Regulators and academics paving new paths
for cancer clinical research

Roberto Sagado - Denis Lacombe

IBCD 2018 will explore routes through the constantly evolving scientific, methodological and regulatory environment for drug and biomarker development. The EORTC, NCI, EMA, and AACR with the involvement of FDA and PMDA and Health Technology Assessment specialists endeavour to build upon the recommendations and action points decided upon at the IBCD2016-edition. Topics, such as, Health Technology Assessment (HTA) of biomarker assays, comparative effectiveness research and the translation of findings of clinical trials into daily practice will be addressed.  The conference will also discuss the emergence of new regulatory routes to approve new anti-cancer agents based on biomarkers, demonstrating the relevance and feasibility of innovative clinical trial designs.

Interview with the speakers

EORTC Director General,
Denis Lacombe

Julia Beaver from FDA’s perspective
on IBCD2018 Conference

HTA’s perspective from #IBCD2018 with
Francois Maignen, NICE, London UK

HTA’s perspective
Amr Makady

Patient’s perspective,
Rafal Swierzewski

Roberto Salgado



Setting the Scene

09.00 – 09.30 Introduction
Speakers: D. Lacombe (EORTC, Belgium) &
R. Salgado (TCRU GZA Antwerp, Belgium)

Session 1


Evidence driven healthcare systems: the way forward

Chairs: R. Canetta (Independent Consultant, USA) &
H. Kim Lyerly (Duke University, USA)

9.30 – 9.50 Current trends for immunological profiling
speaker: D. Rimm (Yale University School of Medicine, USA)
9.50 – 10.10 Current trends for molecular profiling
speaker: C. Massard (Institut Gustave Roussy, France)
10.10 – 10.30 Compassionate Use and Pre-Approval Access (CUPA): matching patients to new therapies
Speaker: A. Bateman-House (NYU Langone Health, USA)
10.30 – 10.50 Patient Access to new therapies: HTA perspective
Speaker: A. Makady (Zorginstituut Nederland, The Netherlands)
10.50 – 11.10 The impact of drug access upon survival and outcomes in Europe
Speaker: L. Bergmann (Ambulantes Krebszentrum Frankfurt, Germany)
11.10 – 11.30 Coffee Break
11.30 – 12.30 Panel discussion
Chairs: R. Canetta & K. Lyerly
Panelist: F. Maignen, B. Besse, R. Swierzewski, D. Rimm, C. Massard, A. Makady, L. Bergmann, A. Bateman-House
12.30 – 13.30 Lunch Break

Session 2


Challenges of Clinical Trial Design: New Perspectives

Chairs: T. Lively, NCI, USA & Denis Lacombe, EORTC, Belgium

13.30 – 13.50 NCI MATCH trial: Lessons learnt
Speaker: L. Harris NCI, USA
13.50 – 14.10 EORTC SPECTA: Challenges of a European platform for precision medicine
Speaker: J. Bogaerts, EORTC, Belgium
14.10 – 14.30 Precision medicine trials, regulator issues: the way forward
Speaker: S. Nagai, (Translational Research Center, The University of Tokyo Hospital and PMDA, Japan)
14.30 – 14.50 Regulatory issues on molecular testing
Speaker: A. Pathak (FDA, USA)
14.50 – 15.10 Are companion diagnostic useful?
Speaker: M. Thomas (Roche, Switzerland)
15.10 – 15.30 Coffee Break
15.30 – 16.30 Panel Discussion
Chairs: T. Lively & Denis Lacombe
Panelists: I. A Cree, J. Beaver, O. Collignon, S. Hopper, L. Harris, J. Bogearts, S. Nagai, A. Pathak, M. Thomas, P. Démolis

Session 3


Generating the scientific evidence: the challenges in implementing to daily practice

Chairs: J. Bogaerts,  EORTC, Belgium & D. Solit, Memorial Sloan Kettering Cancer Center
New York, USA

09.30 – 09.50 Liquid Biopsy: Validation of cell free DNA profiling.
Speaker: C. Smith (CRUK Cambridge Institute,University of Cambridge, UK)
9.50 – 10.10 Germline testing to dictate drug response
speaker: M. Robson (Memorial Sloan Kettering Cancer Center New York, USA)
10.10 – 10.30 Centralized testing vs local testing from the industry perspective
Speaker: M. Savage (Merck, USA)
10.30 – 10.50 Centralized testing vs local testing from the academic perspective
Speaker: E. Voest (NKI, The Netherlands)
10.50 – 11.10 Data sharing: How can we leverage big data?
Speaker: C. Sweeney (Dana Farber Cancer Institute, Harvard, USA)
11.10 – 11.30 Radiomics: Images are more than pictures, they are quantitative Data leading to new knowledge
Speaker: P. Lambin (University of Maastricht, The Netherlands)
11.30 – 11.45 Coffee Break
11.45 – 12.30 Panel Discussion
Chairs: J. Bogaerts & D. Solit
Panelists: M. Ingelman-Sundberg, J. Beaver, C. Smith, M. Robson, M. Savage, E. Voest, C. Sweeney, L. Yee, A. Kiermaier
12.30 – 13.30 Closing Remarks
Speakers: D. Lacombe, EORTC, Belgium & R. Salgado, TCRU GZA Antwerp, Belgium
13.30 – 14.30 Lunch break


Graph ITI

We welcome your support for this meeting which will foster new forms of partnerships between academia, industry, regulatory, health technology assessment bodies and payers adding value to tomorrow’s personalized cancer treatments for patients in a daily practice setting.

Booking form


We wish to thank our sponsors for their generous support.


Janssen Oncology

Media Partners


Hotel Accommodation

  • Radisson Blu Royal Hotel, Brussels

  • +32 2 219 28 28

Hotel bookings are not managed by EORTC

A limited number of rooms have been reserved for this event at the Radisson Blu Royal Hotel, Brussels.

The deadline for hotel reservations is 12 November 2018.
Accommodation requests received after 12 November will be processed on a space-available basis and may be subject to higher rates. Please contact the hotel for any further information and/or confirmation.