Dr. Kamala Maddali has a diverse background in the pharmaceutical industry and gives us an overview on how a new molecule becomes an approved drug to treat cancer.
- Until 5 years ago, it would reliably take more than 10 years to go from the discovery of a promising new molecule until it became an approved pharmaceutical. That’s too long to wait for cancer patients and a very expensive process.
- There are now large libraries of new targets in cancer that the pharmaceutical industry has at its disposal to explore for drug development.
- Cancer is very complicated, but we are better understanding the biology, especially the communication between cancer cells and other cells, leading to new targeted therapies.
- 40% of new cancer drugs are immunotherapies.
- We have better cell culture and animal models that can speed up preclinical research, including looking not just for the new molecule’s efficacy but also for its toxicities.
- More new cancer drugs are coming to market every year than ever before.
- The patient’s voice has been an important factor in speeding up the FDA’s drug approval process through:
- Priority Review
- Breakthrough Therapy
- Accelerated Approval
- Fast Track
All of these changes have led to quicker cancer approvals of new medications to fight cancer.
To read more about the new quicker pathways for the FDA drug approval process, visit their website here.
Watch my interview with Dr. Maddali here: