Programme

Download the PDF draft programme or view it below.

 

DRAFT PROGRAMME

DAY 1: 26th February 2018

15:00 Start of the workshop

INTRODUCTION
Heinz Zwierzina

KEYNOTE LECTURE

 

SESSION 1: CLINICAL TRIAL DESIGN IN AN ERA OF HORIZONTAL DRUG DEVELOPMENT

15:30: The Clinical development on Larotrectinib (LOXO-101)

15:50: Case story

16:10: Statistician’s view

16:30: COFFEE BREAK

17:00: European Regulatory Perspective

17:20: Industry Perspective

17:40: Roundtable discussion

 

SESSION 2: REPORT FROM CDDF MULTI-STAKEHOLDER WORKSHOPS

18:10: ACCELERATE platform

18:25: Innovation in Oncology Clinical Trial Design (June 2017, Frankfurt, Germany)
Jaap Verweij (Erasmus MC, The Netherlands)

18:40: Access to Innovative Oncology Drugs in Europe (September 2017, Madrid, Spain)
Sonia Garcia Perez (AEMPS, Spain)

18:55: Minimal Residual Disease (October 2017, London, UK)
John Smyth (University of Edinburgh/CDDF, UK)

19:10: End of day 1

19:45 Welcome reception & networking dinner
@Interalpen Hotel Restaurant

 

DAY 2: 27th February 2018

SESSION 3: RARE CANCERS/TARGETS

09:00      Rare Cancers Overview

09:20      Case Study

09:40      European Initiatives

10:20      Statistical Aspects of Drug Development for Rare Cancers

10:40      European Regulatory Perspective

11:00      Industry Perspective

11:20      Academic Perspective

11:40:     Roundtable discussion

12:10 – 13:10 Lunch
@Interalpen Hotel Restaurant

 

SESSION 4: PATIENTS’ REPORTED OUTCOMES IN ONCOLOGY PATIENT-CENTERED DRUG DEVELOPMENT: OPPORTUNITIES & CHALLENGES

From 13:10 to 15:20

Aim is to have a collaborative, insightful discussion. Each speaker chooses topics for a brief 7 minute presentation and will be part of the roundtable/panel discussion

Proposed Topics for Presentation and Panel Discussion

  • Trial design (i.e., blinding clinical trials, PROs in the testing hierarchy to inform symptomatic improvement, delayed symptomatic progression or functional impact
  •  Selection of PRO dimensions (i.e., symptoms, physical function, health related QOL), instruments (i.e., EORTC, FHIS, EQ5D), scales (i.e., tumor specific, general health)
  •  Opportunities and challenges with tailoring PRO data collection (e.g. Questionairs) to meet oncology clinical development plans
  • Challenges with PRO analysis, e.g. missing data, inferential analyses

13:10 spotlight presentations on selected topics

14:30 Roundtable/ Panel discussion

15:30 Closing remarks

15:40 End of session

Speakers and panelists: to be announced in January

 

SESSION 5: GETTING BIOMARKERS INTO THE MARKET/INTO PRACTICE

15:50: Critical current assessment on companion diagnostics

16:10: Case story

16:30: Regulatory Perspective

16:50: Industry Perspective

17:10: Payer’s Perspective

17:30: Roundtable discussion

18:00 END OF DAY 2

19:30 Networking event (buffet dinner)
@Interalpen Hotel Restaurant

 

DAY 3: 28th February 2018

 SESSION 6: CELL THERAPY

09:00: Clinical-case examples

09:20 Challenges with CAR T cells: a European regulatory perspective

09:40 Clinical Considerations for Cancer Cell Therapy: US FDA Perspective

10:00 Technical Development/preclinical biology? à Which exact title?

10:20 Data from Lymphoma Pivotal Study and pALL study: Industry perspective

10:40 Early CAR-T development experience from an academic perspective (include translational/correlative data)

11:00: Roundtable discussion

 

11:40 Concluding remarks

12:00 End of the meeting & lunch