FDA phasing out animal testing for monoclonal antibodies and other drugs, NAMs as part of the solution for the simplification of REACH, AI-enabled precision medicine drug discovery and more
News on non-animal methods
APRIL 14 - 18, 2025NEWS, REPORTS & POSITION STATEMENTS
1. FDA announces plan to phase out animal testing requirement for monoclonal antibodies and other drugs
On April 10th, the U.S. Food and Drug Administration (FDA) announced taking a groundbreaking step to advance public health by replacing animal testing in the development of monoclonal antibody therapies and other drugs.
The FDA’s animal testing requirement will be potentially replaced using a range of approaches, including AI-based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting. Implementation of the regimen will begin immediately for investigational new drug (IND) applications, where inclusion of NAMs data is encouraged, and is outlined in a roadmap also just being released. “This initiative marks a paradigm shift in drug evaluation and holds promise to accelerate cures and meaningful treatments for Americans while reducing animal use,” said FDA Commissioner Martin A. Makary.
2. NAMs as part of the solution for the simplification of REACH
On March 19th, the European Parliament hosted an informative lunch gathering MEPs and other stakeholders to explore NAMs as part of the solution for the simplification of REACH. The event was supported by MEP Jutta Paulus (The Greens/EFA), scholar Aleksandra Čavoŝki.
After a previous report and event dedicated to the barriers to the adoption of NAMs, this event focused on solutions, and Laura Holden from the School of Law, University of Birmingham, presented recent findings of EU research project PrecisionTox on solutions to overcome barriers to the adoption of NAMs for accelerating and improving chemical risk assessment in the EU.
3. Is regulatory science ready for artificial intelligence ?
Trust is key in AI (artificial intelligence) for regulatory science, but its definition is debated. If AI models use different features yet perform similarly, which should be trusted ? If scientific theories must be testable, how critical is explainability ? This year, the 14th Global Summit on Regulatory Science (GSRS) was hosted by FDA with a theme on Digital Transformation in Regulatory Science, a 3‑day event with speakers from across the globe.
In a new perspective article, Prof Hartung and colleagues summarised GSRS conference discussions with a specific focus on the readiness of regulatory science for AI, including stakeholders perspectives on building trust, considering both technical and societal aspects, emphasizing strategies to maximize AI’s benefits while mitigating potential risks in regulatory applications.
Read the article in Nature digital medicine
INTERVIEWS, NOMINATIONS & AWARDS
4. EDITH CSA : the ethics and the Virtual Human Twins
The European project EDITH has the objective to develop the architecture of a simulation platform that will support the transition towards an integrated Virtual Human Twin (VHT).
The development of a strategic approach for clinical deployment of the VHT model will require the identification of implementation needs and barriers, including the ethics. Prof Signe Mezinska, associate professor at the University of Latvia, the Deputy Chairwoman of the UNESCO International Bioethics Committee, discusses and explains the ethical challenges of the VHT project.
TOOLS, PLATFORMS, CALLS
5. FNIH : validation & qualification network design phase
Researchers have increasingly been working to develop new laboratory models that more accurately represent human biology compared to traditional models. The goal of the NIH-funded Complement-ARIE program is to complement, and in some cases replace, traditional animal testing with NAMs, while providing more cost-effective, human-relevant results.
The Foundation for the NIH (FNIH) is collaborating with the NIH to establish a Validation & Qualification Network (VQN) as part of a new public-private partnership that would accelerate the deployment and regulatory implementation of NAMs. The VQN will establish common data elements and standardize reporting for preclinical, clinical, and safety performance. In addition to the VQN, Technology Development Centers and the NAMs Data Hub and Coordinating Center are the other components of the Complement-ARIE program.
6. Value of information analysis for in silico evidence on regulatory decision
The UK Centre of Excellence on in-silico Regulatory Science and Innovation CEiRSI’s latest webinar explores how Bayesian decision theory can transform the use and evaluation of in silico evidence for healthcare regulation and funding decisions.
This groundbreaking workshop presented by leading experts demonstrates :
• How to quantify uncertainty in regulatory decisions
• When in-silico evidence is sufficient for approval
• When additional evidence collection is necessary
• How to balance innovation access with evidence requirements
INDUSTRY, BIOTECH & PARTNERSHIPS
7. MultiOmic Health and Alloy Therapeutics collaborate to discover and develop renal tissue-targeting drugs
MultiOmic Health Limited (MOH), an AI-enabled precision medicine discovery company focused on chronic multifactorial diseases, and Alloy Therapeutics Inc. (Alloy), a biotechnology ecosystem company dedicated to democratizing access to cutting-edge drug discovery technologies, announced they have signed a Memorandum of Understanding to jointly discover and develop first-in-class renal tissue-targeting drugs.
Alloy will deploy its bispecific antibody and genetic medicine platforms to engineer drugs that will modulate MOH-identified drug targets in specific kidney cell types. Leveraging its renal biology and pharmacology expertise, MOH will collaborate with Alloy to select optimal preclinical development candidates. “We were impressed by MOH’s patient stratification and target discovery platform while reviewing the drug targets they proposed”, said Mike Schmidt, Alloy Therapeutics’ Chief Scientific Officer.
8. Plex Research Partners with Ginkgo Bioworks on AI-powered drug discovery
Plex Research, a biotechnology company using autonomous AI to aid in drug discovery, announced that it is partnering with Ginkgo Datapoints, a service of Ginkgo Bioworks, to deepen the understanding of compound treatment mechanisms of action, potentially revealing new therapeutic applications, based on a large perturbation response profiling dataset.
Perturbation response profiling is a powerful method for mapping how cells respond to genetic or chemical changes. “AI is a game-changer for efforts to discover exciting new uses for existing treatments that can be brought to patients more quickly,” said Doug Selinger, Ph.D., CEO and co-founder of Plex Research.
SCIENTIFIC DISCOVERIES & PROTOCOLS
9. Human assembloid model of the ascending neural sensory pathway
Somatosensory pathways convey crucial information about pain, touch, itch and body part movement from peripheral organs to the central nervous system. Despite substantial needs to understand how these pathways assemble and to develop pain therapeutics, clinical translation remains challenging. This is probably related to species-specific features and the lack of in vitro models of the polysynaptic pathway.
In a new study published in Nature, a research team established a human ascending somatosensory assembloid, a four-part assembloid generated from human pluripotent stem cells that integrates somatosensory, spinal, thalamic and cortical organoids to model the spinothalamic pathway. Transcriptomic profiling confirmed the presence of key cell types of this circuit. Additional experiments demonstrated the ability to functionally assemble the essential components of the human sensory pathway, which could accelerate our understanding of sensory circuits and facilitate therapeutic development.
Read the publication in Nature
10. Sequential orthogonal assays for longitudinal and endpoint characterization of 3D spheroids
Spheroids are reaggregated multicellular three-dimensional structures generated from cells of healthy as well as pathological tissue. Basic and translational spheroid application across academia and industry have led to the development of multiple setups and analysis methods, which mostly lack the modularity to maximally phenotype spheroids.
A new Nature Protocol article presents the self-assembly of single-cell suspensions into spheroids by the liquid overlay method, followed by a modular framework for a multifaceted phenotyping of spheroids. The presented complementary techniques can be readily adopted by researchers experienced in cell culture and basic molecular biology. The authors anticipate that this modular protocol will advance the application of three-dimensional biology by providing scalable and complementary methods.
Read the method in Nature Protocol
