Welcome Specific Areas of Focus

• 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