NCTR Division of Bioinformatics and Biostatistics Also referred to as: DBB
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
Constructs knowledge bases to provide a data-driven decision-making environment for enhanced safety evaluation and precision medicine.
Conducts research of statistical methods to analyze toxicological and molecular data as well as data-mining techniques for pattern identification and signal detection.
Provides IT support to the entire NCTR.
Translates division research for regulatory application.
Artificial Intelligence for Regulatory Science Research
Artificial Intelligence for Regulatory Science Research
Select Division Accomplishments in 2022
- Completed Phase 1 of NCTR-driven PrecisionFDA Challenge, receiving 49 submissions.
- Awarded three FDA-level awards: Chief Scientist Publication, Group Excellence for SEQC2 Team, and Outstanding Inter-Center Scientific Collaboration for SmartTemplate.
- Presented R2R program at the inaugural FDA Digital Transformation Symposium public meeting with over 1,000 online participants.
- Published 45 papers in 2022, including a paper selected as “Spotlights” feature in ACS Chemical Health & Safety.
- Received first- and second-place awards for the 2022 Environmental Mutagenesis and Genomics Society’s Bioinformatics Challenge.
- Awarded FDA intramural research grants for projects with topics including artificial intelligence (AI) bias, big data and women’s health, and COVID-19 and its variants.
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)
- Smart Template System (STS)
- FDA drug labeling documents (FDALabel)
- SafetAI Initiative
- Tools for SARITA
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
- Completing the final studies under 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)
- Applying the most advanced AI methods using the AI4Tox program to develop new tools to support FDA regulatory science and strengthen the safety review of FDA-regulated products.
- 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.
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.
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
Contact Us
- NCTR Bioinformatics Support
- National Center for Toxicological Research
Food and Drug Administration
3900 NCTR Rd
Jefferson, AR 72079
-
Hours Available
- NCTRBioinformaticsSupport@fda.hhs.gov
- (870) 543-7538