Division of Bioinformatics and Biostatistics Also referred to as: DBB

Major Functions and Responsibilities

The 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.

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Division Director: Weida Tong

Branches Within the Division

• Bioinformatics — Research efforts focus on predictive toxicology, precision medicine, biomarker development, drug safety, and drug repositioning. Most research projects are in collaboration with scientists within NCTR, across FDA Product Centers, and in the larger
  
  scientific community. One key endeavor of the branch is to construct knowledge bases in the specific areas of FDA’s responsibility to provide a data-driven decision-making environment for enhanced safety evaluation and precision medicine.
• Biostatistics — Conducts peer-reviewed research of statistical methods to analyze toxicological and molecular data as well as data-mining techniques for pattern identification and signal detection. The branch also provides statistical support related to FDA’s mission to protect and promote public health.
• Scientific Computing — Provides critical support and enhancement to infrastructure in the areas of software and database development for research support and research management, high performance computing, systems integration, and information system-asset management and procurement.
• R2R (review-to-research and return) — Strengthens the division, focuses on “knowledge uptake” of the Division’s research products for regulatory application, and enables “data liberation” of regulatory data from the FDA Product Centers. Thus, facilitating regulatory-science research in the Division and increasing NCTR's linkages with FDA Product Centers.

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NCTR Bioinformatics Tools

• ArrayTrack™ HCA-PCA Standolone Package — Hierarchical Cluster Analysis (HCA) and Principal Component Analysis (PCA) – powerful data-exploring tools extracted from ArrayTrack™.

• The de novo Assembly Quality Evaluation Tool (dnAQET) — Framework designed to evaluate the contigs of a de novo assembly against a trusted reference genome.

• Decision Forest — Novel pattern-recognition method for analysis of data from microarray experiments, proteomics research, and predictive toxicology.

• Drug-Induced Liver Injury Rank (DILIrank) Dataset — A large reference list of drugs ranked by their risk for developing DILI in humans. This is an updated list from the LTKB Benchmark dataset.

• 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 for estrogen and androgen activity of potential endocrine disruptor chemicals.

• FDALabel — Tool to conduct full-text search of drug labeling.

• Liver Toxicity Knowledge Base (LTKB) — Collection of diverse drug-induced liver injury data associated with individual drugs and the use of systems biology analysis.

• MicroArray/Sequencing Quality Control (MAQC/SEQC) Project — Project to develop microarray quality control metrics and thresholds.

• Mold2 — Software that generates 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 better carcinogenicity models by FDA and other organizations.

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2018 Select Accomplishments

• Scientists from NCTR’s Division of Bioinformatics and Biostatistics and Immuneering Corporation have identified the structural changes of the androgen receptor (AR) caused by antiandrogens (chemicals that inhibit male hormones) using simulations. The identified structural changes could facilitate AR targeting-drug discovery. More information can be found in the May 2018 issue of Frontiers in Pharmacology.
• The inaugural meeting of the Little Rock Chapter of the Massive Analysis Quality Control Society — organized by NCTR — was held September 7-8, 2018, in Little Rock, Arkansas. The participants were from FDA, the National Institutes of Health, biotechnology companies, and academia, with roughly 40 participants onsite and 10 online. Participants examined the progress of the FDA-led Sequencing Quality Control Project/Phase 2 (SEQC-2) in comprehensively assessing next-generation sequencing oncology-panel technologies. The panels examined the similarities and differences among the genomic and cellular alterations found across diverse tumor types. They also examined four liquid biopsy-focused panels that can detect rare mutations of circulating tumor DNA.
• Division scientists developed novel data mining and visualization methods which resulted in a total of 63,082 drug adverse-event pairs that were identified from the FDA Adverse Event Reporting System as the significant association between 936 drugs and 10,316 adverse events. New safety signals were identified when compared with the currently available information in various sources. Results were presented in the Society of Toxicology 2018 Annual Meeting.

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2019 Select Research Projects

• Bioinformatics Methodology Development for Microbial Next-Generation Sequencing Data Analysis and Data Mining
• A Systematic Investigation of Personal Genome Assembly for Precision Medicine with Next-Generation Sequencing
• Integrating Pharmacokinetics and Adverse Effects Data from Agency Approval Documents with the Rule-of-Two Model to Improve the Assessment of Hepatotoxicity Risk
• Study of Translational Biomarkers for Drug-Induced Liver Injury with Next-Generation Sequencing
• A Database of Pharmacogenomics Biomarkers for Application to the Minority Groups

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Resources for You

• Annual Reports
• Bioinformatics Tools
• Division of Bioinformatics and Biostatistics Principal Investigator Pages

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