Drug Development Benefits Realisation Plan
This is a practical guide to building a benefits realisation plan for a drug development project — how the project’s benefits will be measured and actually realised, adapted to the realities of developing a pharmaceutical product through regulatory stages.
What a Benefits Realisation Plan is
A benefits realisation plan is how the project’s benefits will be measured and actually realised. For the full concept and how it works in general, see Benefits Realization. On a drug development project it plays the same role, tuned to this kind of work.
Why it matters for a Drug Development project
Drug Development projects live or die on developing a pharmaceutical product through regulatory stages. A well-built benefits realisation plan gives the team a shared, explicit reference for exactly that — reducing ambiguity, aligning stakeholders, and making problems visible early enough to act. Skipping it, or doing it generically, is how drug development projects drift into avoidable delay and cost.
What to include
- Target benefits
- Metrics / KPIs
- Baseline values
- Owner
- Realisation timeline
Drug Development-specific considerations
Tailor the benefits realisation plan to the risks that most often derail drug development projects:
- Regulatory approval delays
- Trial/validation failures
- Strict GxP compliance
Example
On a real drug development project, the benefits realisation plan would be shaped by developing a pharmaceutical product through regulatory stages. In particular, it should explicitly account for the project’s biggest risks — regulatory approval delays, trial/validation failures, strict GxP compliance — rather than treating them as afterthoughts.