Pre-Conference Workshop Day
Tuesday April 23, 2024
8:00 am Morning Registration
9am-12pm Workshop A
Standardizing Exosome Development & Manufacturing – What We Need to Know to Ensure Success
Synopsis
Given the ever-evolving field and the significant lack of regulatory guidelines, the industry must begin to come together and collaborate on defining clearer standards of practice. Learn what techniques are working best and what regulatory bodies want to see from data being produced. Define what best practice looks like to you and your
business to ensure further success with your product pipelines in the future.
Join this workshop to:
- Outline where gaps lie in your practice and how this is holding back regulatory progress
- Develop your understanding of available tools and what the industry leaders are currently using to ensure success
- Build your expertise and ensure you are up to date on industry knowledge and goals
12pm-1pm Lunch
1pm-4pm Workshop B
Regulatory Challenges in the Development of an Extracellular Vesicle-Based Clinical Product
Synopsis
In this workshop we will discuss how to navigate the intricate regulatory requirements to translate extracellular vesicles loaded with PTEN-siRNA (ExoPTEN) from preclinical to clinical phase.
Strategies for the manufacturing process and controls include:
- Scaling up the bioprocess to produce higher yields and quantities.
- Development of a proprietary moiety for efficient loading of siRNA
- Establishing a matrix array of multiple potency assays to measure several attributes related to ExoPTEN’s therapeutic activity
The following preclinical aspects will be considered:
- Biological relevancy of the animal model
- Dose finding and quantification studies. How will the therapeutic unit be defined, for example, EVs concentration, total RNA content
- Safety studies for off‐target assessments of ExoP
- Biodistribution and pharmacokinetics profiles.