Critical Path Institute Launches Global One to Millions Initiative to Scale Individualized Medicine via Modular Regulatory Frameworks

Critical Path Institute’s One to Millions initiative scales individualized therapies through modular regulatory frameworks and a global data-sharing ecosystem.

By: AXL Media

Published: Mar 27, 2026, 7:33 AM EDT

Source: Information for this report was sourced from Critical Path Institute (C-Path)

A Modular Paradigm Shift in Advanced Therapeutic Development

The Critical Path Institute (C-Path) has officially unveiled One to Millions, an international initiative aimed at solving the scalability crisis facing individualized medicine. While modern science can now design treatments for a single patient, the traditional linear models of drug development and regulatory approval remain optimized for mass-market pharmaceuticals. According to Klaus Romero, Chief Executive Officer of C-Path, this new framework utilizes a centralized, regulatory-grade data platform to move beyond the current one-medicine-for-one-disease approach. The initiative seeks to align the interests of developers, regulators, and payers to ensure that precisely targeted interventions, such as genome editing and RNA-based treatments, can reach small patient populations without the prohibitive costs of bespoke development.

Standardizing the Architecture of Genetic Interventions

A cornerstone of the One to Millions strategy is the adoption of a modernized platform approach that prioritizes consistency in manufacturing and release testing. By treating advanced therapeutic technologies as modular foundations rather than entirely new entities for every application, the initiative addresses the disproportionate financial burdens typical of small-volume drug production. This established architecture allows regulatory bodies to focus their reviews on the novel components of a therapy, such as a specific genetic sequence, rather than re-evaluating the entire technological delivery system. Experts suggest this "plug-and-play" model is essential for making rare disease treatments economically viable for both biotechnology firms and healthcare systems.

Data Sharing as a Catalyst for Regulatory Agility

The initiative is built on the premise that collective learning is the only way to overcome the conservative nature of existing regulatory requirements. By compiling preclinical, translational, and clinical data from diverse sources, C-Path aims to create a continuous "learn-and-confirm" cycle that informs every stage of the development pipeline. Former FDA Acting Commissioner Janet Woodcock noted that progress often stalls when vital information remains siloed, preventing the systemic analysis required to evolve safety and efficacy standards. One to Millions intends to break these silos, ensuring t...