宇华 侯

1. In charge of full-process DMPK work for siRNA drugs from early screening to clinical phase, completed study design and PK/TK/PD strategy formulation for 10+ early screening, 2 IND and 3 clinical phase projects, with full control of data quality and project progress. 2. Conducted clinical dose/ratio prediction for new platform molecules via modeling, improved project screening efficiency by 30%; Simulated human PK parameters based on pre-clinical data, participated in FIH starting dose determination for 2 Phase I projects and E-R trend analysis for 1 Phase II project, providing core data for clinical dose selection. 3. Established standardized SOP for cross-border communication, solved 30+ cross-department/cross-border project problems, improved cross-border communication efficiency by 20%; Completed technical docking with 3+ global partners/investment institutions, achieving 100% pass rate in DMPK section review. 4. Solved 10+ core technical problems in filing trials, reviewed 10+ English/Chinese CTD dossiers (DMPK/CP section), and successfully responded to technical inquiries from international regulatory authorities. 5. Evaluated and selected 8+ international pre-clinical/clinical CROs, established standardized project evaluation mechanism, improved overall project completion efficiency by 15%.

1. Led full-cycle PK/toxicology evaluation for 3 projects (2 peptides, 1 siRNA), completed English/Chinese dossier review/revision and FDA/CDE technical inquiry response, 100% passed different regulatory authority reviews without supplementary data/trials. 2. Accurately predicted human PK for 2 projects based on animal PK data to support FIH starting dose determination, designed scientific clinical sampling and dosing schemes, and completed SAD/MAD PK parameter calculation and interpretation for clinical development. 3. Tracked global DMPK industry trends and ICH/FDA/CDE regulatory requirements, established the initial SOP system for PK platform, and conducted standardized training for instrument/software operation. 4. Established a full-process project tracking mechanism, oversaw the daily operation of the platform and project management, and ensured the efficient progress of DMPK work for all undertaken projects with no delayed deliveries.

1. Established the company's PK platform from 0 to 1, including full-process SOP formulation, instrument selection/validation, laboratory operation system construction and team training, building a professional international DMPK R&D team. 2. Led human PK modeling and prediction for a GLP-1 innovative drug project (now Phase III), accurately supporting FIH starting dose determination, and participating in early clinical trial design and global R&D strategy formulation. 3. Independently led full-process DMPK trials for 2 biologics from early screening to IND filing, completed PK/TK protocol/report review and CTD dossier (2.4/2.6 section) writing, successfully promoting the projects to obtain IND approval. 4. Completed pre-clinical DMPK research for 10+ drugs such as PROTAC, ADCs, including early screening, filing, PK/PD analysis and allometric scaling, providing key data for druggability evaluation. 5. Conducted an in-depth analysis of the core clinical dose-exposure issues of a small-molecule drug using the PBPK model, accurately predicted the human PK differences of different formulations, proposed targeted optimization solutions, and effectively advanced the project R&D progress.

1. Served as Project Director/SD, responsible for full-process DMPK work including experimental design, method development, sample processing and report writing, providing high-quality in vivo PK services for global MNCs and ensuring on-time and on-quality project delivery. 2. Participated in pre-clinical PK research for 5+ world-renowned pharmaceutical companies, responsible for PK/PD trial design, in-depth data interpretation and IVIVE analysis, successfully completing more than 1000 projects in pilot study phase. 3. Acted as a technical expert for cross-departmental projects, identifying and solving core technical problems to promote the smooth progress of key international projects. 4. Conducted systematic English technical training for the team, covering experimental operation, data analysis and English report writing, improving the overall international technical capability of the team.