Scientific Programme
Friday 23rd October (All times at CEST) |
| 14:30 | Introduction: Roberto Salgado, GZA, Belgium |
| 14:45 | Keynote Lecture Do journals have a societal responsibility with respect to healthcare settings? Speaker: Fabrice André, Institut Gustave Roussy, France |
Session 1 |
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| 15:15 – 17:45 | Critical issues in Drug- and Biomarker Development Chair: Tracy Lively, National Cancer Institute, USA |
| 15:15 | Effective integration of pharmacodynamic (PD) markers into phase 0, phase 1 and phase 2 trials What have we achieved two decades after? Speaker: Lillian L. Siu, Princess Margaret Hospital, Canada |
| 15:35 | Lessons learned from molecularly-directed single agent basket trials and plans for the future: NCI’s match precision medicine initiatives Speaker: Lyndsay Harris, National Institutes of Health, National Cancer Institute, USA |
| 15:55 | Validation of biomarker assays in clinical trials: a pathologists dream – or worst nightmare? Speaker: John Bartlett, Ontario Institute for Cancer Research – MaRS Centre, Canada |
| 16:15 | Most drugs entering health care systems do not show added benefit compared to existing drugs but give more options for late-stage cancer patients. Should we need a new concept for the establishment of independent prognostic and predictive biomarkers for cancer treatment? Speaker: Sacha Gnjatic, Icahn School of Medicine at Mount Sinai, USA |
| 16:35 | Biomarker-driven clinical trials: promises and pitfalls Speaker: Renzo Canetta, Independent Consultant, USA |
| 16:55 | Panel Discussion Q&A Chair: Tracy Lively, National Cancer Institute , USA Renzo Canetta, Independent Consultant, USA Sacha Gnjatic, Icahn School of Medicine at Mount Sinai, USA Lillian L. Siu, Princess Margaret Hospital, Canada Lyndsay Harris, National Institutes of Health, National Cancer Institute, USA John Bartlett, Ontario Institute for Cancer Research – MaRS Centre, Canada Funda Meric-Bernstam, The University of Texas MD Anderson Cancer Center, USA Ruth Plummer, Northern Centre for Cancer Care, United Kingdom Ian Cree, IARC, France Reena Philip, FDA-Food and Drug Administration, USA Sumimasa Nagai, The University of Tokyo Hospital and PMDA, Japan |
| 17:45 | Break |
Session 2 |
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| 18:00 – 20:30 | Bringing Drug-biomarker development to a next stage of clinical utility Chair: David Solit, Memorial Sloan-Kettering Cancer Center, USA |
| 18:00 | How do the expensive and labour-intensive formal harmonization exercises in the service of clinical trials fulfil our expectations for the degree of inter-laboratory concordance? Speaker: Ian Cree, IARC, France |
| 18:20 | Validating AI for clinical trials and uses as a community effort. Speaker: Brandon Gallas, FDA, USA |
| 18:40 | Utility of lung cancer biomarker testing as real world evidence – does it really matter for patients? Speaker: Ani John, Roche Diagnostics, USA |
| 19:00 | Companion diagnostics and tumour agnostic registration Speaker: Ruth Plummer, Northern Centre for Cancer Care, United Kingdom |
| 19:20 | Implementing the New In Vitro Diagnostic Device Regulation – impact on precision medicine development and regulation in oncology Speaker: Armin Ritzhaupt, EMA, Netherlands |
| 19:40 | Panel Discussion Q&A Chair: David Solit, Memorial Sloan-Kettering Cancer Center, USA Brandon Gallas, FDA, USA Ruth Plummer, Northern Centre for Cancer Care, United Kingdom Ani John, Roche Diagnostics, USA Ignacio Wistuba, University of Texas MD Anderson Cancer Center, USA Stanley Hamilton, City of Hope, USA Sean Khozin, Janssen R&D, Johnson & Johnson, USA Julia Beaver, FDA, USA Ian Cree, IARC, France |
| 20:30 | Break |
| 20:40 | Keynote Lecture New avenues on the regulation of molecular diagnostic devices in Precision Medicine. What went wrong, should we make it better and if yes, how? Speaker: Timothy O’Leary, Chief R&D Officer Emeritus, U.S. Department of Veterans Affairs, USA |
| 21:10 – 21:30 | Conclusion: Roberto Salgado, GZA, Belgium |