Conducting pediatric clinical trials can be a challenge due to limited patient populations. This can become further complicated when therapeutic areas have numerous competitors looking to expand their pipelines with novel agents. The FDA Reauthorization Act (FDARA) of 2017 made significant modifications to the Pediatric Research Equity Act (PREA), in particular, how adult cancer therapies are evaluated for their application to pediatric cancers (Section 504). As a result (effective August 18, 2020), the requirements under PREA will now apply to products intended for the treatment of an adult cancer and “directed at a molecular target FDA determines to be substantially relevant to the growth or progression of a pediatric cancer.” These new requirements will impact how pediatric cancer drug development is currently conducted in the United States.

During this session, panelists will discuss a variety of methods to consider when designing development programs to address pediatric cancer. This complex topic, critical to facilitating efficient availability of new therapies for pediatric cancer, will include disease and/or product prioritization, in addition to innovative analytical approaches to data generation. This open dialogue is necessary to ensure continued innovation in pediatric drug development, in oncology and beyond.

Session ID: 49182