Xuejun Victor Peng, Dr.

Leadership role in Marketed Products Group covering a portfolio of established drugs in multiple therapeutic areas: endocrinology, CNS, oncology, hematology, GI, etc.

Leadership role in the Life Cycle Management of a potent Fixed Ratio Combination drug (GLP1RA + Basal Insulin) for T2D. Indication expansion in both US and EU. Integrated evidence generation (from RCTs and RWE), dissemination, and commercialization support.

Study Responsible Physician for a global outcome trial with an SGLT2 inhibitor on chronic diabetic kidney disease

Leading clinical research program on modified-risk tobacco products.

Made significant contributions to a global development program of a novel class antidiabetic compound, including multiple phase 1, 2 and 3 studies. Played leadership role in a matrix team environment. Job responsibilities ranged from study design, synopsis and protocol development, execution and monitoring of studies, analysis, interpretation and presentation of study results, as well as contributions to regional and global development strategies.

Phase 1/2/3 global clinical development, covering the US, EU, LA, and especially the APAC region; Led strategic planning of APAC program and regulatory submission of CTA to China sFDA, successfully obtained the Special Review Procedure Status and approval of CTA by sFDA in record time. Secondment assignment to Singapore to advise sister company on phase 3 development strategy and design of studies. Training Asian colleagues on Antidiabetic drug Development. Sharing my APAC experience and knowledge with US colleagues.

Worked on an Alliance Project on a combination biologics with target indication of weight loss in over-weight and obese patients. The project was ended by joint-decision of the Alliance companies.

Completed multiple phase 3 studies and participated in preparation of NDA filing of a monotherapy and a fixed dose combination compound

As a primary biostatistician for phase 2-4 clinical studies of several chemical compounds with targeted indications of insomnia, jet-lag syndrome, diabetic neuropathy, and diabetes, participated in 1 sNDA and 2 NDA filings.

Co-investigator of several NIH funded studies in cardiovascular, gastrointestinal, and oncology fields. Specialized in statistical genomics, experiment design and statistical analysis.

Resident physician training in the Department of Internal Medicine and the Institute of Metabolism and Endocrinology. Rotated through multiple disciplines of internal medicine with emphasis on metabolic and endocrine diseases.