The convergence of AI and pharmaceuticals holds immense promise for revolutionizing drug discovery, clinical trials, and healthcare delivery. However, ensuring regulatory compliance is paramount to realizing this potential. This presentation offers a comprehensive overview of AI in pharma and the regulatory roadmaps guiding its implementation. Through interactive discussions and expert insights, attendees will explore the complexities of regulatory compliance in AI-driven pharmaceutical practices and discover practical strategies for overcoming regulatory barriers while fostering innovation and patient-centric care.

Learning Objectives:

• Familiarize yourself with the transformative impact of AI on various aspects of the pharmaceutical industry, including drug discovery, development, and regulatory affairs.
• Identify the regulatory challenges and considerations associated with integrating AI technologies into pharmaceutical workflows, including data integrity, validation, and safety.
• Gain an understanding of the regulatory frameworks governing AI in pharmaceuticals, including FDA guidelines, international standards, and emerging regulatory trends.
• Develop actionable strategies for navigating regulatory roadmaps effectively, ensuring compliance, and driving ethical, responsible AI adoption in the pharmaceutical sector.

Stephanie A. Pasas-Farmer, Ph.D.

Stephanie Pasas-Farmer is a recognized bioanalytical expert in the areas of discovery and regulated bioanalysis for pharmaceutical, biologics and hybrid technologies, including antibody-drug conjugate technology. Relying on insights gained over a 20-year career focused on bioanalytical operations across global biopharmaceutical companies, contract research organizations and consulting, Stephanie founded Ariadne Software in 2018 and led development of Red Thread, guiding it from inception to production as an artificial intelligence (AI)-enabled solution for common challenges in bioanalytical data review.
Prior to Ariadne Software, Stephanie created BioData Solutions, a scientific advisor firm whose aim is to help sponsors advance early stage molecules into potential new drug candidates with bioanalysis support and regulatory compliance planning. Before founding BioData Solutions, she led a team of scientists at a global bioanalytical laboratory focused on the support of large molecule and antibody drug conjugate programs using LBA, LC‐MS/MS, and cell-based assays. Earlier career roles included management responsibility for quality control functions of bioanalytical laboratory operations, in addition to business development and research scientist positions.