As the fervor around ending animal testing in drug development has grown since President Donald Trump started his second term, a group of nonprofits, corporations and regulators has been meeting to discuss plans for creating alternative methods. Now, it's ready to invest in the projects with the most potential.
The Validation and Qualification Network (VQN) is an initiative of the Foundation for the National Institutes of Health (FNIH), a congressionally mandated nonprofit that supports the mission of the NIH. The network, publicly announced July 24, brings together dozens of partners from regulators, like the FDA and European Commission, to Big Pharmas and CROs, such as Sanofi, Novo Nordisk, GSK and Charles River Laboratories.
Today, the VQN sent out a call for new alternative method (NAM) developers to send in their ideas for network consideration. Submitted proposals will be reviewed on a rolling basis until Dec. 31, with the goal of choosing four projects in this first round of proposals, according to the notice.
Submitted projects should “clearly define how their proposed concept may reduce, replace or refine the use of live animals,” the network said, referring to a set of principles known as the 3Rs.
Because the space is flush with ideas right now, the job of the VQN will be “to take new approach methodologies that are well validated, or at least well on the pathway to validation, and push them towards acceptance for use in regulatory packages,” Stacey Adam, Ph.D., the FNIH’s vice president of science partnerships and translational science, told Fierce Biotech on July 29.
The FNIH’s process is the reverse of the NIH’s grants, Adam explained. Rather than giving a NAM developer money to go off and finish their project, the VQN will instead bring chosen projects in and hone their ideas with the collaboration of network partners.
“We may bring in people who you might think of a little bit as competitors,” Adam said. “Then, once we know that we've got the project team and the project designed and the budget that we need identified, we go out and fundraise.”
Funds to actually get the NAM over the regulatory finish line can come from network members themselves, and each member has already contributed modestly to the VQN, Charles River Chief Scientific Officer Julie Frearson, Ph.D., told Fierce on July 28.
“We've contributed monetarily, but a small amount,” Frearson said. “When we see some of the programs coming through, if we think they're particularly interesting and aligned to our roadmap, we have an opportunity to further invest, be that in dollars or in time and advice.”
Sanofi, too, “is investing capital and expertise” in the VQN as part of the pharma's work to "adopt new approach methods across the drug development value chain,” a spokesperson told Fierce. “We are delighted to partner with FNIH as part of a public-private effort to apply findings from in vitro, in silico and organoid models to human health and medicine.”
An organoid example
To illustrate how the VQN’s chosen projects will move forward, Adam used the example of a company developing liver organoids. A pre-competitive project team would be formed consisting of the organoid company and end users, like pharmas and CROs, as well as regulators like the FDA and any relevant nonprofits, like the Physicians Committee for Responsible Medicine.
“You retain your IP that you come in with, what we're asking you to do is help us think through the readouts from your organoids,” Adam said. “Can they all read out these five liver enzymes and 10 cytokines within these parameters? Do we all agree these are the right parameters, not just from you as the methods developer, but from the end user side? And then do the regulators believe that when they see data within these parameters, it's acceptable for their use?”
The goal of this alignment is not to change or dictate what the underlying NAM does, Adam added, but to standardize the method so that it can actually be adopted as a replacement for animal testing.
“We really do think that this will be a good central hub for getting these methods well-established and well-developed and accepted by the regulators for preclinical packages,” she said.
The VQN is especially interested in combinatorial projects, or a mixture of NAMs that, together, “create a better predictive scenario than current tests,” Charles River’s Frearson said.
“That could be an advanced cell model combined with an in silico computational model, for instance,” Frearson explained. “I think that's good because it's bringing the advanced cell model side of the field and the computational AI and modeling sides together. That's probably a big concept that's going to develop in this space over the next five to 10 years.”
A big push for gradual change
NAMs and animal testing have been a vocal priority of the second Trump administration. In April, the FDA announced a plan to phase out animal testing requirements for new monoclonal antibody drugs. and the NIH unveiled a new Office of Research Innovation, Validation and Application (ORIVA) to lead the agency’s charge on developing NAMs.
Since then, no public updates have been shared on ORIVA. When asked for an update on July 28, a NIH spokesperson referred Fierce to the new office’s original April 29 announcement.
Despite the recent buzz, the effort to reduce animal testing in favor of NAMs has been underway for years. The VQN falls under the NIH’s Complement Animal Research in Experimentation (Complement-ARIE) program, which was launched in January 2024 under former President Joe Biden.
For its part, the FDA published a report (PDF) in 2021 outlining the agency’s work on alternative methods and expressing the agency’s “strong commitment” to moving away from animal testing.
“There are, I don't think I'm overestimating to say, thousands of new approach methodologies that are out in the world already,” Adam said. “Everybody talks about it like it's a new, revolutionary thing. It's been around a while.”
Within the broader umbrella of Complement-ARIE there are two other pillars of focus, Adam said. Technology development centers will focus on early-stage research of NAMs, while a data hub and coordinating center will serve as a “central repository” for NAM data sets. The VQN sits at the end of the NAM development pipeline, when a technique is ready to be refined into a usable, accepted method.
The NIH brought the FNIH on board at the end of last year to facilitate the public-private partnership required for the VQN, Adam said. Since then, “we've been pushing really hard,” and the work hasn’t changed despite the shift in presidential administrations.
Still less than a year old, the VQN has been looking to the FNIH’s biomarkers consortium—which has been running since 2006 and has supported more than 40 projects—as a model of long-term success, Adam said.
Charles River's Frearson believes a big push on NAMs is needed to get them into the preclinical testing toolbox but said the CRO doesn’t foresee a future where animal testing is replaced entirely. She thinks animal testing will be more easily swapped out for some modalities, like monoclonal antibodies and cell therapies, than others.
Adam agrees. “There was a reason that they chose the name for the Complement-ARIE program that they did,” she said. “To complement animals in research experimentation.”
At the end of the day, no one technique will ever be able to fully capture the complexity of biology and replace all animals outright, according to Adam.
“My background is in animal modeling, so I have a strong passion to see it reduced and replaced,” Adam said. “But I do understand the old modelers adage: Every model is good for something, no model is good for everything.”