Abstract

Luncheon Presentation on Policy: Advancing Nonclinical Regulation, Policy, Science, Education and Training in the United States

Kristie Sullivan, VP for Research Policy, Physicians Committee for Responsible Medicine

Recent developments, 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 can be expected to be more predictive for humans, and have begun mapping 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 and International Council on the Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) regulations from requiring “animal” data to “nonclinical,” which encompasses in vivo, 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 new drug applications (NDA) that found no inclusion of organ chips in U.S. FDA submissions for approved drugs.