Recent technological advances have set the stage for a renewed focus on human-based solutions called new approach methodologies (NAMs) that can complement, and in some cases replace, animal models in research and regulatory testing. These NAMs generally span advanced cell-tissue-organoid (in vitro), computational modeling (in silico), and cell-free biochemical analysis (in chemico) techniques, with each type of NAM offering different advantages. A combination and integration of multiple NAMs elements into a synergistic approach that augments gaps and/or deficiencies in individual NAMs approaches is a “combinatorial NAM” and could ultimately allow for improved predictions of human clinical response. Although many combinatorial NAMs are still early in development, not validated and standardized, nor available to the market broadly, combinatorial NAMs can potentially transform the way biomedical research, drug development, and clinical trials are conducted. To accelerate development and validation of combinatorial NAMs for human-based scientific and regulatory purposes, the National Institutes of Health (NIH) Common Fund’s Complement-Animal Research In Experimentation (Complement-ARIE) program in collaboration with the Food and Drug Administration (FDA) and Environmental Protection Agency (EPA), is launching the Reduction to Practice (RTP) Challenge. This challenge invites innovative combinatorial NAMs solutions from multidisciplinary teams who can successfully dem …
