FDA/EMA Experience

The regulatory environment surrounding childhood cancer drug development is changing, and increased attention to such development within industry is becoming a higher priority. COG can directly assist industry partners in this global landscape. From formulating development plans that can support pediatric exclusivity, to establishing a feasible Pediatric Investigation Plan, Children’s Oncology Group expertise can assist.

The expertise within COG is widely recognized by regulatory agencies. Thus, independent assessments from our experts can help refine initial proposals into studies that provide key data in a clinical trial development plan designed for pediatric patients. Understanding the current cancer treatment landscape is essential when developing such plans, as feasibility of study proposals are central to future success.

The COG has successfully collaborated with numerous industry partners, from small biotech to global pharmaceutical companies. To learn more, email COG Industry Sponsored Trials Program (IST) at ISTProgram@childrensoncologygroup.org or call (626) 241-1512. The Children’s Oncology Group – The world’s childhood cancer experts.