Acting Commissioner of Food and Drugs - Food and Drug Administration
(Remarks as prepared for delivery)
Thank you, Bill [Slicker], for that kind introduction.
It is a pleasure to be with you again, Governor Hutchinson, albeit virtually. I look forward to signing the MOU with you shortly, which will allow us to continue the successful scientific and medical collaborations between the State of Arkansas and the FDA.
I want to acknowledge the Arkansas Research Alliance for its vital support and leadership, as well as the State of Arkansas University System, and the surrounding community of central Arkansas.
Let me also recognize the Arkansas Congressional delegation, which has been an essential supporter of NCTR, and no doubt will continue to play an important role as we work to build on these achievements.
Our society has a long tradition of celebrating anniversaries. Maybe it’s our appreciation for things that demonstrate resilience and sustainability. Or maybe we just have a penchant for big, round numbers.
Both of these certainly ring true for NCTR’s golden anniversary. But our tribute today is not just because this unique FDA Center has existed for 50 years. Rather, it is because throughout the past five decades, NCTR has been a paragon of scientific leadership, vision, and innovation, and a model of successful partnership.
Bill, you and your team deserve a great deal of the credit for this success. You’ve helped make NCTR an essential part of our nation’s public health structure and the FDA’s work to protect and promote public health. Thank you for your leadership.
NCTR’s success is especially notable because in the world of science and public health nothing is static; we are constantly working to stay ahead of scientific and technological advances.
We not only are tasked with finding answers to increasingly complex questions, but we must accomplish this by expanding both the scientific methods we use to arrive at our conclusions and the sources and types of evidence on which we base our decisions.
At the FDA, this application of the best available science and the most rigorous data is our north star. It informs and shapes every aspect of the work we do in support of our mission to advance patient and consumer health and safety.
And nowhere is this more evident than at NCTR, with its mission of data generation and research to help address the nation’s regulatory science priorities and provide comprehensive safety assessments for FDA-regulated products.
To do this successfully requires the skills of teams of multidisciplinary scientists working together not only across the FDA but also with other agencies, academia, and research communities around the world.
NCTR’s groundbreaking work has ranged from nanotechnology-related research and support for the development of standards to safely assess FDA-regulated products in this area, to essential research on often understudied maternal, perinatal, and pediatric populations.
It has included work on precision medicine and genomic technology -- promising scientific tools that have important implications in the treatment of many different diseases, and support for the FDA’s responses to public health emergencies, including, most recently, the COVID-19 pandemic.
To give you an example, during the current pandemic, NCTR’s Division of Biochemical Toxicology developed a method to detect SARS-CoV-2 RNA in wastewater and is applying it to selected metropolitan areas in Arkansas to monitor the presence and the extent of the COVID-19 epidemic.
The Division of Bioinformatics and Biostatistics developed two AI-related projects focused on drug repositioning to fight COVID-19.
And researchers in NCTR’s Division of Microbiology are developing an approach to rapidly indicate effectiveness of COVID-19 therapeutic treatments.
In short, NCTR helps ensure that like science itself, the FDA remains forward looking and a step or more ahead of the science, so that we have the capabilities to take on the challenges of the future.
Let me quickly give you a few examples.
NCTR researchers are facilitating, supporting, and advancing modern scientific techniques such as genomic technology, bioinformatics, artificial intelligence, bio-imaging, computational modeling, biomarker identification, and organs-on-a-chip.
NCTR scientists are developing new and alternative approaches to safety assessment.
While animal models continue to serve as NCTR’s foundation of hazard identification and dose-response assessment, we are investing in the development and evaluation of models that shift from animal to in vitro or computational approaches. This supports a higher predictive value in clinical performance, can reduce the time and costs of product evaluation and development, and potentially allow for the replacement, reduction and/or refinement of animal testing.
NCTR scientists are also working to fulfill the promise of a new tool kit for physicians that will allow genetic, bio-imaging, and metabolomic information on each patient and help treat disease and maintain wellness.
And NCTR scientists continue to identify new biomarkers that can be used in many different ways to help patients and treat disease, including identifying populations susceptible to drug side effects, predicting harmful effects of drugs during safety evaluations, reducing or reversing cardiac injury, and improving therapeutic patient treatments.
These developments are enormously important, with the potential to make a real difference in the treatment of patients.
At 50 years young, NCTR continues to grow and explore new scientific worlds, and provide new energy to human-translational research and regulatory science.
For example, NCTR is working to establish a dedicated NCTR Immunotoxicology resource as part of the Nanotechnology Core Facility at Jefferson Laboratories. This initiative would be used to investigate emerging immunotoxicological issues associated with complex drug products and devices that contain nanomaterial or that are otherwise known to cause immunological problems.
Another initiative to fund collaborative research will support the detection, identification, quantitation, and degradation pathways of micro and nanoplastics in FDA-regulated products.
Still another newly proposed initiative will advance product development and facilitate access to treatment for patients with rare diseases by enabling the generation of internal and real-world data that can be used to address unmet regulatory needs.
Sometimes these areas of research push the boundary between science and science fiction. But it is that kind of vision that is at the focus of NCTR’s work in support of the FDA’s mission to protect patients and consumers, in Arkansas, across the nation, and the globe.
Marie Curie once said: “Nothing in life is to be feared; it is only to be understood. Now is the time to understand more, so that we fear less.” It is a principle that NCTR understands well.
I congratulate NCTR on 50 years of understanding more and better, and its achievements in getting us there.
And I look forward to watching the continued success of this important research facility in the years to come.