AI in Drug Discovery: Aligning with FDA's Latest Risk-Based Framework

The FDA is embracing the future of pharmaceutical innovation by supporting the integration of Generative AI in drug discovery and development. As AI technologies rapidly evolve, the Agency is introducing a risk-based regulatory framework aimed at guiding their safe and effective use across the industry. This includes applying existing authorities in new ways to address challenges in validation, clinical trials, and data interpretation. The recent FDA authorizations of medical devices and their drug development policy statements indicate these technologies are viewed as a harbinger of progress that the FDA expects to seeing the five basic elements of drug development:

• Discovery and development
• Preclinical research
• Clinical research
• FDA review
• FDA post-marketing safety monitoring

Generative AI and machine learning algorithms are already enhancing disease screening and treatment planning. Now, with FDA's growing support, AI is positioned to transform how drugs are discovered, developed, and monitored post-market. This seminar will explore the FDA’s latest policy developments, examine the impact of Generative AI on drug development, and provide practical insights on navigating regulatory expectations in this advancing field.

WHY YOU SHOULD ATTEND:

The FDA is actively shaping policies around Generative AI, signaling a major shift in how pharma innovation is regulated. With systems like AIRIS leading the way, the focus is now on adaptive AI that learns, solves, and evolves without explicit programming. This session helps you understand these regulatory changes, how the FDA views autonomous AI in drug development, and what it means for your organization. Stay ahead by learning how to align your strategies with FDA expectations and unlock the full potential of AI in pharma.

AREAS COVERED:

• Generative AI
• AIRIS example
• The Drug Discovery / Development Process - 5 Key Steps and AI
• The US FDA Commissioner's Comments
• Discovery and Development (aligned with FDA guidance and ICH M3(R2))
• Preclinical Research
• Clinical Research
• FDA Review (including 21 CFR Parts 312 and 314)
• Post-market Safety Monitoring / Reporting
• Patient Focused Development

WHO SHOULD ATTEND:

• Quality Assurance Departments
• Regulatory Affairs Departments
• AI Software Programming, Documentation, Testing Teams
• Research and Development Departments
• Engineering Departments
• Production Departments
• Operations Departments
• Senior Management
• Consultants; others tasked with pharmaceutical development responsibilities

Course Director: JOHN E. LINCOLN  

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis. He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.