Zebra is regularly asked about what type of research and intelligence should be explored at different stages in the drug development cycle. Therefore we 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 and commercial evaluation processes. Consequently, 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 the posts.
Disease Landscaping for Compound Selection Analysis
In order to select disease targets, companies need to start focusing on the core areas where there is likely to be:
- A high unmet need
- A likelihood of success regarding clinical outcomes
- The commercial opportunity
In order to achieve this, companies must first answer these nine questions:
- What is the unmet medical need in each disease area?
- What is the commercial potential of each core disease area?
- Which competitor pipeline products are likely to pose a threat to your assets?
- What are the critical success factors for the asset?
- What is the core product profile criteria?
- Which clinical attributes does a disease target product profile need to have?
- Which key attributes should be considered for an initial target product profile?
- What are the minimal clinical thresholds for the product?
- What would be a game changer in terms of clinical outcomes?
If not previously undertaken, a literature review and preliminary work with practising clinicians would be in order. This gives an external perspective and more insight into recommendations. Moreover, key opinion leaders will be able to assess your asset in relation to other developments, giving you a view of the minimum clinical parameters for commercial success.
What Analysts Should Be Doing in Preparation for the Commercial Evaluation
- Estimating the commercial potential using epidemiology (incidence and prevalence)
- Providing current sales and volume data of marketed products
- Ascertaining the critical issues in each disease area
- Establishing any environmental factors such as treatment guidelines, type of reimbursement, healthcare systems, etc.
- Outlining minimum clinical parameters of the product profile from a clinical perspective (efficacy, safety, route of administration, dosing regimen and other key clinical endpoints).
Ultimately, this is the type of information companies will need when seeking funding from venture capitalists, shareholders, etc.
What Has Zebra Undertaken in this Area?
We recently conducted such an assessment for a start-up company developing polymers to provide direction on how to prioritise their research efforts.
In short, we found that approaching a small number of external experts helped:
- Re-align their initial thoughts on where they should be focusing
- Validate the forecast in terms of potential and possible opportunities available to develop into (life cycle management)
- Provide reassurance to investors that the start-up company was informed about their market
Therefore, having an external perspective—even if it is a small number—will pay dividends in the decision making process and make assumptions more robust.
Stay tuned for our next post, which will explain the types of activities you should be looking to conduct that feed into the Commercial Evaluation.
In addition, if you would like more company-specific ideas of how to conduct this work, please feel free to reach out to us.