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  1. NCTR Publications

NCTR Research Highlights

Periodic report on research activities and special events at NCTR

2024 Research Highlights

May 7, 2024

NCTR Artificial Intelligence Initiative Proposes General Framework for Adopting LLMs in Regulatory Application

Are you curious about how the FDA uses large language models (LLMs) and artificial intelligence (AI) in its regulatory work? Scientists in NCTR’s Division of Bioinformatics and Biostatistics (DBB)—led by Dr. Leihong Wu—proposed a general framework for adopting LLMs and demonstrated the framework through AskFDALabel, a system customized to assist with drug labeling review. The findings were shared in Regulatory Toxicology and Pharmacology and show how AskFDALabel provides a more efficient, accurate, and reliable solution for extracting relevant information from drug labeling documents. 

More importantly, AskFDALabel showcases the development of a localized, transparent LLM fine-tuned to assist with labeling review by asking questions and retrieving information in the labeling documents. It can be readily extended to other documents under regulatory review to address an usually difficult and labor-intensive aspect of the review process. This framework represents a significant, secure, and inexpensive example of using AI to advance regulatory needs.

The NCTR-developed AI4TOX is an AI toxicology program under the leadership of DBB Director, Dr. Weida Tong, that aims to apply the most advanced AI methods to develop new tools to support FDA regulatory science and strengthen the safety review of FDA-regulated products. AI4TOX consists of four initiatives—BERTox (which is also led by Dr. Leihong Wu), AnimalGAN, SafetAI, and PathologAI.

Visit NCTR's Research Focus Area: Artificial Intelligence section to learn about these initiatives or contact Dr. Weida Tong for additional information.

March 26, 2024

FDA Grand Rounds, March 2024: Evaluating Mutagenicity by Error-Corrected Sequencing

Javier Revollo, Ph.D., research biologist and principal investigator in NCTR’s Division of Genetic and Molecular Toxicology, presented at the virtual FDA Grand Rounds public event on March 14, 2024. The goals of Dr. Revollo’s presentation—"Evaluating Mutagenicity by Error-Corrected Sequencing"—were to: 

  • Compare and contrast germline and somatic mutations.
  • Discuss the importance of identifying somatic mutations.
  • Describe how DNA sequencing can be used to identify somatic mutations.

As explained on the FDA Grand Rounds main page, somatic mutations are permanent and heritable genetic alterations that increase cancer risk. They can occur spontaneously but most often result from DNA damage induced by the environment (e.g., sunlight) or genotoxic compounds (e.g., chemical mutagens). Conventional mutation detection assays can only indirectly estimate somatic mutation frequencies through reporter genes, which can limit the implementation of such assays. To overcome this challenge, error-corrected sequencing methods and bioinformatic algorithms capable of directly identifying somatic mutations from any DNA samples are being developed and refined. 

Learn more about Dr. Revollo in his Principal Investigator Bio-sketch.

March 25, 2024

NCTR Researcher Serves as Chair for Women in Cancer Research During its 25th Year

Dr. Beverly Lyn-Cook, senior research biologist within NCTR’s Division of Biochemical Toxicology, serves as the chairperson for the American Association for Cancer Research (AACR) professional group, Women in Cancer Research, which celebrates its 25th anniversary this year. According to its website, Women in Cancer Research supports women scientists, provides critical mentorship and funding opportunities, and advocates for equality in cancer research.

Dr. Lyn-Cook was recently profiled in the AACR blogpost, “Women in Cancer Research: 25 Years of Progress.” Learn more about Dr. Lyn-Cook in her "Researcher Spotlight."


March 11, 2024

FDA/NCTR Highlighted at 2024 Arkansas Bioinformatics Consortium 

The 10th annual Arkansas Bioinformatics Consortium (AR-BIC) meeting was held February 26-27, 2024, in Little Rock, Arkansas with the theme, “Real World Impact of AI.” The AR-BIC annual meeting has become the largest bioinformatics gathering in the State and provides a platform for networking, collaborating, and sharing ideas with meetings of 200+ attendees.

Participation of Senior Leadership from FDA and NIEHS 

The FDA Principal Deputy Commissioner, Dr. Namandjé Bumpus, and Director of the National Institute of Environmental Health Sciences (NIEHS), Dr. Rich Woychick, shared their vision on the promises and challenges of utilizing artificial intelligence and data informatics in the regulatory science space. In addition, this year’s AR-BIC agenda (*PDF download) featured plenary sessions, workshops, roundtable discussions, breakout sessions, and a poster session/contest. Many of these events featured NCTR researchers.

NCTR Postdoctoral Fellows Awarded in AR-BIC Poster Contest

During the two-day event, AR-BIC featured a competitive poster session for postdoctoral fellows and students. Two of NCTR’s postdoctoral fellows were winners in the poster contest which recognized the research contributions of trainees.

  • Dr. Chandra Mohan Reddy Muthumula’s (Division of Microbiology, NCTR) poster titled, “Impacts of In Utero Antiretrovirals on Offspring Intestinal Microbiome and Metabolites” won second place. 
  • Dr. Shivangi Shrimali (Division of Bioinformatics and Biostatistics, NCTR) won third place with a poster titled, “Assessment of Challenges Towards Implementing New Approach Methods for Predicting Drug Induced Liver Injury.”

NCTR Contributions to AR-BIC

In 2011, a Memorandum of Understanding (MOU) between FDA and the state of Arkansas established a framework for cooperation between NCTR and Arkansas research universities and institutions, which eventually led to the creation of AR-BIC. Since the inception of AR-BIC in 2013, NCTR has continued to be an influential and active partner, with researchers and leaders from NCTR currently serving on AR-BIC’s Advisory Council and Scientific Program Committee.

NCTR Representation on the AR-BIC Advisory Council:

  • Tucker Patterson, Ph.D., NCTR Center Director 
  • Weida Tong, Ph.D., Director, Division of Bioinformatics and Biostatistics (DBB)

NCTR Representation on the AR-BIC Scientific Program Committee:

  • Steve Foley, Ph.D., Director, Division of Microbiology
  • Huixiao Hong, Ph.D., Bioinformatics Branch Chief, DBB
  • Dongying Li, Ph.D., Staff Fellow, DBB
  • Weida Tong, Ph.D., Director, DBB
  • Joshua Xu, Ph.D., Review-to-Research and Return Branch Chief, DBB

The 2025 AR-BIC annual meeting is scheduled for February 27-28, 2025, in Fayetteville, Arkansas. Visit the AR-BIC website for more information about the Consortium.


March 1, 2024

NCTR Publishes 2023 Annual Report

NCTR 2023 Annual Report Cover Image

Check out NCTR's 2023 Annual Report. The report includes research project information, collaboration highlights, and ongoing initiatives for each of NCTR's research divisions as well as key accomplishments from the calendar year. 

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