{"id":122270,"date":"2026-07-06T09:00:25","date_gmt":"2026-07-06T16:00:25","guid":{"rendered":"https:\/\/ixcellsbiotech.com\/?p=122270"},"modified":"2026-07-06T09:00:25","modified_gmt":"2026-07-06T16:00:25","slug":"nam-only-inds-are-moving-from-theory-to-strategy","status":"publish","type":"post","link":"https:\/\/ixcellsbiotech.com\/nam-only-inds-are-moving-from-theory-to-strategy\/","title":{"rendered":"NAM-Only INDs Are Moving From Theory to Strategy"},"content":{"rendered":"\t\t
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NAM-Only INDs Are Moving From Theory to Strategy<\/b>\n<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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A recent LinkedIn article by Stefano Gaburro, PhD<\/a>, raises an important question for drug developers: under what conditions could a NAM-supported, or even NAM-only, IND be accepted?<\/span><\/p>

The answer is not as simple as \u201canimal studies are no longer needed.\u201d The more useful takeaway is this: regulatory expectations are changing, and human-relevant models are becoming a more strategic part of early development planning.<\/span><\/p>

For sponsors working with modalities that already have established safety knowledge, this shift could be especially meaningful.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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The opportunity is in the evidence gap<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Many development programs are not starting from zero. A sponsor may be optimizing an AAV capsid, modifying a known therapeutic platform, evaluating a structurally related compound, or developing a combination therapy where the individual components already have established safety profiles.<\/span><\/p>

In these cases, the key regulatory question may not be: \u201cCan we prove everything again from the beginning?\u201d<\/span><\/p>

It may be: \u201cCan we show that this modification, combination, or platform application does not introduce a new safety signal?\u201d<\/span><\/p>

That is where NAMs can become highly valuable.<\/span><\/p>

As Christy Holt, VP of Marketing and Sales at iXCells, notes, combination therapies are a strong example. When individual components already have established safety profiles, NAM data showing that the combination does not create new safety concerns may help support an IND strategy without requiring a full set of new animal studies.<\/span><\/p>

The same logic may apply to other platform-based approaches. For example, AAV capsid optimization or other modality improvements may be supported by existing class or platform knowledge, while human biological models help evaluate what has changed.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Human-relevant models can help sponsors move faster<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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For development teams, the impact could be significant.<\/span><\/p>

A stronger NAM package may help shorten development timelines, reduce cost, and support faster IND acceptance when the data are scientifically justified and aligned with regulatory expectations.<\/span><\/p>

This is not about replacing scientific rigor. It is about generating more relevant evidence earlier.<\/span><\/p>

Human iPSC-derived models, organoids, gene-edited disease models, and other advanced in vitro systems can help sponsors evaluate biology in a context that is closer to the patient. These models can be used to assess mechanism, target engagement, toxicity risk, off-target effects, and therapeutic response before advancing into more expensive and time-sensitive stages of development.<\/span><\/p>

For programs where prior animal and human safety data already exist, NAMs can help fill specific gaps rather than repeat work that may not add meaningful value.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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The next step is strategic model selection<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The regulatory path is still case-specific. NAM data must be matched to the right context of use, the right biological question, and the right endpoint. A model that is useful for one safety question may not be appropriate for another.<\/span><\/p>

That makes model selection critical.<\/span><\/p>

Drug developers need human-relevant systems that are well characterized, reproducible, and aligned with the scientific question they are trying to answer. For some programs, that may mean scalable iPSC-derived cell models. For others, it may mean CRISPR-edited isogenic controls, patient-derived disease models, organoids, or assay-ready cells designed for screening and translational studies.<\/span><\/p>

The opportunity is not simply to use NAMs. It is to use the right NAMs for the right question.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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A practical shift for preclinical development<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The movement toward NAM-supported INDs represents a practical shift in how development teams can think about preclinical evidence.<\/span><\/p>

For platform technologies, optimized modalities, and combination therapies, sponsors may have an opportunity to build a more focused data package around human biology, existing safety knowledge, and clearly defined risk questions.<\/span><\/p>

That could mean shorter development timelines, lower costs, and a more efficient path toward IND-enabling decisions.<\/span><\/p>

At iXCells, we see this as an important moment for human-relevant preclinical research. As regulatory frameworks continue to evolve, the ability to generate reliable, disease-relevant human model data will become increasingly valuable for teams working to move therapies forward.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Author:<\/strong><\/p>

Christy Holt
VP of Marketing and Sales
iXCells Biotechnologies<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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References<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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  1. Stefano Gaburro, PhD \u2014 \u201cThe NAM-Only IND: Where We Actually Stand in the US and Europe\u201d
    LinkedIn, February 2026

    <\/li>
  2. U.S. Food & Drug Administration \u2014 \u201cFDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs\u201d
    FDA Press Announcement, April 10, 2025

    <\/li>
  3. U.S. Food & Drug Administration \u2014 \u201cRoadmap to Reducing Animal Testing in Preclinical Safety Studies\u201d
    FDA Scientific Roadmap, April 2025

    <\/li>
  4. U.S. Food & Drug Administration \u2014 \u201cGeneral Considerations for the Use of New Approach Methodologies in Drug Development\u201d
    FDA Draft Guidance for Industry, March 2026

    <\/li>
  5. U.S. Food & Drug Administration \u2014 \u201cNew Approach Methodologies (NAMs)\u201d
    FDA Science & Research Topic Page

    <\/li>
  6. European Medicines Agency \u2014 \u201cRegulatory Acceptance of New Approach Methodologies (NAMs) to Reduce Animal Use in Testing\u201d
    EMA Regulatory Guidance Page<\/li><\/ol>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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    PARTNER WITH US<\/h6>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    \n\t\t\t\t\t\tWith over a decade of experience in cellular biology and preclinical research, iXCells delivers human-relevant models that help researchers improve predictability and move new therapies forward.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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    \n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tCONNECT WITH A SCIENTIST<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    \n\t\t\t\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

    iXCells Biotechnologies develops a diverse range of off-the-shelf and custom iPSC-derived cell models\u2014sourced from both healthy and patient donors\u2014with the goal of enabling \u201cclinical-trials-in-a-plate.\u201d<\/p>\n","protected":false},"author":234903478,"featured_media":122284,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":{"_acf_changed":false,"content-type":"","_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_wpcom_ai_launchpad_first_post":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"{title}\n\n{excerpt}\n\n{url}","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"_wpas_customize_per_network":false,"jetpack_post_was_ever_published":true},"categories":[2412,2413],"tags":[],"news_type":[],"news_areas":[],"class_list":["post-122270","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-ipsc","category-services"],"acf":[],"yoast_head":"\nNAM-Only INDs Are Moving From Theory to Strategy<\/title>\n<meta name=\"description\" content=\"Explore how iPSC-derived models support rare disease research, with case study examples in ALS and Duchenne muscular dystrophy.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/ixcellsbiotech.com\/nam-only-inds-are-moving-from-theory-to-strategy\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"NAM-Only INDs Are Moving From Theory to Strategy\" \/>\n<meta property=\"og:description\" content=\"Explore how iPSC-derived models support rare disease research, with case study examples in ALS and Duchenne muscular dystrophy.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/ixcellsbiotech.com\/nam-only-inds-are-moving-from-theory-to-strategy\/\" \/>\n<meta property=\"og:site_name\" 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