Pharmaceutical and biotechnology companies with oncology departments must adhere to Title V of the FDA Reauthorisation Act (FDARA), commonly known as the Research to Accelerate Cures and Equity for Children Act (RACE Act). The RACE Act requires that studies and investigations involving products that treat adult cancer must also assess the use of those products in children.

In this whitepaper, our experts examine:

• Key success factors for companies: Following several interviews conducted in the development of this whitepaper, experts at ICON identified the five critical success factors to a company’s readiness to navigate the shift in the oncology development landscape catalysed by the RACE Act. These factors also broadly outline a roadmap for organisational readiness.
• Challenges presented by the RACE act: Companies will face internal and external barriers in navigating the act. Three significant challenges will be encountered by pharmaceutical and biotech companies, including a lack of in-house expertise in paediatric oncology, a lack of established relationships with paediatric oncology academia, and a minimal paediatric oncology patient pool to support clinical research.
• Successes through collaboration: Authors assess three case studies that exemplify how collaboration with patient organisations drives progress in paediatric cancer research. The aim of these case studies is to inform and embolden industry stakeholders to champion the vision of the RACE Act and the value of partnership in conducting these studies.