometry (ISAC) and the International Clinical Cytometry Society (ICCS). She serves on the ICCS Advocacy Committee whose mission is to interface with regulatory agencies and has been an invited speaker at FDA/NIST on many occasions.

Virginia is the chair of the Document Development Committee for the CLSI H62. She edited the book, Flow Cytometry in Drug Discovery and Development, as well as journal special issues: JIM- Flow Cytometry Biomarkers and Translational Medicine (2011); Cytometry Part B- Receptor Occupancy (2015); Cytometry Part B- Cytometry Advancing Next Generation Drug Development (2021).

After obtaining a Ph.D. in Virology/Immunology from the University of Iowa, Virginia joined Lewis Lanier at DNAX as a post-doctoral fellow where she identified the KIR receptor, KIR3DL1 (CD158E1). She has held leadership roles in several contract research organizations. Currently she is a Research Scientist at Charles River Laboratories in Québec, Canada.

https://www.linkedin.com/in/virginia-litwin-99869511

https://twitter.com/VirginiaLi...

Dr. Nithianandan Selliah, PhD

Global Head of Flow Cytometry

Cerba Research

Nithianandan Selliah’s professional work spans academia, the biotech/pharma sector and most recently CROs. His Ph.D. research at the University of Kentucky focused on the effect of epinephrine in the modulation of T cell activation. After his PhD, he joined Dr. Terri Finkel’s lab at National Jewish Medical center to study the mechanism of by stander killing of CD4 T cells by HIV. This worked continued at the Children’s Hospital of Philadelphia. Later he conducted pioneering research in CAR T-cells for HIV therapy under the mentorship of Dr. Richard Junghans at Roger Williams Medical Center in Providence, RI. He then moved to a Biotech company to identify biomarkers for lupus disease utilizing flow cytometry. He joined Celgene to work on a specific project to explore therapeutic potential of red blood cells derived from in vitro differentiation of HSCs.

In 2015, Dr. Selliah joined LabCorp drug development (formerly Covance) to help facilitate their expansion of flow cytometry supporting clinical drug development. He has developed and validated more than 10 flow cytometric methods which were deployed in numerous global clinical trials. His work has been represented at the International Clinical Cytometry Society (ICCS) Annual Course and the International Society for the Advancement of Cytometry’s annual meeting, CYTO. He has contributed to recommendation papers in Cytometry B and Current Protocols in Cytometry, and a chapter on receptor occupancy assays.

He is an active member of the ICCS Quality and Standards committee whose mission is to create educational modules for the international flow cytometry community on standardizing processes for flow cytometry assays, including reagent quality testing and instrument standardization.

Currently Dr. Selliah is the Global Head of Flow Cytometry at Cerba Research, where he leads a team of 12 scientists in developing and validating Flow cytometry assays for global clinical trials. 

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