Spotlight session: Funding development programs to support clinical and commercial success

Selecting the right endpoints is critical to demonstrating clinical benefit, supporting regulatory submissions, and guiding translational research. This session examines strategies for identifying, validating, and implementing endpoints that are both scientifically robust and relevant to patients, particularly in small or heterogeneous populations. 

Key Takeaways:  

• Identify clinically relevant and patient-centered endpoints for advanced therapies 

• Apply methods to validate endpoints in small or variable patient populations 

• Integrate translational science insights to inform endpoint selection 

• Navigate regulatory expectations for endpoint justification and reporting 

• Learn from case studies of developers successfully implementing effective endpoints