PRE-CONFERENCE WORKSHOP DAY
Tuesday, January 28
9:00 am Workshop A – Navigating Suprachoroidal Delivery in Gene Therapy to Capitalize on Ocular Anatomy
Synopsis
This session will detail the intricacies of suprachoroidal delivery in gene therapy, discussing the strategies for optimizing vector selection, the current landscape of clinical programs, and the future potential of this ground-breaking approach. You’ll also be able to explore how suprachoroidal delivery could change the paradigm of retinal care by transforming complex surgeries into routine office procedures.
Key Topics to be Discussed:
- Optimizing Vector Selection: How to target the correct retinal layers with the right vectors — discussing which AAV serotypes and non-viral vectors are most effective for precise and safe gene delivery through the suprachoroidal space
- Current Landscape and Innovations: An overview of what others are doing in the suprachoroidal gene therapy space, including clinical programs, differentiating features of emerging platforms, and areas where improvement is needed
- Future Directions: Addressing the potential shift in retinal care towards less invasive, office-based procedures and how suprachoroidal delivery could transform gene therapy into a repeatable and adaptable treatment modality, potentially improving outcomes and accessibility for patients
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