2022 Research Highlights
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.
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