Archives: Agenda

KEY NOTE: Driving CRO Performance in Clinical Trial

  • Determining the optimal stage for CRO engagement to maximize efficiency
  • Engaging CROs in protocol development to inform strategic decisions, including country selection and trial design considerations
  • Leveraging CRO expertise by fostering a collaborative, partnership-driven relationship

CASE STUDY: Optimizing T Cell Engaging Therapies from Preclinical Study to Human Clinical Trial: Conditional Activation of T Cell in the Tumor Microenvironment by a Novel 4-1BB T Cell Engaging BsAb (Grabody T)

·       The Grabody T platform: A Clinically Validated 4-1BB Bispecific Antibody Approach to Overcome Liver Toxicity

·       Grabody T Exhibits TAA-Dependent 4-1BB Activation and Strong in vivo Efficacy

·       Promising Clinical Activity and Favourable Safety Profile Across the Grabody T Pipeline (Givastomig, Ragistomig, and YH32367)

The role of patient research NGOs in drug development – illustrated by the Children’s Tumor Foundation’s leadership role in the EU PEARL project

  • 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

CLOSING PANEL DISCUSSION: How AI is powering a new era of cancer drug discovery and development

  • 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

KEYNOTE: Clinical trials in the age of AI – What you’ll discover

  • 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.

From chaos to clarity: A data-driven CRO selection framework for lean biotechs

  • 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