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Get Ready for Regulatory Changes and the Future of NAMs
Join us for an insightful fireside chat between Chief Scientists from CN Bio, and LifeNet Health on how to get ready for regulatory changes in light of the recent FDA announcement.
In this virtual event our expert speakers, Ed LeCluyse and Tomasz Kostrzewski, discuss the FDA’s move to phase out animal testing for mAbs and other drugs, detailing how to get ready for regulatory changes in safety toxicology testing. They highlight the synergy in our company’s partnership that drives the adoption and future evolution of microphysiological systems (MPS, also known as Organ-on-a-chip), noted by the FDA as vital for a NAM-based drug development approach. Learn the steps required to accelerate MPS use, alongside other NAMs, within your organization to reshape preclinical research, and gain insights into upcoming developments to stay ahead in this rapidly changing landscape.
Key takeaways, Understanding:
- The FDA’s regulatory shift & opinions on April’s announcement to facilitate NAMs use in drug development & IND submissions
- Why is MPS technology specifically called out by the FDA?
- How have initial MPS adoption challenges been met?
- What upcoming MPS developments will further address unmet market needs and further accelerate change
- What steps should be taken to enable efficient onboarding of MPS within your organization?
- Additional MPS applications that reduce our reliance on animals in drug development
- Which other NAMs are important to get ready for regulatory change?
Don’t miss this opportunity to hear from distinguished scientific experts from two human-relevant solutions providers. Sign up and secure your spot today!
About the Presenters
Tomasz Kostrzewski
With more than 15 years of experience in molecular and cellular biology, Dr. Kostrzewski joined CN Bio in 2015. He was promoted to Director of Biology in 2018, with responsibility of biological model development and collaborative research projects with academia, pharma, and regulators. In 2021 he became the VP of Science and Technology and subsequently in 2023, he was appointed the Chief Scientific Officer, overseeing all technical activities, including the development of new products, technologies, and assays, as well as Contract Research Services.
Dr. Kostrzewski has successfully led numerous grant-funded collaborative projects at CN Bio and currently serves as the project lead for a high-profile partnership between CN Bio and the FDA. Over the past five years, he has published more than a dozen peer-reviewed scientific publications and has filed multiple patent applications.
Edward L. LeCluyse
Dr. Edward LeCluyse is a Research Fellow in the LifeSciences Division at LifeNet Health, Research Triangle Park, NC. Dr. LeCluyse received his Ph.D. in Biochemistry at the University of Kansas and did his post-doctoral training in Pharmacology and Toxicology at the University of Kansas Medical School. He has over 35 years of experience in basic research and in vitro translational model development in industry, biotech and academia, and has held prior positions at Merck & Co., Invitrogen (ThermoFisher), The Hamner Institutes for Health Sciences and UNC’s Eshelman School of Pharmacy. Dr. LeCluyse has done extensive research, development, and implementation of novel in vitro human hepatic model systems to study mechanisms of liver metabolism, DILI, and disease. He is the author of over 135 publications, book chapters, and review articles, and has presented numerous lectures and workshops on in vitro liver related model systems and research applications.