Summary of: Alliance Webinar with National Center for Toxicological Research Director Dr. Slikker, Jr.

Alliance for a Stronger FDA Webinar with National Center for Toxicological Research Director Dr. William Slikker, Jr.

The Alliance held an interesting and informative webinar with National Center for Toxicological Research (NCTR) Director Dr. William Slikker, Jr. His thoughtful presentation increased our understanding and appreciation for NCTR’s work on its own behalf as well as with all of FDA’s other Centers. The workload is large: NCTR may have between 200 and 250 projects underway at any one time.

NCTR with its thirty buildings covering nearly five hundred acres was developed on land that was once part of the U.S. Army’s Pine Bluff Arsenal. It had been the site for research into biological pathogens and the production of chemical warfare agents and offered prime facilities for NCTR’s mission.

During his presentation Dr. Slikker spoke about some of NCTR’s efforts, including the safe use of anesthetics in children, dealing with domoic acid in seafood, and research into veterinary medicine including safe pet food. The facility is organized around research expertise, working on biochemical toxicology, genetic and molecular toxicology, bioinformatics, and biostatistics, and more recently an increased role in artificial intelligence.

He spoke about NCTR’s various budget priorities. He offered particular emphasis on biomarker development and efforts to prioritize the most promising. He talked about the use of innovative technologies and how they compare with traditional technologies. Dr. Slikker discussed the need to identify and recruit skilled personnel, the use of on-site contractors, and what it takes to maintain staff today compared to three or four years ago.

Bioinformatics and artificial intelligence are a growing area of importance. Food safety is also a priority, including work on developing “close to zero” protocols for substances like arsenic and mercury in baby food. NCTR’s hiring and recruitment efforts include both a summer student program for undergraduates as well as work in training many PhDs and postdoctoral fellows. Each division has four to five postdoctoral fellows. NCTR has a “Wall of Fame” for the 1,300 individuals who have been trained at the facility.

Dr. Slikker highlighted certain key research areas including biomarkers, the Perinatal Center of Excellence, rare diseases, nanotechnology and nanotoxicology. He also suggested the need for NCTR to have “level 3” laboratories to be better prepared for challenges that lie ahead. He would like to see increased research on approaches to rare diseases so they can make it to clinical trials. Overall, hundreds of applications are coming in.

Dr. Slikker responded to several questions regarding 1/ the importance and immediacy of NCTR’s work, 2/ evaluating microplastics in food, 3/ the opportunities for companies, trade groups, and associations to be involved with NCTR, and 4/ the potential for patient advocacy organizations to collaborate with NCTR. He spoke about NCTR’s use of a computer automated system for all steps in a project, including document tracking. Research reports are reviewed and cleared internally and may have to be cleared by other Centers.

He repeated his emphasis on developing rare disease therapies as a critically underserved area, saying there is a need to do much better. He placed an emphasis on children and pregnant people in clinical trials and the identification of biomarkers.

The transcript of this webinar will be available shortly. We strongly encourage Alliance members to join in for several upcoming webinars that will help each of us supplement our knowledge of FDA’s vital work and expertise.

Editorial Note: The Analysis and Commentary section is written by Steven Grossman, Executive Director of the Alliance for a Stronger FDA, with special thanks this week to Roger Szemraj from OFWLaw.