NCTR Welcomes New Deputy Director for Research
NCTR welcomes Daniel Acosta, Jr., Ph.D., as Deputy Director for Research. Dr. Acosta joins FDA/NCTR from the University of Cincinnati, where he served as the 4th Dean of one of the most prestigious Colleges of Pharmacy in the United States, the University of Cincinnati James L. Winkle College of Pharmacy, from 1996 to 2011. He served since 2012 as the Joseph W. Carl Chair of Pharmacy. Dr. Acosta’s role, as Deputy Director for Research, will be to expand research collaborations with other FDA Centers, other government agencies, academia, and international scientists. His experience and capabilities complement and enhance those of the NCTR Director. Together, the Director and the Deputy Director for Research will support NCTR’s research mission to develop and support innovative tools, evaluate emerging technologies and approaches, generate data that FDA uses to protect and promote individual and public health, and promote regulatory science to expand collaborations across the globe.
Estrogenic Activity Database for Assessing Potential Endocrine Activity
NCTR scientists, in collaboration with FDA's Center for Drug Evaluation and Research, FDA's Center for Food Safety and Nutrition, U.S. Environmental Protection Agency, National Institute of Environmental Health Sciences, Texas A&M University, and Chang’an University (China) have developed the publicly availableEstrogenic Activity Database (EADB) of in vitroand in vivo estrogenic activity data for a diverse set of over 8,000 chemicals, including drugs, food additives, and environmental chemicals. The EADB enables the user to search and evaluate the estrogenic activity of chemicals of interest as well as create models to predict the estrogenic activity of chemicals for which that data is not available. Estrogenic chemicals can interfere with the body’s normal estrogen signaling pathways and can have adverse effects. The development of the EADB and its applications are described in Toxicological Sciences.
Genotoxicity of Doxorubicin in Rat
NCTR scientists showed that treatment of rats with doxorubicin induced a dose-dependent increase in oxidative DNA damage in cardiac tissue and changes in the expression of DNA damage and repair genes. Doxorubicin is an anti-cancer drug most effective against pediatric lymphomas. However, it carries a risk of cardiotoxicity as a serious adverse effect which limits the lifetime dose and its utility as a chemotherapeutic agent. This study suggests that the production of reactive oxygen species and the resulting persistent oxidative DNA damage may contribute to this cardiotoxicity.The research article describing this study was selected as the Editor’s Choice and is highlighted in the January 2014 issue ofEnvironmental and Molecular Mutagenesis.
Because it is important for international regulators, policy makers, and scientists to exchange views on innovative methodologies and regulatory science research, FDA/NCTR established an annualGlobal Summit on Regulatory Science. The 1st, 2nd, and 3rd Global Summits covered themes: Regulatory Science Research and Innovation, Modernizing Toxicology, and Nanotechnology, respectively. The 4th annual Global Summit to be held in Montreal, Canada, is hosted by the Canadian Food Inspection Agency and will include international participants discussing “Regulatory Genomics and Beyond.”
Global Coalition for Regulatory Science Research
The FDA Commissioner’s initiative of advancing regulatory science globally prompted the development of a Global Coalition for Regulatory Science Research (GCRSR) that is comprised of regulatory science leaders from around the world. The GCRSR 1) builds knowledge of and promotes regulatory science, 2) defines research needs, and 3) seeks to strengthen product safety worldwide by training regulatory scientists. NCTR’s Center Director, William Slikker Jr., Ph.D., serves as a co-chair of the Coalition’s executive committee and works with the GCRSR to promote global interaction between FDA and other agencies.
Nanotechnology Training at NCTR
In FY14, the second annual nanotechnology “Hands-On” training course was held at the NCTR/ORA Nanotechnology Core Facility. The course had participants from the six FDA Product Centers, ORA, and NCTR. Participants were introduced to the most commonly used methods for characterization of nanoparticle size with an emphasis on their strengths and limitations, and included "hands-on" operation of the analytical equipment. The course was sponsored by the FDA Nanotechnology Task Force to continue its charge to identify and recommend ways to enable agency investigators to evaluate possible adverse effects from FDA-regulated products that use nanomaterials. The NCTR/ORA Nanotechnology Core Facility fulfills part of this mission by supporting FDA research and regulatory needs by providing appropriate equipment and trained personnel, and by conducting training courses that enable FDA scientists to understand nanomaterial characterization and detection methods.
Developmental Rat Genome
The Sequencing Quality Control Consortium, a large international effort led by NCTR scientists, generated a comprehensive gene expression atlas using next-generation sequencing technology. This technology catalogues variations in gene expression in 11 tissues at four developmental stages of male and female rats. The web-based, publicly-available Rat BodyMap database is expected to provide a comprehensive platform for biomedical research. The database is also expected to increase understanding of disease, drug efficacy, and toxicity in the rat model and ultimately improve the translation of preclinical findings to humans. This study is published inNature Communications (2014, 5:3230).