A July 24 Federal Register notice announced that the Reagan-Udall Foundation (RUF) for the US Food and Drug Administration (FDA) is requesting nominations for the PredicTox Steering Committee. The Steering Committee will provide oversight and guidance for the PredicTox project and will report to the Reagan-Udall Foundation for the FDA’s Board of Directors. All nominations must be submitted to the Reagan-Udall Foundation for the FDA by August 28, 2015.
The Reagan-Udall Foundation for the FDA (the Foundation) is an independent 501(c)(3) not-for-profit organization created by Congress to advance the mission of FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development; accelerate innovation; and enhance product safety. The Foundation acts as a neutral third party to establish novel, scientific collaborations. With the ultimate goal of improving public health, the Foundation provides a unique opportunity for different sectors (FDA, patient groups, academia, other government entities, and industry) to work together in a transparent way to create exciting new research projects to advance regulatory science.
The primary objective of PredicTox is to advance systems-based science and tools necessary to support mechanism-based drug safety assessment and prediction. To accomplish this objective, the PredicTox pilot project will be conducted in an iterative, phased manner over the course of several years. The first phase will center on building and populating a knowledge management platform for molecular data, preclinical in vivo pharmacologic and toxicologic data as well as clinical data from both public and private sources.
Nominees for the voting positions will be evaluated by the RUF Board based on criteria provided in this Federal Register notice. Areas of expertise being sought include risk assessment, drug safety profiling, pharmacology or systems pharmacology, toxicology or systems toxicology, biostatistics, cardiology, oncology, bioinformatics, ontology, multi-scale modeling, knowledge management platforms, software development, or data sharing.
Questions should be sent to The Reagan-Udall Foundation for the FDA, 202.828.1205, PredicTox@ReaganUdall.org