Conclusions Drug Development Explainer Series (6/6)

< 1 min read – Conclusions from the 4 core articles in this series on history, stakeholders, quality, and operations.

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 🙌!

Other articles in this series

  1. Stakeholders in Drug Development
  2. The Blueprint of Drug Development
  3. Origins of Drug Regulation
  4. Recommended Literature and Courses
  5. Alvea – A Case Study of the Fastest Biotech to Go to In-Human Trials
  6. Conclusions