Archives: Agenda

• Embedding QA from day one: Shifting Quality from a reactive, inspection driven process to proactive design and execution
• Leveraging RBQM frameworks and real time data analytics to anticipate issues, prioritize oversight, and make informed decisions
• Integrating emerging technologies to streamline inspection readiness and improve data integrity
• Applying quality tolerance limits (QTLs), analytics, and cross functional strategies to drive quality forward, reduce deviation risk, and strengthen regulatory confidence
• Delivering future-ready QA practices aligned with ICH expectations to sustain a quality culture

Moderator: Lois Wallace, Senior Manager, Clinical Development, SERB Pharmaceuticals

• Building cross-functional fluency across clinical operations, biometrics, medical affairs and commercial to identify where AI can create value between functions
• Developing boundary-spanning skills by learning enough of each function’s language to translate needs and priorities across teams
• Testing ideas through rapid AI prototyping using LLMs and low-code tools to demonstrate what’s possible
• Partnering across IT, data science and vendors to transform successful prototypes into governed, audit-ready solutions and move from AI-curious to leading an initiative within 90 days

• Strategies for embedding AI tools into everyday workflows and gaining buy-in across cross-functional teams
• Practical lessons for small biotech companies transitioning from experimentation to enterprise-level AI capabilities
• Why data quality, governance, and integrated systems must be established before AI can deliver meaningful insights
• Identifying realistic use cases where AI can support decision-making, forecasting, and operational oversight in drug development

• The Premise: Evolution, Not Replacement
• Current State: AI Use-Cases on the Ground
• Future State: The “Last-Mile” of Drug Development
• Builders, Not Bystanders: Why We Must Drive AI Development

• Traditional IDMC reports are struggling to keep pace with the complexity of modern clinical trials. Lengthy, table-heavy reports can make it difficult to identify emerging safety signals, a challenge recognized by both IDMC members and the FDA’s 2024 draft guidance.
• This presentation explores how modern data visualization techniques, including targeted graphical displays and interactive dashboards, can transform interim data into clear, actionable insights. By improving the interpretation of safety trends, patient trajectories and clinically relevant deviations, visualization enables faster signal detection and more informed IDMC decision-making.
• Attendees will discover practical strategies for modernizing IDMC reporting to improve patient safety, support regulatory expectations and enhance oversight throughout clinical development.

• Planning transitions between trial phases while maintaining clear governance and operational continuity for small biotechs as well as large pharma
• When does governance not happen when it should?
• Fit-for-purpose governance: Tailoring oversight strategies to the biotech environment, where agility and limited resources are critical
• Strengthening responsible vendor oversight with up-to-date documentation and compliance aligned with evolving ICH guidance and regulatory expectations

Moderator: Krissy Meckel Parker, Associate Director, Clinical QA, Neurocrine Biosciences

• Background and rationale for obtaining ethnic data in Phase I
• Case for collecting the data outside of China and Japan
• Regulatory updates from PMDA and NMPA
• Strategic planning. How, when and where to collect the data