The Cancer Drug Development Forum – CDDF is the platform for all stakeholders involved in the development of cancer drugs.

CDDF Multi-Stakeholder Workshop

Enabling Smarter Clinical Trials

17 November – 18 November 2025, Hybrid Workshop

 

Presentations

 

SESSION 1: Clinical trials and real world evidence: what really matters

Enabling Clinical Trials: Taking a proportionate approach – focusing on what really matters – Juan Estevez (AEMPS, ES)

Turning Data into Decisions: Real-World Evidence in Regulation – Alexandra Pacurariu (EMA, NL)

 

SESSION 2: Use of pragmatic elements in clinical trials

Matching trials aims to design decisions: how PRECIS-2 can help, and how PRECIS-3 will be better – Shaun Treweek (University of Aberdeen, UK)

Patient perspective – Gilliosa Spurrier-Bernard (MelanomeFrance, FR)

Designing trials with pragmatic elements to generate high-quality real-world evidence for regulatory decisions – Nafsika Kronidou-Horst (Roche, CH)

Safety data report – ICH E19 – how we streamline – example of pragmatic elements – regulatory component – Peter Mol (University of Groningen, NL)

 

 

SESSION 3: Driving research using health data

EMA article – clinical evidence 2030 – Marianne Lunzer (CTCG, AT)

Unlocking the Power of Real-World Data Across the Full Lifecycle of Cancer Clinical Trials – Ariel Bourla (Johnson & Johnson, U.S)

From Patient Experience to HTA Evidence: The MyLymphoma Model for Real-World Data Generation – Natacha Bolanos (Lymphoma Coalition, ES)

Supporting drug development through new evidence generation approaches – Alison Cave (Medicines and Healthcare products Regulatory Agency, U.K)

Round table discussion “How will the EU health data space empower cancer clinical trials in EU” – Alexandra Pacurariu (EMA, NL)

SESSION 4: Wrap-up and panel discussion

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