C-Path Global Impact Conference

ABSTRACT Critical Path Institute (C-Path) is an independent, nonprofit public-private partnership (PPP) with the U.S. Food and Drug Administration (FDA), with a mission to improve the efficiency and safety of medical product development. The purpose of the 4-day interdisciplinary conference, titled “C-Path Global Impact Conference”

is to showcase the work done by several C-Path public private partnerships (PPPs) in generating actionable solutions to accelerate drug development. Additionally, this conference will feature C-Path consortia current contributions towards the development of novel therapeutics for challenging conditions in neurology, rare and

orphan conditions, and pediatric populations. This conference will be the largest and broadest reaching conference organized by C-Path during the organization’s nearly 20-year history. The C-Path Global Impact Conference will bring together and capitalize on the strong existing pre-competitive relationships between C-

Path and diverse stakeholders - including regulatory agencies (U.S. Food and Drug Administration [FDA], European Medicines Agency [EMA], Japanese Pharmaceuticals and Medical Devices Agency [PDMA]), pharmaceutical industries, academic researchers, non-profit organizations, and patient groups - to hold

productive dialogue among the conference attendees and advance efforts to produce publicly available drug development tools to optimize the evaluation of the efficiency and safety of novel therapeutics. This conference will advance science and clinical practice through the interactive discussions between stakeholders, such as

industry, academia, regulatory agencies, and patient groups. By spurring further productive dialogue regarding data sharing, standardizing methodologies, and the generation of actionable solutions for drug development across challenging therapeutic areas, this conference will position C-Path’s PPPs to further accelerate the

development and approval of new therapies, improve clinical trial efficiency, and enhance patient outcomes.