The View From Here

Michael J. Curtis

Safety Pharmacology and Drug Discovery

Safety Pharmacology is presently an orphan discipline that occupies a space between science and regulation. As a science, it is subject to the laws of the scientific method (hypothesis testing). However, it is also a professional activity driven by the need to generate a regulatory (legal) portfolio on the risk liability of each drug that is put up for approval. The dynamic between the development of safety pharmacology as a genuine scientific discipline and its need to keep its eye on the regulatory bottom line is an interesting one. This issue of Editor’s Choice presents a selection of articles that inform this conundrum, and may contribute to resolving it:

• In vitro safety pharmacology profiling: an essential tool for successful drug development
• In silico prediction of drug safety: despite progress there is abundant room for improvement
• Why optimize cancer drugs for ADMET?

In the next few years we can expect to see important developments in Safety Pharmacology. For the pharmaceutical industry, the key issue is to know with confidence which tests to employ in order to generate a portfolio acceptable to regulators in its extent and persuasiveness. In the long term, Industry requires to be able to anticipate what is required to avoid the disappointment of having a truly safe drug fail approval owing to regulators regarding the portfolio as being unconvincing, and also avoid the more worrying scenario of having a truly unsafe drug achieving approval because regulators failed to appreciate that the portfolio was misleading or incomplete. To achieve this with confidence, Industry must strive to make reason and the scientific method their drivers, not simply the pragmatic goal of anticipating what formulation of tests is the minimum to make the regulators happy.

Michael J Curtis PhD FBPharmacolS
Reader in Pharmacology