NCTR Research Highlights October-December 2009

OCTOBER 2009

NAS Workshop on Computational Toxicology

National Center for Toxicological Research (NCTR) scientists represented FDA at a workshop sponsored by the National Academy of Sciences (NAS). The workshop was titled, "Computational Toxicology: From emerging sciences and knowledge databases for improving risk estimates on effects of environmental stressors on human health." Major topics included:

• Limitations to predictive nature of high-throughput data
• Identifying susceptible sub-populations
• Dose-response assessment
• Identification of environmental stressors

This is the second of three conferences convened to review applications of state-of-the-art sciences for regulatory decision making. The next conference is scheduled for February 25-26, 2010.

For more information, contact Dr. William Slikker, Director, NCTR, or Dr. Rick Beger, Division of Systems Toxicology, NCTR.

National Center for Toxicological Research (NCTR)/FDA International Outreach

Dr. William Slikker, NCTR Director, and Dr. Carl E. Cerniglia, Director of NCTR's Division of Microbiology, were featured presenters at the 2009 Symposium on "The Metabolism of Foods and Drugs by Intestinal Microflora" held in Seoul, Korea on October 20, 2009 and the follow-on colloquium at the National Institute of Food and Drug Safety Evaluation on October 21. The topics they discussed are listed below.

• Symposium Presentations
  Dr. Slikker — "Advances in Approaches to Food and Drug Safety Assessment"
  Dr. Cerniglia — "Involvement of Human Intestinal Microbiota in the Metabolism of Antimicrobial Agents, Food Contaminants, Dietary Supplements, and Xenobiotic Compounds"
• Colloquium Presentations
  Dr. Slikker — "The Direction of Future Collaboration Between NCTR/FDA and the National Institute of Food and Drug Safety Evaluation/Korea Food and Drug Administration"
  Dr. Cerniglia — "Recent NCTR Research Efforts in Food Safety and Food Biosecurity"

National Center for Toxicological Research (NCTR) Opens Bio-Imaging Facility

NCTR hosted an open house on October 30, 2009 for the newly completed Bio-Imaging Facility.  The new facility houses small animal Magnetic Resonance Imaging (MRI), Spectroscopy (MRS),and MicroPET technologies and is located within the vivarium providing multiple species access.  MRI and PET technologies are and have been used in clinical practice for over 20 years to distinguish changes in anatomical features (MRI) and biochemical processes (PET) in health and disease.  By comparison, the instruments in the Bio-Imaging Facility operate at higher field strengths and with less variability than clinical instruments providing investigators opportunities for more complex experimental designs and resulting discoveries. As with clinical applications, the non-invasive nature of these technologies enable continued monitoring of animals, providing new possibilities for biomarker discovery for safety and efficacy and for cross-species comparisons.  The facility is open to studies from all disciplines at NCTR and other FDA Centers and is managed by a newly-hired MRI/MRS specialist with more than a decade of pre-clinical imaging experience.
  

For more information contact Dr. William Slikker, Director, NCTR, or Dr. Merle Paule, Director, Division of Neurotoxicology, NCTR.

NOVEMBER 2009

NCTR Toxicology Studies Reviewed by Toxicology Study Selection and Review Committee (TSSRC)

The TSSRC met November 3-4, 2009 at FDA's White Oak campus to discuss ongoing studies and newly proposed studies that generate toxicology data to support regulatory decision-making.

Ongoing studies that were discussed included:

• bisphenol A (BPA) monomer (food contaminant) 
• furan (food and tobacco smoke contaminant) 
• di(2-ethylhexyl)phthalate (DEHP)(plasticizer in medical devices and environmental contaminant) 
• melamine with cyanuric acid (food contaminant) 
• nanoscale silver (food contaminant, medical device component/contaminant) 
• bitter orange (Citrus aurantium) with caffeine (dietary supplement) 
• glucosamine and chondroitin sulfate (dietary supplement) 
• usnic acid and Usnea lichen (dietary supplement) 
• permanent makeup inks 
• AIDS therapeutics

The newly proposed studies included:

• triclosan (antibacterial component in many products) 
• pediatric anesthetics: predictive rapid, in vitro assay for potential adverse effects of the pediatric anesthetics and preventive measures
• goldenseal/berberine (dietary supplement) 
• cellular telephone radiation

The TSSRC is comprised of subject experts from the FDA Product Centers and ORA, scientists from the National Institute of Environmental Health Sciences (NIEHS), and invited subject matter experts from other government agencies, industry, and academia.  The committee meets twice a year and is responsible for scientific oversight of study design and progress of ongoing work.

Safety of Key Inhaled and Intravenous Drugs in Pediatrics (SAFEKIDS) Workshop

NCTR Director, Dr. William Slikker, Jr., and Dr. Merle Paule, Director, NCTR Division of Neurotoxicology, gave presentations at the "1^st Scientific Workshop of the SAFEKIDS Initiative" held November 4, 2009 at FDA's White Oak campus.  These presentations discussed the effects of anesthesia on the developing animal brain and the cognitive defects in rhesus monkeys following early postnatal ketamine anesthesia.