Below are my personal core conclusions from this series (and my work in drug development). I think many of these lessons are not limited to pharma but describe general principles for working on high-stakes products, finetuned over decades of discourse and experience.
- History
- Many dramatic incidents related to drugs happened in the past
- Regulators have often been reactive and but also proactive in shaping the drug development landscape
- Harmonisation and standardisation across nations is a big trend
- All Stakeholders
- … do everything possible to prevent harm to participants (and to a lesser extent animals)
- … Train everyone involved constantly
- … Get independent opinions and have a system of checks and balances – audit and inspect each other
- Quality
- Have a process that reproduceably and reliably creates what you want and verify that
- Document everything such that anyone can reconstruct exactly what has happened
- Prepare for risks and tackle issues with comprehensive measures
- Don’t take shortcuts and invest the time and resources necessary
- Operations
- While highly regulated, drug development can be an extremely agile process depending on the involved individuals.
This concludes this series. Hope you enjoyed the read 🙌!
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