Why this phase is critical

At this stage it is decided whether clinical programs are designed not only to achieve regulatory success, but also to be reimbursable, differentiated and economically viable. Missing commercial planning at this point is one of the most common reasons why clinical assets later fail to archive sustainable market success.

Company perspective

For companies, this phase means:

• Need to translate clinical data early into market and reimbursement strategies
• Decision on target indications, subpopulations and differentiation
• Preparation for future launch, pricing and market access strategies

Clinical development without a commercial perspective leads to products that my be medically relevant, but are not economically sustainable.

Investor perspective

For investors, this phase represents a central validation point:

• Are the clinical endpoints relevant for reimbursement and pricing?
• Is there a plausible market and competitive logic?
• Are commercial assumptions realistic and robust?
• How clear is the path from clinical data to value realization?

Investability is driven by early commercial clarity, not by late stage optimization.

Typical risks and flawed decisions

In practice, we frequently observe::

• Clinical programs without an early market access perspective
• Endpoints that are regulatorily acceptable but commercially non differentiating
• Unrealistic pricing and revenue assumptions
• Lack of alignment between clinical, regulatory and commercial strategy
• Late engagement with competition and alternative therapies

These risks can only be corrected to a very limited extent in later development stages.

What Excellere delivers in practice

Excellere supports companies and investors in tightly linking clinical development and commercial planning from an early stage. Our services include:

• Translation of clinical development plans into commercial hypotheses
• Assessment of clinical endpoints with respect to differentiation, reimbursement and pricing feasibility
• Early development of pricing and market access scenarios
• Analysis of competitive landscapes, therapy environments and patient pathways
• Definition of commercial target profiles and value propositions
• Derivation of clear commercial decision gates along clinical development

Our goal is to design clinical programs that enable commercial decisions, not just generate data.

Integration of clinical development, market access and commercialization

Our work in this phase is deliberately integrated. We do not view clinical programs in isolation, but in the interaction of:

• Clinical evidence
  
• Regulatory requirements
  
• Market access logics
  
• Pricing and reimbursement mechanisms
• Competitive and market dynamics
  

This ensure that early clinical decisions do not lead into later commercial dead ends.

Added value for companies and investors

For companies

• Early clarity on commercial success requirements
  
• Better preparation for launch and market entry strategies
• Reduced risk of non reimbursable assets

For investors

• Increased transparency on commercial success drivers
• Robust assumptions for business cases and financial models
• Higher likelihood of sustainable value realization

How we work

Engagements are led by Excellere's senior management and, depending on the question and indication, complemented by our advisor and partner network in market access, pricing and commercial strategy. We work:

• Decision oriented rather than presentation driven
  
• Integrated with clinical, regulatory and commercial teams
  
• Without delegation to junior teams

Our ambition is to consistently de risk clinical and commercial decisions.

When clinical success needs to become commercially sustainable

The path from clinical data to commercial success is not automatic. Let us jointly assess how Excellere can support you in aligning clinical development and commercial planning early, realistically and in an investable manner.

Contact us