Why I Am Not Buying It: Top Excuses for Not Adopting a New Safety Evaluation Technology
In both my personal experience as a senior manager at large pharma for over 20 years, and in my role facilitating peer evaluations of new technologies at CHA for the past five years, I have noticed that there a few reasons that are consistently offered for why a particular new technology for safety evaluation was not adopted. Below are the top four.
1) “We could not determine a favorable value proposition.”
When prospective buyers calculate the overall cost of the new method, versus the cost of the existing approach, they often find that the added value does not justify the added expense. This is especially true when buyers can establish a similar tool using in-house resources for far less investment. Safety evaluators were once perceived as having a “blank check” when it came to spending money on developing new compounds but now, with the push to conduct safety testing much earlier in the discovery process, this is clearly no longer the case. New technologies must demonstrate a true return on investment, and new technology vendors must therefore develop thorough and robust cost-effectiveness business cases that clearly demonstrate added value (time and money saved) for their new technology to be deemed worth the expenditure.
2) “We were not convinced the new technology would deliver as promised.”
Most vendors have some validation data, but usually not the breadth or depth that has become the expected norm. Prospective clients are especially eager to see “real world” examples and are increasingly disappointed when presented with data on a few well-documented examples. We strongly recommend that vendors target a validation of at least 50 compounds and, ideally, a total greater than 100. This data should include adequate quantities of known non-active compounds to understand the false positive rate.
3) “Our ‘test drive’ did not go well.”
The reason car dealers like to get you behind the wheel of a potential new car is to create the vision of a new reality with you as the owner of the shiny new car. A lot of effort goes into detailing the car, training the sales rep, etc., to ensure that the test drive is a powerful and motivating experience. Similarly, the sales evaluation process should be efficient, effective and motivating. We are surprised when we conduct surveys and find that the majority of new technology evaluations are considered by prospective clients to be unsatisfactory. Vendors must adjust their sales evaluation processes so that they are productive for potential clients.
4) “We questioned the science behind the technology.”
Safety evaluation staff can appreciate the need for trade secrets and proprietary information when producing and marketing new technology, however vendors must present enough documented evidence to convince someone who is experienced in validating the proposed tools. Too often vendors either cannot provide the supporting information requested or they claim it is proprietary and cannot be shared with potential customers. One of the most widely accepted forms of scientific validation is publication in peer-reviewed journals. Another is endorsement or utilization by a person or institution with a reputation for conducting good science. Vendors must strive to provide a strong scientific rationale for why their new technologies are feasible and they should be prepared to provide potential clients with a wealth of supporting data.
In the current economic climate, pharmaceutical companies are looking for new technologies to help reduce costs and improve the bottom line, and the opportunities have never been greater for new safety technologies.
by Ernest D. Bush, PhD
