Xin Xu, Ph.D.
Therapeutics for Rare and Neglected Diseases (TRND) Program
9800 Medical Center Drive
Rockville, MD 20850
Pharmacokinetics (PK) plays a critical role in the drug discovery and development process. The key objective of the Drug Metabolism and Pharmacokinetics (DMPK) group, within the Therapeutics for Rare and Neglected Disease (TRND) program, is to utilize the PK concept effectively in structure optimization, lead selection, pivotal study design for efficacy and safety evaluations, and dose regimen forecast for human clinical trials. Scientists in the DMPK group will discover and implement new techniques and approaches for Absorption, Distribution, Metabolism and Excretion (ADME) studies. The DMPK group will also act as a driver in introducing translational science to PK and efficacy studies, recommend responsibleationalizing the use of animal models for human drug tests, and bridging gaps between in vitro and in vivo studies.
In addition, the group will be an "experimental hub" that, even with limited resources, will blend pharmacodynamics and toxicity evaluations of new drug candidates together with traditional ADME studies in a creative way. The DMPK group will also actively seek input and feedback from the FDA in conducting essential studies for TRND drug candidates.
Xin Xu, Ph.D., joined the National Center for Advancing Translational Sciences in 2011 as Senior Scientist, Director of Pharmacokinetics. In this role, she oversees absorption, distribution, metabolism, and excretion (ADME) studies for projects administered by NCATS’ Therapeutics for Rare and Neglected Diseases (TRND) program. She also advises the Bridging Interventional Development Gaps (BrIDGs) program.
She has over 20 years of industrial experience in the non-clinical drug metabolism and pharmacokinetics (DMPK) research field. She was the DMPK representative for three Merck products: Singulair, Cancidas, and Invanz. She also contributed to the filing of Infuse (rhBMP-2) and Enbrel (anti-TNFa Fc fusion protein) at Genetics Institute/Wyeth. She has extensive experience in IND filings of novel therapeutics, ranging from small molecules to biologics, such as monoclonal antibodies, nanobodies and protein-drug conjugate.
Dr. Xu obtained her BSc degree from the School of Pharmacy, Peking University Health Science Center, China. She earned her Ph.D. degree in pharmacokinetics from the Faculty of Pharmacy, University of Toronto, where she did her post-doctoral research training in controlled release formulations. Dr. Xu has authored more than 140 publications (64 journal papers or book chapters, and 81 conference presentations and abstracts) and holds 4 patents.
Xu X, Vugmeyster Y. Challenges and opportunities in absorption, distribution, metabolism, and excretion studies of therapeutic biologics. AAPS J. 2012;14(4):781-91.
Vugmeyster Y, Entrican CA, Joyce AP, Lawrence-Henderson RF, Leary BA, Mahoney CS, Patel HK, Raso SW, Olland SH, Hegen M, Xu X. Pharmacokinetic, biodistribution, and biophysical profiles of TNF nanobodies conjugated to linear or branched poly(ethylene glycol). Bioconjug Chem. 2012;23(7):1452-62.
Wang M, Tian X, Leung L, Wang J, Houvig N, Xiang J, Wan ZK, Saiah E, Hahm S, Suri V, Xu X. Comparative pharmacokinetics and metabolism studies in lean and diet- induced obese mice: an animal efficacy model for 11β-hydroxysteroid dehydrogenase type 1 (11β-HSD1) inhibitors. Drug Metab Lett. 2011;5(1):55-63.
Vugmeyster Y, DeFranco D, Szklut P, Wang Q, Xu X. Biodistribution of [125I]-labeled therapeutic proteins: application in protein drug development beyond oncology. J Pharm Sci. 2010;99(2):1028-45.
Vugmeyster Y, Tian X, Szklut P, Kasaian M, Xu X. Pharmacokinetic and pharmacodynamic modeling of a humanized anti-IL-13 antibody in naive and Ascaris-challenged cynomolgus monkeys. Pharm Res. 2009;26(2):306-15.
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This page was last updated on December 6th, 2013