Beyond Animal Testing: The FDA Modernization Act and the Future of Drug Discovery

What if the biggest barrier to faster, safer drug development isn't a lack of technology, but a decades-old reliance on the wrong models?

In this episode of CrownCast, host Michelle Dawn Mooney sits down with Prof. Thomas Hartung, member of Crown Bioscience's Scientific Advisory Board and Director of the Johns Hopkins Center for Alternatives to Animal Testing, to unpack how the FDA Modernization Act, AI, and next-generation in vitro systems are transforming drug discovery. Watch or listen to the full conversation below.

A Regulatory Shift Toward New Approach Methodologies

Signed into law in 2022, the FDA Modernization Act marked an important regulatory signal: drug developers can increasingly consider non-animal approaches alongside established methods. These New Approach Methodologies (NAMs) include computational tools, advanced in vitro systems, organoids, and organ-on-chip technologies.

For Prof. Hartung, this is part of a broader transformation rather than an overnight change. As regulators, funders, and industry continue to recognize the limitations of traditional models, the focus is shifting toward approaches that can generate more human-relevant data.

MPS and AI Are Driving Change

Prof. Hartung identifies Microphysiological Systems (MPS) and AI-enabled methodologies as two particularly disruptive areas. MPS, including organ-on-chip systems, aim to reproduce key aspects of human tissue and organ function, creating new opportunities to investigate efficacy and safety earlier in development.

AI is also already supporting drug design, candidate prioritization, and toxicity prediction. While validation and trust remain essential—particularly for complex endpoints—these tools can help researchers make faster, more informed decisions and focus resources on candidates with stronger predicted profiles.

CROs as Scientific Partners

As NAMs become more widely adopted, CROs have an increasingly important role in helping drug developers navigate a more complex scientific and regulatory landscape. Beyond delivering individual studies, they can help integrate complementary in vivo, in vitro, and in silico approaches into practical development strategies.

Prof. Hartung describes this integrated mindset as “invivitrosi”: combining the strengths of different models rather than viewing them as direct replacements for one another.

The Path Forward

The convergence of regulatory momentum, technological progress, and growing experience with human-relevant models has created a meaningful opportunity for the industry. Moving forward will require collaboration among developers, CROs, technology providers, and regulators to establish robust standards and generate confidence in the data these methods produce.

Crown Bioscience is at the forefront of New Approach Methodologies adoption, collaborating with leading organizations to validate and advance human-relevant research methods across drug discovery and development.

In July 2026, Crown Bioscience joined Critical Path Institute's (C-Path) New Approach Methodologies Developer Coalition (NAMs-DC). This collaborative initiative is dedicated to advancing the validation, qualification and regulatory adoption of innovative human-relevant research methods. Through this partnership, Crown Bioscience contributes its expertise in patient-derived xenograft (PDX) models, patient-derived tumor organoids, ex vivo patient tissue platforms, and translational biomarker analysis to help bridge the gap between NAM development and regulatory implementation.

Collaborate with Crown Bioscience on advancing New Approach Methodologies.