IBCD 20182018-10-05T09:39:21+00:00

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.

Faculty

Programme

Setting the Scene

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

Session 1

  Description

Evidence driven healthcare systems: the way forward

Chairs: R. Canetta (Independent Consultant, USA) &
H. Kim Lyerly (Dept of Surgical sciences, Duke University, Durham, USA)

9.30 – 9.50 Current trends for immunological profiling
speaker: D. Rimm (Dept. of Pathology, Yale University School of Medicine, New Haven, USA)
9.50 – 10.10 Current trends for molecular profiling
speaker: C. Massard (DITEP,Institut Gustave Roussy, Paris, France)
10.10 – 10.30 Compassionate Use and Pre-Approval Access (CUPA): matching patients to new therapies
Speaker: A. Bateman-House (Division of Medical Ethics, NYU Langone Health, New York, USA)
10.30 – 10.50 Patient Access to new therapies: HTA perspective
Speaker: A. Makady (Interne Geneeskunde Sector Zorg Zorginstituut Nederland, Diemen, 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 (EORTC) & K. Lyerly (NCI)
Speakers: F. Maignen (NICE, London, UK) , B. Besse (Institut Gustave Roussy, Paris, France), R. Swierzewski (ECPC, Belgium), TBC
12.30 – 13.30 Lunch Break

Session 2

  Description

Challenges of Clinical Trial Design: New Perspectives

Chairs: T. Lively (NCI, Bethesda, USA) & F. Pignatti (European Medicines Agency (EMA), London, UK)

13.30 – 13.50 NCI MATCH trial: Lessons learnt
Speaker: L. Harris (NCI, Bethesda, USA)
13.50 – 14.10 EORTC SPECTA: Challenges of a European platform for precision medicine
Speaker: J. Bogaerts, (EORTC, Brussels, 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, Tokyo, Japan)
14.30 – 14.50 Regulatory issues on molecular testing
Speaker: A. Pathak (FDA, Washington, USA)
14.50 – 15.10 Are companion diagnostic useful?
Speaker: M. Thomas (Roche, Basel, Switzerland)
15.10 – 15.30 Coffee Break
15.30 – 16.30 Panel Discussion
Chairs: T. Lively (NCI, Bethesda, USA) & TBC
Speakers: I. A Cree (IARC, Lyon, France), P. Hegde (Genentech South San Francisco, USA), J. Beaver (Division of Oncology Products, CDER, FDA, Washington), O. Collignon, (European Medicines Agency (EMA), London, UK), S. Hopper, (Medicines and Healthcare products Regulatory Agency, London, UK)

Session 3

  Description

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

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

09.30 – 09.50 Liquid Biopsy: translational potential of cell free DNA profiling in oncology
Speaker: C. Smith (CRUK Cambridge Institute,University of Cambridge, 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, Amsterdam, The Netherlands)
10.50 – 11.10 Data sharing: How can we leverage big data?
Speaker: C. Sweeney (Dana Farber Cancer Institute, Harvard, Boston, USA)
11.10 – 11.30 Coffee Break
11.30 – 12.30 Panel Discussion
Chairs: J. Bogaerts (EORTC, Brussels, Belgium) & D. Solit (USA)
Speaker: M. Ingelman-Sundberg (Karolinska Institut, Sweden), J. Beaver (FDA)
12.30 – 13.00 Closing Remarks
Speakers: D. Lacombe (EORTC, Brussels, Belgium) and R. Salgado (Dept. of Pathology/TCRU GZA Antwerp, Belgium)

Registration

Online registration opens on 17 May 2018 and closes on 15 November 2018*
* 10.00 AM Central European Time (CET)

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Sponsorship

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.

Opportunities
Booking form

Acknowledgments

We wish to thank our sponsors for their generous support.

Sponsors

Janssen Oncology

Media Partners

EMJ

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.

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