Schedule & Agenda

Monday, June 5
2:15 PM - 3:15 PM

Commissioner Califf has on numerous occasions noted combatting misinformation as a high priority…

The clinical development of advanced therapies often proceeds without a robust understanding of the…
3:30 PM - 4:30 PM

COVID-19 lit a fire under global regulatory systems, triggering regulatory bodies and pharma…
Tuesday, June 6
11:00 AM - 12:00 PM

This session will engage an expert panel in a discussion on a number of timely regulatory policy…
1:45 PM - 2:45 PM

FDA and sponsors share the goal of productive and timely engagement during drug development. …
Thursday, June 8
9:00 AM - 10:00 AM

The use of patient experience data (PED) to inform the development and benefit-risk assessment of…

Companies are using AI/ML models to make pre-clinical drug development a more streamlined process…