NCTR Division of Bioinformatics and Biostatistics Also referred to as: DBB

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Division Director: Weida Tong, Ph.D.
Bioinformatics Branch Chief: Huixiao Hong, Ph.D.
Biostatistics Branch Chief: Dong Wang, Ph.D.
R2R Branch Chief: Joshua Xu, Ph.D.
Scientific Computing Branch Chief: Edward Bearden, Ph.D

Meet the Principal Investigators — Biostatistics & Bioinformatics

About the Division

Mission

Develop integrated bioinformatics and biostatistics capability to address increasing need in areas such as biomarker development, drug safety, drug repositioning, precision medicine, artificial intelligence (AI), rare diseases, endocrine disruptors, and risk assessment.
 

Branches Within the Division

Bioinformatics Branch

Constructs knowledge bases to provide a data-driven decision-making environment for enhanced safety evaluation and precision medicine.

Biostatistics Branch

Conducts research of statistical methods to analyze toxicological and molecular data as well as data-mining techniques for pattern identification and signal detection.

Scientific Computing Branch

Provides IT support to all of NCTR.

R2R (Review-to-Research and Return) Branch

Translates division research for regulatory application.

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Select DBB Accomplishments in 2023

• Made significant progress in several focused areas, including the opioid crisis, CBD, endocrine disruptors, drug safety, COVID-19, toxicogenomics, and precision medicine, and specifically, in AI/Machine Learning (ML).
  
• Developed DICTrank (Drug-Induced Cardiotoxicity Rank), the largest reference list of 1,318 human drugs ranked by risk of drug-induced cardiotoxicity using FDA labeling, which facilitates the development of NAMs (Drug Discov Today).
• Developed AnimalGAN, a Generative Adversarial Networks (GAN) model that simulates animal studies to reduce animal use in preclinical studies for drug development (Nature Comm).
• Led five projects that were newly funded by FDA intramural grants on the following topics: AI bias funded by Office of the Chief Scientist, drug safety in women’s health by Office of Women's Health, COVID-19 and its variants by the Medical Countermeasures Initiative, and real-world data for minority health by Office of Minority Health and Health Equity. 
• Published approximately 38 manuscripts, some in well-respected journals such as Nature Biotechnology, Nature Communications, and Genome Biology.

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Intercenter Support

2023 AI/ML Publications by NCTR Researchers

• AnimalGAN — Nat Commun

• SafetAI — Regul Toxicol Pharm 

• BERTox — Exp Biol Med

• PathologAI — Chem Res Toxicol

In 2023, NCTR scientists developed RxBERT, an AI model optimized to better understand human prescription drug labeling. They also supported Center for Drug Evaluation and Research (CDER) regulatory missions by:

• Improving the accuracy and timeliness of the Novel Drug Approvals Dashboard by creating software to identify new and updated information in the Data Analysis Search Host Database of marketing application information derived from CDER-generated regulatory documentation.
• Completing population of a searchable Executive Carcinogenicity Assessment Committee (ECAC) database within the Smart Template System that allows pharmacology/toxicology reviewers to search ECAC meeting minutes from 1995 to present for information relevant to their current reviews.

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Outreach

In 2023, DBB scientists contributed to or participated in the following outreach events:

• 9^th Arkansas Bioinformatics Consortium (AR-BIC) Annual Conference — Scientific Program Committee (chair)
• 13^th Annual Global Summit on Regulatory Science (chair)
• Cheminformatics Resources of U.S. Governmental Organizations — FAIR-ifying and Sharing Chemical-Related Data session (chair); “Machine Learning Models for Rat Multigeneration Reproductive Toxicity Prediction” (presentation)
• FDA 11^th Annual Scientific Computing Days (three posters presented and one breakout session hosted)
• Institute of Electrical and Electronical Engineers-USA Innovation, Workforce, and Research Conference (three DBB staff represented NCTR)
• Large Language Model (LLM) workshop hosted by Swissmedic and instrumental in establishing the interagency LLMs Workforce (DBB staff led this first ever workshop)
• “Making Sense of Electronic Health Record (EHR) Race and Ethnicity Data Challenge” (Biostat Team presented at precisionFDA)
• SOT 62^nd Annual Meeting and ToxExpo (DBB staff played a pivotal role in preparations and event and presented 18 scientific posters)

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Resources for You

• DBB Fact Sheet
• NCTR Grand Rounds: "Artificial Intelligence for Regulatory Science Research" (Presentation recorded in Adobe Connect on May 14, 2020)
• Annual Reports
• Bioinformatics Tools
• Artificial Intelligence at NCTR
• Meet the Principal Investigators

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