Junyi Li Email & Phone Number

South San Francisco, California, Us

South San Francisco, California, Us

Working on the clinical study design of bispecific product in immunology/oncology area.

Silver Spring, Md, Us

 PD biomarkers in Biologics License Applications (BLAs) • Participated in clinical study design, including protocol writing, for a PK/PD pilot study.• Conducted pipeline assessment - extracted pharmacokinetic and pharmacodynamic data and study design from Phase I -III clinical study using FDA’s internal database• Established a statement of work for research contract on an archival system for PD assessments in BLA• Comparied methods for assessing the Dose- Area Under the Effect Curve (AUEC) Curve for PD Biomarker.• Expored methods to analyze dose-response and exposure-response relationship of a biologic drug• Developed and optimized Target-mediated Drug Disposition PopPK model for drugs with different avalible data.• Developing a PK/PD modeling & simulation method to compare the PK and PD time profile between healthy subject and patient population. The goal is to select the most informative population for detecting and evaluating the differences in PK and PD profiles between the proposed biosimilar and reference product. Drug Development Skills Competition Oct, 2018-Mar, 2019Task: Design a Phase III Clinial Study based on the results from previous Phase I SAD, Renal Impairment Studies, Phase II PK/PD Study and DDI Studies.• Served as project manager for the team: coordinated between clinical pharmacology team and pharmacometrics team, and ensured timely completion of the project.• Participated in the Non-compartmental Analysis, Pop PKPD modeling and simulation, and proposal preparation.• Represented the team in the final oral presentation and Q&A section in front of FDA senior officers and won the second prize. Guidance learning journal club • Participated in discussing the FDA regulatory guidance with senior reviewers weekly

Pittsburgh, Pa, Us

Silver Spring, Md, Us

 Meta-analysis for PK parameters of antibiotics among hospital-acquired pneumonia patients, ventilator-associated pneumonia patients and healthy • Collected the PK parameter information of the three populations from literatures.• Performed meta-analysis using R statistical software to make a statistic conclusion.• Presented the findings at OCP Science day for poster walk and won a blue-band for the poster in American Society for Clinical Pharmacology and Therapeutics, 2018 Studied on the comparison of PK/PD indices of anti-infectious agents in the central nerve system between animal and human studies. • Collected the PK profile & parameters in both CNS and central compartment, MIC, bacterial kill in animal model, and clinical success rate information of 7 anti-infactious agents in the treatment of Meningitis and calculated the PK/PD indices using R. • Summarized and evaluated the PK/PD indices in Cerebrospinal Fluid (CSF) and plasma and bridge between animal and human studies.

Lead through the organization of major student activities at the School of Pharmacy, Graduate Student Union. Developed the skills of leadership, communication, and coordination of events.

Ph.D., Pharmaceutical Sciences, Pharmacology Track

Master'S Degree, Biochemical Pharmacology

Bachelor'S Degree, Pharmaceutical Science