Day Two: Friday, September 5Friday, September 5, 2025

This talk presents final, unpublished findings from a collaborative case study between Weave Bio and a Top 20 global pharmaceutical company—one of the first scientific comparisons of AI-assisted and traditionally authored regulatory content. The study focused on the efficiency and quality of outputs from two previously submitted IND applications, specifically Sections 2.6.2, 2.6.4, and 2.6.6, known for their analytical and narrative complexity.

Results show how AI-driven platforms like Weave can accelerate content preparation by structuring and formatting source data into draft-ready material. Teams generated first drafts instantly, reduced repetitive tasks, and rapidly iterated, while human oversight remained essential for strategic interpretation and program alignment.

The session will explore:

• Human-only vs. AI-assisted drafting approaches
• A framework for evaluating quality and speed
• Practical insights for improving regulatory workflows with AI-augmented tools

Grounded in measurable outcomes, this talk offers a pragmatic view of how AI can enhance—without replacing—scientific expertise in regulatory writing.

• Discuss case studies of how compliance programs can leverage AI to enhance monitoring activities
• Learn how to develop AI governance policies and procedures to identify and mitigate risk for AI usage within your organization, including concerns with data privacy and AI-generated content

• Hear an overview of the updated SIUU guidance and analysis of the differences between the former draft guidance and final guidance
• Explore areas of the guidance subject to interpretation and best practices in interpreting these areas to minimize risk
• Examine how to implement and operationalize the final guidance to optimize risk

• Discuss how to define precise scopes of work for emerging field-facing roles (e.g., thought leader liaisons, reimbursement managers), explicitly outlining permissible and prohibited activities
• Learn how to establish clear lines of demarcation between promotional and non-promotional activities to prevent inadvertent off-label promotion or other compliance violations
• Explore strategies to implement monitoring and auditing procedures to detect and address potential compliance violations, including reviews of field activity reports and interactions with HCPs and patients

• Examine FMV methodologies to prevent Anti-Kickback Statute violations and ensure transparent interactions
• Navigate FMV complexities in distributor agreement through understanding price reporting implications and establishing compliant discount and service fee structures
• Develop strategies to implement robust FMV oversight and monitor and audit FMV determinations, safeguarding against regulatory scrutiny and financial penalties

• Learn how to establish and maintain compliant investigator relationships and navigate fair market value (FMV) determinations, contract negotiation, and transparency in transfers of value
• Delve into regulatory expectations for investigator interactions to understand and implement optimal guidelines for communication, data integrity, and conflict of interest management in clinical trials for both pre-approval and post-approval companies
• Discuss how to implement effective oversight and monitoring of investigator activities and discuss best practices for documentation, audits, and addressing potential compliance risks throughout the trial lifecycle

• How to establish robust criteria for speaker selection and attendee participation, ensuring transparency and mitigating conflict of interest risks
• Assess the risks associated with speaker programs for legacy products and determine best practices for ongoing compliance
• Analyze recent enforcement actions and apply lessons learned to strengthen your speaker program compliance strategy