• Early definition of critical questions
- Design of most cost- and time-effective studies to explore and resolve these questions• Design of and data evaluation from preclinical studies directed
toward support of FIH and POC studies
- Toxicology, drug metabolism, pharmacokinetic, safety pharmacology, biopharmaceutic,
and mechanistic studies
- Effective interface with non-clinical study conduct process• Development of effective strategies to address critical issues in
cost- and time-efficient manner• Development of optimized preclinical regulatory strategy
- Support rapid global review and approval of FIH/POC protocols• Development of positions for presentation to global regulatory
agencies as well as potential commercial partners