Roundtable Discussion: Successes and Setbacks with IND Submissions

Time: 12:30 pm
day: Conference Day Two


Roundtable discussions place a larger focus on group discussion. A moderator will introduce the session topic and attendees then split into groups to discuss a series of assigned questions. At the end, all groups report back on their discussions, and findings are collated.

  • Highlighting areas of CMC and nonclinical testing most commonly met with regulatory feedback
  • Sharing experiences with on- and off- targeting assessment
  • What level of sensitivity and specificity do I need to demonstrate to the regulators?