Archives: Agenda

• Breaking down silos to include clinical supply in other departmental discussions earlier
• Bridging the gap between clinical supply, CMC, quality, clinical operations and other stakeholders
• Utilizing robust relationships to be better prepared when running into problems conducting trials
• Increasing the resilience of your trial through succinct collaboration

• Sanofi’s IRT transformation journey, highlighting key challenges in clinical supply and technology delivery and how IRT functions as a core system to enable a scalable and resilient supply strategy.
• Practical examples of how Sanofi leverages tailored IRT functionalities, advanced features, and specific integrations to optimize drug supply, enhance visibility, and drive operational efficiency.
• How joint planning and strong partnership resulted in continued innovation and measurable improvements supporting Sanofi’s portfolio growth.

• Moving from basic functionalities to more meaningful impact and examples of this in practice
• When AI is progressing so quickly, how will regulation evolve to match this speed?
• When is AI not the answer?
• How AI has revolutionised innovative ways of collecting data, biosimulation, and early disease diagnosis for oncology trials

Moderator: Asiyah Nawab, Senior Healthcare Analyst (Immunology Team), GlobalData

THIS SESSION WILL BE IN THE ONCOLOGY CONFERENCE ROOM

• The new era of pharmaceutical compounds
• Regulatory landscape: From traditional IMPs to ATMPs
• Clinical operations: Managing an ATMP study, main challenges

• Hear about a pragmatic, data-driven framework developed and piloted at HDP to transform CRO selection from an ad-hoc, relationship-based process into an objective and reproducible model
• Move beyond defaulting to global CROs and instead identify the optimal partner profile for each trial type and region.
• Quantify performance, cost, and quality trade-offs using structured assessment tools and scoring matrices.
• Integrate input from clinical, regulatory, and finance stakeholders to ensure balanced decision-making.
• Embed e-clinical and operational system compatibility checks into the evaluation process to prevent integration failures downstream.
• Align sponsor and CRO incentives early—so that success metrics are shared, measurable, and sustainable.
• Faster onboarding, clearer accountability, and partnerships that foster trust rather than friction

• The Clinical Trial Bottleneck and how AI can break this cycle.
• AI as a Full-Lifecycle Catalyst: From protocol design to regulatory submission.
• Recruitment Reinvented: How AI-driven models and molecular matching slash screening times and cut screen failures.
• Smarter Trial Design
• Ethics in the Algorithm Era: Bias mitigation, federated learning for privacy, and transparency frameworks ensuring compliance and trust.
• Blueprint for Implementation: A pragmatic 4-phase roadmap – Foundation, Integration, Scale, Leadership – designed for operational success.
• Future Horizons: Digital twins, foundation models, and quantum computing shaping the next decade of oncology research.

• Changing how researchers select potential patients for better success rates
• How to improve drug efficacy and patient safety before it’s too late
• Back to square one: Differentiating with simpler, patient-centric protocols and optimised study design
• Avoiding disappointing results by implementing the right technology tools to advance your trial
• Lessons learned to mitigate trial failures

Moderator: Sumeet Ambarkhane, Chief Medical Officer, Pathios Therapeutics