APPLY – Challenge-based NAM implementation

EDUCATE

Interactive Online Training

ENABLE

On-site Training & Consulting

APPLY

Challenge-based NAM implementation

The APPLY programme is a challenge-based competition designed to foster SME–industry collaboration and accelerate real-world NAM implementation.

Current OPEN CALL 

Application Deadline: 02.08.2026
Down below, you will find a total of 12 challenges as part of the APPLY Programme. 
We look forward to receiving your application!


Who can apply?

  • Completion of an EDUCATE module
  • Minimum TRL 4
  • Dedicated team capacity (0.5–2 FTE)
  • Strong innovation and execution capability

Concept

Large and mid-sized BioPharma and MedTech companies act as Challenge Providers. The challenges are published through open calls, allowing SMEs to apply to the challenge(s) that match their expertise and technology focus. Selected SMEs co-develop solutions together with the Challenge Provider, addressing concrete industrial needs and advancing NAM implementation towards market readiness.

What selected SMEs receive

  • Four months of structured mentoring
  • A dedicated training package (valued at €3,000 per SME)
  • On-site collaboration with the Challenge Provider (travel voucher included)
  • Opportunities to connect with investors and manufacturers
  • Visibility at final dissemination events and European innovation platforms

Why Participate?

The STEP4NAMs Training & Support Programme offers more than theoretical training. It provides:

    • Scientifically rigorous, expert-led education
    • Direct pathways to implementation
    • Regulatory and industrial insights
    • Structured SME support
    • Access to a transnational innovation ecosystem
    • Opportunities for industrial co-development
  • For SMEs, researchers and institutions aiming to advance the use of NAMs in BioPharma and MedTech, STEP4NAMs provides a coherent, practice-oriented framework to move from knowledge acquisition to validated application.


APPLY - Challenges

Here you can find a concise and harmonised overview of the challenges launched within the STEP4NAMs project. Each challenge is presented with a short pitch to help SMEs, startups, and CROs rapidly understand the scientific scope, industrial needs, and collaboration opportunities.
 
Applications for the challenges are open: 
Apply via Moodle


Challenge Provider: 

#01 Integrated Multi-Organ Zebrafish Toxicity Screening Platform

Develop a scalable zebrafish-based assay to detect multi-organ toxicities during embryonic and larval development. The platform should combine solubility/formulation optimization, dose range finding, bioanalytical exposure assessment, and organ-specific readouts (e.g. cardiac, neuro, hepatic, developmental). High-content imaging and behavioural analyses are expected to support early safety de-risking and go/no-go decision-making. The solution should be robust and adaptable to routine early-stage screening.

For more details:  

#03 Multi-Organ, Multi-Species In Vitro Phospholipidosis Assay


Establish a robust in vitro platform to assess drug-induced phospholipidosis across multiple human organs and relevant non-clinical species. The system should provide quantitative and mechanistic readouts to enable translational comparison across species. The goal is to support early safety risk assessment and better inform progression decisions during drug discovery.

For more details: 

#05 Human Organoid Models for Efficacy and Toxicity Evaluation in Oncology



Develop functional human tumor organoid models to assess pharmacological efficacy and structural or functional toxicity of drug candidates. The platform should leverage disease-relevant biology combined with advanced 3D imaging and functional biomarkers. The aim is to increase human relevance and predictive value compared with conventional 2D or animal models.

For more details: 

#07 Organ-on-Chip Model for Human Intestinal Toxicity



Development and qualification of a human‑relevant intestinal organ‑on‑chip (OoC) model to assess drug‑induced intestinal toxicity in an early, predictive, and mechanistically informative manner, as an alternative or complement to animal studies. The model should reproduce key structural and functional features of the human intestinal epithelium (e.g. polarized barrier, flow, mechanical cues, epithelial–endothelial crosstalk where relevant) and enable quantitative assessment of intestinal safety liabilities.

For more details: 

#09 Liver-on-Chip Platform for Quantitative ADME and Low Clearance



Develop and qualify a liver-on-chip platform capable of measuring low intrinsic clearance and identifying human-relevant metabolites. The system should support multi-day culture, quantitative bioanalysis, and reproducible outputs. Deliverables should be PBPK-ready and suitable for integration into early ADME and DMPK decision workflows.

For more details: 

#11 A predictive model of blood–brain barrier permeability with translational relevance to humans



Develop a predictive in vitro human blood–brain barrier (hBBB) model with strong translational relevance. The goal is a medium‑throughput platform combining Transwell, co‑culture, and/or organ‑on‑chip technologies to quantitatively assess BBB permeability and transporter activity (e.g. P‑gp, BCRP). The model should support CNS drug permeability studies, neurotoxicity screening, and comparison of healthy versus impaired BBB states.

For more details: 

#02 Cell Painting-Based Neuronal Toxicity Assessment


Develop a human iPSC-derived neuronal model using cell painting to assess neurotoxicity of drug candidates. The assay should capture population-level and single-cell morphological and functional features, including neurite architecture and mitochondrial integrity. Advanced multiparametric image analysis is expected to support sensitive detection of neurotoxic liabilities and future model expansion toward disease-relevant contexts.

For more details: 

#04 Human Gut–Liver Microphysiological System for Oral Bioavailability


Develop an integrated human gut–liver microphysiological system capable of distinguishing intestinal and hepatic first-pass metabolism. The platform should support oral dosing, time-resolved PK sampling, and metabolite profiling. Outputs should be suitable for improving oral bioavailability prediction and informing PBPK or translational modelling approaches.

For more details: 

#06 Human Organoid Models for Efficacy and Toxicity Evaluation in Rare Disease



Develop functional human organoid models to assess pharmacological efficacy and structural or functional toxicity of drug candidates in the rare disease therapeutic area, (Neuropathology, Liver, kidney…) The platform should leverage disease-relevant biology combined with advanced 3D imaging and functional biomarkers. The aim is to increase human relevance and predictive value compared with conventional 2D or animal models, covering 2 different therapeutic Areas, Oncology and rare diseases (Neuropathology, liver, kidney etc…).

For more details: 

#08 Immuno-Oncology Organoid and Immune Coculture Assays



Establish tumor organoid and immune cell coculture systems for oncology indications with poor in vivo predictivity. The model should capture key tumor–immune interactions and allow functional evaluation of immunomodulatory compounds. The objective is to improve translational relevance while significantly reducing animal use in immuno-oncology programs.

For more details: 

#10 Immune-Competent Liver-on-Chip for Cytokine-Driven DDI Assessment



Develop an immune-competent perfusable human liver-on-chip integrating hepatocytes and immune cells. The platform should enable quantitative evaluation of cytokine-mediated modulation of hepatic drug metabolism. A key objective is to assess clinically relevant antibody–small molecule drug–drug interactions under inflammatory conditions.

For more details: 

#12 Standardized Materials Selection for MPS BBB and Lymphoid Models



Develop a standardized framework to guide the selection of thermoplastic materials and hydrogel matrices for microphysiological systems (MPS) used in pharmaceutical research. The project will benchmark candidate thermoplastics and extracellular matrices based on physicochemical, biological, and operational criteria relevant to complex epithelial–endothelial–immune co‑culture models. A key objective is to generate a practical decision tree supported by experimental data, enabling R&D teams to rationally select materials for blood–brain barrier (BBB) and lymphoid‑organ models. Thermoplastics in MPS will be biocompatible, xeno‑free, and exhibit low adsorption to maintain stable drug and nutrient concentrations. The expected outcome is a validated material–matrix recommendation that supports robust, reproducible, and industry‑ready MPS platforms while ensuring compatibility with human‑relevant pharmacological studies

For more details: