In this webinar, Edward LeCluyse and Tomasz Kostrzewski will discuss the FDA's move to phase out animal testing for mAbs and other therapeutics – and what it means for the future of safety assessment. Gain firsthand insights into how our partnership is accelerating the adoption of NAMs and future evolution of microphysiological systems (MPS/Organ-on-a-Chip), which the FDA recognizes as key to the NAM-based drug development paradigm.
You will learn practical steps for validating and integrating MPS and other NAMs into your preclinical workflows and hear the experts’ perspectives on emerging trends shaping regulatory expectations, innovation, and investment in next-generation models.
Key Takeaways:
- Insights on the FDA’s recent announcement and its implications for the future role of NAMs in regulatory submissions and drug development strategy.
- Understanding the key drivers behind the FDA’s endorsement of microphysiological systems (MPS) technology.
- Lessons learned from early challenges in adopting MPS and how they have been successfully addressed.
- How future MPS developments are positioned to address unmet needs and accelerate regulatory and industry transformation.
- Practical steps to enable efficient onboarding of MPS within your organization.
- Emerging MPS applications that are advancing non-animal drug development.
- Additional NAMs to consider as you prepare for upcoming regulatory changes.
Guest Speaker: Tomasz Kostrzewski, Ph.D., Chief Scientific Officer, CN Bio
Guest Speaker: Edward LeCluyse, Ph.D., Research Fellow, LifeNet Health LifeSciences