Archives: Agenda

• Current EU biotech landscape
• Early Phase (EP) done right: How robust EP FIH, healthy volunteer studies, and patient studies can be the launch pad for EU biotech clinical trial development
• Global reach, local intelligence: Leveraging strong networks across geographies while working within local regulatory, patient, and site environments with alignment of strategy and operations
• Late-Phase pull-through advantage and partnering for scale: examples from EU biotech of EP Phase I to Phase II/III programs, minimizing rework and accelerating timelines

• Competition for patients in clinical trials is fierce, and putting the trial at the front of mind of PIs, site teams, referral networks, and patients is crucial to win in patient engagement​
• A successful recruitment and retention strategy has to reach target HCPs and patients with accelerated precision through an engagement campaign that starts with an evidence-based point of reference, builds confidence in the trial, delivers a resonating call to action, and evolves as clinical insights start flowing in​
• A new approach to recruitment and retention takes inspiration from ways of working within Medical and Commercial teams and produces durable outputs that evolve into the essentials of a product launch toolkit, facilitating organizational efficiency

• Designing AI responsibly under proper governance: ethical frameworks for the implementation of AI agents
• Discussing how AI is being applied across the trial lifecycle
• Balancing patient privacy and data protection: Bridging regulatory frameworks with real-world implementation

• Enhancing feasibility assessments using AI algorithms
• Streamlining clinical trial designs with predictive AI models
• Leveraging AI for identifying optimal patient populations

• Leveraging digital solutions for enhancing candidate engagement in specific clinical trial settings
• Integrating data insights for continuously optimizing recruitment practices
• Innovating methods to ensure the best fit between recruiting tactics and clinical trial environments
• Digital Twins in clinical trials: how far out are we from seeing this?

• Why we believe that choosing multiple expert partners on your program is worth the risk
• Why we believe that a focus on expertise pays off in terms of both quality and budget
• What to consider when choosing your partner. How to identify the expert on the market
• How to establish oversight in a multi-vendor environment
• Ensuring sponsor control while partnering with several specialized CROs

During the roundtable discussion session, the conference hall will be divided into three ‘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 clinical operations in oncology trials. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

ROUNDTABLE 1
Clinical trial applications (CTAs) in Europe

ROUNDTABLE 2
Enhancing collaboration between clinical operations and clinical supply
Marie Rasoanandrasana, Head, Supply Chain and Vendor Management, Debiopharm Group

ROUNDTBALE 3
Navigating geopolitical risks in global clinical trials
Mara Hummel, Associate Director of Global Clinical Operations, Team Leader, Roche

ROUNDTABLE 4
Integrating AI into clinical operations
Constantin Weberpals, Machine Learning Researcher, Former Stanford School of Medicine