Refining Preclinical Regulations: Clarifying Requirements for Safety, Efficacy, and Pharmacological Evidence to Establish the Regulatory Gold Standard & Minimize Uncertainty in Clinical Translation
Time: 1:00 pm
day: Pre-Conference Workshop
Details:
As the in vivo cell engineering and gene editing space rapidly develops, leaving uncertainties in regulatory requirements, this workshop delves into considerations for effective model selection and strategies for producing comprehensive safety and efficacy evidence to effectively prepare for treatment evaluation and approval from regulatory boards.
This workshop will gather experts to discuss:
- Evaluating the selection of appropriate and effective preclinical models to guarantee optimal decisions
- Identifying regulatory requirements essential for approval utilizing preclinical models in in vivo cell engineering and gene editing treatments
- Discussing strategies for effective model triangulation to achieve safety and efficacy requirements with reliable translational outcomes
- Pinpointing regulatory and evidence requirements to streamline the drug validation process
- Exploring approaches to generate safety and efficacy evidence from IND-enabling studies
- Overcoming key challenges in IND regulations
