Pre-Conference Workshop Day - Tuesday | July 9, 2024
Discover practical solutions for current industry challenges at our pre-conference workshops! This is an opportunity for you to dive into regulatory concerns and animal model selection, and gain actionable insights for your in vivo editing projects.
8:00 am Check-In & Coffee
9:00 – 12:00Workshop A
Evaluating the Suitability of Different Animal Models for In Vivo Cell Engineering & Gene Editing to Find the Most Appropriate Model for Your Pipeline
Synopsis
Finding a suitable animal model that is cost-effective and all-encompassing is a major challenge. With many approaches, from using mice with humanized immune systems to non-human primates, each with distinct benefits and drawbacks, this session aims to assess suitability.
Take part in this workshop to join us in:
- Discussing the advantages and disadvantages of different animal models including mice with humanized immune systems or non-human primates to compare which criteria (efficacy, safety, biodistribution etc.) are most suitable to measure
- Addressing topics such as cost and accessibility of different models against benefits, to gain insights into the range of animal models and the respective benefits
- Planning how data from animal models may translate into humans as companies begin to shift toward the clinic
12:00 pm Lunch Break & Networking
1:00 – 4:00Workshop B
Delving into Regulatory Guidelines to Gain Clarity on Requirements for Data, Animal Models, Clinical Considerations, & Safety, to Plan Accordingly
Synopsis
As this space develops towards the clinic, it’s essential to crystallize regulatory guidelines so companies can align their work with what is required by agencies, thereby streamlining pipelines for a smooth transition from pre-clinical to clinical trials. However, as the field is still emerging, it is imperative to unite efforts to stay ahead of regulatory ambiguities and ensure you are up to date with colleagues.
Take part in this workshop to join us in:
- Elucidating which animal models may be favored by regulatory bodies to strategize approval pathways and effectively progress into clinical phases
- Clarifying which types of data comply with regulatory guidelines, and facilitating actionable goals to acquire such data
- Addressing how tighter regulations on ex vivo CAR-T therapies may impact the in vivo space
- Discussing risk benefit considerations for younger patient populations and developmental and reproductive risk considerations
- Navigating long-term clinical follow-up plans and requirements