アジェンダ
8:00 AM — 8:30 AM
8:30 AM — 8:45 AM
Welcome and Introductions8:45 AM — 10:45 AM
Module 1: Overview of Drug Development10:45 AM — 11:00 AM
11:00 AM — 11:45 AM
Table Exercise 111:45 AM — 12:30 PM
Module 2: Candidate Identification/Preclinical Testing12:30 PM — 1:30 PM
1:30 PM — 2:30 PM
Module 3: Phase 1 – Initial Human Testing2:30 PM — 3:30 PM
Module 4: Phase 2 – Preliminary Human Efficacy and Safety3:30 PM — 3:45 PM
3:45 PM — 4:45 PM
Table Exercise 2a: Phase 2 Risk-Return Decisions4:45 PM — 5:00 PM
Questions and Answers5:00 PM — 6:00 PM
8:00 AM — 8:30 AM
8:30 AM — 9:00 AM
Module 4: Phase 2 – Preliminary Human Efficacy and Safety (continued)9:00 AM — 9:30 AM
Table Exercise 2b: Phase 3 Decision9:30 AM — 10:30 AM
Module 5: Phase 3 and Regulatory Review10:30 AM — 10:45 AM
10:45 AM — 11:15 AM
Table Exercise 3: Decision to File11:15 AM — 12:45 PM
Module 5: Phase 3 and Regulatory Review (continued)12:45 PM — 1:45 PM
1:45 PM — 3:15 PM
Module 6: Phase 4 and Lifecycle Management3:15 PM — 3:45 PM
Table Exercise 4: Lifecycle Management Choices3:45 PM — 4:00 PM
Questions and Answers / Wrap-up