Advanced human brain organoids for modeling patient response in neurodegeneration (ABROND)

Purpose and goal

Developing new brain disorder medicines fails in 94% of clinical trials. New technologies, like BrainZell’s organoids can change this and we will apply for EU funding recognizing this need. We will develop a strong consortium spanning clinical and regulatory experts, define the use case and develop a validation road map to deliver tech and regulatory acceptance outcomes.

Expected effects and result

The planning grant will support the preparation of ABROND – Advanced human BRain Organoids for modeling patient response in NeuroDegeneration. We bridge preclinical-clinical translation while establishing the foundations for regulatory acceptance of human-based organoids in drug development, delivering a validated bio-computational platform integrating organoids, biomarkers, and predictive models to improve disease modelling, patient stratification, and clinical trial design.

Planned approach and implementation

We will focus on preparing and submitting a strong proposal to EU funding: 1. Consortium development: identify and engage partners across biotech, clinical research, AI, data, and regulation. 2. Scientific and regulatory concept refinement: defining the use case, drafting a validation roadmap aligned with OECD/EMA guidance. 3. Proposal development: refine methodology, work plan, budget, excellence, and impact narrative for a competitive proposal.