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Description
Join us for an insightful webinar where we delve into the predictive value of cytotoxicity assays in determining in vivo outcomes for medical devices. Cytotoxicity assays have long been a cornerstone in the biocompatibility testing of medical devices due to their in vitro nature, cost-effectiveness, and quick turnaround. However, the true predictive power of these assays in relation to in vivo outcomes of acute systemic toxicity, intracutaneous irritation, and sensitization remains unclear.
In this webinar, we will explore extensive data analyses conducted on biocompatibility studies to uncover whether cytotoxicity results can reliably predict these critical biological endpoints.
Key Takeaways:
- Understanding Cytotoxicity Assays: Explore the traditional role of cytotoxicity assays in biocompatibility testing and their perceived predictive value.
- Data-Driven Insights: Learn about the extensive data analysis conducted on thousands of biocompatibility studies and the findings regarding correlations between cytotoxicity results and in vivo outcomes.
- Future Directions: Discuss the implications of these findings for regulatory practices and future research directions in biocompatibility testing.
Don’t miss this opportunity to gain valuable insights and engage with experts in the field. Register now!
Speakers
Principal Toxicologist
Phillip holds a PhD in Molecular and Cellular Biology from the University of Toledo Medical Center (formerly Medical College of Ohio) and a BS in Biology from Bowling Green State University (summa cum laude; with minors in Chemistry and Italian Language). He was a Postdoctoral Fellow at the University of Texas Southwestern Medical Center (awarded two grants to support his research), authored several articles that were published in peer-reviewed journals (regarding his research of DNA repair in mammalian cells), and authored a book chapter appearing in Telomerases: Chemistry, Biology, and Clinical Applications, and has provided several oral presentations. Dr. Smiraldo’s timeless experience in the medical device industry encompasses toxicology, biological safety and preclinical study design, as well as extensive preparation of biological and toxicological risk assessments for submission in countries complying with EU and US FDA regulations. Prior to his current position as Toxicologist, he was a Medical Research Scientist and Study Director (NAMSA), overseeing special/custom preclinical functional studies, preclinical safety studies and simulated-use chemistry studies. Before joining NAMSA, Dr. Smiraldo was a Staff Toxicologist at WIL Research (approximately 2.5 years), where he was a Study Director of preclinical safety studies for pharmaceutical- and chemical-based products.
Toxicologist
Dr. Ruch is a Board Certified Toxicologist with over 6 years of experience in the medical device industry. She was previously a Study Director responsible for conducting safety and efficacy preclinical studies and studies in compliance with the ISO 10993 standards, and a Project Manager for the Biological Safety Team. Dr. Ruch received her PhD in Nutritional Biochemistry from the University of Minnesota – Twin Cities, with a research focus on high fat diet induced cognitive decline. In 2023, she received her Diplomate of the American Board of Toxicology (DABT) certification. Dr. Ruch is an active member of the Society of Toxicology.
Nicole Bronson
Biological Safety Scientist
Nicole R. Bronson B.I.S currently serves as a Biological Safety Specialist at NAMSA. Nicole has 16 years’ experience in the medical device industry with a strong background in biological safety. She began her career at NAMSA working in the toxicology laboratory and has since held roles such as GLP Study Director and Technical Advisor. Nicole has broad expertise and knowledge of medical device regulations and expectations from the U.S. FDA and other global regulatory entities. Nicole holds a Bachelor of Science Degree from Lourdes College.
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