What we do for Biotech Teams
The focus of our partnership with biotech companies is to develop customized early development strategies that are adjusted to unlock the full potential of their innovative concept. Our work usually starts with a thorough analysis of the available data and is focused on the key questions to be addressed during early development.
Evaluation & Analysis
Opportunity/Risk Assessment
- Pressure test of key assumptions and identification of show stoppers
- Trouble shooting (removing road blocks and develop solutions)
Prediction of potential therapeutic dose range/dosing regimen in humans
- PKPD evaluation across a variety of pre-clinical pharmacology experiments
- Computer models to bridge to humans and include relevant literature data
Prediction of safe starting dose and efficient dosing escalation schemes for studies in humans
- PKTD evaluation on tox data
- Consideration of on- and off-target toxicity
- Special toxicity: addiction potential, immunogenicity etc.
Strategy & Design
Design of fast-track Early Development Strategy
- Deliver key information for stakeholders and investors and unlock the full potential of the lead molecule
- Set foundation for the successful registration and marketing of the new medicine
- Balance information, time and cost of the development activities in accordance with the company needs
Design of pre-clinical and early clinical studies
- Safety, Pharmacokinetic, Pharmacodynamic, Biomarker, Translational Medicine
- Adaptive Designs & Trial Simulations
Design of biomarker strategies
- Surrogate markers to support efficient development
- Stratifications markers for Personalized Medicine