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 patient research. 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.
Areas of Research to Consider between Phase 2 & 3
In Part 1 of this post, we discuss the creation of a detailed market landscape document, the types of questions to answer in this document, and segmentation by key customers.
Other major areas of work to carry out between Phase 2 and 3 include patient research, unmet needs, refinement of the product profile, the value story and early pricing.
Patient research captures any burden of illness/QoL elements of a particular disease. In addition, it assesses any attributes from a patient perspective in terms of willingness to pay; this is especially important in markets where patients have to pay some level of co-pay or full cost. It helps to identify critical success factors for the product.
Patient research is important to ensure that the drug development focuses on the patients’ unmet needs. For example, understanding a patient journey from diagnosis to now, helps elicit the pain points. It also helps to determine what additional support over and above the drug itself is required at the time of launch (e.g. education, device training etc.).
Understanding a patient perspective is powerful in a number of ways, including the start of a value proposition and communication ideas. As one moves more towards Phase 3 the level of understanding the patient perspective should increase. If you want to know different methods of reaching out to patients then please contact us at Zebra.
Unmet medical needs by customer group is also key at this stage; it will help focus the development programme and ensure the right endpoints are incorporated into Phase 3. Each need identified has to be viewed from each of the stakeholder perspectives; what does the need mean across the different customer groups? For example, a trough FEV-1 improvement may be an endpoint for physicians; however, walking up a flight of stairs may be more important for the patient. One has to translate each of the perspectives into a meaningful endpoint.
It’s about discovering how the product can meet existing as well as future unmet needs at the time of launch. It’s important to always project forwards and consider what the competition is likely to accomplish in meeting needs if they launch first.
The key objective is to understand the early perceptions of product value and establish the key characteristics, mode of action and requirements of the ideal drug treatment whilst identifying any pricing/reimbursement expectations in this context.
Refinement of the Product Profile
All of the above information works to support inputs into the target product profile. Additional information required for input into Phase 3 would include:
- Testing of product positioning and target product claims
- Testing of brand promise
- Refinement of customer groups
- Further refinement of forecasts
- Testing of proposed product appearance
- Testing of product messages
Value Story and Early Pricing
Other areas for consideration are value story development (which we’ll discuss in depth in future posts) and early price research. At this stage, pricing would focus on understanding the pricing environment to provide the groundwork for further activity. The main objectives are to fully understand the healthcare environments, funding dynamics and payment systems (including establishing the chain of influence and assessing price bands that are currently in the marketplace for forecast scenarios).
You may want to consider three perspectives: physician, patient and payer. The latter are increasingly influential as seen by the mandated switch in some markets from branded products to generic and biosimilar—a decision mainly based on cost (once safety and efficacy are proven).
All products are different and would therefore require different types of research at this stage, including formulation and packaging support as appropriate.
You should continue monitoring other activities such as competitor analysis and forecasting on a regular basis throughout this period. We’ll also share a blog post on the different types of competitor analysis at different development stages in the future.
Stay tuned for our next post, in which we’ll cover the different commercial activities in preparation for launch.
If you would like more company-specific ideas of how to conduct this work, please feel free to reach out to us.