About ProNAMs
ProNAMs builds and runs human-relevant evaluation models — 3D tissue systems, patient-derived tumor models, and microphysiological platforms — for teams who need preclinical data they can actually act on.
Who We Are
ProNAMs operates as an independent brand supported by the scientific foundation of Protheragen Inc., allowing us to integrate established pharmaceutical expertise with a dedicated focus on New Approach Methodologies (NAMs).
That arrangement is deliberate. NAMs work requires two things that rarely sit together — specialist model-building expertise, and the operational backbone to run studies reproducibly and document them properly. The group contributes over a decade of biopharmaceutical experience, established material supply chains, and an existing quality management system. ProNAMs contributes focus.
Why We Exist
Traditional animal models carry scientific, economic and ethical limitations that are now widely recognized. Cross-species extrapolation is weakest precisely where programs depend on it most, and the regulatory environment has begun to open to human-relevant alternatives.
Our objective is to make that transition practical rather than aspirational. That does not mean claiming in vitro human models predict clinical outcomes — establishing predictivity for any given readout requires clinical concordance data, and we distinguish the two carefully. It means generating human-relevant data at the point where it can still change a decision, with enough documentation for you to judge how much weight it carries.
What We Actually Run
Our portfolio spans three areas:
- Tissue & Disease Modeling: human 3D tissue models and microphysiological systems for efficacy, organ-level safety and mechanism
- Oncology Evaluation: patient-derived tumor models, tumor–immune co-culture, and native tissue-context studies
- Enabling Technologies: model engineering and platform configuration, delivered standalone or built into an evaluation study
Culture format is selected by the endpoint rather than by preference. Depending on the question, that means static culture, air–liquid interface, or dynamic perfusion. Where a study requires instrumented perfusion and recording, that capability is delivered through an established collaboration operating commercially available MPS platforms. We do not manufacture devices.
Our current services are in vitro. We are developing in silico and in chemico capability to complement them.
Quality Management and Regulatory Compliance
Our group holds ISO 9001 certification, and ProNAMs operates within that system. We provide documented procedures, traceable records, controlled deviations, defined responsibilities, and a data package in which reported results can be traced back to the measurements behind them.
How We Work
The same governance applies across every service:
Criteria are fixed before the data exists.
Endpoints, controls, replicates, statistical approach and acceptance criteria are written into a protocol and signed off before work begins.
Feasibility is a stage, not an assumption.
Every program includes an explicit feasibility step. Where it indicates the approach will not hold, scope and timeline are revised and re-confirmed before the full study commits.
Limits are part of the deliverable.
Every report states the applicability domain of the data it contains. Where results diverge across endpoints, or from your existing data, we report the divergence and its likely sources rather than resolving it in the direction that flatters the candidate.
Our Team
Our NAMs division brings together stem cell biologists, bioengineers, pharmacologists and data scientists. Model protocols are developed per tissue origin and platform parameters selected against the intended endpoint — developed per system, not applied generically.
Beyond Drug Discovery
The same platforms support safety assessment and efficacy profiling in cosmetics and personal care, where they support replacement of animal testing under 3Rs principles. A note worth stating plainly: non-animal testing is not the same as animal-origin-free materials. Where a study requires animal-component-free scaffolds and media, specify it at scoping so materials can be selected accordingly.
Controlled 3D microenvironments also support foundational and translational work in regenerative medicine, disease modeling and stem cell biology.