Abstract

Advancing Nonclinical Regulation, Policy, Science, Education and Training

Elizabeth Baker, Pharmaceutical Policy Program Director, Physicians Committee for Responsible Medicine

Recent advances, such as the U.S. Food and Drug Administration’s Predictive Toxicology Roadmap, represent a fundamental shift in how drugs will be developed and regulated. U.S. regulators now state the need to move away from animal testing towards new approach methodologies that are expected to be more predictive for humans, and have mapped their plans for doing so. The Nonclinical Innovation and Patient Safety Initiative (NIPSI) collaboration is addressing the factors that impede the uptake of modern, predictive approaches, such as organ chips. Projects include changing U.S. FDA regulations from requiring “animal” data to “nonclinical,” which encompasses animal in vivo and human and animal-based in vitro and in silico approaches; lobbying the U.S. Congress to increase funding allocated for human-based approaches; and working to establish a qualification pathway that covers in vitro platforms and computer models. The presentation will include results from a recent review of NDAs that found no inclusion of organ chips in U.S. FDA submissions for approved drugs. Results will be updated for the meeting.