Topic-Contributed Paper Session
Estimand Framework in Safety Assessments
Shanti GomatamOrganizerYong MaChair
Biopharmaceutical Section
4 Presentations
2:05 PM - 2:25 PM
Cesar Torres (FDA)
2:25 PM - 2:45 PM
Jonathan Siegel (Bayer US Pharmaceuticals)
Co-authors: Janet Wittes (Wittes LLC), Brenda Crowe (Eli Lilly and Company), Pedro Romero-Lopez (Novartis), Natalia Kan-Dobrosky (AbbVie Inc)
2:45 PM - 3:05 PM
Shanti Gomatam (Food and Drug Administration)
3:05 PM - 3:25 PM
Ellen Snyder (Merck & Co., Inc.)
Co-authors: Yong Ma (FDA), Jonathan Haddad (GlaxoSmithKline), Wei Liu (FDA), Ellen Snyder (Merck), Dimitri Bennett (Takeda), Susan Mayo (FDA)
Discussant
Scott Evans (George Washington University)