About FDA

Bioinformatics and Biostatistics

Bioinformatics Tools
Ongoing Projects
Contact Information

Director:  Weida Tong, Ph.D.

Dr. Tong is a gifted computational chemist with broad expertise that spans the entire spectrum of computational methods in molecular modeling and bioinformatics applied to systems biology, predictive toxicology, and knowledge management. He is internationally recognized for his leadership in the areas of computer modeling and bioinformatics, serves as a Science Advisory Board (SAB) member for the Netherlands Toxicogenomics Center, and as a SAB member for the EU Framework Project on CarcinoGenomics. Weida received his B.S. in Chemistry (1983) and his Ph.D. in Polymer Chemistry (1990) from Fudan University in China. Weida’s efforts and leadership qualities have made a significant impact within FDA and worldwide. He has supervised the FDA-led community-wide MicroArray Quality Control Consortium, analyzing technical performance and practical utility of emerging molecular technologies; and coordinated the development of the Liver Toxicity Knowledge Base to address public health concerns related to drug-induced liver injury. He played a major leadership role in the conception, design, and development of numerous computational tools in bioinformatics, chemoinformatics, computational toxicology, biostatistics, and systems biology. His work and creativity have public health impacts in predictive systems toxicology and risk assessment. His research (>200 publications) is cataloged in eminent peer-reviewed journals.


Division of Bioinformatics and Biostatistics develops integrated bioinformatics and biostatistics capability to address increasing needs in biomarker development, drug safety, drug repositioning, personalized medicine, and risk assessment. Its capability is directed towards integration with FDA business processes to ensure that NCTR linkages with FDA Product Centers are strengthened, and that the NCTR informatics capabilities continue to become more diverse, robust, and capable of meeting future and demanding needs of FDA.  Read more about the Division of Bioinformatics and Biostatistics in the Consumer Update titled "The Lab for These FDA Scientists Is a Computer Screen."

The Division develops:

  • informatics capabilities and coordinates these capabilities within NCTR, across FDA Centers, and in the larger toxicology community
  • methods for the analysis and integration of omics datasets with classic in-life parameters
  • biometrical methods for all aspects of FDA’s mission, goals, and objectives  

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NCTR Bioinformatic Tools

  • ArrayTrack
    DNA microarray data management, mining, analysis, and interpretation software
  • atBioNet
    An Integrated PPI (protein-protein interaction) Network Analysis Tool for Systems Biology and Biomarker Discovery
  • Decision Forest
    A novel pattern recognition method for analysis of data from microarray experiments, proteomics research, and predictive toxicology
  • Estrogenic Activity Database (EADB)
    Comprehensive set of estrogenic activity data from a variety of data sources and a component of the enhanced Endocrine Disruptors Knowledge Base (EDKB) 
  • Endocrine Disruptor Knowledge Base (EDKB)
    Scientific resources to predict estrogen and androgen activity
  • FDALabel
    Full-Text Search of Product Labeling
  • Gene Ontology for Functional Analysis (GOFFA)
    ArrayTrack™ tool to identify terms in Gene Ontology associated with a list of genes
  • Liver Toxicity Knowledge Base (LTKB)
    Collection of diverse drug-induced liver injury data associated with individual drugs and development of predictive models to assess risk of drug-induced liver injury
  • MicroArray Quality Control (MAQC) Project
    Development of microarray quality control metrics and thresholds
  • Mold2
    Generate molecular descriptors from two-dimensional structures
  • NCTR Liver Cancer Database (NCTRlcdb)
    Database of 999 chemicals with assigned liver-toxicity classifications to facilitate the construction of cleaner and better carcinogenicity models by FDA and other organizations
  • SNPTrack
    An integrated solution for the management, analysis, and interpretation of genetic association study data

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Ongoing Research Projects

  • Biomarker study to improve adjuvant treatment for ER-positive and HER2-negative breast cancer patients (E0748401)
  • Blood pressure threshold for cardiovascular risk: an assessment of sex-based criterion (E0754201)
  • CTP Scientific Enclave, Tobacco Constituents Knowledge Base, and Topic Modeling for Tobacco Industry Documents (E0753501)
  • Data-Mining Strategy to Identify Hepatotoxic Drugs and Sensitive Patients (E0740301)
  • Development and Refinement of the FDA Genomic Tool, ArrayTrack™   for Advancing Pharmacogenomics and Personalized Medicine in the Context of the FDA’s Critical Path Initiative (S00671)
  • Development of Liver Toxicity Knowledge Base (LTKB) to Empower the FDA Review Process (E0721511)
  • Drug Repositioning with Bioinformatics (E0747001)
  • Further development and refinement of the FDA Endocrine Disruptor Knowledge Base for assessing endocrine disrupting potential of drugs and food additives (E0741501)
  • High-throughput Screening Tobacco Constituents for Addiction Potential Using Docking of Nicotinic Acetylcholine Receptors (E0754801)
  • Integrated Analysis Of Single Nucleotide Polymorphism And Copy Number Variation In Genome Association Of Breast Cancer (E0744401)
  • Predicting Patient-Specific Treatment Outcomes:  Identification and Validation of Molecular Biomarkers Using In Silico Tools (E0748601)
  • Priority Setting of Harmful and Potentially Harmful Constituents (HPHCs) in Tobacco Smoke Products with Bioinformatics (E0750901) 
  • QT interval correction via mixed-effects modeling (E0734601)
  • Scientific Enclave, Knowledge Base and Topic Data Mining for Tobacco Products (E0749001)
  • SEQC -(MACQ-III) -  The Sequencing Quality Control Project (E0731901)
  • Study of Translational Biomarkers for Drug-Induced Liver Injury with Next-Generation Sequencing (E0753201) 

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Contact Information

For more information, please contact Weida Tong, Ph.D. at 870-543-7142 or weida.tong@fda.hhs.gov.

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Page Last Updated: 03/18/2015
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