Risk Assessment and Mitigation: Managing Uncertainty in Drug Development
Analyze sources of uncertainty and failure risk throughout drug development and evaluate mitigation strategies.
Drug development is inherently risky: of ~5,000 compounds screened initially, only one typically reaches market, and even approved drugs can fail post-launch. Risk sources include scientific (does the mechanism work in humans?), clinical (do benefits outweigh risks?), regulatory (will the FDA approve?), manufacturing (can we scale production?), and commercial (will patients and payers accept the drug?). Mitigation strategies include go/no-go decision gates at each phase (using predefined criteria to discontinue unpromising programs), portfolio management (balancing high-risk/high-reward with lower-risk programs), and adaptive trial designs (adjusting enrollment or dose based on emerging data). Some risks cannot be eliminated; instead, companies build contingency…
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