Beginner’s Guide to Independent Asset Reviews
A thorough asset review optimizes the potential for an asset to achieve an organization’s clinical, regulatory, commercial, and market access goals.
As a new asset moves through development phases, organizations focused on optimizing resources may consider partnering with seasoned, industry practitioners to conduct an independent asset review. This blog provides a beginners’ guide to understanding independent asset reviews (IAR) and their role in clinical research.
What is an IAR?
Typically, an IAR is done to evaluate a biopharmaceutical company’s assets quickly and efficiently at each development stage. As an asset moves through each phase, reviews are conducted to ensure investment dollars and resources are effectively utilized to maximize development and comply with time-to-market milestones. It’s important to conduct IARs at each stage, as development may shift as the program moves forward. An effective IAR can surface risks as well as recommendations for optimizing investment dollars in addition to bringing focus to assets with the greatest probability of making it to market and fulfilling trial forecasts.
What do IARs reveal?
It’s beneficial for organizations to engage seasoned experts to conduct an IAR since they provide an independent voice on development options, informing critical decisions at each program phase. An IAR evaluates the costs and risks at each phase as well as potential performance in succeeding stages.
There may be conflicting opinions internally on how the next stage should proceed, if at all. As the program moves through development, the cost of conducting a trial and its associated risk level rises. An IAR evaluates the costs and risks and how they may do in the succeeding stage.
Additionally, IARs are particularly useful when working on an orphan drug or rare disease trials. Since these trials are small and generally unknown territory for a sponsor, they may need creative ways of examining the development and regulatory challenges. In these scenarios, it’s best to get a fresh perspective from seasoned, independent practitioners.
Other common reasons for sponsors to conduct an IAR may also include monitoring potential issues that may have surfaced in early trials. Even if they appear non-critical in a particular study, there still may be a concern; in these cases, conducting an IAR ensures everyone knows and understands the risk factor.
Common Risks to Identify
Clinical and Regulatory
- Safety/efficacy, participant population, endpoints, dosing/duration
- Participant population: Insufficient quality and quantity
- Endpoints: Suboptimal number, choice, clarity, data to support
- Research: Missed useful data (sponsor’s own studies, data on similar therapies, and competition)
- Most surprising: Disregarded earlier agency feedback
Commercial and Market Access
- Timing, forecasting, and price
- Timing: Value speed-to-market over reducing risk of agency approval
- Price: Unlikely to be covered by insurance; high copay
- Most surprising: Missed useful data (sponsor’s own studies, data on similar therapies, competition)
Is an IAR Right For us?
In many cases, partnering with an outside vendor helps streamline research operations, and it’s no different with an IAR. In order to conduct a seamless and quick IAR, there are many benefits to partnering with another organization. Relying on experts to help make informed decisions faster can reduce the risk of program delays, ultimately bringing a drug to market faster. By having a fresh set of eyes on a study, vendors can identify critical risks and mitigation strategies to solve them.
Initiate an IAR if you want to:
- Optimize your investment dollars and resources in the assets with the greatest probability of making it to market and fulfilling their forecasts
- Improve your competitive edge
- Ensure new methods and approaches are successful in new therapeutic areas
- Leverage historical misses and impact speed-to-market
Additionally, vendors can work with sponsors to identify strategies to increase the value of key assets along the development process, as well as identify the non-viable assets. By knowing which assets are valuable and which are non-viable, it can help drive down the overall cost of a study or free up funds to allocate in areas needed in the study.