晓伟 马

• Engaged in DMPK and Toxicology study design, data interpretation, issue-solving, report review and provided cost and time-efficient strategy to medical chemistry, CADD and AI groups in finding novel “hits” with appropriate ADMET profiles. • Collaborated with CROs to perform DMPK and Toxicology studies and deliver reliable results moving projects forwards in a timely fashion.

• Contributed to protocol and clinical study report drafting, and participated in IND documentation, including CTD (2.5&2.7section), investigator brochures, and other regulatory documents. • Cooperated with clinical operation team for CROs selection, lab manual preparation and quotation review. • Directed bioanalytical method validation in Australian lab and method transfer to China lab, reviewed validation and sample analysis reports to support clinical PK studies • Acted as a DMPK representative to provide strategic and technical input to study design in lead optimization, clinical candidate identification/characterization stage, and conducted DMPK assays to support clinical projects, including in vitro DDI studies, Met ID studies, etc.

• Project management on DMPK and Toxicology, including CROs selection, contract negotiation, progress monitoring, reports review, data interpretation and annual audit • Contributed in project strategy-making with DMPK and Toxicology input • NMPA/FDA IND filing regulatory documents writing • Successful CTD submission of two small molecules and one ADC project IND package

• Provided sponsors with fit-for-purpose study design, monitored studies implementation, updated progress, and summarized results and findings • Drafted protocols of DMPK studies at screening and IND stages, including liver microsomal stability, plasma protein binding, permeability assay, Met ID assay (in vivo and in vitro), CYP inhibition/induction, rodent/non-rodent PK study • Conducted dose range finding studies to support study design of GLP Toxicology studies • Communicated with sponsors on results of DMPK and Toxicology studies to recognize problems, discuss troubleshooting and deliver solutions