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A Regulators Viewpoint

November 9, 2020 by

Resource > Webinars >

A Regulators Viewpoint


Establishing Strategies To Evaluate Microphysiological Systems for Drug Development

Filed under: ADME and Safety toxicology

web s1e4 |

Video content if present

In this webinar, we describe current research efforts being developed in the FDA’s Division of Applied Regulatory Science (CDER), for evaluating microphysiological systems while considering their potential use in drug development.


Watch this webinar to learn:

  • Challenges in using microphysiological systems as drug development tools
  • Examples of evaluation efforts of systems as drug development tools
  • Hepatic and cardiac systems
  • Key contexts of use in drug evaluation for these systems

Microengineered in vitro platforms that enhance the physiology of the cellular microenvironment have been developed and improved in the last decade for modeling focused properties of several tissues or organs, which are not recreated with traditional in vitro cell culture systems.

Despite published advancements in modeling tissue physiology in vitro, microphysiological systems are not yet routinely used in drug development.

FDA’s initial projects have been focused on heart and liver systems and we are now expanding to other organ systems of relevance for evaluating drug effects.


Speaker Information:

Dr Alexandre RibeiroDr Alexandre Ribeiro

Staff Fellow (Biological Scientist)
FDA

Video content if present

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  • The FDA further expands collaboration with CN Bio to evaluate the PhysioMimix Multi-organ microphysiological system January 17, 2023
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  • CN Bio appoints Dr Paul Brooks as Chief Executive Officer December 19, 2022

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