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  1. NCTR Publications

NCTR Research Highlights

Periodic report on research activities and special events at NCTR

2022 Research Highlights

August 18, 2022

Nano-Enabled Medical Products Standard Published by NCTR Nanocore Scientists

Scientists from the U.S. Food and Drug Administration’s, NCTR Nanotechnology Core Facility (Nanocore) published a standard through the ASTM International Subcommittee E56.08 on Nano-Enabled Medical Products. This “Standard Test Method for Detection of Nitric Oxide Production In Vitro” can be used for biocompatibility testing of nanomaterial. The in vitro immunology protocol was originally developed by the Nanotechnology Characterization Laboratory at the Frederick National Laboratory for Cancer Research and further evaluated at the NCTR Nanocore to develop into an ASTM International test method standard. This consensus standard was developed in collaboration and engagement with subject matter experts from:

  • FDA product centers,
  • National Institute of Standards and Technology,
  • National Institute of Environmental Health Sciences (NIEHS)/Division of the National Toxicology Program’s (NTP) Interagency Coordinating Committee on the Validation of Alternative Methods Nanotechnology Working Group,
  • Academia, industry, and other U.S. government agencies.

International test method standards are an invaluable resource for both FDA and industry to protect and promote public health by increasing predictability and streamlining pre-market review.

This project was funded by an interagency agreement between the NIEHS/NTP and FDA. Dr. Anil Patri, NCTR Nanocore Director, served as the principal investigator for this project and NCTR’s Dr. Tariq Fahmi served as a technical lead for this standard.
 

August 17, 2022

Monitoring SARS-CoV-2 and Its Variants in Arkansas Wastewater

NCTR researchers, in collaboration with the Arkansas Department of Health and the University of Arkansas for Medical Sciences, developed a method to monitor the presence of SARS-CoV-2 and its genetic variants in local wastewater in the Arkansas metropolitan areas of Little Rock and Pine Bluff and correlated these data with COVID-19 clinical cases.

Using this method, researchers were able to identify the SARS-CoV-2 variants in wastewater that were responsible for epidemic outbreaks. The variants that were identified by the method also were found in COVID-19 patients in Arkansas during the same period, and the viral titers found in the wastewater correlated with the number of COVID-19 cases. These findings support the use of wastewater surveillance as a reliable complementary tool for monitoring SARS-CoV-2 and its genetic variants at the community level and can serve as an early indicator of viral spread and new variants. (It should be noted that changes in the virus genome can affect the sensitivity of the assays used in COVID-19 testing.) An article on this work has been accepted for publication in Science of the Total Environment.

 

August 12, 2022

NCTR Scientist Chairs International Metabolomics Quality Assurance and Quality Control Consortium

Rick Beger, Ph.D.—Chief of the Omics, Modeling, Imaging, and Chemistry Branch in NCTR’s Division of Systems Biology—serves as the Chair for the international Metabolomics Quality Assurance and Quality Control Consortium (mQACC). NCTR and other parts of FDA have participated in this consortium of scientists from academia, biotechnology companies, analytical companies, and government laboratories since it was created in February 2018.

The mQACC includes representatives from Asia, Australia, Europe, North America, and South America. The consortium promotes the development, dissemination, and harmonization of best Quality Assurance (QA) and Quality Control (QC) practices in untargeted metabolomics studies. These untargeted studies are characterized by analyzing many metabolites in a single sample—including unknown chemicals—as opposed to analyzing specific metabolites. Metabolomic methods can be used to explore the efficacy and toxicity of FDA-regulated drugs and identify biomarkers (biological indicators) or pathways associated with these drugs, as well as with diseases. These methods also have the capability to identify hundreds of metabolites and chemicals in biofluid samples and can play a major role in personalized medicine because they provide a patient’s current phenotype and xenobiotic status. The mQACC’s goal is to enable the metabolomics community to adopt QA/QC best practices, promote and support systematic training in these best practices, and encourage the prioritization and development of reference materials applicable to metabolomics research.

Examples of recent and upcoming consortium activities, led by NCTR’s Dr. Beger are listed below.

  • The paper titled “Reference Materials for MS-based Untargeted Metabolomics and Lipidomics: a review by the metabolomics quality assurance and quality control consortium (mQACC)” was published in April 2022 by the scientific journal, Metabolomics. NCTR’s Dr. Beger and Dr. Jinchun Sun were among the authors.
  • Dr. Beger will be presenting at the annual Metabolomics Association of North America (MANA) conference being held September 16-18, 2022, in Edmonton, Canada. His presentation will discuss “A Community-Led Initiative to Strengthen Quality Assurance and Quality Control Practices and Reporting in Untargeted Metabolomics Research.” Register for the MANA 2022 conference.

The mQACC is currently working to establish standards for submitting data to journals and public metabolomics databases. The consortium’s activities in QA and QC will aid reproducibility and reliability of metabolomics data, foster better metabolomics biomarkers, and improve the understanding of drug effects.

 

June 16, 2022

NCTR Scientists Publish Three International Test Method Standards on Nanotechnology with Support from Collaborators including the National Institute of Environmental Health Sciences (NIEHS)

Scientists from the U.S. Food and Drug Administration’s, NCTR Nanotechnology Core Facility (Nanocore) developed three International Test Method Standards in Nanotechnology. The three NCTR-developed standards published by the American Society for Testing and Materials (ASTM) International E56-08 Sub-Committee on Nano-Enabled Medical Products are:

  1. E3297-21 Standard Test Method for Lipid Quantitation in Liposomal Formulations Using High Performance Liquid Chromatography (HPLC) with a Charged Aerosol Detector (CAD)
  2. E3323-21 Standard Test Method for Lipid Quantitation in Liposomal Formulations Using High Performance Liquid Chromatography (HPLC) with an Evaporative Light-Scattering Detector (ELSD)
  3. E3324-22 Standard Test Method for Lipid Quantitation in Liposomal Formulations Using Ultra-High-Performance Liquid Chromatography (UHPLC) with Triple Quadrupole Mass Spectrometry (TQMS)

The NCTR Nanocore team conducted research supporting collaborative consensus standards-development for liposomes. This collaborative research effort was supported by the FDA Nanotechnology Task Force, FDA product centers, stakeholders, and subject matter experts from U.S. government agencies, academia, and industry. International Test Method Standards are an invaluable resource for both FDA and industry to protect and promote public health. These standards will increase predictability, streamline pre-market review, and facilitate new product entry to market.

The Nanocore team responsible for this effort included the NCTR Nanocore Director, Dr. Anil Patri, and his team Drs. Goutam Palui, Sanghamitra Majumdar, and Achyut Raghavendra. This ongoing project is funded by NIEHS.
 

March 21, 2022

Global Summit on Regulatory Science (Past and Future)

2022:  The 12th annual Global Summit on Regulatory Science (GSRS22) will be held October 19-21, 2022, in Singapore and virtually. It is being co-hosted by the Singapore Food Agency (SFA) and the Global Coalition of Regulatory Science and Research. The theme for this year’s Global Summit is “Advances in Nanotechnology for Food and Medical Products: Innovations, Safety, and Standards.” There is no registration fee; however, registration is required to attend the GSRS22.

2021:  The 2021 Global Summit on Regulatory Science (GSRS21) was held virtually October 4-6, 2021, and was co-hosted by NCTR and the Global Coalition of Regulatory Science and Research. The theme for GSRS21 was “Regulatory Sciences for Food/Drug Safety with Real-World Data (RWD) and Artificial Intelligence (AI).” The conference hosted speakers from 10 countries and drew extensive participation (>800) from 46 countries during the three-day event, including Brazil, Canada, the European Union (EU), India, Italy, Japan, Switzerland, Singapore, and the U.S. Discussions on the first day of the conference focused on digital health and safety, and discussion centered around AI and RWD for drug/food safety. On the second day, discussions focused on Artificial Intelligence and Machine Learning. By taking advantage of the virtual format, two new sessions were added to last year’s GSRS program — the debate sessions and workshop. 

  • Opening remarks by Acting FDA Commissioner (now Principal Deputy Commissioner), Dr. Janet Woodcock. 
  • Two keynote presentations by government-agency senior leadership from the U.S. and the EU:
    • Frank Yiannas (Deputy Commissioner for Food Policy and Response, FDA)
    • Stephen Quest (General Director at Joint Research Center, EU) 
  • Platform presentations from scientists representing Brazil, Canada, EU, India, Italy, Japan, Singapore, Switzerland, and the U.S.
  • A live debate on the topic, “Is Regulatory Science Ready for AI?” 
  • A special workshop to showcase data-science tools currently in regulatory use by FDA, the European Medicines Agency (EMA), and Swissmedic.

The annual Global Summit is sponsored by the Global Coalition for Regulatory Science Research which is comprised of regulatory-science leaders from around the world. NCTR’s Director has served as the co-chair of the Coalition’s executive committee since its inception and has worked with the Coalition to promote global interaction. 

Despite the worldwide challenges from the COVID-19 pandemic, the virtual GSRS21 was a huge success with in-depth scientific presentations on AI and Real-World Data for regulatory application. Conference attendance jumped from approximately 200 attendees in the previous in-person meetings to >800 attendees from 46 countries during the three-day GSRS21 virtual event. A recording of the Q & A session where research presenters answered participants’ questions in real-time via chat is available for viewing at https://gsrs21.org/.

2020:  A manuscript titled “Emerging Technologies and Their Impact on Regulatory Science” that summarizes the GSRS20 was published in the journal Experimental Biology and Medicine. The publication represents many of the presentations by scientists from NCTR and other research entities at the virtual GSRS20. There were 48 co-authors from 27 different research institutes representing 13 countries that contributed to the publication.

Read more about GSRS at www.fda.gov/globalsummit and more information is also available about previous Global Summits.
 

March 16, 2022

Artificial Intelligence Approaches as Alternatives to Animal Studies — Presented by NCTR’s Dr. Weida Tong

Dr. Weida Tong, Director of NCTR’s Division of Bioinformatics and Biostatistics, was featured at the Arkansas Research Alliance (ARA) Project Scope webinar on February 16, 2022. A recording of his presentation titled “Artificial Intelligence Approaches as Alternatives to Animal Studies” is available now to view. Selected as an ARA Fellow in 2016, Dr. Tong in addition to being a research leader at FDA, is a founder of the Arkansas Bioinformatics Consortium and a rapidly growing influencer in the fields of bioinformatics, machine learning, artificial intelligence, and more. Each month ARA Project Scope features a member of the ARA Academy of Scholars and Fellows. As stated on the ARA web site, “As the toxicology community and regulatory agencies are moving towards reduction, refinement and replacement (3Rs principle) of animal studies, Dr. Tong and his team are exploring an artificial Intelligence approach to learn from the existing animal studies so that it can generate the animal data without conducting animal experiments.” A publication related to Dr. Tong’s research at NCTR in this area can be found in Toxicological Sciences.

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