What does it take to get a new drug to market?

I have been involved in the drug industry for 35 years. I’ve worked for big pharma like GlaxoSmithkline, contract research organisations (CROs) like Charles River and IQVIA, and for several biotech and “virtual” drug companies. I’ve consulted for many more. I now run a laboratory instruments company that supplies crucial equipment used by thousands of labs in the biomedical research industry.

In my career, there have been many changes due to advances in technology, testing practices and more. But the key principles remain the same - proving that the drug is safe, and that it works as intended.

In this episode I give an overview of how we get from the idea in the laboratory to the medicine in the bathroom cabinet. From the methods used to find new molecules, to testing them and bringing them to market.

I explain the importance of patenting new molecules and the challenges of testing and developing drugs. The episode preclinical testing, including why some animal testing is still necessary. I talk about clinical trials, the regulatory approval process, the post-approval surveillance process, and more.

Overall, this short introduction provides a glimpse into the complex and costly journey of turning an idea into a medicine. A great primer for anyone who needs to interact with this industry professionally, or is just curious about science or medicine. As always, the content is broken down into digestible chunks.

“1 in 10 new drugs that enter clinical development will make it into a medicine” – Mark Davison

You’ll hear about:

01:11 - When will it be a medicine?
01:50 - A quick tour of how it works
04:46 - Computer predictions and theoretical models
08:02 - Figuring out if a molecule is unique
11:42 - Reaching the point of testing the molecule
13:19 - How am I going to give this medicine to patients?
17:39 - The bar for success is high
22:26 - Phase 3 studies
26:43 - The patent clock
28:49 - The post approval process

Connect with me:

LinkedIn: https://www.linkedin.com/in/markdavison100/
Grant Instruments: https://www.grantinstruments.com/
Grant Instruments on LinkedIn: https://www.linkedin.com/company/grant-instruments-cambridge-ltd/