Zebra is regularly asked about what type of research and intelligence should be explored at different stages of the drug development cycle. We have therefore created a series of posts that look to provide some answers, including those pertaining to unmet medical needs. The posts in this series will follow the different phases of the drug development process. Therefore, we have created an image showing the key commercial activities throughout the drug development pathway. Please click here to download the graphic that follows along with these posts.
The Importance of Unmet Medical Needs As Part of the Disease Area Evaluation
Thus far we’ve discussed what companies need to consider at the early stages of the drug development cycle, typical questions for a preliminary Disease Evaluation, and segmentation of the different diseases. Now it’s time to establish the unmet medical need in each disease option.
This step is important because, even though the assessment of unmet needs is likely to be very preliminary (secondary data or limited KOL input), the information will provide the basis for future activities.
In addition, it will allow your business to have a full understanding of the chosen disease area. Thus ensuring the target product profile has a wide application—one which is scientifically and commercially led—and that there is an identifiable target market. Furthermore, it will be critical to assess reactions to the disease target product profile and proposed clinical programme framework to maximise clinical benefit at time of launch.
Identifying Unmet Needs
The key to successful growth is having a clear understanding of:
- The customer’s unmet medical needs
- What the end user is trying to accomplish
In an ideal world, every disease would be cured, but it is rare to reach utopia. You then want the next best thing.
For example, you may never cure COPD, but if you can help people walk up a flight of stairs—something they couldn’t do before—then that is an unmet need in their eyes. With psoriasis, patients may be okay with some on the body, but not on the face where it is visible. One has to balance what is important and the needs that are unmet.
Ultimately, it’s all about creating value for customers and demonstrating differentiation and growth. The more important and less satisfied a need is, the greater value creation it presents.
Exploring unmet needs at the early stages of product development lies in understanding customer satisfaction or dissatisfaction with not only existing solutions, but what is likely to be around when your product goes to launch.
At this early phase, secondary desk research/literature review will help establish some unmet needs in a particular disease area. However, this can only get you so far. Understanding an external perspective will add greater value by eliciting:
- Whether you have an extensive list of unmet needs
- The relative importance of those unmet needs
- The likelihood to achieve those needs
- What evidence needs to be in place to support the product against those needs
This helps companies know where to focus and what to do to develop future products.
Who To Talk To
When looking for unmet medical needs, businesses need to take into account the stakeholders involved—whether they be physicians, patients, or technicians—and understand all of the different perspectives. Any one or all can tease out that one unmet need that could be a game changer.
Furthermore, advisory boards with a small number of key opinion leaders are quite informative at this stage. However, this can be costly if conducted in a face-to-face setting. Virtual advisory boards at key stages may be worth considering, and this is something that Zebra can facilitate. That’s because we have strong links with KOLs across a number of disease areas, including rare diseases.
However, one cannot forget the patients: group discussions (whether face-to-face or online) with patients offer a wealth of information, especially when discussing the progression of a disease. These types of activities can open up numerous options for additional exploration.
When companies have more limited budgets, a small number of individual discussions with practising physicians/payers can be effective. Zebra recently conducted 12 interviews (per market US, UK, DE) to assess a diagnostic and companion therapy company. This enabled the company to demonstrate a high level of need and gain additional funding from their investors.
Stay tuned for our next post, in which we’ll look at early price benchmarking and the competitor landscape.
If you would like more company-specific ideas of how to conduct this work, please feel free to reach out to us.