The use of Generative AI in the Drug Development Process. The US FDA's encouragement of AI technology in pharma development and clinical.
The US FDA has announced steps toward a new regulatory policy 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 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 see in the five basic elements of drug development: 1) Discovery and development, 2) Preclinical research, 3) Clinical Research, 4) FDA review, and 5) FDA post-marketing safety monitoring. AI production software validation has some new requirements as well. The Agency plans to apply its 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 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 the FDA specifically mentions AIRIS, their statements indicate a willingness to work with their regulated industry partners in expanding the use of generative AI into all appropriate areas of pharmaceutical development, production, and post-market monitoring.
Course Content
- Generative AI
- AIRIS example
- The Drug 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
Course Provider
John E Lincoln,
Principal ,
J. E. Lincoln and Associates LLCJohn E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries, 18 of which as a full time independent FDA-regulated industry consultant. Mr. Lincoln 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 / CGMP audits and problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).
In addition, he 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 is a graduate of UCLA.
Who Should Attend
- Senior management in Pharmaceuticals
- QA / RA
- AI software programming, documentation, testing teams
- R&D
- Engineering
- Production
- Operations
- Marketing
- Consultants; others tasked with pharmaceutical development responsibilities
