DAY 2 – TUESDAY 27 FEBRUARY 2018
PLENARY SESSION 2 (PART II) : RARE CANCERS
- General Introduction on Rare Cancers – Francesco De Lorenzo (ECPC, IT)
- Statistician’s Perspective – Lucinda Billingham (University of Birmingham, UK)
- US Regulatory Perspective – Amy Barone (FDA, USA)
PLENARY SESSION 3: DEVELOPMENT AND APPROVAL PATHWAY FOR CHANGES IN DOSING REGIMES
- Finding the Right Dose and Schedule of New Drugs – Clinical Considerations – Axel Hanauske (academic consultant, DE)
- Clinical and Statistical Challenges of Bridging Approaches to Alternative Dosing Regimen or Formulations – Dominik Heinzmann (Roche, CH)
- Regulatory Considerations of Bridging Approaches to Alternative Dose Schedule or Formulation – Essam Kerwash (MHRA, UK)
- Report on the CDDF workshop on Innovation in Oncology Clinical Trial Design – Jaap Verweij (Erasmus MC, NL)
PLENARY SESSION 4: PATIENTS’ REPORTED OUTCOMES IN ONCOLOGY PATIENT-CENTERED DRUG DEVELOPMENT: OPPORTUNITIES & CHALLENGES
See the general presentation including:
- Introduction of Panelists and Topics – Sarah Bobiak (EMD Serono/Merck KGaA, USA)
- Study Design – Daniel O’Connor (MHRA, UK)
- Endpoints – Amylou Dueck (Mayo Clinic, USA)
- Instruments, Measure Validity – Andrew Bottomley (EORTC, BE)
- Closing remarks – Eva Skovlund (NTNU, NO)
PLENARY SESSION 5: TRANSLATION OF CANCER BIOMARKERS INTO CLINICAL PRACTICE
- Patient Representatives’ Perspective – Francesco De Lorenzo (ECPC, IT) – please contact CDDF to access the slides
- Challenges of Biomarker Development in Europe: an Industry Perspective – David Brunel (Biodesix, USA)
- Challenges of Getting an NGS Assay to the EU Market – Thomas Holtschke (Foundation Medicine, USA)
- Perspectives from the Healthcare Ecosystem – Annie Pannelay (UK)
PLENARY SESSION 6: REPORT FROM CDDF MULTI-STAKEHOLDER WORKSHOPS
- Minimal Residual Disease (October 2047, London, UK) – John Smyth (CDDF/University of Edinburgh, UK)
- Access to Innovative Oncology Drugs in Europe (September 2017, Madrid, Spain) – Sonia Garcia Perez (AEMPS, Spain)