Research Discovery & Early Drug Development
"Let's start at the very beginning". Successful development requires a vision and understanding for the marketed end product, right from the outset. As such, the discovery efforts benefit from the expertise from those who are responsible for bringing the products to market, to guide the earliest stages of discovery and development. Expert input from medical, regulatory, nonclinical safety and marketing are essential to the early development process.
The CNE-team has years of experience working with early stage development teams to optimise their efforts, reduce risk of failure and enhance the chances of successful product registration and marketing.
- Selection of animal models and study design for discovery efficacy projects
- Efficacy parameter selection in discovery animal models
- Early candidate evaluation and selection (in vivo) using histopathology and clinical pathology endpoints
- Nonclinical and clinical expertise for GO/NOGO-decision making for drug candidate selection
- Data gap analysis, identification of potential nonclinical and clinical issues and risk management strategy development (see also GAP Analysis and Due Diligence services)
- Clinical development, medical-technical and medical regulatory support to drug discovery and preclinical teams
- Translational medicine expertise
- Target Product Profiling