Cutting animal testing without cutting science

If implemented badly, the Trump administration's moonshot for animal-free research could be a trojan horse for a broader anti-science agenda.

Hi readers,

It’s been a few weeks since the FDA announced its plans to phase out animal testing, and the takes are starting to roll in.

You’re all starting to roll in too! I’m frankly starstruck by some of the email addresses popping up on the The Replacement’s subscriber list.

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Alright, enough housekeeping.

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In today’s newsletter:

💡 What I’m reading: realistic, yet cautiously optimistic takes on what the animal research phase-out actually means.

🤖 In other news: FDA embraces AI, Vinay Prasad steps up at CBER, and the Trump administration’s science chaos continues.

💸 In the weeds: Valinor Discovery launches, Insitro cuts staff, and Charles River shakes up their board.

📚 In the stacks: new reports and roadmaps on NAM regulation

✨ + resources, opportunities, and events for paid subscribers!

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What I’m reading:

Is the FDA’s plan to phase out animal toxicity testing realistic?

May 15 | Nature Reviews Drug Discovery

• According to Lorna Ewart, Chief Scientific Officer at Emulate, “it could be.”

  • On the bright side:

    • She’s excited by the FDA’s ambitious roadmap, and optimistic about its potential for positive disruption.

    • Ewart thinks the FDA’s initial focus on phasing out animal testing for monoclonal antibodies makes sense: many antigens are human-specific, and the primate studies normally required for these drugs are expensive, cruel, and reliant on illegal wildlife trafficking.

    • She’s hopeful that the announcement will help with small things that make a big difference, like pushing regulators to create templates for initial application documents.

  • But…

    • The Society of Toxicology recently raised concerns about the FDA’s ultrafast timeline, urging the government to “maintain flexibility in their policies and language.”

    • Good human-centered, immune-competent in vitro models are still a work in progress. Cutting off animal testing entirely (key word: entirely) in the next five years doesn’t seem feasible.

    • “Funding is a big problem,” she said. To my knowledge, the FDA hasn’t shifted funding yet, and with the NIH and NSF cutting staff and shrinking budgets, “there is a legitimate question mark around where that money is going to come from.”

The massive stakes of the Trump administration’s plans to end animal testing

May 14 | Vox

• The Trump administration is steamrolling research institutions without reallocating any funds towards actually advancing animal-free research methods.

  • While the FDA, EPA, and NIH all announced their commitment to reducing animal testing, only the FDA published a plan.

• Reporter Rachel Fobar captured exactly what’s been making my stomach churn: “It’s unclear whether a moonshot for alternatives to animal research can emerge from an administration that’s imposing widespread austerity on science.”

• Although phasing out animal research makes scientific, ethical, and economic sense, I fear that the mission is being co-opted as a convenient way to phase out science.

  • And while organ chips and computational models are getting better, many scientists aren’t yet convinced that they can fully replicate the complexity of living bodies.

  • If you’re an activist struggling to connect with the scientific community, keep this in mind! Given very real threats to their jobs (and the jobs of their trainees), biomedical researchers can be understandably defensive when told that their work should be defunded and replaced with under-validated alternatives.

  • If you’re a researcher who feels threatened by animal rights groups, I challenge you to hear them out and ask questions. You might be surprised by how much of PETA’s Research Modernization NOW roadmap you align with.

• I spent a lot of my time as a Vox Future Perfect fellow reporting on the political, cultural, and scientific strangeness of animal experimentation. Some more of my thoughts:

  • The harrowing lives of animal researchers

  • Animal rights advocates are ready for Trump’s war on science

  • What went wrong with autism research? Let’s start with lab mice.

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In other news:

FDA commissioner Marty Makary announced an “aggressive timeline” to scale agency-wide AI.

• The day before the announcement, WIRED reported that high-ranking OpenAI employees had been meeting with the FDA to AI in drug evaluation.

• Experts told Axios that the integration of AI at the FDA is “a good move,” but the “aggressive timeline” bit is concerning.

  • Using AI to accelerate the drug review process will make it easier for drugmakers to get their products to market, and the industry seems to be welcoming the change.

  • Optimistically, generative AI will help scientists do less busywork. But the announcement lacked specifics, so it’s unclear exactly what work will be automatized.

    • The FDA’s Digital Health Advisory Committee warned that risks like hallucinations and privacy concerns merit a more gradual rollout than Makary has planned.

ICYMI: Vinay Prasad was named the next head of the FDA’s Center for Biologics Evaluation and Research.

• Biotech is guessing how Vinay Prasad might change the FDA. His research, writing offer clues | May 8 | Biopharma Dive

• Vinay Prasad, in his own words, outlines the philosophy he’ll bring to the FDA | May 6 | STAT+ ($$$)

• RFK Jr. picks controversial doctor as top vaccine regulator | May 6 | Axios

Speaking of the Trump administration steamrolling science…

• Upheaval at FDA pushes some biotech firms to move early trials out of US | May 14 | Reuters ($$$)

• Trump officials take steps toward a radically different NSF | May 13 | Science

• The EPA will likely gut team that studies health risks from chemicals | May 12 | WIRED

• Trump’s ‘fear factor’: Scientists go silent as funding cuts escalate | May 12 | Science

• NIH grant terminations under Trump have totaled at least $1.8 billion, analysis finds | May 8 | Reuters

• Trump moves to tighten rules on risky research on viruses, bacteria, and toxins | May 6 | Science

Animal Wellness Action and the Center for a Humane Economy urged Jay Bhattacharya to wind down federal funding from primate research centers | May 13 | read the letter

++ some NAM-y headlines:

• Stem cells coaxed into most advanced amniotic sacs ever grown in the lab | May 15 | Nature

• AI conjures up potential new antibody drugs in a matter of months | May 12 | Science

• Few drugmakers embrace a newer test for contamination, placing horseshoe crabs at risk | May 6 | STAT ($$$)

• Medical AI trained on whopping 57 million health records | May 6 | Nature ($$$)

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In the weeds:

• Valinor Discovery launches to simulate drug performance in virtual patients | May 13 | Business Wire

• International group proposes best practices for AI in pharmacovigilance | May 12 | Regulatory News | submit comments here by June 6

• AI biotech Insilico Medicine goes for third attempt at Hong Kong IPO | May 9 | Endpoints ($$$)

• Insitro cuts 22% of workforce, extending runway into 2027 | May 9 | BioSpace | more from STAT ($$$)

• Inductive Bio raises $25M series A to transform small molecule drug discovery with industry-wide AI platform | May 8 | Press Release | more from STAT ($$$)

• Charles River launches strategic review and shakes up board amid regulatory uncertainty, sliding revenue | May 7 | Fierce Biotech

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In the stacks:

• Application of new approach methodologies for nonclinical safety assessment of drug candidates | Nature Reviews Drug Discovery

• Leveraging innovative research tools to meet public health challenges: a BioMed21 workshop report | NAM Journal

• Non-animal methods in science and regulation | EURL ECVAM Status Report

• Animal welfare definitions, frameworks, and assessment tools: Advancing the measurement and laying the foundation for improved animal welfare through a three-step approach | Animal Welfare

• Roadmap to Reduce Animal Testing — The EU Talks, the US Acts! | Frontiers Policy Labs

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Opportunities: