Projects per year
Personal profile
Personal profile
Dr. Jun Yang has over 25 years of experience in drug development in both the regulatory agency (US FDA) and the pharmaceutical industry. He specializes in regulatory strategies, clinical development strategies, clinical pharmacology, and PK/PD applications. Dr. Yang obtained his Ph.D. in pharmaceutical sciences from the Ohio State University. Dr. Yang obtained his Master degree from The University of Tennessee focusing on biostatistical modeling using SAS. Dr. Yang spent two years as a Pharmacometrics fellow at Pfizer-SUNY Buffalo strategic alliance. During his 9-year tenure at the FDA, Dr. Yang reviewed more than 1000 new IND submissions and approved more than 30 NDAs/BLAs as a clinical pharmacology/pharmacometrics reviewer. After leaving the FDA in 2016, Dr. Yang was executive Director and vice president in the pharmaceutical industry, heading the Translational Medicine and Global Regulatory Affairs department. He was the founder and CEO at JP Global Pharma. Dr. Yang has rich experience guiding and advising lean and efficient preclinical and clinical strategies at various RD stages. He also has extensive hands-on experience in PK/PD MS and model-informed drug development (MIDD) using different statistical software. He has helped more than 100 IND/NDA submissions from 2016-2023. Dr. Yang assisted more than 30 pharmaceutical companies in addressing dose optimization for oncology drugs (Project Optimus) from 2020 to 2023.
Research interests
Regulatory Science
Clinical Pharmacology and Pharmacometrics
AI-based Clinical Development
Drug Discovery, small molecular drugs, oncolytic virus, PDC etc
Drug repurposing with new formulation, new dosage, and/or new patient population
Person Types
- Staff
Fingerprint
Projects
- 1 Active
-
Jiangsu Province Higher Education Key Laboratory of Cell Therapy Nanoformulation (Construction)
Ruan, G., Lee, M. H., Wu, Q., Lu, T., Xu, P., Loo, S., Sun, Y., Kam, A., Liu, X., Wen, X., Zhang, J., Wang, M., Xu, M., Cheng, K., Zhang, X., Song, J., Guo, B., Wang, Y., Wang, J., Wu, S., Yang, J., Fu, L., Zhang, J., Qiao, Y., Chen, Y., Li, T., Huang, D., Gu, J., Zhan, T., Wan, Y., He, Z., Cheng, Y., Leng, J., Qi, M., Ho, J., Sun, Y., Zhang, N., Soe, H. M. S. H., Ling, C. & Zhou, H.
1/07/24 → 30/06/27
Project: Governmental Research Project
Research output
- 9 Article
-
Pharmacokinetics, pharmacodynamics and metabolism of a novel anticancer agent for prostate cancer
Yang, J., Ahn, S., Wu, Z., Hwang, D. J., Miller, D. D. & Dalton, J. T., Jul 2012, In: International Journal of Oncology. 41, 1, p. 337-344 8 p.Research output: Contribution to journal › Article › peer-review
Open Access3 Citations (Scopus) -
A novel bis-indole destabilizes Microtubules and displays potent in vitro and in vivo antitumor activity in prostate cancer
Ahn, S., Hwang, D. J., Barrett, C. M., Yang, J., Duke, C. B., Miller, D. D. & Dalton, J. T., Feb 2011, In: Cancer Chemotherapy and Pharmacology. 67, 2, p. 293-304 12 p.Research output: Contribution to journal › Article › peer-review
23 Citations (Scopus) -
Pharmacokinetics, biodistribution and metabolism of a novel selective androgen receptor modulator designed for prostate cancer imaging
Yang, J., Wu, Z., Wu, D., Darby, M. V., Hong, S. S., Miller, D. D. & Dalton, J. T., Jan 2010, In: International Journal of Oncology. 36, 1, p. 213-222 10 p.Research output: Contribution to journal › Article › peer-review
3 Citations (Scopus) -
Effect of B-ring substitution pattern on binding mode of propionamide selective androgen receptor modulators
Bohl, C. E., Wu, Z., Chen, J., Mohler, M. L., Yang, J., Hwang, D. J., Mustafa, S., Miller, D. D., Bell, C. E. & Dalton, J. T., 15 Oct 2008, In: Bioorganic and Medicinal Chemistry Letters. 18, 20, p. 5567-5570 4 p.Research output: Contribution to journal › Article › peer-review
Open Access42 Citations (Scopus) -
Arylisothiocyanato selective androgen receptor modulators (SARMs) for prostate cancer
Hwang, D. J., Yang, J., Xu, H., Rakov, I. M., Mohler, M. L., Dalton, J. T. & Miller, D. D., 1 Oct 2006, In: Bioorganic and Medicinal Chemistry. 14, 19, p. 6525-6538 14 p.Research output: Contribution to journal › Article › peer-review
Open Access31 Citations (Scopus)