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October-December 2012 Research Highlights


October 5
Biomarker Discovery and Qualification

An NCTR scientist presented a keynote address at the IMPROVER Symposium that was held in Boston, Mass. on October 2-3, 2012.  The presentation focused on biomarker discovery and qualification and specifically addressed the need for new biomarkers, the multiple omics approaches used at NCTR, and the use of pharmacogenomics biomarkers in preclinical and clinical applications.  The goal of the symposium was to discuss the results and approaches from the IMPROVER challenge, which was a competition to find diagnostic signatures from mRNA data in four areas: chronic obstructive pulmonary disease each, lung cancer, psoriasis, and multiple sclerosis.

For additional information, please contact Donna Mendrick, Ph.D., Director, Division of Systems Biology, FDA/NCTR.

Nanotechnology for Health Care Conference

Scientists from NCTR presented their research results at the 4th Annual Nanotechnology for Health Care Conference held at the Winthrop Rockefeller Institute near Morrilton, Ark, on September 26-29, 2012 she.  The topics of the presentations included approaches to evaluate the toxicity of nanomaterials and summaries of nanotoxicology projects in Arkansas research institutions.

For additional information, please contact Paul Howard, Ph.D., Director, Office of Scientific Coordination, FDA/NCTR.

Leflunomide-Induced Liver Injury

An NCTR scientist gave a presentation at the Developing More Predictive In Vitro Models 3rd Annual Summit that was held in Boston, Mass., on September 26-27, 2012.  The presentation focused on studies that indicate involvement of toxic reactive metabolites, CYP polymorphisms, and CYP-inhibitory drugs in leflunomide-induced liver injury.  The goal of the meeting was to provide a forum for experts from industry, academia, and government to discuss cutting-edge advancements and to debate challenges and solutions to develop more predictive in vitro models.

For additional information, please contact Xi Yang, Ph.D., Innovative Safety and Technologies Branch, Division of Systems Biology, FDA/NCTR.

Biomarkers of Acetaminophen-Induced Toxicity

An NCTR scientist gave a presentation at Metabomeeting 2012 held in Manchester, United Kingdom, on September 25-27, 2012.  The talk presented research data concerning clinical serum metabolic biomarkers of pediatric acetaminophen overdose.  The goal of the meeting was for further development of metabolic profiling and its applications that include metabolic research in plants, microbes, preclinical screening, nutrition, and human health.

For additional information, please contact Richard Beger, Ph.D., Director, Biomarkers and Alternative Models Branch, Division of Systems Biology, FDA/NCTR.

Organization of Economic Cooperation and Development (OECD) Test Guidelines

Two NCTR scientists participated in the OECD Expert Work Group for Genotoxicity Test Guidelines held in Paris, France, on September 24-28, 2012. As members of the OECD expert workgroup, the NCTR scientists are providing leadership in various subgroups as the OECD is drafting new guidelines and revising a number of the current OECD Test Guidelines for genotoxicity testing.  Genetic toxicology tests are used as a part of the hazard identification evaluation for a number of different FDA-regulated product classes.

For additional information, please contact Robert Heflich, Ph.D., Division of Genetic and Molecular Toxicology, FDA/NCTR, or Martha Moore, Ph.D., Director, Division of Genetic and Molecular Toxicology, FDA/NCTR.

October 12
Food Safety

NCTR scientists contributed a chapter describing Campylobacter jejuni to the second edition of FDA’s "Foodborne Pathogenic Microorganisms and Natural Toxins Handbook," also known as "Bad Bug Book," published by the Center for Food Safety and Applied Nutrition (Bad Bug Book, 2012, 2nd Edition: 17-20).  C. jejuni is the most frequently identified etiological agent from food samples in human cases of Campylobacter-associated gastroenteritis, which can last from two to ten days.  Major sources of C. jejuni are raw poultry, unpasteurized milk and cheeses, and contaminated water.  The Bad Bug Book is a handbook that provides scientific and technical information in plain language about pathogens and toxins that contaminate foods.

For additional information, please contact Rajesh Nayak, Ph.D., Division of Microbiology, FDA/NCTR.

Carcinogenic Activity of Aloe Vera Whole Leaf Extract

NCTR scientists have shown that Aloe vera whole-leaf extract administered to rats in drinking water in a two-year carcinogenicity bioassay was an intestinal irritant and had clear carcinogenic activity in the colon.  Aloe vera is a widely used herbal remedy used for the treatment of constipation, detoxification, and as a prophylaxis.  This study was supported through the Interagency Agreement with the National Toxicology Program.  A manuscript describing this study was recently accepted for publication in Toxicological Sciences. 

For additional information, please contact Mary Boudreau, Ph.D., Division of Biochemical Toxicology, FDA/NCTR, or Frederick Beland, Ph.D., Director, Division of Biochemical Toxicology, FDA/NCTR.

Development Effects and Pregnancy Outcomes Associated with Cancer Chemotherapy Use During Pregnancy

The National Toxicology Program (NTP) at the National Institute of Environmental Health Sciences held a public meeting on October 1-2, 2012, on the NIEHS campus to review the monograph "Development Effects and Pregnancy Outcomes Associated with Cancer Chemotherapy Use During Pregnancy."  The peer-review panel included nine subject-matter experts and representatives from the FDA and National Institute for Occupational Safety and Health, and the content of the draft monograph was reviewed for accuracy of the content.  This publically reviewed document will be further reviewed for content at the next meeting of the NTP Board of Scientific Counselors. 

For additional information, please contact Paul Howard, Ph.D., Director, Office of Scientific Coordination, FDA/NCTR.

October 19
Carcinogenicity of Acrylamide

Scientists from NCTR and Portugal's Centro de Quimica Estrutural, Instituto Superior Tecnico have shown that acrylamide has clear carcinogenic activity in rodents from a two-year drinking water study.  Acrylamide administration produced dose-dependent increases in tumors at multiple organ sites in male and female mice and rats.  Based upon these data, the World Health Organization concluded that acrylamide in food is of public health concern.  Acrylamide is found in many foods that are prepared by high-temperature frying, baking, or roasting.  Additional exposures to acrylamide occur from smoking cigarettes and occupational exposure.  This study was supported through NCTR's Interagency Agreement with the National Toxicology Program.  A manuscript describing this study was recently accepted for publication in Food and Chemical Toxicology ( icon). 

For additional information, please contact Frederick Beland, Ph.D., Director, Division of Biochemical Toxicology, FDA/NCTR.

October 26
NCTR Science Advisory Board Meeting—October 23-24

The annual NCTR Science Advisory Board (SAB) meeting was held October 23-34, 2012. The FDA Science Board was represented by Dr. Daniel Acosta, Dean of the University of Cincinnati College of Pharmacy. The Board heard presentations on the current research priorities and brief overviews from the six NCTR Division Directors. Each of the Center representatives presented the priorities and research views of their respective FDA product centers; with special emphasis on CTP presented by Dr. Cathy Backinger, CTP Deputy Director for Research, and Dr. Patricia Richter; and CFSAN presented by Mike Landa, CFSAN Director. NCTR’s response to the report of the SAB NanoCore Subcommittee site visit was presented. Following all presentations, the Board members discussed the future strategic direction for research at NCTR. The next meeting of the NCTR SAB will be held during the Fall of 2013.

CFSAN Visit—October 24-25

NCTR hosted Mike Landa, Director, CFSAN and a number of CFSAN staff to meet with NCTR senior staff on October 24-25, 2012. The goal of this visit was to discuss collaborative research initiatives and develop strategies for enhanced collaboration between CFSAN and NCTR.


November 2
Ethnic Differences in DNA Methyltransferase Expression in Lupus Patients

NCTR scientists have shown an increase in the expression of DNA methyltransferases (DNMT3A and DNMT3B) in human peripheral-blood mononuclear cells from lupus patients compared to age-matched healthy controls; and expression of DNMTs were higher in female lupus patients of African-American ethnicity compared to those of European descent.  Furthermore, a subset of African-American women on DHEA (a hormone naturally made by the human body) therapy showed a significant decrease in DNMT3A expression which correlated with a lower disease-activity index. 

These findings suggest that epigenetic changes may play a critical role in the manifestations of lupus observed among ethnic groups, particularly African-American women who often have a higher incidence of the disease.  This study was funded in part by FDA's Office of Women’s Health.  A manuscript describing the results of this study has recently been accepted for publication in the Journal of Clinical Immunology ( icon).

For additional information, please contact Beverly Lyn-Cook, Ph.D., Regulatory Activities, FDA/NCTR.

November 9
American College of Toxicology

NCTR scientists gave presentations at the American College of Toxicology 33rd Annual Meeting held November 4-7, 2012, in Orlando, Florida.  NCTR presentations at this meeting included "The Holy Grail of Genetic Toxicology: Short-Term Tissue-Specific In Vivo Genotoxicity Assays" as part of a continuing education course and "Practical Considerations and Approaches for the Design and Conduct of Routine Toxicological Studies with Various Engineered Nanoparticles" as part of a nanotoxicology symposium. 

For additional information, please contact Robert Heflich, Ph.D.,  Division of Genetic and Molecular Toxicology, FDA/NCTR, or Paul Howard, Ph.D.,  Director, Office of Scientific Coordination, FDA/NCTR, respectively.

November 16
FDA-NIEHS: Regulatory Science Interagency Agreement Milestone

The 20th Anniversary of the Interagency Agreement (IAG) between FDA and the National Institute of Environmental Health Sciences (NIEHS) was celebrated in a ceremony at FDA's White Oak Campus on November 14, 2012. The FDA’s NCTR and NIEHS’s National Toxicology Program (NTP) are the key participants in the IAG, where the toxicological assessments of chemicals or substances that are of regulatory interest to FDA are conducted at NCTR with resources provided by NTP. Over the past 20 years, this program has resulted in the generation of 19 technical reports, over 220 scientific publications, and hazard assessment data that has contributed to the risk assessment of many compounds by agencies worldwide. 

For additional information, please contact Paul C. Howard, Ph.D., Director, Office of Scientific Coordination, FDA/NCTR.

Regulatory Science Research Studies Reviewed by TSSRC

The 40th meeting of the Toxicology Study Selection and Review Committee (TSSRC) was held on November 14-15, 2012, at FDA's White Oak Campus, to discuss ongoing studies and newly proposed study designs that are part of the interagency agreement between FDA and the National Institute of Environmental Health Sciences/National Toxicology Program (NIEHS/NTP) that support the FDA risk assessment process.

Ongoing studies in the following areas were discussed:

  • Food contaminants (Bisphenol A, Furan, Nanoscale Silver, Melamine, and Glycidamide)
  • Dietary supplements (Glucosamine)
  • Topically applied compounds (Oxybenzone and Retinyl Palmitate)
  • Medical device components (Nanoscale Silver)
  • Antibacterial chemicals (Triclosan)
  • Cell Phone Radiation
  • AIDS therapeutics

The TSSRC is comprised of regulatory scientists and subject-matter experts from the FDA Product Centers (CBER, CDER, CDRH, CFSAN, and CVM), the NIEHS/NTP, and the National Institutes of Health. The committee meets twice each year and is responsible for scientific oversight of study design and progress of ongoing work under this Interagency Agreement. The next meeting of the TSSRC will be held at NCTR on May 7-8, 2013. 

For additional information, please contact Paul C. Howard, Ph.D., Director, Office of Scientific Coordination, FDA/NCTR.

November 30
NCTR Article Receives SOT Honorable Mention for "2013 Best Paper Award"

The NCTR research publication titled “Identification of Urinary microRNA Profiles in Rats That May Diagnose Hepatotoxicity” (Toxicological Sciences, 2012, 125: 335-344) was selected as one of four papers for Honorable Mention for the 2013 Best Paper Award by the Society of Toxicology (SOT) Board of Publications.  The article reported the identification of a number of miRNAs with elevated levels in the urine along with putative miRNA target genes altered in the liver of hepatotoxicant-treated animals; suggesting that urinary miRNAs may be useful as biomarkers of overall liver injury.  Posters announcing the Honorable Mention papers will be displayed at the 2013 SOT Annual Meeting. 

For additional information, please contact Xi Yang, Ph.D., Division of Systems Biology, FDA/NCTR.


December 7
Effects of Crude Oil-Dispersant Mixtures on the Human Microbiome

NCTR scientists showed that high concentrations of a mixture of crude oil and chemical dispersant can adversely affect intestinal microbiota in in vitro human fecal slurries; but crude oil or dispersants alone have no effect.  In this study, the effects of Deepwater Horizon crude oil and the dispersant, Corexit 9500, on bacterial communities and bacterial numbers in the cultures were analyzed using a combination of molecular techniques.  It is important to note that the low-level residue concentrations of these materials that could potentially contaminate seafood products are well below the higher concentrations that were shown to affect human intestinal microbiota in this study.  The results of this study have been published in mBio ( 

For additional information, please contact Carl E. Cerniglia, Ph.D., Director, Division of Microbiology, FDA/NCTR.

December 14
Translating Basic Science Innovations into Public Health Applications

William Slikker, Jr., Ph.D, Director, NCTR, served as a panel member at the inaugural Health and Environmental Sciences Institute (HESI) Combining Interdisciplinary & Translational Expertise (CITE) workshop titled “Towards New Science for Public Health” held in Arlington, Virginia, on December 6-7, 2012.  This panel discussion focused on the incentives and hurdles in translating basic science innovations to public health applications.  Dr. Slikker presented the FDA Global Summits on Regulatory Science Research (GSRS11 and GSRS12) as examples of a successful approach to build a global coalition to aid in the translation of scientific research into enhanced public health outcomes. 

For additional information, please contact Dr. William Slikker, Jr., Director, FDA/NCTR.

December 21
NTP Board of Scientific Counselors

The National Toxicology Program (NTP) Board of Scientific Counselors (BSC) met at the NIEHS Campus in Research Triangle Park, North Carolina, on December 11, 2012.  The agenda included presentations on:

  • Proposed NTP toxicity testing on polycyclic aromatic hydrocarbon (PAH) mixtures related to the Gulf oil spill (e.g. PAH contaminated shellfish following oil spills) 
  • NTP’s approach for systematic review and evidence integration for literature-based health assessments, which could set standard for future literature reviews by NTP and other agencies 
  • NTP’s studies on Bisphenol A (BPA), a compound of regulatory interest to FDA; and specifically the ongoing BPA U01 consortium studies conducted at NCTR

The BSC is a federally chartered advisory committee that provides scientific advice to the NTP Director and evaluates the scientific merit of the NTP’s intramural and collaborative projects.  Slides from the presentations will be posted to the NTP website ( 

For additional information, please contact Paul Howard, Ph.D., Director, Office of Scientific Coordination, FDA/NCTR.

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