EXPERTISE
Translational Development Strategy
Bridging the gap between preclinical promise and clinical success by aligning formulation, pharmacokinetics, and development strategy with human-relevant outcomes.
The Challenge
- Many programmes fail due to disconnects between preclinical data and clinical performance
- Formulation and dosing strategies are often developed without clear linkage to human exposure targets
- Preclinical models may not adequately predict clinical pharmacokinetics or variability
- This results in inefficient study designs, delayed decisions, and increased development risk
The Challenge
- Early-stage molecules often lack the physicochemical stability required for downstream development
- Poor solid-state characteristics can compromise manufacturability and scalability
- Limited early characterisation leads to late-stage failures and reformulation cycles
How We Bridge Preclinical to Clinical
Human Exposure Target Definition
Establishing clinically relevant exposure windows based on pharmacology, indication, and therapeutic index
Formulation–Performance Alignment
Ensuring formulation design delivers exposure profiles required for clinical success
PK Modelling & Simulation
Using modelling approaches to predict human pharmacokinetics and guide dose selection
Study Design Optimisation
Structuring first-in-human and early clinical studies to reduce uncertainty and maximise decision value
Where Translation Fails — And We Intervene
Preclinical–Clinical Disconnect
When promising preclinical data fails to translate into human efficacy
Uncertain Dose Selection
When lack of exposure clarity leads to suboptimal or risky dosing decisions
Formulation–PK Mismatch
When formulation does not deliver the exposure required for efficacy
Inefficient Clinical Progression
When poorly aligned strategies lead to delays, redesigns, or failed studies
PK modelling aligned with formulation strategy reduced uncertainty in first-in-human study and enabled confident dose selection.
Outcomes
- Reduced uncertainty in first-in-human and early clinical studies
- Improved alignment between formulation performance and clinical exposure
- More efficient and informed dose selection strategies
- Increased probability of clinical success through integrated planning
- Accelerated progression from preclinical to clinical development
WHERE THIS FITS IN DEVELOPMENT
Applied at the preclinical-to-clinical interface to ensure that formulation, pharmacokinetics, and development strategy are aligned before entering human studies.
Preparing for first-in-human or struggling with translation?
Partner with Dhee Lifesciences to design development strategies that align preclinical insights with clinical success.
