1.3 Drug Development
Drug development transforms a promising compound into a safe, effective medicine. This process typically takes 10-15 years and costs $1-2 billion.
Preclinical Development
Pharmacology Studies
In vitro efficacy, mechanism of action, selectivity profiling, PK in animals.
Toxicology
Acute, subchronic, chronic toxicity. Genotoxicity, carcinogenicity, reproductive toxicity studies.
Formulation Development
Drug substance characterization, dosage form design, stability studies.
Manufacturing Scale-up
GMP production, process chemistry, quality control methods.
IND Application
Investigational New Drug (IND) application to FDA contains:
CMC
Chemistry, Manufacturing, Controls
Pharmacology/Toxicology
Preclinical data package
Clinical Protocol
Proposed Phase I study design
Development Timeline
| Phase | Duration | Success Rate | Cost |
|---|---|---|---|
| Discovery | 2-4 years | ~1% hit-to-lead | $100-200M |
| Preclinical | 1-2 years | ~50% | $150M |
| Phase I-III | 6-7 years | ~10% | $800M |
| Regulatory | 1-2 years | ~85% | $100M |