Updates

NIH ORIVA holds workshop on human-based models

ORIVA's innovation division convened a one-day workshop on current human-based models and their use in disease research.

EFSA workshop on applying the EU roadmap to pesticides and biocides

Two-day workshop in Parma on implementing the Commission roadmap in pesticide and biocide assessments.

TGA publishes its position on NAMs

Weight-of-evidence approach. NAMs may need to run alongside animal studies where uncertainty remains.

EFSA publishes scoping review of in silico and PBK models

External scientific report reviewing existing in silico and physiologically based kinetic models for humans and rats.

SystImmune reports IND clearance with a NAM-based safety package

Company says organ-on-chip and primary human tissue models replaced conventional animal toxicology for bispecific SI-B037. FDA has not commented publicly.

Polyphron: Venture financing, Seed

Seed to build an automated human tissue foundry and AI tissue models.

New approach methodologies in neurotherapeutics development

Government, academic and industry view of NAMs for CNS drugs, including blood-brain barrier and neurotoxicity models.

Emulate files full qualification package for Liver-Chip

Final step of three in ISTAND. If FDA qualifies it, it would be the first organ-chip drug development tool, for DILI assessment.

EPA announces changes to new chemical and pesticide reviews

Two changes aimed at modernizing safety reviews while reducing reliance on animal tests.

CN Bio: Grant / non-dilutive, Innovate UK

Grant to use organ-on-chip models to cut animal use in pharmacokinetic studies.

MIMETAS: M&A, Majority stake

Bruker took a majority stake in MIMETAS to pair organ-on-chip models with its multiomics and imaging tools.

Tracxn counts 46 organ-on-chip companies and about $478M raised

Tracxn's 2026 sector report covers 46 companies in 16 countries with about $478M across 67 equity rounds. Five countries hold about 99% of disclosed equity.

House passes FDA Modernization Act 3.0 (H.R. 2821)

Passed by voice vote and received in the Senate on Jul 21. The Senate must pass the House bill before it goes to the President. No final vote found as of this update.

Crown Bioscience joins C-Path's NAMs Developer Coalition

Crown Bioscience became the coalition's ninth member, adding patient-derived models and biomarker expertise.

Simulations Plus faces law-firm inquiry after guidance cut

A law firm announced an inquiry, citing a revenue guidance cut, a $77.2M impairment charge and an auditor dispute. No wrongdoing has been established.

Exponential toxicology

Argues chemical exposure grows faster than animal testing can scale, so testing must move to high-throughput, computational and AI methods.

Xellar Biosystems: Venture financing, Series A / A+

Series A and A+ to scale organ-chip data generation, automation and virtual cell models.

Charles River Laboratories: Partnership

Charles River joined Lilly's TuneLab AI/ML platform to contribute nonclinical testing expertise.

ALTEX review: FDA year one still leaves animal testing as the default

Commentary argues FDA met its process goals but animal studies remain the starting point, and calls for more specific commitments in year two.

NIH formally launches ORIVA

New office with two divisions: DAIBR for extramural NAM investment, and D-NICEATM, which absorbs NICEATM.

EPA updates its accepted NAMs list for TSCA and FIFRA

First update in five years. Adds 13 methods from external authoritative bodies and opens a nomination process.

EU roadmap to phase out animal testing in chemical safety assessments

22 actions and 30+ recommendations across 15 legislative domains, from industrial chemicals to pharmaceuticals, with indicators, a public dashboard and a 2029 review conference.

Draft guidance: oncology biologics and conjugates, streamlined nonclinical safety

Weight-of-evidence approach centered on three-month toxicology studies for certain oncology biologics and conjugated products.

PhenoVista Biosciences: M&A

InSphero bought San Diego imaging and phenotypic assay provider PhenoVista to expand in the US.

C-Path launches NAMs Developer Coalition

Precompetitive coalition of NAM developers working with regulators on shared validation and qualification standards.

Human organoids: Fit for drug discovery?

PSC-derived organoid screening: readouts, ML methods, and open problems in assay robustness, throughput and standardization.

ProxyBio: Venture financing, Seed

Investment to scale patient-derived organoid and AI products for drug response and safety.

Certara: Divestiture

Certara is selling its regulatory and medical writing unit ($50M of 2025 revenue) to focus on model-informed drug development.

FDA Year One progress report on reducing animal testing

FDA says first-year goals were met: ISTAND made permanent, a NAMs acceptability database, and its first qualified AI drug development tool. Critics note animal studies remain the default starting point.

Reimagining human-centric drug development with new approach methodologies

Synthesizes biological and computational NAMs and the regulatory reforms positioning them as a complement to or replacement for animal testing.

New approach methodologies for drug discovery

Review of stem cell, organoid and in silico NAMs across discovery, plus the biological, technical and regulatory bottlenecks to adoption.

Emulate organ chips fly on Artemis II

Organ chips containing astronauts' bone marrow cells flew on the Artemis II lunar mission in April 2026.

Vanda says FDA's NAMs draft guidance is too cautious

Vanda Pharmaceuticals asked FDA to withdraw and rework the draft, arguing it adds barriers instead of removing them.

NIH Complement-ARIE: Government funding

First Complement-ARIE awards: five NAM technology centers, a data hub, a validation network and a $7M challenge with FDA and EPA.

Draft guidance: General Considerations for the Use of NAMs in Drug Development

CDER validation framework built on context of use, human biological relevance, technical characterization and fit for purpose. Comments closed May 18, 2026.

Complement-ARIE first awards ($150M+)

Five NAM technology development centers, a NAMs data hub, a validation and qualification network with FNIH (about $20M), and a $7M challenge run with FDA and EPA.

Microphysiological systems to accelerate and de-risk AAV gene therapy development

Proposes organoids and organ-chips as a human-relevant filter for AAV tropism, liver toxicity and immune response.

Endotoxin testing Q&A update backs non-animal reagents

Updated pyrogen and endotoxin questions and answers supporting a shift away from horseshoe crab-derived reagents.

Charles River (discovery sites): M&A

IQVIA agreed to buy Charles River's five in vitro discovery sites and a small-molecule AI platform.

New approach methodologies (NAMs) for improved developmental and reproductive toxicity (DART) assessment with focus on endocrine disruption: a PARC project

EU PARC work on human-relevant NAMs for developmental and reproductive toxicity and endocrine disruption.

Inductive Bio tops the OpenADMET-ExpansionRx blind challenge

Its Beacon ADMET models placed first among 370+ submissions in a blind challenge run with Expansion Therapeutics.

EPA recommits to ending mammalian testing by 2035

Administrator memo revives the 2035 goal first set in 2019 and rescinded in 2021.

Challenges and opportunities for human Organ Chips in FDA assessments and pharma pipelines

Organ Chips are widely explored in pharma labs but not yet built into development pipelines; reviews what must change to get there.

PathoQuest: M&A

Charles River exercised its option to buy NGS viral safety firm PathoQuest to expand in vitro QC testing.

Charles River's incoming CEO calls the NAM shift an evolution

In January 2026, Birgit Girshick told Fierce Biotech the industry will run hybrid approaches and Charles River is not giving up on animal models.

Senate passes FDA Modernization Act 3.0 (S.355)

Passed by unanimous consent. Directs FDA to issue an interim final rule within one year replacing animal-specific language in its regulations with nonclinical language.

A CDER perspective: Landscape of New Approach Methodologies (NAMs) submitted in drug development programs

15 years of submission data: 93% of NAM submissions were in silico (49%) or in vitro (44%). 3D and organ-chip data were less common than standard in vitro models.

Inductive Bio: Government funding, ARPA-H CATALYST

DATAMAP project to build AI liver and heart toxicity models trained on organoid, ex vivo tissue and MPS data, with FDA input on regulatory fit.

Deep Origin: Government funding, ARPA-H CATALYST

PREDICTS consortium to build in silico and ex vivo models that predict drug safety and dosing before clinical trials.

Revalia Bio (Draper-led team): Government funding, ARPA-H CATALYST

ARPA-H CATALYST team led by Draper with Revalia Bio, Yale and LifeShare Network, building AI models on human organ, organ-chip and multimodal data. Revalia reports the award as up to $26.7M.

ARPA-H names CATALYST performer teams

Up to $125M over 4.5 years for AI and computational ADME-Tox models meant to support regulatory filings. Eight teams: Draper (with Revalia Bio), Deep Origin, Inductive Bio, Jackson Laboratory, Black Mesa Technology, Cedars-Sinai, Peptilogics and UNC Chapel Hill.

Draft guidance: monoclonal antibodies, streamlined nonclinical safety studies

Draft guidance to reduce or remove certain nonhuman primate studies for monoclonal antibodies.

Integrating New Approach Methodologies (NAMs) into Preclinical Regulatory Evaluation of Oncology Drugs

Reviews organoid, organ-chip and AI-based NAMs for oncology and their regulatory context.

FDA/CDER/OND Experience With New Approach Methodologies (NAMs)

CDER reviewers describe how NAMs became accepted alternatives and what they look for in NAM submissions.

UK Government: Government funding

Funding behind the UK strategy to replace animals in science, alongside dated targets for specific tests.

UK strategy: Replacing animals in science

GBP 75M, a new validation center (UKCVAM) and dated targets: skin and eye irritation and skin sensitization tests replaced by end of 2026, Botox potency tests by 2027, fewer dog and primate PK studies by 2030.

BeCytes Biotechnologies: M&A

BioIVT bought the Barcelona human tissue and primary cell supplier to grow its European preclinical business, citing rising demand for NAMs.

Charles River forms a NAMs scientific advisory board

Cross-functional board led by former FDA official Namandje Bumpus to guide regulatory acceptance and adoption of NAMs.

DOPPL: M&A

InSphero acquired Lausanne organoid company DOPPL.

Challenges and solutions in measuring commonly used biomarkers for drug-induced liver injury in a liver-on-a-chip platform

FDA scientists found standard ALT activity assays can fail in liver-chip perfusate and urea and albumin assays need care. Assay choice can explain conflicting DILI results.

Complement-ARIE Reduction to Practice Prize launched

Prize competition for NAMs that can show practical, real-world viability.

Revalia Bio: Venture financing, Seed

Seed to launch Human Data Trials on perfused donor organs.

Cellbox Labs: Grant / non-dilutive

Non-dilutive funding for gut-on-chip systems with built-in sensors.

EMA qualification opinion for the Simcyp PBPK platform

First PBPK platform qualified for EU regulatory submissions, for defined CYP-mediated drug-drug interaction contexts of use.

NIH unified strategy on human-based NAMs

NIH restated its commitment to promote human-based methods and reduce animal use across its portfolio.

NIH stops issuing animal-only funding opportunities

NIH no longer releases funding opportunities focused exclusively on animal models.

Parallel Bio: Venture financing, Series A

Series A to scale its immune organoid platform; eight pharma partners reported.

Vivodyne: Venture financing, Series A

Series A to scale robotic human tissue testing as pharma demand rose after the FDA roadmap.

Inductive Bio: Venture financing, Series A

Series A to expand its ADMET data consortium and Compass prediction software.

Application of new approach methodologies for nonclinical safety assessment of drug candidates

Cross-pharma review of cases where animal models fell short and four drug candidate categories where human in vitro approaches apply today.

NIH initiative to prioritize human-based research

NIH said it would create ORIVA and judge methods in funding applications on suitability, context of use, translatability and human relevance.

Organovo relaunches as VivoSim Labs for NAM toxicology

The Nasdaq-listed company now offers liver and intestinal toxicology services on 3D human tissue models.

FDA roadmap to reduce animal testing in preclinical safety studies

Stepwise plan that starts with monoclonal antibodies and aims to make animal studies the exception within three to five years.

MatTek: M&A

Sartorius bought MatTek and Visikol from BICO for $80M; MatTek had more than $20M of 2024 sales.

Axiom Bio: Venture financing, Seed

Seed to replace animal liver toxicity testing with AI models trained on human hepatocyte imaging data.

Quris-AI: Partnership

Merck KGaA integrated Quris-AI's platform for preclinical small-molecule safety evaluation.

HUB Organoids: M&A

Merck KGaA's life science arm bought organoid pioneer HUB, adding its patent estate and screening services.

Newcells Biotech: Venture financing, Series B

Series B for a UK human cell and organoid assay developer, per Tracxn.

MEPSGEN: Venture financing, Series C

Series C for an organ-on-chip developer, per Tracxn.

AxoSim: Venture financing, Series A

Series A for nerve-on-chip and brain organoid models, per Tracxn.

Nortis (Numa Biosciences): M&A

Quris-AI acquired the assets of kidney-on-chip developer Nortis and said it would continue Nortis's collaborations with the FDA, research institutes and pharma.

ISTAND accepts first organ-chip submission

FDA accepted Emulate's letter of intent for a Liver-Chip tool to assess drug-induced liver injury, the first of three qualification steps.

Chemaxon: M&A

Certara agreed to buy cheminformatics provider Chemaxon, expected to post more than $20M of 2024 software revenue.

CN Bio: Venture financing, Series B

Series B to fund global expansion of PhysioMimix organ-on-chip systems.

The Current Status and Use of Microphysiological Systems by the Pharmaceutical Industry: The IQ MPS Affiliate Survey and Commentary

Surveys of 20+ pharma companies (2019 and 2021) on MPS resourcing, organs of interest, contexts of use and barriers to using MPS data in submissions.

Applied BioMath: M&A

Certara acquired QSP specialist Applied BioMath to build a larger QSP practice.

Inductive Bio: Venture financing, Seed

Seed round for machine learning models of small-molecule ADMET.

Vivodyne: Venture financing, Seed

Seed round to build a robotic, AI-driven platform that tests drugs on lab-grown human tissues.

Instem: M&A, Take-private

Healthcare private equity firm ARCHIMED agreed to take Instem private; the deal closed in November 2023.

Immunetrics: M&A

Simulations Plus bought QSP modeling firm Immunetrics, adding oncology and immunology models.

Industry Adoption of Organoids and Organs-on-Chip Technology: Toward a Paradox of Choice

Genentech view that the supply of human model systems has outrun pharma's ability to choose among them; argues for shared multi-omic data across models.

FDA Modernization Act 2.0 enacted

Removed the statutory requirement for animal testing before human trials. Nonclinical tests can now include cell-based assays, microphysiological systems and computer models.

Performance assessment and economic analysis of a human Liver-Chip for predictive toxicology

870 Liver-Chips tested on a blinded set of 27 drugs from IQ consortium benchmarks: 87% sensitivity, 100% specificity. Company-authored; includes an economic model of R&D productivity.