Yoshiki Tadehara

• Preparation and quality control of all preclinical sections (pharmacology, pharmacokinetics, and toxicology) in J-CTD and J-IB • Preparing comprehensive responses to PMDA inquiries related to preclinical matters • Reporting Japan-specific preclinical development requirements to global team members • Consulting with regulatory authorities regarding acceptability of preclinical data for marketing authorization applications

Responsible for improving operational efficiency in nonclinical research supporting department and focus on supervising and developing team members. -Nonclinical SOP management including global and Japanese SOPs preparation -Responsible for quality management in nonclinical area (Training, supplier management) -Support for nonclinical project leaders, nonclinical medical writing and project management team -CDISC-SEND preparation/outsourcing management -Management of test article handling and process improvement

Preclinical Department :Responsible for DMPK activities for small and large molecules development in Japan. Support pharmacology and toxicology activities. -Prepare IB, NDA documents and respond to inquiries from Japan health authorities.--Neuroscience, oncology, immunology, infectious disease drugs--

Clinical Pharmacology Department(1-year internal rotation program ): -Conduct clinical trials in healthy volunteers :protocol development, PK analysis and CSR writing etc.

DMPK & RI laboratory -Study director for in vivo and in vitro PK studies, distribution and excretion studies, metID studies, bioanalysis studies -First grade radiation protection supervisor