FDA establishes research partnerships with four universities
The Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) announced on September 18 the creation of four Animal and Veterinary Innovation Centers (AVICs).
The AVICs have three areas of concentration:
- Highly pathogenic avian influenza (HPAI) and emerging zoonotic disease threats or One Health issues
- Intentional genomic alterations (IGAs) in animals and the advancement of regulatory science in this field, with a focus on IGAs that support agricultural resilience, food security, animal health, or public health
- Unmet veterinary medical needs in minor and major species that create a significant animal or public health burden
These centers will receive funding to advance regulatory science and further development of innovative products and approaches to support animal health and veterinary interventions, according to the announcement.
These AVICs are long-term partnerships with the FDA intending to address priority areas for the CVM’s Animal and Veterinary Innovation Agenda, which guides its plans to better protect human and animal health.
The four funding recipients are the Kansas State University, the University of Arkansas, the University of California-Davis (UC-Davis), and the University of Wisconsin-Madison.
Wisconsin will use the funding to explore the development of genome-edited chickens to reduce susceptibility to HPAI and other avian viruses. The research will involve genetically targeting pro-viral host factors, antiviral proteins, or viral genes.
UC-Davis will research intentional genomic alterations in livestock species to advance the use of gene editing technologies in food animals. Additional research will generate and share phenotypic and bioinformatic data to support a science-based approach to regulating IGAs in food animals.
Alison Van Eenennaam, PhD, is the co-primary investigator for this research and a distinguished professor of cooperative extension in the field of animal genomics and biotechnology at UC-Davis.
She says gene editing offers an approach to introduce IGAs into livestock breeding programs that result in useful characteristics, such as resistance to porcine reproductive and respiratory syndrome virus in pigs.
“Ultimately, this AVIC will help advance the safe application of gene editing in livestock to improve the sustainability of animal agriculture,” she told AVMA News.
Kansas State will develop models to evaluate the efficacy of analgesics in food animals in support of new drug approvals. Specifically, this work supports pain relief in pigs, goats, and cattle.
And finally, Arkansas will research the infection and formation of cyst-like Histomonas meleagridis—the cause of blackhead disease in turkeys–in vitro and in vivo. The university will identify the cellular pathways that facilitate encystation in H. meleagridis and screen inhibitors against encystation of H. meleagridis in vitro and in vivo.
Selecting the partnerships was done by a competitive cooperative agreement process to establish the AVICs and address health needs in priority areas, the FDA release says.
Funding is renewable for up to four years. The FDA CVM is still accepting applications for other AVIC opportunities.
The FDA CVM will work with Congress and partners to expand this new initiative and support animal and veterinary medical innovation, the agency says.
Expert panel selected to guide FDA CVM’s innovation agenda
The Reagan-Udall Foundation for the Food and Drug Administration (FDA) wants to figure out how best to address opportunities and challenges in animal health and veterinary medicine.
The foundation has created an expert panel to conduct this work, and the FDA will use this analysis to help its Center for Veterinary Medicine (CVM) identify areas where new or adapted regulatory approaches may be needed to accommodate innovative solutions, according to a September 18 press release. Overall, these efforts will contribute toward the FDA CVM continuing to implement its Animal and Veterinary Innovation Agenda.
As its first task, the panel will conduct a strengths, weaknesses, opportunities, and threats (SWOT) analysis.
“This SWOT analysis aims to research the challenges within, and unmet needs of, the animal health, animal food and veterinary industries, and explain the economic impact of these gaps,” the release states.
How the animal health sectors integrate with One Health will also be considered in the analysis. The panel expects to release its report in the second quarter of 2025.
Expert panel members are as follows:
- Dr. Lisa A. Tell, chair, professor of veterinary medicine at the University of California-Davis
- Caitlin Boon, PhD, U.S. public affairs director for health and nutrition at Mars
- Dr. Sathya Chinnadurai, senior vice president of animal health, welfare, and science at Brookfield Zoo Chicago
- Dr. Virginia Fajt, clinical professor at Texas A&M University School of Veterinary Medicine and Biomedical Sciences
- Randall Gnatt, JD, associate general counsel for U.S. regulatory at Elanco
- Dr. Michelle Kromm, principal at Food Forward, LLC
- Katelyn McCullock, AVMA chief economist
- Dr. Kurt Schrader, U.S. representative for Oregon's 5th Congressional District from 2009-23
In the meantime, the panel is asking for input from a variety of stakeholder perspectives, including veterinarians and pet owners. Input provided by November 15 will be considered as part of the panel’s deliberations. In addition, market research, roundtable discussions, and individual interviews will be used.