PRE-CONFERENCE WORKSHOP DAY
Tuesday, January 28
9:00 am Workshop A – Expanding the Potential of the Suprachoroidal Space in Retinal Therapy
Synopsis
Key Topics to be discussed:
- Overview of the current landscape of suprachoroidal delivery, and available technologies
- Non-clinical distribution and AAV expression achieved with Everads’ SCS injector
- Clinical experience from Everads’ ongoing clinical trial
- Use of thermal imaging for confirmation of suprachoroidal delivery
12:00 pm Lunch
1:00 pm Workshop B – Overcoming Hurdles in Ophthalmic Clinical Trial Design to Spearhead Development
Synopsis
This session will be delving into how clinical trial design can be optimized for ophthalmic delivery, leveraging experienced clinical trialist’s knowledge on robust design to accelerate development.
Key Topics to be Discussed:
- Reducing Screen Failures: Strategies for designing effective trials that minimize patient screen failures
- FDA Guidelines for INDs: Understanding and implementing the necessary FDA guidelines for successful Investigational New Drug (IND) submissions
- Achieving Targeted Endpoints: Best practices for defining and meeting trial endpoints
- Patient Enrolment Challenges: Approaches to overcoming challenges in patient recruitment and retention
- Navigating Stratification: Techniques for effectively stratifying patients within trials to enhance data reliability
- Operational Synergies: Creating synergies in trial operations to streamline processes and improve efficiency