A study from the Tufts Centers for the Study of Drug Development estimated that the average cost of obtaining approval for marketing was $2.6 billion. Failing can be even costlier, due to the combination of out-of-pocket costs and losses in share prices and investments along the way. The three problems outlined are a representative sample of the full range of risks to pharma milestones, covering technical as well as practical hurdles.
For pharmaceutical and life sciences companies, project management is inherently complex. Completing a drug development project on time and under budget and in turn bringing new IP to market is challenging, with risks ranging from failing to flag a toxic compound in the early stage of testing, to not having enough full-time employees to handle key responsibilities.
Moreover, nine in ten drug candidates ultimately fail to win regulatory approval (the rate is even higher, at more than 99%, for drugs targeting complex conditions such as Alzheimer’s Disease) and the costs associated with these failures are considerable. A study from the Tufts Centers for the Study of Drug Development estimated that the average cost of obtaining approval for marketing was $2.6 billion. Failing can be even costlier, due to the combination of out-of-pocket costs and losses in share prices and investments along the way.
Controlling the costs of an ambitious pharma project, one focused on securing IP on a working novel compound(s) for as long as possible, requires setting clear milestones, having access to sufficient technological resources and ensuring sustainable collaboration between key personnel. Meeting these goals saves valuable time and money.
With the emergence of technologies such as machine learning that allow for virtual screens, teams have more tools at their disposal than ever before for keeping the project on track, but some familiar practical and technical challenges remain.
Let’s look at a few of them in more detail to see how to overcome them.
1. Not identifying problematic compounds early on in the discovery process
In the context of a pharma project, failure is unavoidable and should be carefully managed. More specifically, processes should be in place to facilitate fast and relatively inexpensive failures, so that problematic compounds do not consume excessive resources and instead get flushed out of the candidate pipeline early and often. Such efficiency can also lead to lower cost per well.
Failing fast requires more than just initial identification of faulty candidates. For example, high-content screening can frequently flag potential issues with compounds, including toxicity levels that would likely result in failed animal tests down the line. However, this alone does not guarantee that they will be promptly removed from proceedings.
They could still make it further into the process due to various oversights or incentives. Chemists might ignore the results of a screen or wrongly see them as outliers. If a compound currently has no IP around it, the pressure to keep going could be strong, as it could be if there was also a goal to identify a set number of compounds in the course of the project.
2. Seeing poor assay performance due to excessive variability in plates, reagents and instruments
Consistent, repeatable performance for assays is essential in establishing the potential viability of a compound for safe use. As much as $28 billion is lost each year on irreproducible research, with various procedural and equipment-related issues with assays a major contributor to that total.
Avoiding these problems requires close attention to multiple common points of failure, including but not limited to:
- Contamination of kit reagents, which can result from something as simple as using reagents from different batches, as they are optimized for different lots.
- Malfunctioning plate readers due to improper or insufficient calibration or poor maintenance.
- Improper plate handling and/or storage, e.g. stacking plates in such a way that they are inconsistently incubated and end up giving disparate readings.
- Overly aggressive or, on the other hand, inadequate washing techniques that create high variability in signal strength that yield inconsistent results.
- Not having enough plates of the same type.
These issues and others degrade assay performance, lower the quality of the data produced and collected and jeopardize the overall timeline and trajectory of the project. Fortunately, teams have multiple proven options for solving these problems.
Procuring the highest-quality instruments and reagents from a partner such as PerkinElmer provides a strong starting point for the ensuing research and discovery. Calibrating and certifying instruments as part of a well-defined process will also help keep assays within the bounds of statistical acceptability. Finally, it is prudent to order ample numbers of plates in advance to ensure optimal consistency and availability of lab resources.
3. Lacking communication and collaboration between project teams
Even with the best instruments, reagents and other infrastructure all fully secured, an ambitious project cannot succeed without the right workflow planning.
For starters, this step is integral in determining whether there is enough technician time and available FTEs to see the project through to the end. Plus, it is necessary for making sure that the different stakeholders in the project - everyone from senior management to the housekeeping staff - can efficiently work with each other.
Even a simple lapse in communication between these stakeholders can lead to costly delays. For instance, if everyone does not follow the project’s environmental protocols, spores could be introduced into a critical area, putting any sensitive work there on hold.
Similarly, significant problems could arise in the how project is planned and baselined. If the committee does not set realistic, agreed-upon goals, then any work toward them could be in vain from the start. There could also be other issues, such as difficulties in understanding the biology of the targeted phenotypes, that emerge along the way and merit prompt, clear communication between teams before such problems get out of control.
How to consistently reach your project milestones
The three problems outlined above do not represent the full range of risks to pharma milestones, but they are a representative sample, covering technical as well as practical hurdles. By focusing on consistent assay performance and finding the best available plates, reagents and instruments, pharmaceutical and life sciences organizations can more readily reach their milestones. With a fundamental commitment to quality along with deep experience in the field, PerkinElmer is here to guide your team on their journey toward more efficient project that produce positive results.