Ever since 2004 when the FDA released its "Critical Path" white paper, there has been broad agreement that the drug development enterprise needs "new tools to get fundamentally better answers about how the safety and effectiveness of new products can be demonstrated, in faster time frames, with more certainty, and at lower costs." Over nearly a decade, a number of academic-industry/public-private collaboratives that aim to transform or accelerate clinical trial processes and product development have been convened. In this forum, leaders of TransCelerate Biopharma Inc (TransCelerate) and the Clinical Trials Transformation Initiative (CTTI) will provide a status report on current projects, with additional perspectives provided by representatives of the FDA, the Association of Clinical Organizations (ACRO), and the Society for Clinical Research Sites (SCRS).