Stay up-to-date on NAMs, ISTAND, and developments for other new technologies on InnovApproach’s “NAM Insights” blog page.
Weight-of-Evidence: The Future of NAMs-Based Preclinical Strategy
Weight-of-Evidence has become a key phrase in drug development. It shows up in nearly every New Approach Methodologies (NAMs) guidance regulators have published over the last two years. It is quickly becoming the cornerstone of evaluating modern preclinical packages. A term this important ought to be well understood. Unfortunately, it isn’t. Too many NAMs developers…
A CRS Prediction Platform Just Entered ISTAND. It Could Change How Bispecific Antibodies Get to Patients.
Every FDA-approved T cell-engaging bispecific antibody carries a boxed warning for cytokine release syndrome (CRS). Seven of nine require mandatory hospitalisation during step-up dosing. In pivotal trials of BCMA-targeting bispecifics, any-grade CRS occurred in 59% of patients. Severe CRS (grade 3 or higher) occurred in 2%. These numbers shape every first-in-human trial for this drug…
The First Practical Guidance for Review of NAMs-Supported Trials Is Here!
On 14 July 2026, Bellberry and ASCEPT released the draft of their NAMs HREC Review Checklist: a risk-proportionate, hybrid-model guide for Australian Human Research Ethics Committees for first-in-human trials supported by New Approach Methodologies. The draft guidance is open for comment until 31 August. It is, to my knowledge, the first guidance document anywhere in…
The FDA Is About to Make US Clinical Trial Starts Much Faster
In a previous post, I argued the competitive stakes. Operation TrialBlazer names Australia’s speed as the benchmark the US wants to beat. This post is about what is actually on the table. Most coverage reads the package as one big acceleration play. It is not. It bundles two separate reforms for Expedited IND (with further…
Is the US trying to eat Australia’s lunch? The risk to Australia’s clinical trials advantage
Everyone is talking about the FDA’s proposed accelerated IND program. They are missing the startling document that spawned it. Concurrent with the FDA announcement, HHS (FDA’s parent department) published Operation TrialBlazer, a roadmap that sets the stage for FDA’s IND changes. Its intent is extremely clear. Start with who gets named. The roadmap discusses one…
Comparing the US, UK, and EU Roadmaps for Phasing Out Animal Testing: A Pharmaceutical Lens
Three jurisdictions, three emphases: NAMs, timelines, and chemicals. Three major regulatory jurisdictions have now published formal strategies for reducing and replacing animal testing in preclinical and safety science. The US FDA released its roadmap in April 2025. The UK published its strategy in November 2025. The European Commission (EC) followed with a formal Communication in…
Can You Trust a Preclinical Package Built Without Animals?
A question posed during a debate at the MPS World Summit last week really stuck with me: “Would you be the first person to take a medicine that had never been tested in an animal?” Really, this is asking something much more blunt: “Would you trust your life on NAMs?”. I realised, my answer was…
The NAMs Conundrum: Lots of Hype, Little Translation
Global regulators have spent the last two years making their position on New Approach Methodologies (NAMs) impossible to miss. The FDA has published a roadmap to phase out animal testing for monoclonal antibodies. The UK has released an aggressive strategy to replace animals in science. The EU will imminently publish its own roadmap toward phasing…
What NAMs Can’t Do (Yet): Identifying Gaps
Momentum behind New Approach Methodologies (NAMs) has accelerated rapidly in recent years. Regulators, industry, and academia are investing heavily in human-relevant technologies such as organoids, microphysiological systems (MPS), other complex in vitro models, and computational models. Governments have been clear. Replace animals in research wherever possible. Reduce everywhere else. This benefits human health and animal…
Existing NAMs May Already Cover Most Clinical Safety Risk
The past 12 months have shown an incredible focus on New Approach Methodologies (NAMs) to reduce our reliance on animals and incorporate human-relevant biology into drug development and preclinical studies. 2025 saw the US FDA’s roadmap to reduce animal testing and the UK’s strategy to phase out animals. Global regulators have clearly communicated that NAMs…
Eliminating Animals in Research Is the Goal. Even If We Fail.
The flurry of attention New Approach Methodologies (NAMs) have recently received has come with a range of ambitious promises. These include significantly improving safety and efficacy of new drugs and dramatically decreasing drug costs and development times. However, NAMs’ most controversial claim is the possibility of entirely replacing the use of animals in drug discovery…
Should Proof of Efficacy Be Required Before Human Testing?
The traditional focus of preclinical studies has always been on safety. And for good reason. Many global medical regulatory bodies can trace their origins to specific drug-related catastrophes. The core focus on preventing harm to humans extends to first-in-human trials of new drugs. Regulators often demand overwhelming evidence of the safety of a candidate drug…
ISTAND SNAPSHOT: What ISTAND Technologies Reveal About the Future of NAMs
The FDA’s Innovative Science and Technology Approaches for New Drugs (ISTAND) Program is one of the clearest windows into how New Approach Methodologies (NAMs) are moving from promise to regulatory reality. As of the 21st of January, 2026, 20 ISTAND technologies have now been disclosed in the FDA’s Drug Development Tool (DDT) database. 15 were accepted into the program and 5 rejected.…
NAMs Developers’ Number One Mistake: Poorly Defined Scope
2026 is already promising to be another huge year for the advancement of New Approach Methodologies (NAMs). From the hotly anticipated EU Roadmap Towards Phasing Out Animal Testing to recent publications from US HHS leadership, the adoption of new methods to reduce and replace animal testing is not slowing down. Of special interest is the…
New Approaches, New Opportunities: NAMs News to Watch in 2026
Medical research saw a tectonic shift in 2025. The promise of New Approach Methodologies (NAMs) to improve human health and replace animals in drug testing is no longer hypothetical. Global governments took notice and acted. In 2025: 2026 promises to deliver even more NAMs bombshells. We are likely to see new government initiatives, a multitude…
Animal-Free Medicine: NAMs Are Powering Human Clinical Trials Without Animal Research
How NAMs are powering animal-free clinical trials.
Navigating Global NAMs Regulators: Key Definitions Vary Significantly Between Different Governments
New Approach Methodologies (NAMs) have the potential to transform global drug development in the next few years. Global governments and regulators have recently put intense focus on integrating NAMs data to replace animal methods in drug development. This focus appears to have intensified in 2025 with different regulators in multiple regions seeking to use NAMs…
NAM Your Price: Will the Next Biotech Investment Trend be New Approach Methodologies?
Qualification of New Approach Methodologies will improve investor appeal.
Risk and Reward: How New Approach Methodologies (NAMs) Will Replace Animals in Medical Research
Scientific and regulatory sentiment has reached an inflection point. Around the world, governments are signaling a decisive shift toward replacing animal testing in biomedical research. The CDC is eliminating nonhuman primate use in agency laboratories. The FDA has published a comprehensive roadmap to “Phase Out” animal testing. The United Kingdom just released an aggressive action…
Microphysiological Systems (MPS) Are Beating Organoids in the NAMs Qualification Race
Microphysiological Systems (MPS) Are Beating Organoids in the NAMs Qualification Race
NAMs Crash Course: Everything You NEED to Know About New Approach Methodologies
New Approach Methodologies are revolutionizing drug development.
What’s in a NAM: Defining New Approach Methodologies in Regulatory Science
Confused about what “NAM” really means? Explore the many definitions of New Approach Methodologies (NAMs), why regulators are standardizing terminology, and what it means for safer, more ethical drug development.
Quality Systems: The Backbone of New Approach Methodologies Qualification
The qualification of a New Approach Methodology (NAM) through the FDA’s ISTAND Program represents a significant scientific and regulatory milestone. It signals that a NAM has demonstrated the utility and reliability necessary to be recognized as a trusted Drug Development Tool (DDT). However, qualification alone does not guarantee long-term success. For a NAM to deliver…
Context of Use: The Three Most Important Words in NAM Qualification!
Every successful regulatory submission for a New Approach Methodology (NAM) qualification is built around a clear, precise Context of Use (COU).
FDA ISTAND Snapshot: The Future of Qualified NAM Technologies
Explore the FDA ISTAND snapshot. See how NAMs, AI, and organ-on-a-chip technologies are advancing qualification under the FDA’s roadmap to reduce animal testing.
FDA Makes ISTAND Permanent: A Clear Pathway for NAMs and Novel Drug Development Tools
The FDA has made ISTAND a permanent qualification program. Learn how to qualify NAMs and novel Drug Development Tools and strengthen your FDA submissions.