A Regulatory Perspective: How Government Funding Spurs Scientific Innovation

Webinar Abstract

Although animal models can emulate physiological complexity at the whole-organism level, their scientific validity and translatability to humans are now facing increased scrutiny and skepticism. Recent systematic studies on the predictive value of animal models have demonstrated a poor correlation between animal data and human outcomes owing to substantial interspecies differences in key disease pathways and disease-induced changes in gene expression profiles. These findings highlight the critical need for alternative methods of modeling the complex human-relevant conditions. To address this challenge in drug development, the FDA and NIH have multiple programs underway to support the development of microphysiological systems, such as Organ-on-a-Chip technology.

In this panel discussion hosted by Rowan Walrath, Life Sciences Reporter at the Boston Business Journal, Dr. Danilo Tagle, Director, Office of Special Initiatives at the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH), and Dr. Tina Morrison, Director of the Office of Regulatory Science and Innovation (ORSI) in the FDA’s Office of the Chief Scientist, reviewed the different ways the United States government supports alternative, innovative approaches for more reliable readouts of toxicity and efficacy. 

In this webinar, topics the panel discussed included:

  • NIH Tissue Chips or Microphysiological Systems (MPS) Program and the establishment of Translational Centers for MPS to qualify tissue chips as drug development tool
  • Activities FDA scientists are undertaking to spur the development of new regulatory approaches that can help improve predictivity—and potentially replace, reduce, and/or refine animal testing
  • Additional regulatory and funding support needed to accelerate the rate of adoption of microphysiological systems

Organ-on-a-Chip Technology 

Outside of drug development, Organ-on-a-Chip technology is useful for modeling human diseases and studying precision medicine and environmental exposures. Organ-Chips are poised to deliver a paradigm shift in drug discovery. By emulating human physiology, Organ-Chips have the potential to increase the predictive power of preclinical modeling, which in turn will move the pharmaceutical industry closer to its aspiration of clinically relevant and ultimately animal-free drug discovery. These novel preclinical modeling platforms offer improved clinical predictions of human response and provide a more efficient approach to mechanistic investigation, early safety liability screening, and translationally relevant modeling of drug distribution and metabolism. Near-term regulatory approval of these human-relevant platforms will fill gaps in current capabilities for assessing important properties of disposition, efficacy, and safety liabilities. The recent passage of the FDA Modernization Act 2.0 will only hasten this process. 

The Center for Contemporary Sciences is a nonprofit 501(c)(3) organization focused on advancing human, animal, and planetary health and wellbeing. CCS is pioneering a paradigm shift towards innovative, evidence-based research methods that are based on human biology. Through industry collaboration, coalition building, public education, and policy and advocacy, CCS champions technologies that are better for humans and animals.