How to Make the Go/No Go Decision

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 the go/no go decision. 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.

Preclinical: The Go/No Go Decision Making Process

Prior to deciding the scale of the clinical programme, you need to agree upon confirmation of first indication(s). Therefore, the company has to have a deep understanding of each disease option their asset is targeting and which have the most commercial potential in their future market scenario. This is a full and final Disease Area Evaluation Report.

Many companies may start their clinical development knowing which indication(s) they will be targeting and start at this point. All in all, it is about having a detailed understanding of the chosen market, its dynamics, clinical positioning and market segmentation.

For each disease area, the evaluation needs to contain:

• A clear, high-level summary of the target therapy area, its attractiveness to the company as a development opportunity, unmet needs and a definition of the differential advantage necessary for commercial success. 
• An outline of the internal and external critical success factors that will influence the compound decisions 
• A business forecast 
• Suggested inputs for the Phase I clinical programme
• A highlight of competitive threats

The Information a Business Analyst Needs to Collect

1. Secondary data sources/literature review:
   1. Disease area characteristics both current and future
   2. Classification, diagnosis, symptoms
   3. Epidemiology (incidence, prevalence, patient numbers)
   4. Value and volume forecast assessment
   5. Key competitors, market comparators e.g. pipeline funnels
   6. Unmet needs in different indications
2. Research with external stakeholders (esp. KOLs):
   1. Attitudes towards disease 
   2. Market drivers (unmet needs, satisfaction)
   3. Segments (patient and customer)
   4. View on competitors and other products in development 
   5. Review of the target product profile and relevant clinical endpoints (minimally acceptable levels), safety concerns
   6. Unmet needs

The disease evaluation (as discussed in earlier posts) becomes more comprehensive as development progresses towards Phase 2. At this point, the focus should be:

• Moving to external decision influencers
• Perceptions of the disease target and its progression
• Pricing and reimbursement issues
• The influence chain to pricing and approval

Segmentation should now begin to explore the individual segments of each disease option, whether that be by attitudes and behaviours and/or customer segments including small scale payer review. In addition, exploring unmet needs by segment also grows in importance at this stage. This is because companies will need to explore the extent of unmet need and establish characteristics of the ideal treatment.

Discussions with External KOLs and Practitioners

Research can now be conducted with Key Opinion Leaders (KOLs) to drive the development of the target product profile (TPP) and provide a preliminary steer to the optimal approach to market entry across different indications. Work with KOLs at this stage may also highlight areas for life cycle management.

All the posts to date outline the type of information that is required for different decision points. This inclues initial selection of potential and lead targets to the Go/No Go decision to enter Phase 1. As a business progresses towards that decision point the level of information becomes more detailed. Secondary data forms the majority of this information. However, discussions with external KOLs and practitioners is important to have an external perspective.

Although many companies have limited budgets, it is still critical to have this perspective—and it will pay dividends in the long-term. Getting a clinical target profile right and ensuring your product reaches the minimum threshold for acceptance at launch (rather than the current market) is worth some investment at this stage.

Zebra have worked with KOLs across many different diseases (including ultra rare) in determining minimum and game changer thresholds for TPPs. Zebra26 recently conducted a clinical review with KOLs and payers in IBD that provided the company in question with valuable insight into what was required for development as well as the price benchmark. It was not an extensive study, but was conducted in the three countries appropriate with their potential success and provided direction for their plans. We can help regardless of the size of the project.

---

Stay tuned for our next post: What Business Analysts Should Be Considering between Phase 2 and 3.

If you would like more company-specific ideas of how to conduct this work, please reach out to us.