FINAL program FFM Friends day

Date: March 9, 2013 (9AM-3.30PM)

Espace Moselle
Rue des Drapiers , 40 
1050 Brussels

How industry requirements impact early development of a biomarker


09.00-09.05:  Welcome by Bernard Majoie

09.05-09.40:  Phases  of Biomarker development/ Update FFMI biomarker & imaging projects/   Situating todays program
Speakers: Els Vanheusden, COO FFMI and Koen Kas, CSO FFMI

09.40-10.15:  Meeting your regulatory objectives in the EU : IVD Directive, CE mark, quality    systems &  certification of EU labs
Speaker: Dirk Stynen, Qarad, President

10.15-10.50 Regulatory Challenges in Conducting International Biomarker Driven Trials : the   EORTC experience 

  Speaker: Prof . Denis Lacombe, EORTC, Director Headquarters

10.50-11.10: coffee break

11.10-11.50: Biostatistical pitfalls & solutions for biomarker discovery 
  Speaker:  David Venet, IDDI

11.50-12.30: Clinical validation:  the challenges in building a solid clinical strategy plan for    biomarkers
  Speaker: Dominique Demolle, Aepodia, CEO & co-founder

12.30-13.30:  LUNCH

13.30-14.10: CLIA and registration hurdles in the US: lessons from the industry
Speaker:  Wim Van Criekinge,  MDx Health, CSO

14.10-14.50:   Reimbursement hurdles: Belgium & Europe
Speaker: Ri De Ridder, RIZIV-INAMI , Director General

14.50-15.20: Panel discussion: impact of industry requirements on early development of a    biomarker

15.20-15.30:  Evaluation & closing remarks
  Els Vanheusden , COO FFMI