1. Discovery projects
... Scientific review of preclinical projects
... Strategy planning for clinical development of preclinical assets
... Support IND enabling studies
... Design of Translational Medicine concepts for early projects
- Biomarker assessment and development - PK/PD modeling
... SOP writing and review
.... Quality assessment and management
... Designing smart short term clinical proof of concept trials
... Identifying appropriate patient populations to increase probabililty of success
... Developing biomarker plans for target engagement, efficacy and safety assessment
... Modeling PK/PD relationships
... Ensuring back-translation of clinical results
... writing and reviewing regulatory documents (IND/IMPD, IB, briefing packages)
... Providing expert opinion on pharmacology and preclinical safety data
... preparing for and participating in communication with regulatory agencies
... Assuring GXP compliance
... Protecting your in house resources from contamination with external priority and protected information during In-licensing
... Evaluation of projects and participating in due diligence efforts to identify project gaps and development hurdles
... Preparation of scientific material for out-licensing and divestment