Ernie Bush: The Case for Investing in Predictive Safety Technologies
In my previous article, Can My Efficacy Screening Test also Be a Drug Screen, I explained the often-misunderstood differences between a discovery-stage efficacy test and a drug safety test. Although the differences are conceptually simple, entering the drug safety market requires more effort than breaking into the discovery market. This presents the logical question:
Why should my company consider a drug safety application for our drug discovery technology? What is benefit for the company and investors?”
Demonstrating ‘predictivity’ requires a large investment.
Significant data is necessary to establish the predictivity of a drug safety test to a pre-clinical safety department. The time and cost of producing this data for an in vitro screen is often very high. The investment usually involves the assessment of anywhere from 100 to as many as 500 compounds, with known liabilities, to demonstrate the tool’s ability to predict adverse effects.
This naturally leads us to consider the value of a safety test. If the standard is higher for a safety test, and if the cost of convincing the users of its value is also significantly higher, then why invest in creating a safety test? Why not develop a biology or pharmacology screen to aid discovery screening?
Accepted safety tests are used across ALL development programs.
The answer to this question tends to be remarkably simple and well documented. Discovery screens may have a lower hurdle to adoption, but they are usually much more narrowly defined. Often, they are used by pharmaceutical companies only for specific targets or diseases. Safety screens, on the other hand, once adopted, are used across the portfolio by project teams on nearly all molecules. Therefore the fee for entry is higher for developing a safety screen, but the target market and sales potential is five to ten times greater than the market for discovery screening tests.
So, my advice is that you take a long, hard look at your technology, to identify whether it is applicable in a drug safety environment for pharmaceutical and biotech companies. If it is, it would be well worth your time to consider how you can invest the appropriate resources to provide this technology to drug safety customers; you will find there are more uses for the technology beyond the drug discovery phase.