8:30 am Check-in & Morning Coffee
09:00 am | Workshop A
Comparing CNS Delivery Devices to Highlight the Value of Each & Select the Most Optimal One for Your Gene Therapy
Synopsis
Choosing what delivery device to use to administer gene therapies to the CNS is one of the biggest questions facing drug developers right now. Whether it is directly injecting into the brain, injecting into the cerebrospinal fluid, or systemic delivery, each of them has their merits and drawbacks. Dive into the workings of each and debate their effectiveness to ultimately come up with a plan for which one is the best suited for your administration.
Join this workshop to:
- Examine the working of each route of administration to understand what works with your gene therapy product
- Debate the pros and cons to differentiate between systemic, direct, and CSF injections
- Understand the difference in what each delivery method can accomplish
- Learn how you can leverage each to better meet the needs of the indication you are targeting
- Examine how regulatory guidelines affect device selection
12:00 pm Lunch
01:00 pm | Workshop B
Discussing Changing Regulatory Guidelines to Perfect Regulatory Submissions & Receive Quick Approvals
Synopsis
With the evolving regulatory landscape and changing leadership, regulatory uncertainty is at an all-time high. When it comes to gene therapies for the CNS, there are key regulatory expectations such as safety, biodistribution, long-term follow up, efficacy, delivery methods, and more that need to be met. Working to get IND clearance and reach clinical trials is also a great need and hurdle. This workshop is the best place to brainstorm the ideal IND submission package and come up with a template to assist gene therapy developers.
Join this workshop to:
- Clarify regulatory expectations to understand how to work with evolving guidelines
- Break down the latest updates from the FDA
- Harmonize updates from FDA, EMA, and other regulatory bodies
- Learn from recent regulatory submissions to understand the best practices