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
About the Division
Develop integrated bioinformatics and biostatistics capability to address increasing needs of FDA product centers 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
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.
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.
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.
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.
Artificial Intelligence for Regulatory Science Research
Artificial Intelligence for Regulatory Science Research
DBB projects and related works in 2021 resulted in 30 peer-reviewed research and review articles and one book chapter, many of which will be key milestones in better achieving both NCTR’s and FDA’s missions.
Select Division Accomplishments in 2021
In 2021, the Division focused on harnessing the benefits of big data and AI to support and advance regulatory science. Some of the important projects included:
- Informed drug selection and combination of FDA-approved drugs for COVID-19 treatment using AI.
- Studied drug-induced liver injury (DILI) to support FDA review.
- Developed knowledge base for opioid crisis.
- Performed characterization of different next-generation sequencing (NGS) technologies for precision medicine.
- Studied clinical implication of non-steroidal anti-inflammatory drugs (NSAIDs) using real world data and AI.
- Supported regulatory application requested by other FDA centers.
- Submitted several proposals to the FDA intramural grant solicitation with a broad range of topics such as racial disparities in critical care patients, DILI risk associated with herbal medicine and dietary supplements, and computation strategies and approaches to combat COVID-19.
- Published research including drug repositioning for rare diseases and ways to combat present and future pandemics in numerous prestigious journals including Nature Biotechnology and Genome Biology.
Ongoing Research Projects
The Division’s research programs are designed and aligned with its mission. Research is ongoing in the following five focus areas:
Regulatory Applications and Support
Collaborating with CDER to develop and support:
- Data Analysis and Search Host (DASH)
- Breakthrough Therapy Designation (BTD)
- Safety Policy and Research Team (SPRT)
- Smart Template System (STS)
- FDA drug labeling documents (FDALabel)
- Supporting ORA by developing Automated Laboratory Information System (ALIS)
- Collaborating with CTP to create ASSIST4Tobacco
Alternative Methods and Knowledge Bases
Developing the following:
- Advanced DILI prediction models for FDA-regulated products like drugs and supplements.
- Opioid Agonists/Antagonists Knowledgebase (OAK) for better management of opioid-use disorder.
- Molecules with Androgenic Activity Resource (MAAR) open-access platform for assessing the safety profile for chemicals in various food, supplement, or cosmetic products that may affect the endocrine system and cause hormonal disfunction.
Precision Medicine and Therapeutics
- Conducting studies under the ongoing project, Sequencing Quality Control Phase 2 (SEQC2), an NCTR-led consortium effort to assess technical performance and application of emerging technologies for safety evaluation and clinical application.
Artificial Intelligence and Machine Learning (AI/ML)
- Conducting research to harness AI in mining FDA documents for relevant information to enhance regulatory operations and applications.
- Accessing the safety profile of prospective drugs in Investigational New Drug (IND) applications to assist FDA reviewers.
- Developing explainable AI (XAI) models that will facilitate the agency’s adoption and application of AI technologies in evaluating and regulating AI-based medical products.
Real-World Data and Real-World Evidence
- Investigating racial disparities in patients with heart failure admitted to critical care and its subsequent impact on their health.
- Analyzing safety profiles of various prescription NSAIDs to understand the difference in patient sexes (male vs. female) across the U.S. population.
- Developing an integrative model for assessing DILI risks for various drugs and supplements.
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
- NCTR Bioinformatics Support
- National Center for Toxicological Research
Food and Drug Administration
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