EUFEMED Conference 2019 – Programme

The Changing Landscape of Early Medicines Development:
Be Prepared!

15 – 17 May 2019
Lyon, France

Programme committee members

Yves Donazzolo (CPI)
Henri Caplain (CPI)
Hildegard Sourgens (AGAH)
Ingrid Klingmann (AGAH)
Jan de Hoon (BAPU)
Sylvie Rottey (BAPU)
Steffan Stringer (AHPPI)
Jörg Täubel (AHPPI)
Mike Hammond (AHPPI)
Izaak den Daas (Associate Member)

Organisational committee members

Yves Donazzolo (CPI)
Henri Caplain (CPI)
Steffan Stringer (AHPPI)
Hildegard Sourgens (AGAH)

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PROGRAMME (download programme here)

The Changing Landscape of Early Medicines Development:
Be Prepared!

Day 1: 16 May 2019
08:00 Registration
08:45 Welcome and Introduction (Hildegard Sourgens, Germany)

Session 1: Current and future options for virtual trials in early medicines development
Chairs: Eric Legangneux, France and Georg Wensing, Germany
09:00 Keynote lecture: What is the role of virtual trials in early medicines development – outline, prerequisites and impact
Adriano Henney, UK
09:30 The virtual physiological human – impact on early medicines development
Stig Omholt, Norway
10:00 Open forum discussion with representatives from the European Commission
(Christina Kyriacopoulou, UK, invited)
and Experts in the field
(François-Henri Boissel, France and Ingrid Klingmann, Belgium)
10:45 Break

Session 2: Trends and innovation
Chairs: Henri Caplain, France and Yves Donazzolo, France
11:15 #WeAreNotWaiting for better diabetes care
Andrew Warrington, Switzerland
11:45 Engineering Allogeneic Immune Cells  to Generate Off-The-Shelf CAR T-cell Immunotherapies
Roman Galetto, France
12:15 Translation of Gene Therapeutics in Neurological and Neuromuscular Diseases
Brian K. Kaspar, Switzerland
12:45 Lunch

Session 3: Guided poster tours and selected oral presentations
Chairs: Sylvie Rottey, Belgium and Tim Hardman, UK
Selection of posters: Sylvie Rottey (chair), Jan de Hoon, Tim Hardman, Henri Caplain, George Wensig, Bob Wilffert, Jörg Täubel
13:45 Guided poster tours
14:15 Oral presentations (five presentations will be selected from submitted posters)
15:30 Break

Parallel Break-out Sessions:
16:00 – 17:30
  1. Digital support to study performance in early phase development – from remote visit conduct to biomarker apps
  2. Lay summary requirements – consequences for Phase I trials
    Kerstin Breithaupt, Germany and Thomas Schindler, Germany
  3. Transparency requirements for Phase I trials in times of transition
    Izaak den Daas, NL and NN, NL
  4. What is acceptable/ethical to test in healthy subjects?
    Jan de Hoon, Belgium and Sylvie Rottey, Belgium
17:30 End of Day 1
19:30 Conference Dinner
Day 2: 17 May 2019

Session 4: The impact of Brexit on early clinical development in Europe
Chairs: Mike Hammond, UK and Ingrid Klingmann, Belgium
09:00 MHRA perspective
Samantha Atkinson, UK
09:20 EMA perspective
EMA representative confirmed (NN), Fergus Sweeney (invited)
09:40 Industry perspective
Paer Tellner, Germany (Invited)
10:00 Round-table discussion
10:30 Break
10:45 – 12:15 Parallel break-out sessions:
the same workshops as those presented on the first day will be repeated.
12:15 Lunch

Session 5: How to be prepared
Chairs: Jörg Täubel, UK and Jan de Hoon, Belgium
13:15 Phase I trials in patients: new approaches and designs in Oncology
Nuria Kotecki, Belgium
13:45 Challenges in exploratory clinical research,
Maarten Van den Boer, Belgium
14:15 Current perspectives on digital biomarker development in early clinical research
Virginia Parks, USA
14:45 Closing remarks – How to be prepared?
Yves Donazzolo, France
15:00 End of Conference

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Preconference 1-day workshops: 15 May 2019

Workshop 1: Trial simulation and basic tools
Chairs: Andreas Kovar, Germany and Henri Caplain, France
11:00 Welcome and Introduction by the Chairs
11:10 Basic principles of physiology-based PK
Basic principles of modeling and simulation
12:45 Lunch
13:30 Trial simulation for dose prediction of clinical trials of later phases
15:00 Break
15:15 Trial simulation for waiving clinical trials:

  • Physiology-based PK models replacing drug-drug interaction trials
  • Renal and hepatic impairment
  • Genetic variations (personalized medicine)
  • Age groups
16:45 Training software for virtual trials
17:45 What did we learn? / Open forum discussion with all speakers and participants
18:15 End of Workshop
Speakers: Roberto Gomeni, France
Bernard Orlandini, France
Andreas Kovar, Germany
Capacity: 50 – 60 participants

Workshop 2: Early clinical development of biologics – what is so different about it?
Chairs: Hildegard Sourgens, Germany and Jan de Hoon, Belgium
11:00 Welcome and Introduction by the Chairs
11:10 New therapeutic concepts
Philip Barrington, UK
12:45 Lunch
13:30 What is different in PK of biologicals
Stefan Glund, Germany
15:00 Break
15:15 How to approach PD and safety
Angus MacDonald (invited), US
16:45 ADAs / Immunogenicity
Ann Gils, Belgium
17:45 What did we learn? / Open forum discussion with all speakers and participants
18:15 End of Workshop
Capacity: 50 – 60 participants

Book online here!