Virginia Litwin, PhD

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Virginia Litwin is a thought-leader in analytical method validation for flow cytometry as applied to clinical laboratories, drug development, and in research/translational settings.  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.  At that time there were no guidance documents addressing the validation requirements for flow cytometry-based biomarkers intended to support drug development. As a result, she co-founded the Flow Cytometry Action Program Committee (APC) within the American Association of Pharmaceutical Scientists (AAPS) whose mission statement is “to promote discussion regarding the proper application of flow cytometry in drug development with an emphasis on establishing best practices regarding assay and instrument validation”. The Flow Cytometry APC published the first papers on flow cytometry method and instrument validation which Virginia was invited to present at the FDA Workshop on Clinical Flow Cytometry in 2013.

Virginia is the chair of the Document Development Committee for a new Clinical Laboratory Standards Institute (CLSI) Guideline, H62- Validation of Assays Performed by Flow Cytometry. She is a councilor for both the International Society for the Advancement of Cytometry (ISAC) and the International Clinical Cytometry Society (ICCS). In addition, she serves on the ICCS Advocacy Committee whose mission is to interface with regulatory agencies.

In 2011, Virginia co-edited the book, Flow Cytometry in Drug Discovery and Development (Wiley-Blackwell) with Phil Marder, and a Special Issue of the Journal of Immunology Methods on Flow Cytometry Biomarkers and Translational Medicine. More recently, Virginia, Cherie Green, and Jennifer Stewart were the Guest Editors of a Special Issue of Cytometry Part B dedicated to Receptor Occupancy.  This Issue brings to light the increasing importance of flow cytometry in drug development as the industry focuses more resources on biologics and investigational immunotherapeutics.

After obtaining a Ph.D. in Virology/Immunology from the University of Iowa, Virginia joined Lewis Lanier at DNAX as a post-doctoral fellow. There she identified one of the first human KIR receptors. Later, at Progenics Pharmaceuticals, she was part of the team which characterized the role of CC-CKR5 in HIV viral entry.  For the past 16 years, she has been working as a pharmaceutical scientist with increasing responsibilities on the development and validation of cellular and molecular biomarker methods for the benefit of clinical investigations.  Since 2010, she was the scientific leader for flow cytometry at Covance Central Labs.  In 2014, she was the first recipient of the Covance Science and Technology Award.  Recently, she joined Caprion Biosciences as Vice President, Immunology.