CDDF Multi-Stakeholder workshop
The critical role of Biomarkers in delivering drug development-related precision oncology
13-14 November 2023, Hybrid workshop
Recordings
SESSION 1: Setting the scene of biomarkers
How can we define a biomarker – Academic perspective – Nicola Normanno (INT-Fondazione Pascale, IT)
Industry perspective, biomarkers & drug development – Ademi Santiago-Walker (Janssen R&D, US) – did not consent
SESSION 2: Biomarker-based autorisation and reimbursement
Biomarkers and marketing authorisation of medicines in Europe – Olga Kholmanskikh (Famhp, BE) – did not consent
Biomarker-based drug development and authorisation in US – Reena Philip (FDA, US)
Biomarkers and HTA/PRA – does precision medicine lead to better access and reimbursement? – Sahar Barjesteh van Waalwijk van Doorn-Khosrovani (CZ, NL) – did not consent
SESSION 3: The cost of not using biomarkers
SESSION 4: IVDR
IVDR implementation – industry perspective – Claudia Popp (Roche, CH)
IVDR implementation – regulatory perspective – Ana Trullas (EMA) & Olga Kholmanskikh (Famhp, BE) – did not consent