RegSciAI brings together Northeastern University’s research, education, and global engagement to advance the responsible use of artificial intelligence across the biopharmaceutical ecosystem. The initiative connects regulatory science with data science to support innovation, workforce development, and evidence-based AI policy.

Research Activities

RegSciAI Academy prepares regulatory professionals, scientists, policymakers, and technology developers to work at the intersection of AI and human therapeutics. Our research efforts cover AI applications in discovery, clinical development, manufacturing, pharmacovigilance, regulatory operations, and emerging career pathways.

RegSciAI Program: RegSciAI Program is a course designed for professionals who are interested in learning about the role of AI in regulatory sciences and how AI is regulated. It has 7 modules that cover the bench-to-bedside journey. Badge Level 1 and 2 are granted upon completion of the course. Click here for more details.

AI2ET Framework: The AI-Enabled Ecosystem for Therapeutics, or AI2ET, provides a systems-based framework for understanding and regulating AI across systems, processes, platforms, and products. It shifts regulatory thinking from oversight of isolated AI tools toward risk-based governance of the broader therapeutic ecosystem.

AICURIS Regulatory Intelligence: AICURIS is an AI-enabled, continuously updating regulatory intelligence system developed to monitor and compare AI-related policies from global authorities. By identifying areas of alignment, divergence, and regulatory gaps, it supports transparency, knowledge democratization, and international convergence.

AI in Biopharmaceutical Innovation: RegSciAI research examines how AI can accelerate drug discovery, clinical development, manufacturing, safety monitoring, and regulatory decision-making. The publication Artificial Intelligence and the Transformation of Cell and Gene Therapy Development demonstrates how AI can address scientific, manufacturing, and regulatory challenges across the cell and gene therapy lifecycle.

Regulatory Policy and Advocacy: RegSciAI contributes evidence-based recommendations for adaptive, risk-based, and globally harmonized AI regulation. Research published in Communications Medicine examines current regulatory gaps and proposes an expanded policy model for governing the AI-enabled ecosystem for human therapeutics.

Publications

• Singh, R and Auclair, JR. From Copilot To Autopilot: Why Biopharma Must Stop Renting Its Future Life Sciences Leader · May 5, 2026
• Auclair, J R., Joung, J., Singh, M.A, Debauve, G., Singh, R., Artificial Intelligence and the Transformation of Cell and Gene Therapy Development, Pharmaceuticals., March 2026
• Singh, R., Pareek, M, Prokle, M., Sanchez, E., Hohgrawe, U., Auclair, J. Federating AI-Related Regulations for Human Therapeutics: An AI-Enabled, Continuously Updating Regulatory Intelligence System, Frontiers. Drug Saf. Regulations, Feb 2026
• Singh, R., Zhou, K., and Auclair, J., Reimagining Drug Regulation in the Age of AI: A Framework for the AI-Enabled Ecosystem for Therapeutics., Frontiers Medicine, Sept 2025
• Auclair, J. and Singh, R. Create an Agile New Agency to Regulate the AI-Enabled Ecosystem for Human Therapeutics. Global Forum, Sept 2025.
• Singh, R., Paxton, M.P., Auclair, J.R. Regulating the AI-Enabled Ecosystem for Human Therapeutics, Nature Communications Medicine, May 17, 2025

Research Collaborations

RegSciAI creates a platform for collaboration across Northeastern’s colleges, research centers, and laboratories, connecting expertise in regulatory science, biotechnology, artificial intelligence, engineering, analytics, ethics, and public policy. Collaboration with the Center for Bioinnovation, BATL, and other university partners helps translate AI research into practical applications for drug development, manufacturing, and workforce education.