Home / Resources / Webinar / Fostering Pediatric Oncology Drug Development
Fostering Pediatric Oncology Drug Development

Webinar

Thursday July 30th at 11:15am ET

In 2020 approximately 11,000 children in the US under the age of 15 will be diagnosed with cancer. After accidents, cancer is the second leading cause of death in this population. The most common cancers in children younger than 15 are leukemia, brain, and central nervous system tumors.

The Pediatric Research Equity Act (PREA) gives the US FDA the authority to require biopharmaceutical companies developing drugs for adults to also develop them for children. However, most cancer drugs have not been subject to PREA requirements. Thus, most cancer drugs approved in the last couple of decades have not had any pediatric labeling information.

In addition, pediatric cancer drug development presents multiple challenges. Pediatric cancers include multiple rare tumor types. A substantial proportion of pediatric cancers have genomic alterations that are not shared with common adult cancers. Therefore, there is a small pediatric patient population that can be studied in clinical trials. In addition, pre-clinical models of pediatric cancer are limited. Finally, developing pediatric oncology drugs requires considering both potential developmental and long-term toxicity.

In this webinar, our speakers will give an overview of the pediatric oncology regulatory landscape, explain the principles underpinning the use of modeling and simulation in pediatric oncology, and present a case study on how a pediatric oncology development program used extrapolation approaches to guide dosing recommendations.

The Pediatric Research Equity Act (PREA) gives the US FDA the authority to require biopharmaceutical companies developing drugs for adults to also develop them for children. However, most cancer drugs have not been subject to PREA requirements. Thus, most cancer drugs approved in the last couple of decades have not had any pediatric labeling information. By watching this webinar, you will learn: – Why the Research to Accelerate Cures and Equity (RACE) for Children Act is critical to the advancement of pediatric cancer research – What are the implications for the pharmaceutical industry come August 18, 2020, when the RACE for Children Act goes into effect – How modeling and simulation can empower pharma companies to make informed decisions to accelerate developing pediatric cancer therapies