Episode 004 – The Story of a New Drug

On todays episode, Greg moderates a discussion between John Milligan and Ian Armstrong on the how the pharmaceutical development process works. The process is boiled down into a few steps:

  1. Understanding the Biochemical pathway that leads to disease
  2. High Throughput screening/Molecular modeling
  3. Initial Hits are obtained (small molecule, or biologic)
  4. Hits are optimized for Safety and Efficacy using cell cultures and assays
  5. Pre-clinical studies in animals
  6. Phase I -> Typically healthy patients. Side effects are determined, and tolerable dosages are determined
  7. Phase II -> Afflicted patients, typically to fine-tune effective dosages, and to determine if any new side effects are found in sick patients.
  8. Phase III -> Large scale study to further ensure that the drug is safe and effective.
  9. New Drug Application –
  10. Approval
  11. Market Exclusivity (including pricing)
  12. Patent expiration
  13. Generics!

Novartis has put together an excellent video on the process of how a drug is brought to market, which you can find here!

One final note: Drug development is hard work, and doesn’t happen overnight. It is important to remember that research costs money, and that the final product needs to make money. It is our recommendation to never purchase pharmaceuticals from other countries as you cannot guarantee that it will be safe and effective.

If you have questions, or comments send us an email, tweet, or facebook message and we will personally respond to you!

The featured image is thanks to “Be.Futureproof” on Flickr, and is used under a CC BY 2.0 license

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