The RACE for Children Act: How Industry Can Accelerate Readiness Through Collaboration With Patient Organizations | White Paper
As of August 18, 2020, pharmaceutical and biotechnology companies with oncology pipelines must navigate the implications of Title V of the FDA Reauthorization Act (FDARA), commonly known as the Research to Accelerate Cures and Equity For Children Act (RACE Act). These implications affect oncology clinical development, the most salient of which will be undertaking oncology studies in pediatric patients. 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 light of the RACE Act, patient advocacy organizations have a huge role in providing knowledge and experience as pharmaceutical companies develop pediatric clinical trials. This white paper is based on a series of interviews with stakeholders from some of the leading pediatric cancer patient organizations, academia and industry. The intent is to inform and provide a high-level orientation around the key barriers to readiness and critical success factors for companies navigating the pediatric oncology space in the wake of the RACE Act.
PEDS Impact Statement | 2022
2022 CureSearch Pediatric Early Development Symposium (PEDS): Leveraging Big Data to Advance Pediatric Clinical Trials
The 2022 Pediatric Early Development Symposium convened leaders from all areas of pediatric oncology – pharmaceutical and biotechnology companies, clinical research organizations, academic leaders, parents and patient advocates, venture capitalists, regulators, and like-minded partners.
Derived from the many discussions, questions from attendees, and group conversations over the three-day symposium, we are pleased to share the 2022 PEDS Impact Statement, outlining three key impact areas CureSearch will address over the next year.
CureSearch Summit White Paper Series | 2021
The State of Solid Tumor Biopsies: Innovative approaches to address and understand limited pediatric solid tumor samples and data
The annual CureSearch Summit serves as a unique platform for driving critical stakeholder collaborations to accelerate the pace of pediatric oncology drug development. The 2021 CureSearch Summit is a series of four virtual sessions focused on addressing the relative paucity of available pediatric cancer tissue and data. This outcome-driven meeting will provide resources to the pediatric cancer community aimed at increasing biopsy use and data sharing to support and accelerate research in the field.
The white papers resulting from these sessions will provide an overview of the session discussion, highlight benefits and challenges to implementation of increased biopsy acquisition and data sharing in the pediatric cancer space, and identify future actions to address the challenges and increase pediatric-specific therapy development.
March 9, 2021 | White Paper: New Technologies for Maximizing the Analysis of Solid Tumors
May 14, 2021 | White Paper: Blurred Lines: Therapeutic vs Research-only Biopsies
July 13, 2021 | White Paper: The Journey of a Post-Mortem Tissue Donation
