Archives: Agenda

• Why ATR, why now? Regulatory context (ICH_E6) and the quality/patient-safety imperative
• Risk-based ATR: Principles, assessment methods, and prioritization in audit trail review
• Practical use cases: What to look for, signals to flag, and how to interpret findings
• Systems & enablement: Key platforms, tools, analytics, and workflows that operationalize ATR

• Overviewing current approaches and trends within clinical data management
• Assessing challenges and identifying solutions
• Understanding the where the industry is heading to curb competition

Clinical trials have a notoriously high failure rate. Evidence shows that the inclusion of effective biomarkers can double the success rate of clinical trials. This presentation explores precision medicine technologies that can serve as companion diagnostics for both small and larger pharmaceutical companies. It will explain how such companion diagnostic can help to improve patient selection, strengthen evidence generation, and increase approval rates for anti-inflammatory drugs. It will also highlight data-driven strategies that enable smarter trial design and combinational biomarkers can enhance success rates in drug development for conditions such as inflammatory bowel disease (IBD) and rheumatoid arthritis (RA)

• Evaluating benefits of a risk-based approach when executing a clinical trial
• Making data-driven decisions to forecast and minimize impact of risk
• Integrating RBQM effectively into clinical trial designs to strengthen risk-based approaches

Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Each discussion will be led by a table moderator and will focus on a different challenge within oncology clinical trials. Roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.
After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

RT 1 Effectively managing data across multiple sources

Hosted By Marouane Nouira, Head, Data Management and Data Strategy, Galapagos

RT 2 Encouraging team collaboration to streamline data management processes

Hosted by Catilina Nobre, Director, Alliance Management, AstraZeneca

RT 3 Managing data collection effectively to prioritise quality over quantity

Hosted by Kavita Gaadhe, Data Management Lead, ITM Isotope Technologies