Reconsidering Approaches to Regulatory Interactions to Overcome Challenges in Dose Selection, Preclinical Data Package and Clinical Endpoint Selection
- Join this workshop to enjoy candid and actionable discussions around effectively communicating with regulatory agencies
- Exploring the necessary scientific and clinical data required to successfully advocate for regulatory waivers or alternative review pathways, particularly for a disease with a high failure rate and limited treatment options
- Innovative strategies for presenting a robust scientific rationale and a compelling data package that can persuade agencies to be more flexible, and for establishing a collaborative dialogue from the pre-IND stage through clinical development
- Discussing the validation of non-traditional endpoints and building strong scientific cases to convive regulators to accept them for accelerates approval, particularly given the
- challenges with endpoints like PFS and OS
- Discussing the benefits of a balanced perspective, where regulatory professionals from both the pharmaceutical industry and agencies can share their insights to better align on expectations and overcome shared challenges
- Discussing what a more flexible, adaptive regulatory framework for GBM drug development could look like including streamlining trial designs, facilitation biomarker driven
- patient selection and creating a clearer path to approval that incentivizes innovation whilst maintain patient safety