Workshop B: Regulatory Expectations – Testing ADC Toxicity & Designing Experiments in Accordance to Obtain IND and BLA Approval
Time: 1:00 pm
day: Workshop Day
Details:
With the common goal of developing ADCs with the highest therapeutic index, the industry is gradually shifting away from traditional ADCs and testing methods and towards novel approaches, such as a reduction in animal testing and newer payload and mechanistic technologies. From these advances, a question has to be asked – what are the regulatory standpoints on these novel methods? Join this workshop to gain a further understanding the regulatory requirements when designing your GLP study to achieve both IND and BLA regulatory approval.
What this Workshop Will Cover:
- Regulatory opinions on a variety of topics, such as a push to reduce animal testing, introduction of more advanced in vitro technologies, and novel payload strategies.
- Understanding what is expected from GLP studies for a greater alignment with regulatory expectations.
- How will moving away from NHP testing be feasible from a regulatory perspective and what can aid in that progression.
