2016 Global Summit for Regulatory Science

Dates: September 7-9, 2016

THEME: Nanotechnology Standards and Applications

LOCATION: Natcher Auditorium, National Institutes of Health, 9000 Rockville Pike, Bethesda, Maryland USA

Nanotechnology for Healthcare Conference

The NCTR-ORA Nanotechnology Core Facility co-organized the sixth Nanotechnology for Healthcare Conference, held December 2-4, 2015, in partnership with the University of Arkansas for Medical Sciences, University of Arkansas at Fayetteville, University of Arkansas at Little Rock, and the Winthrop Rockefeller Institute. The keynote address to the Conference was delivered by the 1996 Nobel Laureate in Chemistry, Sir Harold Kroto on the topic of C60 fullerenes or “Buckyballs.” The keynote address was followed by research presentations delivered by national and international scientists on standardization of materials supporting regulatory review and novel nanotechnology-based disease diagnostics and therapeutics.

For additional information, please contact Anil Patri, NCTR Director, NCTR-ORA Nanotechnology Core Facility or visit the conference website .

William Slikker, Jr., Ph.D., NCTR Director

NCTR Director Delivers Keynote Address to Chinese Society of Toxicology

NCTR Director, William Slikker, Jr., provided the invited keynote address to the Chinese Society of Toxicology in Wuhan, China on October 26, 2015. Over 1,200 attendees were present to hear his presentation entitled “World Impact of 3D Cell Models and Microphysiological Systems on Drug and Chemical Safety Assessment.” He also visited with the leadership of the National Institute of Food and Drug Control, Chinese FDA and visited their soon-to-open facility on the outskirts of Beijing.

NCTR Scientist Recognized with "2016 Transational Impact Award"

The Society of Toxicology (SOT) presented Dr. Richard Beger, Division of Systems Biology, with the 2016 Translational Impact Award on March 13, 2016. The award citation outlined Dr. Beger's leadership "using computational modeling, metabolomics, and proteomics to develop translational approaches to improve drug safety, disease detection/management, and human health." Dr. Beger's award address was titled, "Translational Non-Invasive Biomarkers of Acetaminophen-Induced Liver Injury.”

Dr. Beger is the co-inventor of a unique Quantitative Spectrometric Data Activity Re‎lationship, a modeling technique that has been used to predict efficacy and toxicity. A recent model used by FDA's Center for Drug Evaluation and Research predicts the adverse outcome of drug-induced phospholipidosis. Dr. Beger’s and his colleagues’ work with metabolomics studies has characterized biomarkers in preclinical studies that have carried into the clinic, improved drug safety and individualized patient care. Results of kidney toxicity studies in animals and in the clinic can be used to evaluate kidney damage in children undergoing cardiopulmonary bypass surgery. Similarly, biofluid-accessible biomarkers of hepatotoxicity are used to assess damage in children undergoing therapeutic treatment or with overdose of acetaminophen.

Learn more online at Society of Toxicology under "Translational Impact Award." For additional information contact William Slikker, Jr., Ph.D., Director, NCTR or Richard Beger, Ph.D., Director, Biomarkers and Alternative Models Branch, Division of Systems Biology, NCTR.

Human Infant Intestinal Microbiota as a Reservoir of Antimicrobial Resistance

Studies of the microbiota of mothers and their infants by collaborators at NCTR, the Norwegian University of Life Sciences, and the University of Reading in the United Kingdom, demonstrated that intestinal microbiota could serve as a reservoir of antimicrobial-resistance genes. This suggests the careful selection of antibiotics is an important consideration for the treatment of infections. High-throughput sequence analyses indicated a 15% prevalence of integrons in the study population of 147 mothers and their infants, which were typically associated with antimicrobial-resistance genes. These integrons were likely carried on potentially transmissible plasmids and were more stable than the overall bacterial populations. This may explain why the integrons persisted, even though there were changes in the bacterial population structure.

For additional information, please contact Steven Foley, Ph.D., Division of Microbiology, NCTR or refer to Nature’s Scientific Reports.

Effects of Silver Nanoparticles on Accumulation, Distribution, and Toxicity

NCTR scientists conducted a 13-week study in rats to determine the differential accumulation, distribution, and potential toxicity of silver nanoparticles (AgNPs) administered daily by mouth. Significant AgNP accumulations in tissues and organs were observed to be both dose- and size-dependent. Additionally, sex differences were noted with female rats having significantly higher accumulations than males in the kidney, liver, jejunum, and colon. No significant changes in body weight or food/water intake and no treatment-related histopathological results were identified. AgNPs are widely used in consumer products and their use in the food industry has raised public concern related to safety, toxicity, and health risks. These studies were conducted at NCTR under the auspices and funding of the Interagency Agreement between FDA's NCTR and the National Institute of Environmental Health Sciences' National Toxicology Program. A manuscript describing the study is available online at Toxicological Sciences.

For additional information, please contact Mary Boudreau, Ph.D., Division of Biochemical Toxicology, NCTR.

Pediatric Anesthetic NeuroDevelopment Assessment Symposium

Dr. Merle Paule, Director of the Division of Neurotoxicology, gave a presentation at the 5th PANDA (Pediatric Anesthesia and NeuroDevelopment Assessment) Symposium held in New York, NY, on April 16-17, 2016. The presentation focused on NCTR’s nonhuman primate studies on the long-lasting cognitive deficits associated with neonatal general anesthesia. The symposium, sponsored in part by the SmartTotspublic-private partnership between the FDA and the International Anesthesia Research Society (IARS), provides a forum for presentation and discussion of clinical and preclinical anesthesia studies being conducted at multiple U.S. institutions.

For additional information, please contact Merle Paule, Ph.D., Director, Division of Neurotoxicology, FDA/NCTR.