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NCTR Research Highlights

Periodic report on research activities and special events at NCTR

Previous 2021 Research Highlights

January 27, 2021

Nanotechnology at NCTR — 2020

Nanotechnology Standards

Standards provide common ground for product developers and FDA, and these standards facilitate the development of products containing nanomaterials. At the 2016 Global Summit on Regulatory Science (GSRS16), FDA and international regulatory agencies identified the need for nanotechnology standards as a priority. NCTR researchers from FDA’s NCTR/ORA Nanotechnology Core Facility (Nanocore) continue to develop these prioritized standards via the ASTM E56 Subcommittee on Nanotechnology and ISO Technical Committee 229, through stakeholder collaboration and support from the NIEHS/National Toxicology Program. Examples of standards under development include characterization methods to ascertain product quality, consistency, and in vitro safety. Two work items developed by the NCTR Nanocore staff became standards in February 2019 and January 2020 (Standard Practice for Performing Cryo-Transmission Electron Microscopy of Liposomes and Standard Test Method for Quantitative Measurement of the Chemoattractant Capacity of a Nanoparticulate Material in vitro, respectively) and are available through ASTM International. Seven additional work items developed by the NCTR Nanocore scientists are going through the consensus-standard process at ASTM International E56 for quality assurance and testing for biocompatibility.

Nanotechnology Task Force Report

Nanotechnology -- Over a Decade of Progress and Innovation cover

Nanomaterials can have different chemical, physical, or biological properties than their conventionally-scaled counterpart materials used in many products regulated by FDA. To date, over 600 drug products that contain nanomaterials have been submitted to FDA, with over 70 products approved for clinical use. The Nanocore has advanced and comprehensive characterization facilities which allow NCTR to conduct regulatory science research and develop standards that are relevant to FDA-regulated products that contain nanotechnology/nanomaterials. The Nanotechnology Task Force (NTF), chaired by Anil Patri, Ph.D., NCTR Nanocore Director, published a comprehensive progress report, Nanotechnology—Over a Decade of Progress and Innovation, in July 2020. The report highlights the current state of science in nanotechnology and the progress at FDA in:

  • research
  • infrastructure
  • guidance
  • standards
  • interagency engagement
  • international engagement

FDA Grand Rounds

The FDA Grand Rounds seminar, “Nanotechnology, Over a Decade of Progress and Innovation at FDA,” was presented by Anil Patri, Ph.D., on August 13, 2020. This seminar highlighted the 2020 Nanotechnology Task Force Report on the progress FDA has made in nanotechnology since 2007. Also discussed were the basics of nanotechnology, FDA facilities overview, regulatory science research at FDA, guidance documents, standards, domestic and international collaborations, and emerging challenges in regulatory science. 

Nano Day

FDA’s Nano Day Virtual Research Symposium: “A Decade of Progress and Innovation in Nanotechnology at U.S. FDA,” was organized by NCTR and hosted by the FDA Nanotechnology Task Force on October 9, 2020. This 3.5-hour virtual event drew over 300 participants from around the globe and highlighted the 2020 Nanotechnology Task Force Report and regulatory science research conducted at FDA. Additionally, a virtual tour of FDA’s nanotechnology facilities was provided. Over 20 speakers gave presentations that highlighted the collaborative efforts within FDA, other government agencies, and academia, and demonstrated the expertise and strength within the Agency to promote and protect public health. A list of the 20+ speakers is available in the agenda, and presentations can be viewed in the recorded symposium. Read more about nanotechnology at FDA, nanotechnology at NCTR, or contact Anil Patri, for additional information.

 

January 22, 2021

Summary of 10th Annual Global Summit on Regulatory Science (GSRS20)

The 10th Global Summit on Regulatory Science (GSRS20) was held virtually September 28-30, 2020, co-hosted by NCTR and the National Center for Advancing Translational Sciences. The theme for the 10th anniversary Global Summit was “Emerging Technologies and Their Application to Regulatory Science—A Global Perspective.” It included over 60 presentations and 2 workshops, speakers from 14 different countries, and scientific leadership from FDA, National Institutes of Health, European Food Safety Agency, Joint Research Centre, Canadian Food Inspection Agency, National Institutes for Food and Drug Control, and National Institute of Health Sciences—to name just a few organizations. You can click on the links throughout the GSRS20 program to view the recorded scientific presentations and workshops on the following topics:

  • Plenary Presentations from World Health Leaders
  • Artificial Intelligence for Drug Development and Risk Assessment
  • OMICS, Biomarkers, and Precision Medicine
  • Microphysiological Systems and Stem Cells
  • Bioimaging
  • Microbiome
  • Artificial Intelligence/Machine Learning
  • Nanotechnology/Nanoplastics

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 serves as the co-chair of the Coalition’s executive committee and works with the Coalition to promote global interaction. The GSRS20 drew over 1,100 registrants from approximately 50 countries representing regulatory and research institutes along with academic and industry participants.

Despite the worldwide challenges from the COVID-19 pandemic, the virtual GSRS20 was a huge success with in-depth scientific presentations on emerging technologies for regulatory application. A limited number of academic and industry presenters were invited to showcase cutting-edge research, successes, ongoing clinical trials, and challenges. A recording of the Q & A session where research presenters answered participants’ questions in real-time via chat is available for viewing.

Read more about GSRS here: www.fda.gov/globalsummit.

 

January 11, 2021

FDA Alternative Methodologies Report — NCTR Achievements 

FDA has released the Advancing Alternative Methodologies report that focuses on Agency activities to improve predictivity of human and animal response to FDA-regulated products. As noted in the report, the FDA has developed the Advancing Alternative Methods webpage, which hosts related publications, presentations, and a webinar series that enables developers to showcase their pioneering technologies to FDA scientists. The FDA will continue to update our progress on alternatives in real time for stakeholders on our website.

NCTR achievements toward advancing alternative methods included in the report:

  • Evaluation of Patient-Specific Induced Pluripotent Stem-Cell Derived Cardiomyocytes (iPSCCMs) to Improve Oncology Drug-Induced Cardiotoxicity Detection and Prediction 
  • Human ALI Airway Epithelial Tissue Model 
  • Development of In Vitro Testicular Models for Evaluating the Potential Reproductive Toxicity of Regulated Products
  • Global Summit on Regulatory Science

The following quote is attributed to FDA Chief Scientist RADM Denise Hinton.

 “The Advancing Alternative Methodologies report highlights the activities that FDA scientists are undertaking to foster the development of new regulatory approaches-—whether in our laboratories or through innovative collaborations with partners—that can help improve predictivity and potentially replace, reduce and/or refine animal testing. 

While the FDA is committed to doing all that it can to reduce the reliance on animal-based studies, there are still many areas where animal research is necessary. Without the use of animals, it would be impossible to gain some of the important knowledge needed to prevent human and animal suffering for many life-threatening diseases. Animal research has played an important role in advancements such as preventing polio, eradicating smallpox and identifying new cancer treatments. We understand and share concerns that animals be involved in research only when there is no other way to fulfil an important public health objective.

Evaluating groundbreaking alternative methods will add to the body of knowledge that the agency can draw upon in conducting its regulatory mission and may even help bring new FDA-regulated products to consumers faster.”

 

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