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

CDDF Multi-Stakeholder Workshop

Challenges in the Landscape of a Global Development Strategy, including patient access

30 March – 31 March 2026, Hybrid Workshop

Presentations

Key note Lecture : ICH E22 guideline on patient preferences

Key note Lecture : ICH E22 guideline on patient preferences – Francesco Pignatti EMA, NL)

SESSION 1: Navigating the Regulatory Maze: Towards Global Harmonization

Balancing country enrolment requirements – Rosanno Cesari (Pfizer, IT)

Mathematical design challenges – Scott Evans (George Washington University DC, US)

Acceptance of non local data for local approval – Eva Skovlund (Norwegian Medical Products Agency, CHMP, CDDF, NO)

How to ensure patient diversity and inclusion in global clinical trials – Nadia Malliou (Pain Alliance Europe, GR)

SESSION 2: Use of pragmatic elements in clinical trials

Regulatory Considerations for Use of Patient-Reported Outcomes in Oncology – Vishal Bhatnagar (FDA, US)

FDA Project Frontrunner – Accelerating Drug Approval for Patients – Jin Chen (IQVIA, US)

The importance of including Patient Reported Outcomes from patient perspective – Alex Filicevas (World Bladder Cancer Patient Coalition, BE)

Patient Reported Outcomes for reimbursement and patient access – Beate Wieseler (IQWIG, DE)

SESSION 3: Driving research using health data

How the landscape of trials has changed in the last 20 years, from a chain of subsequent studies, to 1 or 2 studies that include everything – Elisabeth De Vries (UMC Groningen, NL)

Global Regulatory Flexibility in Oncology FIH Trials: Navigating Cohort/Trial Modifications in Early Oncology Trials Cohort Adaptations – Lynn Howie (Pfizer, US)

Key Considerations for HA when Reviewing Cohort/Trial Modifications versus preferring completely New Protocols in Early Oncology Trials – Dr Kingyin Lee (MHRA, UK)

SESSION 4: Wrap-up and panel discussion