Netramark completes FDA AI meeting

Executive Summary

• Netramark Holdings Inc. completed a Critical Path Innovation Meeting (CPIM) with the U.S. Food and Drug Administration (FDA) regarding its NetraAI platform.
• The FDA provided scientific feedback on NetraAI’s explainable AI/ML platform, specifically regarding its use as an enrichment methodology in clinical trial design.
• The FDA suggested Netramark explore the Model-Informed Drug Development (MIDD) Paired Meeting Program for further regulatory dialogue, potentially alongside a pharmaceutical sponsor.

Key Details

• Meeting Type: Critical Path Innovation Meeting (CPIM) with the FDA.
• Subject: Scientific exchange regarding NetraAI-Netramark’s explainable AI/ML platform and its application as an enrichment methodology in clinical trial design.
• FDA Feedback on Methodology:
  • Discussed NetraAI’s approach to prespecified, alpha-controlled predictive enrichment.
  • Reviewed considerations for identifying responder-enriched subgroups while maintaining control of Type I error, per FDA enrichment guidance.
  • Clarified how NetraAI differs from complex adaptive designs, Bayesian methods, or computer simulation-based approaches (which are excluded from MIDD eligibility).
• Regulatory Pathway Suggestion:
  • FDA recommended exploring the MIDD Paired Meeting Program.
  • Noted the program is selective with limited quarterly acceptance.
• Potential Applications Discussed:
  • Targeted inclusion/exclusion criteria.
  • Prespecified stratification in the statistical analysis plan (SAP).
  • Trial simulations to assess power, effect size, and design robustness.
• Company Context:
  • NetraAI uses a topology-based algorithm to parse patient data into explainable and unexplainable subsets to prevent overfitting and improve clinical trial success probability.
  • The CPIM is non-regulatory, non-binding, and does not constitute an endorsement of the product by the FDA.

Notable Quotes

• Dr. Joseph Geraci, Founder and Chief Scientific and Technology Officer: "NetraAI was built from the ground up to address one of the most persistent challenges in clinical research: identifying the true biological and clinical signatures that govern patient response, even within small, heterogeneous data sets... FDAs engagement in scientific discussion about our approach reinforces our belief that explainability, reproducibility and scientific rigor are the foundations upon which next-generation AI for drug development must be built."
• Dr. Luca Pani, Chief Regulatory and Innovation Officer: "This milestone reflects nearly three years of disciplined work to ensure that NetraAI meets the highest standards of regulatory science, quality and methodological transparency... Exploring the MIDD program will allow us to formalize this dialogue within an active drug development program and demonstrate how explainable AI -- used appropriately -- can derisk pivotal trials and meaningfully improve the probability of success for sponsors and patients."
• George Achilleos, Chief Executive Officer: "This CPIM discussion is an important step forward for Netramark... In practical terms, this means sponsors can consider NetraAI to target the right patients, improve statistical power and reduce trial risk. The CPIM and the MIDD now become a regulatory reference point across all our engagements -- an important strategic asset for the company."