Why this phase is decisive

This phase determines whether a drug candidate is regulatorily viable, clinically meaningful and economically defensible and whether the underlying decision logic convinces investors, regulators and future partners. Errors made at this point are rarely reversible and directly affect timelines, financing prospects and overall credibility.

Company perspective

For companies, entry into clinical development means:

• Significant financial commitment
• Long term commitment to study designs and endpoints
• Early definition of development and value pathways

Mistakes in this phase usually have lasting consequences for development speed, financing and strategic optionality.

Investor perspective

For investors, this phase represents a central decision checkpoint:

• Is the preclinical data package sufficiently translational?
• Are study design, endpoints and patient selection plausible?
• Have regulatory expectations been anticipated?
• Is there a clear logic explaining how early clinical data will create value?

Investability at this stage results from stringent development strategy rather than ambitious assumptions.

Typical risks and decision failures

In practice, we frequently observe:

• Preclinical data packages without a clear clinical hypothesis
  
• Study designs that are not regulatorily or commercially viable
• Endpoints lacking relevance for later approval or reimbursement
  
• Missing definition of decision gates and stopping criteria
  
• Unclear linkage between clinical development and later commercialization
  

These risks cannot be mitigated through additional studies alone, but through structured decision logic prior to study initiation.

Wat Excellere delivers

Excellere supports companies and investors in securing the transition into clinical development from a strategic, regulatory and commercial perspective. Our services include:

• Integrated assessment of preclinical data with regard to clinical relevance
• Critical evaluation of study designs, endpoints and patient populations
• Anticipation of regulatory expectations including EMA and FDA logic and IND or CTA requirements
• Structuring pf Phase I and Phase II strategies with consideration of safety, efficacy and value drivers
• Definition of clear decision gates and success criteria for early clinical phases
• Translation of clinical development plans into investor and partner ready narratives

Our objective is to design clinical programs that enable decisions rather than merely generate data.

Integration of clinical development, regulation and commercialization

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

• Preclinical evidence
  
• Regulatory requirements
  
• Clinical feasibility
  
• Future market access and commercialization strategy
  

This ensures that early clinical decisions remain viable for subsequent development phases.

Added value for companies and investors

For companies

• Increased confidence in capital intensive clinical decisions
• Clearly structured development and study
• Improved preparation for financing, partnership and regulatory interactions

For investors

• Transparent assessment of clinical and regulatory risks
• Robust decision foundations before and during clinical phases
• Higher likelihood that early clinical data will generate value

How we work

All engagements are led by Excellere's senior management and complemented as needed by our advisor and partner network. We work:

• Decision oriented rather than presentation driven
  
• Integrated with management teams, founders and investors
  
• Without delegation to junior teams
  

Our amibition is to secure and accelerate clinical development decisions, not to complicate them.

When early decisions must have substance

The transition into clinical development often determines whether scientific innovation reaches patients or fails prematurely. Let us jointly assess hoe Excellere can support you in structuring the step from preclinical research into clinical Phase i and Phase II in a regulatorily sound and investable manner.

Contact us