Archives: Agenda

Join this expert-led, peer-to-peer deep-dive session to hear from those in the know. Take back to your business an understanding of what it takes to succeed and lessons learned from those who have been there, done that. 

Delegates must pre-register interest prior to the day of the event.

• Patient driven infrastructure – NF patient registry, NF Preclinical Hub, NF Clinic Network, NF Data Portal – to accelerate trials and insights
• CTF served as IMI research partner on EU PEARL NF1; CTF Europe launched to expand platform trials
• EU PEARL NF1: adaptive platform basket across PN, cNF, LGG/OPG; observational entry → randomization; add/drop arms, early go/ no go signals
• Addresses EMA orphan challenges via clear estimands and central oversight; efficient, de risked paediatric evidence
• NGO impact: contributed to first NF approvals; 60+ US trials; now scaling European execution

• 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

• 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.

• 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

• Evolving Regulatory Environment: Significant regulatory reforms across Latin American countries aiming to align with international standards (e.g., ICH guidelines)
• Opportunities Arising from Regulatory Changes: Faster approval timelines enabling quicker trial initiation
• Role of Vendors in Fostering Opportunities: Need for vendors to adapt to local regulatory nuances and evolving compliance requirements
• Turning to Latin America for a genetically diverse population, valuable for global clinical research, but also understanding the need for culturally sensitive patient engagement strategies to improve recruitment and retention