Drug Development Milestone Timeline

Develop a drug development timeline for:

Program: [Drug candidate name]
Therapeutic Area: [Disease]
Current Stage: [Discovery/Preclinical/Phase I/II/III]
Modality: [Small molecule, biologic, gene therapy, etc.]

Key Information:
- Target indication: [Primary use]
- Regulatory pathway: [Standard, accelerated, breakthrough]
- Development strategy: [Key decisions made]
- Resource allocation: [Team, budget considerations]

Create a timeline covering:
1. Discovery and lead optimization
2. IND-enabling studies
3. IND/CTA submission
4. Phase I (SAD/MAD, PK)
5. Phase II (dose-finding, PoC)
6. Phase III (pivotal trials)
7. NDA/BLA/MAA preparation
8. Regulatory submission and review
9. Launch preparation
10. Post-marketing commitments

Include:
- Duration estimates for each phase
- Key milestones and decision points
- Critical path activities
- Risk factors and contingencies
- Resource requirements by phase