Archives: Agenda

• Building an operating model that aligns sponsors, CROs, and clinical sites around shared timelines and delivery expectations
• Operational strategies for condensing early-phase development timelines while maintaining trial quality and oversight
• Cellectar Biosciences case study: Lessons from a COO on partnering with CROs and clinical sites to rapidly execute studies and meet key clinical milestones
• Managing operational complexity when multiple partners support a single oncology program

• Understanding the Pharmacy Card Model
• The program lifecycle: From design to delivery
• A day in life: Sponsors and sites
• Proof of performance: Feedback and case studies

• Modern FDA Acceleration Pathways: Breakthrough, Fast Track, Accelerated Approval, Priority Review, RTOR, Orbis, CNPV
• Trial Design Innovations That Regulators Support: adaptive designs, master protocols, biomarker‑driven enrichment
• Optimizing Early Regulatory Engagement to Enable Acceleration: strategic FDA/EMA interactions, alignment on endpoints and biomarkers

During the roundtable discussion session, the conference hall will be divided into zones. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within the industry. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

Navigating communication styles by tailoring approaches for different patient personalities
Roel van der Heijde, Facilitator & Trainer, Patient Experience Association The Netherlands

Managing Clinical Trial Budgets in An Unstable Financial World

Working Better with Investigative Sites

Working With CROs More Effectively

• Sharing real examples of decisions that led to delays inefficiencies or trial failure
• Understanding early warning signs that were missed or ignored
• Identifying what should have been done differently in hindsight
• Applying these lessons to improve future trial design and execution

3 x Biopharma panel seats available

1 x Vendor panel seat available