This webinar shares new insights on rare oncology drug development and examines how new processes and regulatory pathways are helping speed development of novel therapies.
Researchers studying rare cancers are, in effect, specialize in two indications. They call on expertise in oncology and rare disease, disciplines where current processes and strategies often differ. The resulting conflicts are more than occasional, with up to 20 percent of new cancer diagnoses today considered “rare.”
Topics will include:
- Trial design and execution, market exclusivity, and today’s evolving regulatory environment.
- Trends in trial design, including application of the continual reassessment method in Phase I, use of adaptive design in Phases II and III, statistical implications, and planning for expanded access.
- Regulatory pathways in rare oncology: breakthrough, accelerated/conditional approvals, and orphan designation.
Presented by Peter Larson, Senior Medical Director, Hematology-Oncology and Colin Hayward, Chief Medical Officer.