Isolating Treatment Contributions in Complex Regimens: Navigating Regulatory Requirements with a Case Study

Music City Center 

As oncology treatment regimens become increasingly sophisticated, isolating the contribution of each component is critical for regulatory approval and clinical application. This talk explores the regulatory landscape for developing new treatments with multiple components and phases, using AstraZeneca's AEGEAN ODAC as an example.

We highlight key regulatory guidelines that require clear evidence of each treatment's impact on efficacy and safety and discuss strategies to meet these requirements. The presentation discusses how AEGEAN ODAC integrates analytical approaches with regulatory compliance to inform personalized cancer treatment strategies. Attendees will gain insights into designing oncology trials that effectively isolate and address the contribution of each treatment effect within regulatory frameworks.