2022 ARCHIVE TOPICS
December 16, 2022
The technical reports for two studies conducted at NCTR under an interagency agreement between FDA and the National Institute of Environmental Health Sciences have been published by the National Toxicology Program (NTP). You can read the technical reports for the two studies linked below.
- (+)-Usnic Acid (CASRN-7562-61-0) Administered in Feed to F344/N NCTR Rats and B6C3F1/NCTR Mice — Investigated the potential toxicity of (+)-usnic acid in male and female F344/N NCTR rats and B6C3F1/NCTR mice that were exposed via feed for three months.
- Usnea Lichens Containing (+/−)-Usnic Acid (CASRN 125-46-2) Administered in Feed to F344/N NCTR Rats and B6C3F1/NCTR Mice — Investigated the potential toxicity of ground Usnea lichens containing (+/−)-usnic acid in male and female Fischer 344/N NCTR rats and B6C3F1/NCTR mice that were exposed via feed for three months.
Usnea lichens and purified usnic acids have been used historically in traditional herbal medicine as bactericidal and antimicrobial agents. Purified (+)-usnic acid has been marketed in the United States for weight-loss either alone or in combination with other chemical agents. Use of some of these fat-burning products that contain (+)-usnic acid has been associated with serious liver damage. The studies showed that dietary exposure to either (+)-usnic acid or Usnea lichens could cause liver damage in rodents.
Dr. Julian Leakey, Research Biologist in NCTR’s Office of Scientific Coordination, was the principal investigator for both studies, evaluating and interpreting results and pathology findings, reporting findings, and preparing the study reports.
November 25, 2022
The American Chemical Society (ACS) selected a paper written by scientists from FDA’s National Center for Toxicological Research (NCTR) and Center for Drug Evaluation and Research as a Spotlights feature in their publication, ACS Chemical Health & Safety. The paper, titled “Machine Learning Models for Predicting Cytotoxicity of Nanomaterials,” was published in Chemical Research in Toxicology in 2022 and aims to provide insight into predicting potential nanomaterial cytotoxicity and promoting the development of safe nanomaterials. It summarized recent studies that focused on the development of machine-learning models for prediction of cytotoxicity of nanomaterials.
ACS Spotlights are community resources that consist of multiple short summaries of papers or resources that advance chemical health and safety knowledge. As summarized in the Spotlights feature, nanomaterials are used in a wide range of consumer and medical products, and experimentally assessing the toxicity of such materials is expensive and time-consuming. Machine learning offers a potential alternative to cytotoxicity assessment. The authors reviewed the machine learning models that have been used to understand nanomaterial cytotoxicity and found that the each have diverse strengths and weaknesses; no single model performed consistently better.
November 22, 2022
NCTR’s Dr. Steven Foley Presents at International Conference on Antimicrobial Agents in Veterinary Medicine
Dr. Steven Foley, Acting Director of NCTR’s Division of Microbiology, gave a presentation at the 11th International Conference on Antimicrobial Agents in Veterinary Medicine (AAVM) in Madrid, Spain on September 11–14, 2022. The title of Dr. Foley’s presentation was “In Vitro Studies on the Impact of Tetracycline Exposure on Resistance Plasmid Transfer in Salmonella Enterica.” The talk highlighted key research findings on how antibiotic exposures can impact the spread of antibiotic resistance in Salmonella, a leading cause of bacterial foodborne illness. The reported findings showed that in some instances the exposure to the antibiotic tetracycline can lead to an increase in the ability of plasmids—mobile elements that can carry and spread antibiotic resistance genes—to transfer to another bacterium in a dose-dependent fashion. These studies are important in that they provide data on contributing factors to the spread of resistance, which has an impact on risk assessments for the use of different drugs. This project is also important to FDA’s One Health initiative because the dissemination of antimicrobial-resistant pathogens through the food supply is a key concern and can lead to treatment failures in severe cases of disease.
The AAVM conference provides the opportunity for scientific discussion and interaction with other speakers and meeting participants. Attendees also shared concerns and challenges that are being faced globally in the realm of antimicrobial resistance. This global dialogue is important to FDA, since the United States relies on a global food supply. Another topic addressed at the conference was the importance of pharmacokinetics and pharmacodynamics (the distribution and availability of bioactive antimicrobials) in understanding the treatment success of therapies and potentially the development of resistance.
October 13, 2022
An NCTR poster, titled “AnimalGAN: A Generative AI Alternative to Animal Clinical Pathology Testing,” was selected as one of five featured posters at FDA’s 10th Annual Scientific Computing Days (SCD). The public event was held September 7-8, 2022 and was hosted by FDA’s Scientific Computing Board, Office of Regulatory Affairs, and the Office of the Commissioner. This year’s SCD theme was “Scientific Computing: In the Field, Around the World, and On the Edge” and included keynote and guest speakers, a poster gallery, and various breakout sessions. Information about SCD and recordings of the event are available for viewing.
NCTR’s Dr. Xi Chen, Division of Bioinformatics and Biostatistics, presented the NCTR poster. The poster-selection process involved participants submitting their abstracts and the SCB reviewing and selecting the posters for inclusion in the FDA.gov poster gallery. The SCD participants then voted on their favorite posters prior to the event. The five posters with the most votes were featured in the SCD poster session with live presentations and those poster presenters participated in the 30-minute question and answer session.
Congratulations to the poster creators Drs. Weida Tong (NCTR), Xi Chen (NCTR), Zhichao Liu (NCTR), and Scott Auerbach (NIEHS-NTP)!
October 5, 2022
Dr. Sangeeta Khare, research microbiologist with NCTR’s Division of Microbiology, was invited to join the European Food Safety Authority (EFSA) One Health Conference 2022 as a “Programme Affiliate.” The conference was held June 21-24, 2022, in Brussels, Belgium. Dr. Khare participated as a speaker in the session “Microbiomes, Chemicals and Health: Unravelling an Intricate Triad.” The title of her presentation was “Unlocking the Potential of Host-Microbiome Interaction in the Risk Assessment.”
In addition to presenting, Dr. Khare also served as a panel member in discussions on “Microbiome and Host Health Interplay.” Other scientists on the panel represented groups such as the Institute of Agrochemistry and Food Technology, Spanish National Research Council, European Food Safety Authority, French National Institute of Health and Medical Research, Food and Agriculture Organization of the United Nations, and the Technical University of Denmark.
Dr. Khare was interviewed by the EFSA communication team to describe the importance of the human microbiome from a One Health perspective. You can view the video on YouTube.
Learn more about the EFSA One Health Conference here.
September 15, 2022
The Center for Drug Evaluation and Research’s Small Business and Industry Assistance (CDER SBIA) group will host the FDA NanoDay Symposium 2022 on October 11th from 8:50 AM to 3:10 PM EASTERN. This event is free to the public, but registration is required.
This symposium will address drug development of products that contain nanomaterials and how the newly finalized industry guidance for products that contain nanomaterials can be implemented in filings to the FDA. Join participants from around the globe as speakers address such topics as:
- Reviewer perspectives on drug development and laboratory efforts to better understand the challenges of manufacturing products that contain nanomaterials.
- Safety evaluations of food contact surfaces that contain nanomaterials.
- The development of standard materials and methods for nanomaterials.
Dr. Anil Patri, NCTR Nanocore Director and chair of the FDA Nanotechnology Task Force, will present the welcome message and discuss nanomaterial standards development at FDA. Dr. Patri will also participate in the Question & Answer panel at the end of the symposium.
For event information, including the agenda and virtual attendance, please visit FDA NanoDay Symposium 2022.
Also, be sure to visit this LinkedIn Poll to test your nano-knowledge prior to the symposium!
September 6, 2022
The FDA’s 10th Annual Scientific Computing Days (SCD) virtual event will be held on September 7-8, 2022, and is open to the public. The event will include keynote and guest speakers, a poster gallery, and various breakout sessions. The theme of this year’s SCD is “Scientific Computing: In the Field, Around the World, and On the Edge.”
The following sessions will feature NCTR researchers:
Day 1 – 11:00AM – 12:00PM (ET) – Poster Session “Top 5”
Day 1 – 12:45PM – 2:15PM (ET) – AI and its Use in the 3Rs (Breakout Session)
Day 2 – 12:55PM – 2:25PM (ET) – Leveraging Edges Using Interdisciplinary Omics (Breakout Session)
The 2022 SCD is open to the public with no cost to attend, but registration is required. For more information and to register, please visit 2022 Scientific Computing Days - 09/07/2022 | FDA.
August 18, 2022
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
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
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.
- Members prepared and presented a “QC Best Practices in Metabolomics Workshop” at the Metabolomics 22 international conference held June 19-23, 2022, in Valencia, Spain.
- 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.
- A graphic from the paper mentioned above was featured on the cover of the June 2022 issue of Metabolomics.
- 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.
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:
- E3297-21 Standard Test Method for Lipid Quantitation in Liposomal Formulations Using High Performance Liquid Chromatography (HPLC) with a Charged Aerosol Detector (CAD)
- E3323-21 Standard Test Method for Lipid Quantitation in Liposomal Formulations Using High Performance Liquid Chromatography (HPLC) with an Evaporative Light-Scattering Detector (ELSD)
- 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.
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.
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.
NCTR Research Highlights Archives
- 2021-NCTR Research Highlights
- 2019-NCTR Research Highlights
- 2018-NCTR Research Highlights
- 2017-NCTR Research Highlights (archived)
- View Research Highlights prior to 2017 (archived)