SOT ToxExpo 2025

Eurofins EAG Laboratories will present two sessions and exhibit in booth 1406, at the SOT 64th Annual Meeting and ToxExpo in Orlando, March 17-19, 2025.

Exhibitor-Hosted Sessions

Monday, March 17: 1:45 PM – Chemical Characterization: FDA Expectations from Draft Guidance

• Speaker: Philip Ferko, Ph.D, Eurofins EAG Laboratories
• Room: W208C
• Session Description:This session will review the chemical characterization draft guidance and chemicals list for analytical performance (CLAP). The draft guidance clarifies Part 18 chemical characterization including extraction, identification of analytes, and method suitability. The CLAP affects determining uncertainty factors, key experimental parameters for determining analytical evaluation thresholds. Understanding these changes will be essential in successful future studies.
  
• Learning Objective:
  • Understand the context of FDA draft guidance and the CLAP
  • Review major points of clarification in the draft guidance
  • Understand potential impact of changes on the chemical characterization process

Tuesday, March 18: 9:15 AM – Addressing Biological Equivalence for Modifications to Medical Devices

• Speakers:
  • Catherine D. Christensen, Principal Toxicologist and Biocompatibility SME, Medtronic plc
  • Steven R. Doonan, Ph.D, Eurofins EAG Laboratories
• Room: W208A
• Session Description: This presentation will discuss a least burdensome approach for evaluating biocompatibility of changes to released medical devices per ISO/DIS 10993-1:2024. The authors will discuss strategy for biocompatibility evaluations of released products while managing test complexity, cost, and timeline, with an emphasis on reducing animal testing by leveraging biological equivalence. Appropriate test method selection will be discussed in detail, as it is a crucial step in generating quality data and meaningful project outcomes.
  
• Learning Objective: Participants will learn about essential considerations when establishing biological equivalence for changes to medical devices. Relevant test methods suitable for surface and chemical characterization will be discussed with an emphasis on the importance of system suitability, sensitivity, and acceptance criteria. Lessons learned from this developing approach will be discussed, including case studies and risk management strategies. 
• Authors:
  • Catherine D. Christensen, Medtronic plc, Minneapolis, MN
  • Whitney V. Christian, Medtronic plc, Jacksonville, FL
  • Steven R. Doonan, Ph.D, Eurofins EAG Laboratories, St. Louis, MO
  • Chad P. Satori, Ph.D,Medtronic plc, Minneapolis, MN