Zebra is regularly asked about what type of research and intelligence should be explored at different stages in the drug development cycle. We have therefore created a series of posts that look to provide some answers. The posts in this series will follow the different phases of the drug development process.
For this series, you can download an image of the drug development pathway that follows along with the posts.
Please click here to download the graphic that will relate to each of the posts.
Do you know your target market and which route your product development is going to take? What commercial questions do you need to ask at the start of the development programme (lead optimisation)?
This part of the educational series focuses on what information companies pre-Phase 1 of product development need. Some know this as “lead optimisation”; compound assessment based on their potential in different potential diseases. It is not uncommon to have compounds focused on respiratory disease with potential to improve clinical outcomes in several diseases (e.g. asthma, rhinitis, COPD and adult respiratory distress syndrome). A business therefore may not be sure what their target indication is at this stage.
Understanding each target disease area and estimated return on investment from an internal company and external market perspective is therefore important. This includes finding out the unmet needs and market drivers in each indication before starting the development of the disease target profiles (disease landscaping). Knowing the commercial implications at the start of development will guide the route the development programme takes.
In larger organisations, data and information derives from new bespoke—but limited—research. In others, this may be simple secondary data analysis. The majority of decisions are based on this analysis and interpretation of secondary data.
Questions to Ask During This Phase
Here are some questions that a business needs to answer during this phase of development:
- Within which potential disease area(s) should a business be concentrating their efforts?
- How do we identify disease area targets?
- What is the commercial value of each target, e.g. market size, structure and dynamics?
- What is the definition of each disease area?
- Can we identify the disease characteristics and progression stages of the disease?
- What is the size of the target disease areas in terms of epidemiology?
- What is the market need (preliminary assessment) and the market drivers for each disease target?
Disease landscaping is a preliminary assessment of market need and drivers supported by an outline of future opportunities across each disease. Inclusion of future indications will also be valuable. Zebra have found that a literature search can answer some of these questions; we tend to start our landscaping assessments by undertaking these.
Disease Area Evaluation
The key output is the framework for a Disease Area Evaluation Report. It gives a topline view of the potential size of target disease areas from an epidemiological perspective and a disease forecast. The information gained feeds into a review matrix combining internal (clinical) and external (commercial) assumptions in order to determine Risk vs. Potential.
This generates different scenarios with typical outputs being disease area ‘heat maps’ or ‘Risk and Reward’ bubble diagrams by indication. Businesses can then make informed decisions and accurate forecasts more easily. This document forms the base and is updated at specific time points and as new information arises.
External Stakeholder Views Add Value
There will be limited external, expert opinions at this stage. However, a small number of discussions will certainly add gravitas to this report and is especially important to a company seeking funding. It can also provide insight and views on developments that may not be found in desk research. Experience has taught us that such discussions add great value to rare disease forecasts and are particularly relevant when patient numbers are hard to come by.
Zebra has access to KOLs across different disease areas whether they be in rare diseases or more common ones.
Stay tuned for our next post, which will review the typical questions for a preliminary commercial evaluation assessment.
If you would like more company-specific ideas of how to conduct this work, please feel free to reach out to us.