The global spread of COVID-19 and its great impact on the health and wellbeing of our population has imposed a race to develop an effective vaccine at unprecedented speed. A development process that usually spans several years is being compressed into one year - or less. Safety is a vital part of this process, and so we identified and discussed several key factors and considerations around safety in vaccine development. This article provides a synopsis of our insights.
The current regulatory environment can help support sponsors with the complex efforts involved in pediatric oncology drug development, as regulatory agencies and legislative acts have helped encourage, incentivize or even require the conduct of pediatric trials in other indications. This white paper provides a brief history of how pediatric cancer treatments have progressed, outlines how regulatory changes have impacted the field of pediatric drug development and provides guidance on applying current regulations, such as the RACE for Children Act which is focused on pediatric oncology. This change should serve to enhance an inclusive regulatory strategy for oncologic drug development.