Modeling and Artificial Intelligence (AI) in Generic Drug Development and Product Lifecycle Management: Regulatory Insights and Future Trends

Artificial Intelligence (AI) is rapidly transforming drug development and regulatory processes across the pharmaceutical industry. This workshop explores cutting-edge applications of modeling and AI throughout the drug development lifecycle, with particular emphasis on complex generics. Through presentations, panel discussions, and interactive sessions, attendees will examine how AI is being integrated into regulatory frameworks to streamline workflows, accelerate development timelines, and advance quantitative medicine approaches.

Key areas of focus include:

• Regulatory Perspectives: Current thinking from FDA, EMA, and other global regulatory bodies on AI integration in drug development and assessment processes
• AI-Driven Workflow Optimization: How AI enhances efficiency in regulatory writing, product development, and modeling workflows
• AI in Drug Development: Exploration of AI’s role in transforming drug development processes, including predictive modeling for drug substance development, formulation optimization, and process optimization
• AI and Quantitative Medicine: Discussion on how AI/ML approaches are extending quantitative medicine approaches, from pharmacometrics and systems pharmacology to translational modeling and digital twins

Join us for an immersive two-day experience featuring presentations from leading experts in regulatory agencies, pharmaceutical industry, and academia. All attendees will benefit from insights shared by a diverse group of speakers, including FDA officials, international regulatory experts, industry leaders, and renowned academics. This workshop offers a unique opportunity to:

• Understand the latest regulatory thinking on AI integration in drug development
• Learn about cutting-edge AI applications in the pharmaceutical industry
• Network with peers and experts in the field
• Gain practical insights into implementing AI solutions
• Explore the future of AI in drug development and regulatory science

Join us to be part of the conversation shaping the future of AI in pharmaceutical innovation and regulation.

Choose your experience:

Virtual Attendees will have free access to all sessions of the workshop except the small group (in-person) working sessions. Virtual attendees will be able to:

• Attend all presentations and panel discussions
• Participate in all Q&A panel discussions by submitting questions online in real time to the speakers and panelists
• Enjoy free access to workshop recordings of presentations and panel discussion (not including the small group working sessions)

In-person Attendees will enjoy all of the benefits of virtual attendance as well as interactive experiences featuring:

• Small group working sessions allowing for deeper dives into specific mock case examples on AI applications in drug development and regulatory assessment. These sessions will simulate real-world scenarios, illustrating how AI can be leveraged to solve complex problems in drug development, while also addressing best practices for communicating with regulatory agencies regarding submissions that incorporate AI tools.
• Collaborative discussion and learning opportunities with FDA, academic, and industry experts

Workshop Topics

• Regulatory Perspectives and Opportunities
• AI Streamlining Workflows
• AI Supporting Drug Development
• AI and Quantitative Medicine

Audience

This workshop is primarily designed for professionals involved in the development, implementation, and regulation of AI tools in the drug development. The target audience includes pharmaceutical scientists (i.e., quality assurance and control experts, formulation and product development scientists), data scientists, AI/ML specialists, pharmacometricians, biostatisticians, bioinformaticians, regulatory affairs professionals, and clinical development professionals. Additionally, the workshop will be valuable for academic researchers in pharmaceutical sciences and computer science, representatives from contract research organizations (CROs) and technology providers, regulatory agency staff, and healthcare professionals interested in AI’s use on drug development. The content is tailored to accommodate participants with varying levels of AI expertise, from those seeking to understand the basics of AI applications in pharmaceuticals to advanced practitioners looking to stay abreast of the latest regulatory considerations and cutting-edge applications.

• Virtual Attendance is optimal for an audience who would like to have access workshop content from anywhere, eliminate travel time and expenses, and who would like to have the flexibility to attend dynamic sessions/presentations at preferred times.

• In-Person Attendance is optimal for an audience that is interested in collaborative discussions and real-time engagement, immersive learning, interactive sessions and group activities.

Registration Fees:

• This workshop is FREE for virtual attendees.

• The combined cost for both days of in-person attendance and activities is:
  • $350, in-person attendees – general
  • $150, in-person attendees – government (must have an email ending in “.gov” in order to register at this rate)

For in-person attendees, beverages and food for breaks will be provided; lunch is not included. A link will be provided closer to the event for ordering lunch each day.

For faculty and students from the University of Maryland, Baltimore; The Universities at Shady Grove; and University of Michigan, the workshop is free for in-person attendance. Other students, please email us for a reduced rate. Please contact us at (info@complexgenerics.org) and indicate which workshop you are interested in.

Continuing education (CE) credits will not be provided for attending this workshop. A certificate of attendance will only be provided to individuals attending the workshop in-person.

Introduction to the Workshop

This 2-day hybrid (virtual and in-person) workshop focuses on exploring the opportunities, applications, and regulatory considerations of Artificial Intelligence (AI) in Generic Drug Development and Product Lifecycle Management. The workshop will include comprehensive sessions examining regulatory perspectives from global agencies, practical applications of AI in streamlining workflows, and innovative AI and modeling approaches to facilitate drug development and quantitative medicine. The program features expert presentations from regulatory scientists, industry leaders, and academic researchers, complemented by interactive Q&A panels and small working group discussions for in-person attendees. This collaborative forum aims to advance understanding of AI’s potential to enhance efficiency, accuracy, and regulatory compliance throughout the drug development continuum, while addressing the evolving regulatory landscape that shapes the safe and effective integration of AI technologies in pharmaceutical innovation.

DAY 1:

Session 1: Regulatory Perspectives and Opportunities

Format: Presentations and a Panel Discussion with Q&A (Virtual and In-Person Attendees)

• This session underscores the critical importance of understanding global regulatory frameworks to responsibly harness AI in Generic Drug Development and Product Lifecycle Management. By exploring the evolving standards, policies, and opportunities for AI integration, this session will highlight how regulatory landscape shapes the safe, effective, and innovative application of AI in advancing pharmaceutical innovation.

Session 2: AI Streamlining Workflows

Format: Presentations and a Panel Discussion with Q&A (Virtual and In-Person Attendees)

• AI technologies complement experts, helping them work more efficiently, consistently, and insightfully. This session will focus on the use of AI for streamlining workflows, which include, but not limited to, assist with regulatory submission document preparation or assessment, and product development. In addition, this session will also focus on current practices in this area with real-world examples in which AI is being used to advance workflows relevant to accelerating generic drug development.

Session 3: Small Working Group Sessions

Format: Interactive Breakout Sessions (In-Person Only)

• In this collaborative session, in-person attendees will participate in focused discussions on mock case examples on the use of AI in drug development and regulatory processes. Guided by experienced moderators, participants will engage in in-depth discussions through immersive round-table conversations, introductory presentations, and well-designed Q&A sessions.

DAY 2:

Session 4: AI Supporting Drug Development

Format: Presentations and a Panel Discussion with Q&A (Virtual and In-Person Attendees)

• AI is becoming increasingly integral to the future of generic drug development. This session will explore how AI offers innovative solutions in transforming the generic drug development process by enhancing efficiency to improve the quality of generic medicines. The session will delve into practical applications of AI within the generic drug domain, including predictive modeling for drug substance development, formulation optimization, streamlining regulatory pathways, process optimization and scale-up.

Session 5: AI and Quantitative Medicine

Format: Presentations and a Panel Discussion with Q&A (Virtual and In-Person Attendees)

• Quantitative medicine has been critical for better decision making in reducing uncertainty and increase precision across the product lifecycle. Given the fact that AI/ML approaches are becoming an indispensable extension of quantitative medicine—augmenting our ability to analyze massive, complex datasets, and enable faster model development, this session will explore how AI is unlocking new possibilities for quantitative medicine for generic drug development and product lifecycle management.

Session 6: Small Working Group Sessions

Format: Interactive Breakout Sessions (In-Person Only)

• In this collaborative session, in-person attendees will participate in focused mock case discussions on the development and evaluation of quantitative medicine models built by AI tools. Guided by experienced moderators, participants will engage in in-depth discussions through immersive introductory presentations and well-designed Q&A sessions.

The workshop will conclude with a summary of key takeaways and future directions for AI in pharmaceutical development and regulation.