Five Points to Consider Before Introducing a New Technology to the Preclinical Drug Safety Assessment Market
The successful commercialization of new predictive safety platforms is an incredibly challenging and resource-intensive process. These challenges are often exacerbated when new technology providers approach the market with products that have not been adequately qualified or scientifically validated; or worse, when the products are poorly positioned to meet the needs of the of the bio-pharma marketplace. All too often the buyers of these technologies spend millions of dollars on their due diligence and purchase only to find the new tools do not provide significant improvement over current approaches. Therefore, a major advantage exists for those vendors who are appropriately prepared when they engage potential buyers. Based on CHA’s experience in helping new technology providers to introduce new products into this space, we have compiled a list of five questions that technology vendors should ask themselves before beginning the process.
1) Am I delivering data, results, or decisions?
High quality and robust data are always necessary, but nonclinical safety managers at biopharma are ultimately seeking the answer to a very simple question: “Is compound A or B the better candidate to move forward?” A new technology must not only to provide high-quality data; it must also provide insights into how to utilize the results to make optimal development decisions.
2) How many compounds should be in my proof-of-concept or scientific validation data set?
In general, safety scientists are perhaps the most conservative investigators in the biopharma R&D space. They are typically highly data-driven and require strong evidence to evaluate the value of new assays. While there is no definitive answer to the question of how many compounds should be presented, most believe that at least 30 compounds are necessary and quantities in the range of 100-300 are generally considered optimal.
3) Can I determine who decides and who pays?
As the fields of Discovery Toxicology or Exploratory Safety become more established within early compound screening, there is an increasing need to appreciate the role that safety scientists play in the new technology purchase and implementation process. It has become typical to conduct early safety evaluations within high-throughput screening groups however it is crucial that these new tests be vetted by the safety scientists before they are purchased and utilized. Therefore, technology evaluators are often associated with multiple groups, and may not be associated with the group that has the budget to purchase a particular instrument. Indeed, in most test systems whose primary function is to perform a safety assessment, the ultimate decision makers will be the safety scientists, even if the budget is not theirs. Because of this, it is important to survey a representative sample of the market in advance to gain a clear understanding of the areas of opportunity and the entry points.
4) Do I have a robust process for supporting new customer evaluations?
In a 2010 survey conducted by DSEC, the biopharma R&D community lists the following factors as the greatest inhibitors of new technology evaluations:
• Evaluations are too expensive or utilize too many resources
• Evaluations take too long
• Evaluations do not produce actionable results
New technology vendors must have a well-planned, economical and actionable process for potential customers to assess the value of a platform.
5) Can I demonstrate a pertinent price-to-value ratio?
There have been instances when a new technology vendor has failed economically despite having a strong platform that was validated and supported through a robust evaluation process. In many of these cases the vendor miscalculated the price-to-value ratio. The price of the new test per compound ultimately outweighed the perceived value. Vendors often calculate value based on a big picture assessment (e.g. if one bad actor is prevented from getting into late-phase development, then the company can save hundreds of millions of dollars). In reality, these types of justifications rarely have much impact even if they are true. Purchase decisions are often based on a much more mundane calculation, i.e. “given my operating budget, what type of test can I afford to run?” Technology innovators must develop a business model that not only weighs cost and perceived value, but also incorporates the increase (or decrease) in department run rates that can be recognized with the adoption of the new tool.
by Ernest D. Bush, PhD
