About FDA

William Mattes, Ph.D., DABT

Director, Division of Systems Biology

william mattes
William Mattes, Ph.D., DABT

(870) 543-7391
NCTRResearch@fda.hhs.gov  

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 About  |  Publications  |  Division Scientists


Background

Dr. William Mattes received his B.A. from the University of Pennsylvania and his Ph.D. in biological chemistry from the University of Michigan, Ann Arbor. He did his postdoctoral training in biochemistry at Johns Hopkins University, and was a staff fellow at the National Cancer Institute/National Institutes of Health (NCI/NIH). In 1997 he became a diplomate of the American Board of Toxicology. 

He is currently the director of the Division of Systems Biology, part of NCTR. His division pursues a wide range of research that uses and develops innovative tools for assessing pharmaceutical safety and advancing public health. Dr. Mattes has been an independent consultant as well as a director of toxicology at the Critical Path Institute where he developed and directed the Predictive Safety Testing Consortium (PSTC). The PSTC is a collaboration of 16 of the world’s major pharmaceutical companies, with FDA and European Medicines Agency advisors, with the goal of qualifying new biomarkers for drug safety in a regulatory setting. This work has resulted in the establishment of a formal process of biomarker qualification for the FDA and EMEA, and a FDA/European Medicines Agency/Pharmaceuticals and Medical Devices Agency qualification of new biomarkers of kidney injury. He also developed the Chronic Obstructive Pulmonary Disease Biomarkers Qualification Consortium, serving as its senior director and overseeing interactions with FDA. His other positions included senior scientific director of toxicogenomics at Gene Logic, associate director of toxicogenomics and group leader of genetic toxicology at Pharmacia Corp, group leader of Experimental Toxicology and Metabolism at Ciba Pharmaceuticals, and group leader of Molecular and Cellular Toxicology, Ciba-Geigy Agricultural Chemical Division.

Research Interests

Through work spanning nearly thirty years in the chemical and pharmaceutical industry as well as coordinating nonprofit consortia, Dr. Mattes has experience in the many phases of drug development. This includes genetic toxicology, molecular toxicology, mechanistic toxicology, gene expression profiling, and database mining as applied to safety assessments. He also has experience in the evaluation of both preclinical and clinical biomarkers. His research has delved into the mechanisms of toxicity and the development of new safety assessment tools, with a continuing interest in the molecular basis and implications of species differences. He has unique expertise in the field of genomics, molecular toxicology, and biomarker qualification ― driven by issues encountered as a member of multiple project teams. At Pharmacia he was chosen to establish and lead a worldwide Center for Excellence in Toxicogenomics; he built a lab group dedicated to using this technology to address issues affecting the entire company. He has accomplishments in leading international collaborative teams, both internally in Pharmacia and as part of directing consortia ― in particular, the Predictive Safety Testing Consortium and the COPD Biomarkers Qualification Consortium. The former is working closely with FDA and EMA to develop a new process for formal regulatory approval for new biomarkers. Dr. Mattes has an accomplished publication record with original research, reviews, and book chapters and has been a frequent conference speaker.

Dr. Mattes would cite his strengths as being in the technical, communicative, and collaborative aspects of science, with an eye toward application of new science to current problems of drug development. His research interests include bioinformatics and data analysis, cross-species comparisons of molecular responses, as well as group dynamics that lead to successful collaboration between scientists and changes in scientific policy. He also currently fills the guitar chair for the group “Jazzicology” at the American College of Toxicology’s annual meeting.

Professional Societies/National and International Groups

American Association for the Advancement of Science
Member
1985 – Present

American College of Toxicology
Full Member
2007 – Present

Member, ACT Website Committee
2012 – 2014

Roundtable of Toxicology Consultants
Member
2010 – 2014

Secretary
2012 – 2014

Society of Toxicology
Full Member
1990 – Present

Member, SOT Continuing Education Committee
2012 – 2015

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Selected Publications

Circulating Mitochondrial Biomarkers for Drug-Induced Liver Injury.
Shi Q., Yang X., Mattes W.B., Mendrick D.L., Harrill A.H., and Beger R.D.
Biomark Med. 2015, 9(11):1215-23. doi: 10.2217/bmm.15.59.

Potential of Extracellular microRNAs as Biomarkers of Acetaminophen Toxicity in Children.
Yang X., Salminen W.F., Shi Q., Greenhaw J., Gill P.S., Bhattacharyya S., Beger R.D., Mendrick D.L., Mattes W.B., and James L.P.
Toxicol Appl Pharmacol. 2015, 284(2):180-7. doi: 10.1016/j.taap.2015.02.013.

Scientific Conduct... and Misconduct.
Genter M.B., Brock W.J., and Mattes W.B.
Toxicol Sci. 2015, 144(1):3-4.

Regorafenib Impairs Mitochondrial Functions, Activates AMP-Activated Protein Kinase, Induces Autophagy, and Causes Rat Hepatocyte Necrosis.
Weng Z., Luo Y., Yang X., Greenhaw J.J., Li H., Xie L., Mattes W.B., and Shi Q.
Toxicology. 2015, 327:10-21. doi: 10.1016/j.tox.2014.11.002. Epub 2014 Nov 6.

Detection of Hepatotoxicity Potential with Metabolite Profiling (Metabolomics) of Rat Plasma.
Mattes W., Davis K., Fabian E., Greenhaw J., Herold M., Looser R., Mellert W., Groeters S., Marxfeld H., Moeller N., Montoya-Parra G., Prokoudine A., van Ravenzwaay B., Strauss V., Walk T., and Kamp H.
Toxicol Lett. 2014, 230(3):467-78. doi: 10.1016/j.toxlet.2014.07.021.

An Integrated Flow Cytometry-Based System for Real-Time, High Sensitivity Bacterial Detection and Identification.
Buzatu D.A., Moskal T.J., Williams A.J., Cooper W.M., Mattes W.B., and Wilkes J.G.
PLoS One. 2014, 9(4):e94254. doi: 10.1371/journal.pone.0094254.

Biomarkers of Tobacco Smoke Exposure.
Mattes W., Yang X., Orr M.S., Richter P., and Mendrick D.L.
Adv Clin Chem. 2014, 67:1-45. doi: 10.1016/bs.acc.2014.09.001.

Prediction of Clinically Relevant Safety Signals of Nephrotoxicity Through Plasma Metabolite Profiling.
Mattes W.B., Kamp H.G., Fabian E., Herold M., Krennrich G., Looser R., Mellert W., Prokoudine A., Strauss V., van Ravenzwaay B., Walk T., Naraoka H., Omura K., Schuppe-Koistinen I., Nadanaciva S., Bush E.D., Moeller N., Ruiz-Noppinger P., and Piccoli S.P.
Biomed Res Int. 2013, 2013:202497. doi: 10.1155/2013/202497.

Recommendations for Biomarker Identification and Qualification in Clinical Proteomics.
Mischak H., Allmaier G., Apweiler R., Attwood T., Baumann M., Benigni A., Bennett S.E., Bischoff R., Bongcam-Rudloff E., Capasso G., Coon J.J., D'Haese P., Dominiczak A.F., Dakna M., Dihazi H., Ehrich J.H., Fernandez-Llama P., Fliser D., Frokiaer J., Garin J., Girolami M., Hancock W.S., Haubitz M., Hochstrasser D., Holman R.R., Ioannidis J.P., Jankowski J., Julian B.A., Klein J.B., Kolch W., Luider T., Massy Z., Mattes W.B., Molina F., Monsarrat B., Novak J., Peter K., Rossing P., Sánchez-Carbayo M., Schanstra J.P., Semmes O.J., Spasovski G., Theodorescu D., Thongboonkerd V., Vanholder R., Veenstra T.D., Weissinger E., Yamamoto T., and Vlahou A.
Sci Transl Med. 2010, 2(46):46ps42. doi: 10.1126/scitranslmed.3001249.

Renal Biomarker Qualification Submission: a Dialog Between the FDA-EMEA and Predictive Safety Testing Consortium.
Dieterle F., Sistare F., Goodsaid F., Papaluca M., Ozer J.S., Webb C.P., Baer W., Senagore A., Schipper M.J., Vonderscher J., Sultana S., Gerhold D.L., Phillips J.A., Maurer G., Carl K., Laurie D., Harpur E., Sonee M., Ennulat D., Holder D., Andrews-Cleavenger D., Gu Y.Z., Thompson K.L., Goering P.L., Vidal J.M., Abadie E., Maciulaitis R., Jacobson-Kram D., Defelice A.F., Hausner E.A., Blank M., Thompson A., Harlow P., Throckmorton D., Xiao S., Xu N., Taylor W., Vamvakas S., Flamion B., Lima B.S., Kasper P., Pasanen M., Prasad K., Troth S., Bounous D., Robinson-Gravatt D., Betton G., Davis M.A., Akunda J., McDuffie J.E., Suter L., Obert L., Guffroy M., Pinches M., Jayadev S., Blomme E.A., Beushausen S.A., Barlow V.G., Collins N., Waring J., Honor D., Snook S., Lee J., Rossi P., Walker E., and Mattes W.
Nat Biotechnol. 2010, 28(5):455-62. doi: 10.1038/nbt.1625.

Research at the Interface of Industry, Academia and Regulatory Science.
Mattes W.B., Walker E.G., Abadie E., Sistare F.D., Vonderscher J., Woodcock J., and Woosley R.L.
Nat Biotechnol. 2010, 28(5):432-3. doi: 10.1038/nbt0510-432.

Translational Toxicology and the Work of the Predictive Safety Testing Consortium.
Mattes W.B. and Walker E.G.
Clin Pharmacol Ther. 2009, 85(3):327-30. doi: 10.1038/clpt.2008.270.

Public Consortium Efforts in Toxicogenomics.
Mattes W.B.
Methods Mol Biol. 2008, 460:221-38. doi: 10.1007/978-1-60327-048-9_11.

Microarray Probe Mapping and Annotation in Cross-Species Comparative Toxicogenomics.
Calley J.N., Mattes W.B., and Ryan T.P.
Methods Mol Biol. 2008, 460:159-83. doi: 10.1007/978-1-60327-048-9_8.

Strategic Paths for Biomarker Qualification.
Goodsaid F.M., Frueh F.W., and Mattes W.
Toxicology. 2008, 245(3):219-23. doi: 10.1016/j.tox.2007.12.023.

Cross-Species Comparative Toxicogenomics as an Aid to Safety Assessment.
Mattes W.B.
Expert Opin Drug Metab Toxicol. 2006, 2(6):859-74.

Tissue and Species Distribution of the Glutathione Pathway Transcriptome.
Mattes W.B., Daniels K.K., Summan M., Xu Z.A., and Mendrick D.L.
Xenobiotica. 2006, 36(10-11):1081-121.

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Division Scientists 

Contact information for all lab members:
(870) 543-7391
NCTRResearch@fda.hhs.gov  

Richard Beger
Director of Biomarkers and Alternative Models Branch

Dan Buzatu
Associate Co-Director, Innovative Technology Staff

Varsha Desai
Research Biologist

James Fuscoe
Supervisory Research Biologist

Elizabeth (Liz) Geesaman, B.S.
Chemist

James (Jack) Greenhaw, B.S.
Biologist

Tao Han
Senior Staff Fellow

Stephen Harris, B.S.
Computer Scientist

Amy Inselman
Staff Fellow

Gwenn Merry, M.S.
Biologist

Carrie Moland, A.A.S.
Biologist

Noriko Nakamura
Staff Fellow

Baitang Ning, Ph.D.
Research Biologist

Lisa Pence, Ph.D.
Chemist

Thomas (Tom) Schmitt, B.S.
Chemist

Laura Schnackenberg
Research Chemist

Svetoslav Slavov
Research Chemist

Jinchun Sun
Visiting Scientist

Vijayalakshmi Varma
Staff Fellow

Vikrant Vijay
Visiting Scientist

Jon Wilkes
Associate Co-Director, Innovative Technology Staff

Anna Williams, M.P.H.
Research Biologist

Li-Rong Yu
Associate Co-Director

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