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U.S. Department of Health and Human Services

About FDA

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Bioinformatics and Biostatistics

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 (>160 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.

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 


NCTR Bioinformatic Tools

Ongoing Research Projects

  • Baseline Practices for Analyzing Genome-Wide Association Study (GWAS) Data (E0729701)
  • Benefit/Risk Classification Models for Regulatory Decision Making in Personalized Medicine (E0722001)
  • 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 a FDA Resource and Knowledge Base for Sex Difference in Drug-Induced Liver Injury (DILI) (E0733801)
  • Development of Liver Toxicity Knowledge Base (LTKB) to Empower the FDA Review Process (E0721501)
  • Further development and refinement of the FDA Endocrine Disruptor Knowledge Base for assessing endocrine disrupting potential of drugs and food additives (E0741501)
  • Integrated Analysis Of Single Nucleotide Polymorphism And Copy Number Variation In Genome Association Of Breast Cancer (E0744401)
  • Integrated Genomics Knowledge Base for Rapid Threat Assessment of Enteric Pathogens: Salmonella (E0733701)
  • Phase II of the MicroArray Quality Control Project (MAQC-II) Toward Personalized Medicine (S00705)
  • Scientific Enclave, Knowledge Base and Topic Data Mining for Tobacco Products (E0749001)
  • SEQC -(MACQ-III) -  The Sequencing Quality Control Project (E0731901)
  • Sex Differences in Molecular Biomarkers for Individualized Treatment of Non-Gender-Specific Disease: A Novel Classification Algorithm for the Development of Genomic Signatures from High-Dimensional Data (E0727901)


Contact Information

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