Workshop B: Regulatory Expectations – Testing ADC Toxicity & Designing Experiments in Accordance to Obtain IND and BLA Approval

Time: 1:00 pm
day: Workshop Day


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.