CDDF Annual Conference
Challenge, Advances, and Open Questions in
Global Cancer Drug Development and Clinical Trials
3 – 5 February 2025, Hybrid workshop
SESSION 1: CDDF/AAADV joint session on diversity in global drug development
The recording of the full session can be watched by clicking on the above link.
The individual recordings of each lecture will follow.
What does diversity involve clinically? – Marie von Lilienfeld-Toal (Univ. Bochum, DE) – the speaker did not consent to have her slides published
CDDF Diversity in Clinical Trials Initiative – Fergus Sweeney (CDDF, IE)
Stakeholder Perspectives Towards Enrolling Representative Oncology Clinical Trials – Kim Lyerly (AAADV, US)
SESSION 2: ENDPOINTS IN DRUG DEVELOPMENT: PROGRESS AND CONTROVERSIES
The recording of the full session can be watched by clicking on the above link.
The individual recordings of each lecture will follow.
Progress and challenges in the use of endpoints in cancer drug development: the multiple myeloma experience – Bruno Paiva (Clínica Universidad de Navarra, ES)
EMA Perspective on the endpoints in cancer drug development – Francesco Pignatti (EMA, NL) – did not consent
Introduction on MPAACT – Harindra Abeysinghe
SESSION 3: OPTIMIZE EVIDENCE GENERATION AND PATIENT ACCESS WITH INNOVATIVE CANCER TRIALS (METHODOLOGY)
The recording of the full session can be watched by clicking on the above link.
The individual recordings of each lecture will follow.
ACT EU – Clinical Trial Methodology – Anja Schiel (NoMA, NO) on behalf of Kit Roes (EMA, NL)
Use of External Control Arm to Support Regulatory Approval: Case study of Pembrolizumab and Lenvatinib Combination – Alexandra Oger (MSD, FR)
Use of External Data for Efficient and Robust Evidence Generation: A Case Study of Dynamic Borrowing with External Control for Overall Survival – Emma Clark (Roche, UK)
Beyond randomization: an EORTC academic perspective – Murielle Mauer (EORTC, BE)
Introduction to panel discussion – Anja Schiel (NoMA, NO)
SESSION 4: NAVIGATING PRECISION ONCOLOGY DEVELOPMENT IN VIEW OF NEW REGULATIONS
The recording of the full session can be watched by clicking on the above link.
The individual recordings of each lecture will follow.
Precision oncology – early development in view of the new regulations – Kate Simon (Bayer, US)
New regulations impact on academic research and patient care – Alberto Hernando (Vall d’Hebron Institute of Oncology, ES)
COMBINE – updates and outcomes – Ditte Zerlang Anderson (DKMA, DK)
SESSION 5: EU HTA REGULATIONS - STAKEHOLDER COLLABORATION TO IMPROVE PATIENT ACCESS
The recording of the full session can be watched by clicking on the above link.
The individual recordings of each lecture will follow.
Inequalities in approval process in EU – Carin Uyl-de Groot (Erasmus University Rotterdam, NL)
Lessons Learned from EMA/HTA Scientific Advice: An Industry Regulatory Perspective – Assia Dembri (BMS, CH)
The Impact of Patient Presence in HTA: Overcoming Barriers with a Realistic Perspective – Natacha Bolaños (Lymphoma Coalition, ES)
From Approval to HTA, 2025 and beyond – Anja Schiel (NoMA, NO)