2 Presentations
10:00 AM - 10:45 AM
Co-authors: Li Wang (AbbVie), Mark Levenson (US Food & Drug Administration), John Scott (CBER at FDA), Florian Lasch (European Medicines Agency), Devan Mehrotra (Merck & Co., Inc.), Gregory Alexander (Center for Devices FDA)
10:45 AM - 11:30 AM
Co-authors: Somnath Sarker (Sanofi), Stella Grosser (FDA/CDER), Mat Soukup (FDA/CDER), Shein-Chung Chow (Food and Drug Administration), Sara Hughes (GlaxoSmithKline), Haoda Fu (Amgen)