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2025 Microphysiological Systems Webinar

The 3Rs Collaborative has been hosting a series of webinars called ISTAND Program.

Iq mps webinar cover 2
View the webinar on Youtube.

On September 30, 2025, the 3RsC hosted Dr. York Tomita from the FDA to give an overview of FDA-CDER’s ISTAND Program. This webinar begins with a brief introduction to the workshop/webinar series, the 3RsC, and the IQ. Then, Dr. Tomita gives an overview of the ISTAND Program, followed by an audience Q&A.

NIH Standardized Organoid Modeling (SOM) Center

Organoids are small, lab-grown models that mimic the structure and function of human organs and are transforming how researchers study disease and test treatments. Yet most organoid models today are created through trial-and-error, making them difficult to reproduce across labs and slowing their adoption across research and industry. The Standardized Organoid Modeling (SOM) Center will be the nation’s first fully integrated platform dedicated to developing standardized organoid-based New Approach Methodologies (NAMs). The initiative is being launched by the NIH Division of Program Coordination, Planning, and Strategic Initiatives, in collaboration with many other NIH Institutes, Centers, and Offices, including the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases’ (NIAID) Research Technologies Branch and Center for Human Immunology, Infection and Autoimmunity, the National Human Genome Research Institute (NHGRI) the National Center for Advancing Translational Sciences (NCATS), and the Office of Research on Women’s Health, with plans to expand partnerships across many other NIH institutes and centers and the broader scientific community.

Learn more.

NIH establishes nation’s first dedicated organoid development center to reduce reliance on animal modeling

The Standardized Organoid Modeling Center aims to produce standardized protocols for organoid research, addressing reproducibility challenges.

09/26/2025, the National Institutes of Health (NIH) announced the award of contracts for launching the Standardized Organoid Modeling (SOM) Center, a national resource that will be dedicated to using cutting-edge technologies to develop standardized organoid-based new approach methodologies (NAMs) that deliver robust, reproducible, and patient-centered research findings. With contracts totaling $87 million for the first three years, the center will be housed at the Frederick National Laboratory for Cancer Research (FNLCR), a facility supported by NIH’s National Cancer Institute (NCI). The center’s goal will be to leverage the latest technologies to enable real-time optimization of organoid protocols.

Learn more on NIH Press Release.

Report: Incorporating new approach methodologies in the development of new medicines (NC3Rs)

NC3Rs logoReport from the NC3Rs, in collaboration with the ABPI and MHRA, explores how New Approach Methodologies (NAMs) can transform the way medicines are developed – harnessing cutting edge human-relevant technologies and reducing reliance on animal testing.

New approach methodologies, more commonly known as NAMs, are technologies that replace or reduce the use of animals in safety testing. They include advanced in vitro models such as organoids and organ-on-a-chip systems, in silico tools including AI and modelling approaches, and other human-relevant approaches that are already contributing to decision-making across the medicines development pipeline.

Read and download the full report

NABR Webinar: “From Promise to Practice: The Current Landscape of New Approach Methodologies”

Event Date: Oct. 7, 2025, at 12:30 p.m. Eastern Time

Speaker: Dr. Szczepan Baran

“From Promise to Practice: The Current Landscape of New Approach Methodologies.”

Host: The National Association for Biomedical Research (NABR)

An abundance of viewpoints have been in the news and on social media surrounding the FDA announcement on April 10, about their Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs; the NIH announcement creating the Office of Research Innovation, Validation, and Application (ORIVA) later on the same month; and the July 7 announcement by the Acting Deputy Director of the Division of Program Coordination, Planning and Strategic Initiatives (DPCPSI) within the NIH Office of the Director that “all new NIH-funded opportunities moving forward should incorporate language on consideration of NAMS” and “The NIH will no longer seek proposals exclusively for animal models.”

The National Association for Biomedical Research (NABR) have invited a special guest speaker to help us understand what all this means as pressure mounts to modernize biomedical research. New Approach Methodologies (NAMs) including in vitro, in silico, and human-relevant models — are gaining visibility as alternatives to traditional animal studies. But visibility does not always equate to implementation. This presentation will offer a high-level yet practical overview of where we stand today with NAMs: which technologies are maturing, which are overhyped, and where policy, infrastructure, and culture must evolve to enable true transformation. Drawing from experiences across regulatory science, industry, and academia, Dr. Szczepan Baran will explore what it takes to bridge scientific innovation with real-world impact — ethically, efficiently, and collaboratively.

Register for Event

FNIH-Seeking Concepts for NAMs Pilot Projects

Foundation for the National Institutes of Health (FNIH) LogoThe Foundation for National Institutes of Health (FNIH) is inviting the scientific community to submit project concepts to help them study New Approach Methodologies (NAMs). The goal is to build scientific confidence in human-based research models, with a focus on regulatory acceptance.

This initiative is part of the Complement-ARIE NAMs Validation & Qualification Network (VQN), a program managed by the FNIH in partnership with NIH and other federal and private stakeholders.

Applications must be submitted by Aug. 31, 2025 at 8 p.m. ET to be considered during the first cycle of review. After that, rolling reviews will be completed every one-two months, depending on the volume of submissions, through Dec. 31, 2025.

Open to Government, industry, academia, and NGOs.

Visit the FNIH-Seeking Concepts for NAMs Pilot Projects site to learn more.

Concept Requirements

Submitted concepts should clearly define the intended application and Context of Use (COU).

Examples for COU may include but are not limited to: safety evaluations for specific organ toxicities (e.g., hepatotoxicity, cardiotoxicity, etc.) for pharmaceuticals, consumer products, pesticides, and other regulated substances; prioritization of lead candidates in therapeutic pipelines; and delineation of specific disease processes.

Applicants are strongly encouraged to clearly define how their proposed concept may reduce, replace, or refine the use of live animals. Proposals without a defined 3Rs impact will be considered incomplete.

Concepts submitted through this RFI are not formal applications for funding. Instead, they will inform the strategic design of cooperative, precompetitive studies to advance human/species-relevant alternatives in biomedical research.

This is an opportunity to co-develop regulatory-ready NAMswith cross-sector stakeholders, including government, industry, academia, and NGOs.

Submission form title: Request for Information (RFI) on Concepts for New Approach Methodologies (NAMs) Precompetitive Projects for the Complement Animal Research In Experimentation (Complement-ARIE) NAMs Validation and Qualification Network (VQN) Public Private Partnership (PPP).

Links

Stay current on FNIH announcements on LinkedIn.

Webinar: A team approach to reducing lab animal suffering: one procedure at a time

Join Responsible Research for a Free 1hr webinar on taking a team approach to refining the lifetime experiences of laboratory animals. Drs Nikki Osborne and Penny Hawkins will introduce resources for reducing and avoiding severe suffering and examples of how to use a Roadmap in your organization.

Date: September 10, 2025
Time: 2:00pm BST (9:00am EST)
Venue: Online

Register for Webinar at Responsible Research-United Kingdom.

Webinar: Mastering NAMs Literature Searches

Animal-Free Workshop Series for Early-Career Researchers

The fourth session in this Workshop Series features Rob Wright, MLS, from Johns Hopkins University’s Welch Medical Library. Participants will learn a structured new approach methodologies (NAM) focused approach to searching the scientific literature using PubMed. This hands-on workshop includes a demonstration on building a targeted search concept and will guide participants through best practices in search strategy development.

Date: October 29, 2025
Time: 10:00 am EST
Venue: Online via Zoom

Co-organized and jointly curated by Dr. Kathrin Herrmann (CAAT Education Program Director) and Mikalah Singer (Science Policy Specialist, Physicians Committee for Responsible Medicine).

Register for Workshop.

New Approach Methodologies (NAMs)

NAMs, or New Approach Methodologies, is a term defined by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). ICCVAM is a federal committee under the U.S. Department of Health and Human Services (HHS) and coordinated by the National Institutes of Health (NIH):

The formal definition was originally emphasized by current NIH leadership during their oversight of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) which describes “any technology, methodology, approach, or combination thereof that can be used to provide information on chemical hazard and risk assessment that replaces, reduces, or refines the use of animals.” Our broader interpretation remains compatible with that definition, while expanding its application to include any approach that advances scientific understanding, including in fields such as biomedical research, drug development, and safety assessment, in a way that replaces, reduces, or refines the use of animals.

But depending on who you’re talking to, NAMs can also refer to:

Novel Alternative Methodologies

Non-Animal Models (which are a subset of NAMs, falling under the Replacement principle of the 3Rs)

Across all interpretations, the focus is clear: NAMs are tools and strategies that support innovation, improve translational science, and reduce reliance on animals.

NAMs are not new. You’re probably already doing a lot.

Let’s Move Progress Forward Together

You may have noticed that some recent Notices of Funding Opportunities (NOFOs) now reference non-animal models or New Approach Methodologies (NAMs). This does not mean that proposals must include NAMs or exclude animal research.

In fact, proposals may fall into any of the following categories:

  • Animal research only
  • Animal research combined with NAMs
  • NAMs-only approaches

What’s changing is the scope of the NOFO, not the requirement for each individual grant.

Previously, many NOFOs were written to support only animal-based models.

The new language reflects a broader, more inclusive framework encouraging innovation across the 3Rs: Replacement, Reduction, and Refinement.

Wondering What’s Going on With NAMs?

You’re not alone. With NAMs in the spotlight—featured in federal initiatives, public discussions, and policy shifts—it’s natural to have questions:

What exactly counts as a NAM?

• How are NAMs being used in research right now?

• How do NAMs fit into the 3Rs (Replacement, Reduction, Refinement)?

• And what do they mean for the future of biomedical science?

This space is designed to help.

Here, we’ll share:

✨ Trusted definitions and updates

🔬 Examples of how NAMs are already in use

📚 Resources to explore

🧭 Opportunities for innovation

🔬 Ways we’re already making progress

The Bottom Line?

We are proud of our ongoing efforts to advance ethical, high-quality science—and we’re committed to continual progress. NAMs aren’t just future concepts. They’re active tools in today’s research landscape, helping us move toward more humane, predictive, and innovative science.

Stay tuned for more updates and examples. Let’s explore NAMs together.

Calling All 3Rs Innovators

Are you advancing Replacement, Reduction, or Refinement in your research?

Whether you’re:

  • Developing a non-animal model (Replacement)
  • Designing studies that use fewer animals more effectively (Reduction)
  • Enhancing animal welfare through improved procedures or technology (Refinement)

We want to hear from you!

Contact aco3rs@uw.edu.

UW’s 3Rs & NAMs Innovator Survey

Feature Your Work

We’re building a showcase of real-world 3Rs innovation, and we’d love to highlight your project. Share how your research is driving ethical, efficient, and forward-thinking science. From early-stage pilots to published programs, we welcome a wide range of work.

Need Help Framing the 3Rs in Your Proposal?

Describing the 3Rs and NAMs clearly in grants, protocols, or outreach can be challenging. We can help you:

  • Identify how your work supports the 3Rs.
  • Use trusted definitions and ICCVAM-aligned language.
  • Connect your project to emerging trends and expectations.
  • Reach out today to collaborate, get feedback, or be featured.

Not Sure if Your Work Qualifies as a NAM?

We can help.

You may already be doing things that count. We’re here to support you in describing, framing, and highlighting those efforts.

Reach out to us if you’d like help aligning your proposal with current language or showcasing your innovative approach.

3Rs Certificate Course

This fully virtual, self-paced training is designed to elevate understanding and application of the 3Rs—Replacement, Reduction, and Refinement—across your organization.

CITI Program Course

NIH-How Does the NIH Initiative to Prioritize Human-Based Research Affect Research Proposing the Use of Laboratory Animals? (July 18, 2025)

NIH-Director’s Desk” The Future of Animal Testing (YouTube PodCast) (July 10, 2025)

FDA-NIH Workshop: Reducing Animal Testing (July 7, 2025)

Letter to NIH/FDA (July 14,2025)

NIH to prioritize human-based research technologies (April 29, 2025)

3Rs certificate course

Driving Progress Through the 3Rs and NAMs

3rs with nams

New Approach Methodologies: Complement Animal Research In Experimentation (ARIE)

Read the full article: Complement-ARIE: Catalyzing the development and adoption of new approach methodologies DirectScience.com.

Abstract:

NAM journal coverNew approach methodologies (NAMs) are proving to be invaluable tools in basic and clinical research to better understand human health and disease, elucidate mechanisms, and study the efficacy and toxicity of novel therapeutics that can improve upon and complement animal-based methodologies.

Over the last 15 years, the National Institutes of Health (NIH) has increased investment in NAMs, including in chemico, in silico, and in vitro approaches, such as cell-free assay systems, digital twins, and microphysiological systems (MPS). To further catalyze and innovate the use of NAMs, the NIH Common Fund has initiated a new program, Complement Animal Research In Experimentation (Complement-ARIE), which aims to pioneer the development, standardization, validation, and regulatory use of combinatorial NAMs that will more accurately model human biology and disease states.

This program specifically aims to 1) better model human health and disease differences in outcomes across populations, 2) develop NAMs that can provide insights into specific biological processes or disease states, 3) validate mature NAMs to support regulatory use and standardization, and 4) complement traditional animal models to make research more efficient and effective.

To inform the implementation of Complement-ARIE, the NIH organized strategic planning activities including an inter-agency retreat, public listening sessions, scientific literature landscape analysis, and a challenge prize. Here we discuss the goals and findings of these activities, and how these results helped identify and address scientific and operational opportunities and roadblocks for implementation of the program towards broader acceptance and impact of NAMs. We anticipate these new methods and approaches could transform the way we do basic, translational, and clinical sciences.