MxS
Conclusions Drug Development Explainer Series (6/6)

Conclusions Drug Development Explainer Series (6/6)

(Updated: )
Drug Development Pharma

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 🙌!