Defining a Functional Standard for Patient Stratification

PIMS® is a label-free technology that directly measures functional drug response in physiologically relevant, patient-derived samples.

Enabling earlier, more confident decisions across drug development and clinical research.

Why Drug Response Remains Hard to Predict

Despite major advances in genomics, molecular profiling, targeted therapies, and the promise of personalised medicine, predicting how a drug will perform in individual patients remains one of the most persistent challenges in drug development and clinical care.

Functional drug response is inferred, not directly measured

Most stratification strategies rely on molecular biomarkers and genomic proxies. While valuable, these markers do not always capture how a drug functionally engages biological pathways in human tissue.

Molecular similarity does not ensure functional response

Patients with comparable molecular or biomarker profiles can respond very differently to the same therapy. This functional divergence contributes to diluted efficacy signals, late-stage trial failure, and uncertainty in treatment decisions.

Critical decisions are made too late

Without early functional insight, biological uncertainty is pushed downstream — into clinical trials, timelines, cost, and patient exposure.

PIMS® addresses this gap by moving beyond molecular inference to directly observe functional drug response in biologically relevant human systems.

Functional insight, grounded in human biology

PIMS® (Physiological Intermolecular Modulation Spectroscopy) is a label-free biophysical technology designed to reveal how patient-derived biological systems respond to therapeutic intervention.

By analysing functional changes in human tissue exposed to treatment, PIMS® helps identify patient subgroups most likely to benefit from a specific therapy — supporting more informed clinical development and patient stratification.

This functional perspective contributes to a healthcare ecosystem that is more predictive, efficient, and patient-centred.

The PIMS® Mechanism

Unlocking the Truth in the Tissue Through Physics

1
The Native Input
(Physiological State)
The Native Input — Physiological State

Analyzes samples in their natural biological matrix (no labels, no artificial buffers). Preserves the complete native interactome.

2
The Natural Probe
(H₂O Resonance)
The Natural Probe — H₂O Resonance

Leverages water as a non-destructive sensor. Drug-target engagement subtly alters the resonance of surrounding water networks.

3
Physiological Modulation
(NIR Spectroscopy + Thermal Stress)
Physiological Modulation — NIR Spectroscopy + Thermal Stress

Applies precisely modulated Near-Infrared light across a controlled temperature gradient to stress the system and reveal binding energies.

4
The Spectral Fingerprint
(Clinical Insight)
The Spectral Fingerprint — Clinical Insight

Decodes unique multi-dimensional patterns to predict patient response and de-risk clinical trials. The Truth in the Tissue.

From human tissue to functional insight

Many current approaches rely on molecular signals to infer drug response. PIMS® takes a different route.

Using established biophysical principles, PIMS® analyses how molecular systems within human tissue reorganise when exposed to a drug. The resulting signal forms a functional fingerprint that reflects the biological response of that specific patient sample.

Because the measurement is label-free and non-destructive, tissues are analysed under conditions that more closely resemble physiology — preserving complexity rather than simplifying it away.

A comparative, patient-derived workflow

PIMS® follows a simple comparative logic:

Baseline

Patient-derived tissue or cells (including blood and biopsies) are analysed under native conditions.

Therapeutic exposure

The same sample is exposed ex vivo to a drug or drug combination.

Functional comparison

Differences between baseline and challenged states reveal whether — and how — the biological system responds.

This enables patients to be grouped based on observed functional behaviour, rather than prediction alone.

PIMS® Instrument

PIMS® instrument supporting functional stratification of patient-derived samples.

What the signal represents

PIMS® does not measure individual targets or expression levels. Instead, it captures integrated biological response — including changes linked to binding, conformational shifts, and downstream pathway engagement.

Across translational studies, this approach has demonstrated high reliability in predicting patient response (around 96%), using clinically relevant human samples. This makes functional stratification possible at a level of confidence suitable for real-world development decisions.

Part of a broader translational ecosystem

PIMS® is designed to answer a focused but critical question: Does this treatment functionally engage the patient's biology?

Where deeper mechanistic insight is required — for example to understand signalling pathways or identify biomarkers — complementary technologies can be applied downstream. In this way, PIMS® acts as an entry point to a broader translational workflow, linking patient stratification to mechanism and, ultimately, to better-aligned clinical development.

Established use in translational research

PIMS® has been used in translational research settings for several years and is supported by peer-reviewed studies, including recent work in colorectal cancer treated with targeted therapy.

These studies illustrate how functional stratification can support patient selection and optimise clinical development strategies.

Adding the functional layer

Clinical outcome
Functional response (PIMS®)
Molecular & biomarker data
Genomics & expression

PIMS® sits between molecular insight and clinical outcome, helping translate biological signal into functional relevance.

Where PIMS® Fits in Precision Medicine

From molecular inference to functional certainty

PIMS® adds a functional layer to precision medicine — directly measuring how patient biology responds to treatment.

It complements molecular and biomarker-based approaches used across drug development and clinical research by moving beyond prediction to observed biological response.

From inference to functional response

Scroll to view Molecular & Biomarker Approaches PIMS®
Core question What is present? What is the system actually doing?
Basis of insight Molecular proxies Observed functional response
Nature of signal Correlative Integrated, pathway-level
Biological context Often dissociated Patient-derived, physiologically relevant
Role in decision-making Prediction & classification Functional stratification & follow-up

Molecular and AI-driven approaches help identify what could work.
PIMS® reveals what actually works — by measuring real drug–patient interaction in functional human biology.

PIMS® is not designed to replace genomics, proteomics, or biomarker discovery.
Instead, it provides functional biological proof — helping interpret molecular insight and reduce uncertainty, particularly in complex or heterogeneous disease where prediction alone is not enough.

Why this matters

Evidence

Functional insight earlier in development helps reduce downstream uncertainty.

Trust

Observed response is in correlation with real clinical results.

Scale

A functional standard supports repeatable use across programmes and indications.

Functional stratification is already established in translational research; the focus now is on reproducible integration across research and clinical pathways.

See how PIMS® has been applied in practice →

From Translational Research to Clinical Deployment

A progressive pathway aligned with how functional technologies earn trust in healthcare.

Evidence Trust Scale

Translational Research

PIMS® is introduced through collaborative translational studies using patient-derived samples.

  • Functional stratification in human tissue (blood, biopsies)
  • Collaboration with academic and hospital research teams
  • Generation of clinically relevant response datasets
Evidence generation

Clinical Integration

PIMS® is embedded within specialist centres to support repeatable stratification in defined use cases.

  • Instrument placement in reference hospitals and translational centres
  • Integration into early clinical and translational workflows
  • Usage models aligned with real clinical practice
Patient-facing decision support

Scaled Clinical Use

With established workflows and regulatory alignment, PIMS® supports broader clinical deployment.

  • Deployment across hospital networks or specialist laboratories
  • Standardised workflows and quality systems
  • Support for routine, high-throughput clinical use
System-level impact

This pathway reflects how functional stratification technologies are responsibly introduced into healthcare — building evidence, earning clinical trust, and scaling where patient value is clear.

Technical Maturity & Regulatory Pathway

Designed for clinical robustness, reproducibility, and regulatory alignment — moving from established research use to broader clinical deployment.

01
Foundation
Platform Foundation
The PIMS® platform is entering its industrialization phase, with units currently manufactured in pre-series production and delivering a throughput of more than 20 patient samples per hour. This scalability enables rapid, high-content functional biological insights to support modern drug development and translational research programs.
02
Current
Translational Readiness
PIMS® is currently progressing through CE self-certification for R&D use, supporting applications across preclinical research, clinical research, and translational medicine.
03
Deployment
Research & Early Clinical Deployment
Early deployments target pharmaceutical/biotechnology companies, hospital research teams, and clinical trial programs, where PIMS® contributes to deeper understanding of treatment response and to narrow patient heterogeneity.
04
Future
Clinical Expansion & Scale
Looking ahead, PIMS Technology is advancing a structured regulatory roadmap aimed at progressively expanding the platform's clinical scope, to support routine clinical use, in alignment with applicable regulatory frameworks & quality standards.
PIMS® Ecosystem

Defining a Functional Standard for Patient Stratification

From isolated insight to integrated decision-making

  • Functional evidence before clinical exposure PIMS® measures how patient-derived biology responds to treatment ex vivo, enabling identification of responders and non-responders before a trial begins.
  • De-risking clinical development By stratifying patient cohorts early, PIMS® helps reduce Phase II/III attrition and optimise trial design and size — lowering the cost of failure and strengthening the evidence base for regulatory approval.
  • A new decision layer for precision medicine Positioned alongside molecular and biomarker approaches, PIMS® adds functional insight where prediction alone is insufficient — supporting more confident, evidence-led decisions across development.

PIMS® Executive Team

Pierre Eftekhari, PhD

Pierre Eftekhari, PhD

Founder & CEO

LinkedIn

Founder and CEO of PIMS® Technology and Inoviem Scientific with over 25+ years in drug development. Led the development of PIMS® instruments, including the prototype and PIMSQ8 pre-series.

Richard Bouaoun, PhD

Richard Bouaoun, PhD

Business & Strategy Advisory

LinkedIn

Business and strategy advisory, with 15+ years of medtech & Biotech experience. Supporting PIMS®' business operations, hands-on.

Alessandro Bona, MBSc

Alessandro Bona, MBSc

Business Development

LinkedIn

Business development specialist with 7+ years pharma/biotech experience. Manages strategic partnerships and client relationships for commercial expansion.

Resources

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