Steve Zdravkovic
Research Scientist II
Steve Zdravkovic is currently a Research Scientist II at Baxter Healthcare, which he joined in February 2021. Prior to joining Baxter, he worked for 16 years in the E/L team at PPD, Inc. In these roles, Steve has been responsible for all aspects of E/L studies with a focus on the design and execution of screening studies using mass spectrometry-based techniques. Steve has published nine peer reviewed journal articles, which pertain to various areas of research within the E/L field, and is a member of the editorial board of the PDA Journal of Pharmaceutical Science and Technology. Steve holds a Bachelor of Science degree in chemistry and mathematics from the University of Wisconsin – Whitewater.
DAY 1: February 27th, 2025
SESSION: ELSIE’s Lab Practices Working Group’s Proposal for Best Practices to Improve the Consistency of Extractable Screening Data Between Laboratories
◆ Inconsistencies in the execution of extractable screening studies between laboratories can result in differences in the qualitative and/or quantitative aspects of the extractable profiles obtained.
◆ Given that such differences can have a significant impact on the validity of the safety assessments performed, it is critical that they be understood and minimized.
◆ The “lab practices” working group within the Extractable/Leachable Safety Information Exchange (ELSIE) conducted two industry surveys that uncovered numerous areas associated with the execution of extractable screening studies where labs were not well aligned that may be impacting the data generated.
◆ To that end, this presentation will summarize the best practice recommendations proposed by the ELSIE lab practices working group to address the discrepancies in extractable study design.
DAY 2: March 8th, 2024
SESSION: Results of the elsie lab practices sub team’s surveys for understanding intra-lab method/procedure variations for the execution of extractable screening studies
◆ Annecdotely, it’s been stated that extractable screening data obtained between laboratories will be unaligned to at least some extent in the qualitative and/or quantitative profiles reported, which has been hypothesized to be attributable to differences in the methods and procedures used.
◆ To that end, ELSIE has surveyed a large number of CRO and pharmaceutical (sponsor) companies with the goal of better understanding variations in methods and lab practices used between labs with the goal of understanding the extent of such variation that currently exists in the E/L field.
◆ This presentation will discuss the data obtained from these surveys, highlighting areas of alignment, or lack thereof, for key method/procedural aspects including surrogate standard selection, uncertainty factor determination and usage, system suitability parameters, and relevant methodology variables.
DAY 1: March 10th, 2023
SESSION: Strategies for assigning compound identities and dealing with unknowns in E/L studies
◆ Proper use of mass spectral libraries in conjunction with manual interpretation in assigning identities.
◆ Need for the use of, and considerations for, identification confidence levels associated with reported E/L compounds.
◆ Classifying a compound as a non-mutagen/cohort of concern without achieving full structure characterization.
◆ Separating true E/L compounds from various “false positives” that can arise in the data.
DAY 1: March 30th, 2022
SESSION: Designing effective E&L studies
◆ Sample preparation considerations for screening studies.
◆ Compound identification and classification.
◆ Understanding and accounting for the impact of analytical variation on data from screening studies.
◆ Using targeted analytical methodologies to monitor leachables over a product‘s lifetime.
