Anna Zhao-Wong, MD, Ph.D., Deputy Director, MedDRA MSSO
MedDRA is the ICH standard medical terminology to facilitate sharing of regulatory information internationally for medical products used for use on humans. MedDRA is used in the registration, documentation and safety monitoring of medical products both before and after a product has been authorized for sale.
MedDRA workshop provides an understanding of the scope, hierarchical structure, and characteristics of MedDRA. Navigating MedDRA terminology using MedDRA Web-Based Browser is included. While offering an overview of the features of MedDRA that relate to the analysis and retrieval of MedDRA-encoded data, the session describes the use of MedDRA to retrieve and present aggregated data, based on the principles outlined in the MedDRA Data Retrieval and Presentation: Points to Consider document. An introduction of Standardised MedDRA Queries (SMQs), an analytical feature of MedDRA, and their application in the investigation of drug safety issues are also provided.The workshop is designed for individuals whose work involves MedDRA or MedDRA-coded data, such as mining FAERS data, mapping terminologies involving MedDRA, etc.
Dr. Anna Zhao-Wong is the Deputy Director and the Manager of Terminology Development and Services of the Maintenance and Support Services Organization (MSSO). She has led MedDRA development projects, such as the expansion of medication error and medical device adverse event terms in MedDRA, and provides medical support of terminology maintenance. Additionally, as one of the MSSO trainers, Dr. Zhao-Wong has conducted face-to-face and webinar training courses for participants from regulatory authorities and the biopharmaceutical industry. Dr. Zhao-Wong received her M.D. from Beijing Medical University and Ph.D. from the Uniformed Services University of the Health Sciences. She joined the MSSO in the year 2000.
Next-Generation Sequencing (NGS) datasets analysis using Galaxy platform
Binsheng Gong, Ph.D.,Visiting Scientist, Division of Bioinformatics and Biostatistics, NCTR/FDA
This workshop is for users who want to acquire the skills required to analyze the Next-Generation Sequencing (NGS) datasets using Galaxy platform. The event is open to all the students, postdocs as well as faculty members who are interested in NGS data processing and analysis with general workflows. The workshop will be focus on the basic usage of Galaxy platform, with demos covering NGS data quality assessment, read alignment to the genome, gene expression quantification and differential gene expression analysis. Galaxy is an open source, web-based platform for data intensive biomedical research. It provides hundreds of tools for next-generation sequencing (NGS) data analysis, including but not limited to genetic variance calling, transcriptomic profiling, DNA methylation, microbial genomics, pan-genomics, metagenomics, etc. With Galaxy, Wet-lab researchers can manage their data and do most general analysis with short-term training. Galaxy also provides a good way to make research more transparent and more accessible, and improve the reproducibility and robustness scientific research.
Dr. Gong is a Visiting Scientist in Division of Bioinformatics and Biostatistics at FDA’s National Center for Toxicological Research (NCTR/FDA), with expertise in next-generation sequencing technologies and high-throughput data analysis. His studies have significantly advanced the application of bioinformatics methods and systems biology strategies in basic biological study and translational medicine and his research achievements have been recognized with several awards from U.S. FDA and from China. He has served as reviewer for multiple prestigious journals such as Oncotarget, PLoS ONE, Scientific Reports, etc. Dr. Gong has been involved as one of the major investigators in the FDA led SEquencing Quality Control (SEQC) project, and he is the leading author of one Nature Biotechnology paper and co-authors of several others produced by SEQC project. Dr. Gong has more than 30 research papers published in prestigious journals such as Nature Biotechnology, Genome Biology, Nucleic Acid Research, etc. His researches have received more than 350 citations from government agencies, armies, pharmaceutical and food companies and research institutes. Dr. Gong was one of the chapter editors of the first bioinformatics text book for higher institutions in China.
Yanli Wang, Ph.D., Lead Scientist, National Center for Biotechnology Information (NCBI), Washington D.C.
PubChem is a database of chemical molecules and their activities against biological assays. The system is maintained by the National Center for Biotechnology Information (NCBI), a component of the National Library of Medicine, which is part of the United States National Institutes of Health (NIH). PubChem can be accessed for free through a web user interface. Millions of compound structures and descriptive datasets can be freely downloaded via FTP. This workshop will provide hands-on experience on using PubChem database.
Dr. Yanli Wang obtained her PhD in computational biology in 1995 from Peking University, China. She completed postdoctoral studies from the National Institute of Cancer (NCI) and National Center for Biotechnology Information (NCBI) of the National Library of Medicine (NLM) during 1995-1998, and since then she has continued to work at NCBI on various research and informatics projects. She is currently a lead scientist at NCBI and primarily responsible for managing the PubChem BioAssay resource. Dr. Wang also mentors several postdoctoral fellows and has published over 40 papers in international journals.
Next-generation sequencing (NGS) and Bioinformatics