Overview
The US FDA has announced steps toward a new regulatory policy and framework specifically tailored to promote the development of safe and effective drugs using advanced artificial intelligence / machine learning algorithms by the regulated industry.
Artificial intelligence algorithms are software that can learn from and act on data. These types of algorithms are already being used on a limited but growing scale by industry to aid in screening for diseases and to provide treatment recommendations.
The recent FDA 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
AI production software validation has some new requirements as well
The Agency plans to apply their current authorities in new ways to keep up with the rapid pace of innovation and ensure the safety of these drugs. This seminar will evaluate these stated FDA policy shifts as it applies to drug discovery and development.
Why Should You Attend
Generative AI is a type of artificial intelligence (AI) that attempts to match or surpass human thinking abilities across a wide range of large data tasks. The FDA is adapting to the use of AI in medical products, and has recently issued policy statements on an advanced form of AI in pharma development, looking to the future. One of these is AIRIS.
AIRIS operates without pre-set commands or training data, solving problems and creating rules as it navigates the virtual world. In artificial intelligence (AI), creating adaptable systems that learn independently is a key goal, and AIRIS (Autonomous Intelligent Reinforcement Inferred Symbolism) is an AI system designed to do just that. It is enabled to adapt and solve problems in new situations without needing explicit programming for each task.
While FDA specifically mentions AIRIS, their statements indicate their thinking in general on AI in drug discovery and development, as well as a wiliness to work with their regulated industry partners in expanding use of generative AI into all appropriate areas of pharmaceutical development, production, and post market monitoring.
Webinar Takeaway
- Generative AI
- AIRIS example
- The Drug Discovery / Development Process - 5 Key Steps and AI
- The US FDA Commissioner's Comments
- Discovery and Development
- Preclinical Research
- Clinical Research
- FDA Review
- Post-market Safety Monitoring / Reporting
- Patient Focused Development
Who Will Benefit
- Senior Management in Pharmaceuticals
- QA / RA
- AI Software Programming, Documentation, Testing Teams
- R&D
- Engineering
- Production
- Operations
- Marketing
- Consultants
Faculty John E Lincoln
Principal, J E Lincoln and Associates
John E. Lincoln is a leading FDA compliance and regulatory affairs consultant with over 41 years of experience in FDA-regulated industries and 27 years as Principal of J. E. Lincoln and Associates LLC. He is recognized globally for his expertise in cGMP compliance, quality assurance, and medical device validation.
Throughout his career, John has partnered with pharmaceutical, biotechnology, and medical device companies — from startups to Fortune 100 organizations — across the U.S., Canada, Mexico, Europe (France, Germany, Sweden), and Asia (China, Taiwan).
His consulting specialties include:
- FDA Quality System Regulation (QSR) compliance and QMS remediation
- Process, product, and software validation (including 21 CFR Part 11 systems)
- ISO 13485 and ISO 14971 risk management implementation
- Design Control, Design History File (DHF), and Technical File development
- Regulatory submissions, including FDA 510(k) filings and responses to FDA audit observations
John has held leadership roles in Manufacturing Engineering, Quality Assurance, Quality Engineering, Regulatory Affairs, and R&D, progressing to Director and Vice President levels.
As a recognized FDA industry expert and speaker, he has:
- Authored peer-reviewed journal articles and five chapters in the RAPS textbook on validation
- Delivered global workshops, seminars, and webinars on FDA cGMP, validation, and risk management
- Helped hundreds of organizations achieve FDA and ISO compliance through practical, hands-on training
