September 2019: Member Spotlight

Author: [AUTHOR] Published on 9/1/2019 12:00:00 AM

Eleftheria Tsakalozou, PhD, Staff Fellow/Science Reviewer, Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, CDER, US Food and Drug Administration, Olney, MD

Dr. Tsakalozou's postdoctoral advisor at the University of North Carolina, Dr. Kim Brouwer, encouraged her to submit an abstract for the 2015 Annual Meeting. Her abstract “Quantitative Systems Pharmacology: Multiscale Model‐Based Drug Development Through Integrating Systems Biology and Pharmacometrics” was selected for presentation, and she attended the meeting. She enjoys attending the Annual Meeting and has witnessed how the topics covered at the Annual Meeting have “spread” throughout the years to meet the needs of the ASCPT membership with the goal of improving patient care. However, she feels that there is more to her membership than the Annual Meeting. She also enjoys having electronic access to the ASCPT Journal Family and through this feature of membership, having access to inspiring ideas and work published by leaders in the field. At this most recent Annual Meeting, Dr. Tsakalozou was honored to contribute her efforts as a speaker during the “PBPK Modeling for the Development and Approval of Locally Acting Drug Products Pre‐Conference,” which brought together experts on the topic . They provided a platform for the exchange of ideas that she believes highlighted the challenges and the aspirations of the community of physiologically‐based pharmacokinetic (PBPK) modelers working toward the approval of locally acting drug products.

Dr. Tsakalozou is confident that ASCPT is leading the field by bringing together scientists and clinicians from different disciplines who are working together to improve patient care. She is fascinated by ASCPT's success in promoting translational research and the development of quantitative tools and leveraging these outcomes toward personalized medicine, which she believes is a valuable tool for young researchers. She also appreciates that ASCPT provides its members with the opportunity to volunteer through reviewing abstracts for the Annual Meeting and engaging within the various Networks and Communities to submit session proposals for the Annual Meeting. These are excellent venues to interact with scientists that have common fields of interest and to grow as scientists and professionals.

The Division of Quantitative Methods and Modeling/Office of Research and Standards/Office of Generic Drugs/Center for Drug Evaluation and Research at the US Food and Drug Administration, where Dr. Tsakalozou is a reviewer, is involved in guidance development and review of Abbreviated New Drug Applications for generic drug products and supports the regulatory science program established under the Generic Drug User Fee Amendments (GDUFA). Although Dr. Tsakalozou doesn't see patients directly, the research conducted and managed by her Division and the regulatory decisions that are made within the Division and the FDA in general do impact public health. Her research interests include skin absorption PBPK modeling, interactions between excipients and molecular targets including gut transporters, and development of quantitative modeling and simulation tools to support bioequivalence assessments. Dr. Tsakalozou invites everyone to visit the FDA's website, which showcases the regulatory science program and shows continuously generated outcomes and how these advance public health by providing access to safe and effective generic drugs. This site can be found at: https://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/genericdrugs/ucm567695.htm.

Dr. Tsakalozou has been a member of ASCPT since 2008.

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