Novavax
22‑month program. Month 1: Mar 2026
Roadmap (22 months)
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Domain
Jan 2026
Feb 2026
Mar 2026
Apr 2026
May 2026
Jun 2026
Jul 2026
Aug 2026
Sep 2026
Oct 2026
Nov 2026
Dec 2026
Jan 2027
Feb 2027
Mar 2027
Apr 2027
May 2027
Jun 2027
Jul 2027
Aug 2027
Sep 2027
Oct 2027
Nov 2027
Dec 2027
Regulatory
Jurisdiction & Application Type
Type C Meeting Engagement Strategy & Meeting Planning
Type C Meeting Execution
Regulatory Interaction Strategy and Timeline
Define Regulatory Data Standards and Submission Infrastructure
Designations and Special Programs Pre‑assessment
Initiate the Type B Pre‑IND Engagement
IND Meeting
Module 3 preparation
CMC
Target Product Profile
CQA & Criticality
Preliminary Analytical Target Profile (ATP)
Reference Standard Selection
Select Expression System & Production Platform (PoC)
Map Unit Operations
HCP Strategy
MCB Strategy
DS Formulation
DP Formulation
Comparability Program
Preliminary Process Description
Risk Assessment (FMEA)
Control Strategy
Clinical
Non‑clinical
Candidate Selection