Archives: Agenda

Fireside Chat: Navigating FDA policy & politics in rare disease drug development under the Trump Administration

Rare disease innovation has always required both scientific courage and regulatory flexibility. Today, under the Trump Administration’s FDA, sponsors are seeing new opportunities for accelerated approvals, digital biomarkers, and innovative endpoints—but also greater scrutiny around confirmatory trials and uncertainty over key incentives like the pediatric voucher program. Meanwhile, political turbulence at FDA and CDC leadership levels underscores just how intertwined policy and science have become.

Interactive Session: Maximizing Site Engagement: A Sponsor’s Perspective in the Evolving Clinical Trial Landscape

·       Understanding Site Needs: Aligning sponsor strategies with site capabilities and expectations

·       Building Trust and Transparency: Fostering long-term partnerships through clear communication and support

·       Technology & Tools: Leveraging digital platforms to enhance site-sponsor collaboration

·       Metrics That Matter: Defining and tracking meaningful engagement KPIs for sustained success

FIRESIDE CHAT: Leveraging Process Improvements as Strategic Assets

·       Corporate Anthropology as the basis for process innovation and optimisation

·       Viewing Process Innovation as Strategic Assets

·       Communities of Practice as vehicles for process innovation and implementing optimal ways of working

·       Process Innovation within highly regulated SOP driven environments

PANEL DISCUSSION: Unravelling the impact of ICH E6 Revision 3: implementing new standards in good clinical practice

ICH E6 (R3) introduces significant updates to Good Clinical Practice guidelines, emphasizing risk-based quality management, patient centricity, and flexibility in trial design and execution. This panel discussion will address the impact of ICH E6 (R3) on clinical trials, comparing it to the previous ICH E6 (R2), discussing approaches to implementation, and considering varied interpretations among stakeholders.

  • Understand the key changes in ICH E6 (R3) and their implications for clinical trial conduct
  • Explore different approaches to implementing the new guidelines in diverse trial settings
  • Analyse the challenges, opportunities, and interpretations associated with ICH E6 (R3)
  • Highlight meaningful differences between ICH E6 (R2) and ICH E6 (R3) and their practical impacts

 

Navigating complexities of managing radioligand therapy oncology trials

  • Site selection considerations specific to Radiopharmaceutical Therapy (RPT) clinical trials
  • A sponsor’s perspective of the technical knowledge and expertise required to deliver RPT studies
  • Country specific RPT clinical trial requirements and regulations
  • Challenges with just-in-time supply for RPT investigational products

Generative AI to improve patient recruitment and retention in oncology trials

·       Provide real-time feasibility insights for better site selection and study design

·       Instantly match eligible patients from unstructured EHR data in seconds

·       Surface future trial candidates based on clinical trajectory (e.g., second-line eligibility while still in first-line treatment)

·       Predict patient dropout risk and improve retention strategies

Has RBQM Reached Its Full Potential?

Risk-Based Quality Management (RBQM) adoption is on the rise — but for many clinical teams, the expected gains in efficiency and cost reduction have yet to materialize.

In this presentation, we’ll examine the disconnect between RBQM’s intended impact and its real-world results. We’ll explore common operational and strategic misalignments and share how TRI is helping clinical trial teams close this gap; transforming RBQM from a theoretical framework into a practical driver of performance and quality.