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.

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.