J. Brian Xu, M.D., Ph.D., DABT®
Toxicologist
 

 
T: 908-393-9165
F: 202-557-3836
 
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EDUCATION:

M.D., Lanzhou Medical College, Lanzhou, China, 1982

Ph.D., George Washington University, Pharmacology/Toxicology, 1996

Postdoctoral Fellow, Yale University, Pharmacology, 1998

 
RANKINGS & RECOGNITION:

Diplomate of the American Board of Toxicology

 

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Dr. Brian Xu is a board-certified toxicologist with The Acta Group (Acta®) who assists clients in developing and managing international projects involving U.S. Food and Drug Administration (FDA) and U.S. Environmental Protection Agency (EPA) regulated consumer products, cosmetics, industrial and specialty chemicals, agrochemicals, and antimicrobials. Dr. Xu is also an M.D. in pathology, holds a Ph.D. in pharmacology and toxicology, and has over 15 years of industry experience as a senior toxicologist and scientist at companies such as Ashland, Inc., Schering-Plough, and Merck.

Dr. Xu's significant experience with FDA and EPA regulations and the Orders and Decrees of the Chinese regulatory system helps him anticipate potential hurdles for clients registering or marketing products in either jurisdiction. Dr. Xu designs safety testing, risk assessment, product safety, and regulatory compliance programs that enable clients to market their products quickly and efficiently, and advises clients how not to solve problems in one jurisdiction only to create them in another. He works with clients to place, manage, and monitor toxicological and clinical tests and ensures Good Laboratory Practices (GLP) at laboratories in the U.S. and China; supports Globally Harmonized System of Classification and Labeling of Chemicals (GHS) classification and implementation; and oversees the preparation of dossiers in English or Chinese.

Dr. Xu joined Acta from Ashland, Inc. where he served as Senior Product Regulatory Toxicologist for Environmental Health and Safety, but he began his scientific career at the Chinese Academy of Medical Sciences as a physician at the Cancer Institute and Hospital in Beijing, China, specializing in cancer pathology. He moved to the U.S. in 1991 to continue his education at George Washington University for his doctorate, from whence he proceeded to Yale, where he was a Post-doctoral Fellow in Pharmacology. His professional career has included time at Merck as a Senior Research Biologist and core member of the gene expression technology working group; Schering-Plough, where he was Principal Scientist and Toxicologist in the Department of Drug Safety and Metabolism; and Enzon Pharmaceuticals, where he was Director of Toxicology and Preclinical Pharmacokinetics.

Representative Engagements:

  • Provided to a major multinational company toxicology and regulatory expertise in medical devices and therapeutic and diagnostic products that combine drugs, devices, and biological elements.
  • Assisted in the preparation of China new chemical registrations for several large multinational companies, including evaluations and responses to inquiries about testing and analytical challenges.
  • Inspected China testing facilities for compliance with GLP Standards to ensure the integrity and regulatory acceptance of health and environmental safety studies.
  • Conducted environmental health and safety (EHS) audit of China manufacturing facility for a multinational company.

Professional & Community Involvement:

Member -- International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) and Co-Chair of the Safety Committee (2011-2013)

Member -- Safety and Regulatory Toxicology Committee, Personal Care Products Council (PCPC)

Member -- Society of Toxicology (SOT)

Member -- American College of Toxicology (ACT)

Member -- Drug Information Association (DIA)

Member -- Biotechnology Industry Organization (BIO)

Invited Manuscript Reviewer -- Journal of Toxicological Sciences and Intl Journal of Toxicology

Publications:

Klumpp, K., Dunn, J., Heilek, G., Zhou, A., Stefanidis, D., Chen, C., Xu, J., et al. 2007.  "R1206, a representative of a new class of potent diphenylether non-nucleoside reverse transcriptase inhibitors broadly active against NNRTI resistant HIV-1 variants and achieving high systemic exposures and benign safety profiles in animal species." 14th Conference on Retroviruses and Opportunistic Infections.

Nantermet, P.V., Masarachia, P., Gentile, M.A., Pennypacker, B., Xu, J., et al. 2005. "Androgenic Induction of Growth and Differentiation in the Rodent Uterus Involves the Modulation of Estrogen-Regulated Genetic Pathways." Endocrinology 146; 564-78.

Nantermet, P.V., Xu, J., Yu, Y., et al. 2004 "Identification of genetic pathways activated by the androgen receptor during the induction of proliferation in the ventral prostate gland." J. Biol. Chem. 279:1310-22.

Wang, H., Sun, H., Della, Penna K., Benz, R.J., Xu, J., et al. 2002. "Chronic neuropathic pain is accompanied by global changes in gene expression and shares pathobiology with neurodegenerative diseases." Neuroscience  114:529-46.

Sun, H., Xu, J., Della ,Penna K.B., et al. 2002. "Dorsal horn-enriched genes identified by DNA microarray, in situ hybridization and immunohistochemistry." BMC.  Neurosci.  3:11.

Gerhold, D.L., Liu, F., Jiang, G., Li, Z., Xu, J.,et al. 2002. "Gene expression profile of adipocyte differentiation and its regulation by peroxisome proliferator-activated receptor-gamma agonists." Endocrinology 143:2106-18.

Gerhold, D.L., Xu, J., Rushmore, T. 2003. "Microaarays in Drug Metabolism and Toxicology: Rat Liver Responses to Prototypical CYP Inducers."  In: Burczynski, ed., An Introduction to Toxicogenomics, CRC Press, pp. 101-115.

Elbrecht, A., Chen, Y., Xu, J., et al. 2001. "Compound Characterization Using Gene Microarrays." JALA 6:71-75.

O'Brien, T., Xu, J., Patierno, S.R. 2001. "Effects of glutathione on chromium-induced DNA crosslinking and DNA polymerase arrest." Mol. Cell. Biochem. 222:173-82.

Gerhold, D., Lum M,, Xu, J., Austin, C., Caskey, C.T., Rushmore, T. 2001. "Monitoring expression of genes involved in drug metabolism and toxicology using DNA microarrays." Physiol. Genomics 5:161-70.

Xu, J., Xiao, H.H., Sartorelli, A.C. 1999. "Attenuation of the induced differentiation of HL-60 leukemia cells by mitochondrial chaperone HSP70."  Oncol Res. 11:429-35.

Xu, J., Bubley, G.J., Detrick, B., Blankenship, L.J., Patierno, S.R. 1996. "Chromium(VI) treatment of normal human lung cells results in guanine-specific DNA polymerase arrest, DNA-DNA cross-links and S-phase blockade of cell cycle." Carcinogenesis  17:1511-7.

Xu, J., Manning, F.C., Patierno, S.R. 1994. "Preferential formation and repair of chromium-induced DNA adducts and DNA--protein crosslinks in nuclear matrix DNA." Carcinogenesis  15:1443-50.

Xu, J., Wise, J.P., Patierno, S.R. 1992. "DNA damage induced by carcinogenic lead chromate particles in cultured mammalian cells." Mutat. Res. 280:129-36.

Speaking Engagements:

“Reforming the US Toxic Substances Control Act - latest developments,” Chemical Watch Regulatory Summit, Hong Kong (September 8, 2016).

“Relevant Regulatory Framework in China for Industry - Updates and developments,” ChemCon The Americas 2016, Toronto, Canada (October 21, 2016).

"K-REACH: What You Need to Know to Do Business in South Korea in 2015," Bergeson & Campbell, P.C. Webinar (December 4, 2014).

"Regulations for Industrial Chemicals in China -- An Industry View," ChemCon The Americas 2014, Chicago, Illinois (October 27-31, 2014).

"Chemical Regulation in the USA -- Important Developments," Chemical Watch Regulatory Summit Asia, Singapore (September 3, 2014).


 
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