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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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 speakers, chairs and experts in the field
Christina Kyriacopoulou, Belgium (European Commission – Invited), François-Henri Boissel, France (Industry perspective) and Ingrid Klingmann, Belgium (EFGCP)
Questions will be taken from the audience.
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
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 recruitment to remote data collection
    Robert Rissmann, The Netherlands and Ingrid Klingmann, Belgium
  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, Gerard Koëter and Sander van den Bogert, The Netherlands
  4. What is acceptable/ethical to test in healthy subjects?
    Sylvie Rottey, Belgium and Jan de Hoon, Belgium 
17:30 End of Day 1
19:30 Conference Dinner
Day 2: 17 May 2019

Session 4: Update on regulatory considerations for early clinical development (including Brexit)
Chairs: Mike Hammond, UK and Ingrid Klingmann, Belgium
09:00 MHRA perspective
Ian Rees, UK
09:20 EMA perspective
Fergus Sweeney, The Netherlands
09:40 Industry perspective
Nick Sykes, Pfizer, UK (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: Modeling and simulations, including PBPK to improve the clinical development 
Chairs: Andreas Kovar, Germany and François Bouzom, Belgium
11:00 Welcome and introduction by the chairs
Henri Caplain, France
11:15 Principles of modeling and simulation including physiology-based pharmacokinetic (PBPK)
François Bouzom, Belgium
11:45 A general in-silico framework for maximizing the benefit-risk ratio of a treatment Roberto Gomeini, France
12:30 Lunch
13:15 Simulation of first-in-human using an allometrically scaled population mechanistic TMDD model
Géraldine Ayral, France
13:45 From phase I data to phase II trial design: simulation and extension of a population pharmacokinetic model
Pauline Traynard, France
14:15 How PBPK modelling together with Bayesian statistics and targeted clinical data can be used to predict drug pharmacokinetics across patient populations?
Lars Kuepfer, Germany
14:45 Various examples for the integration of cellular effect models from computational systems biology into whole-body PBPK models
Lars Kuepfer, Germany
15:15 Break
15:45 Population-based and physiology-based PK models for drug-drug interaction trials and trials waiver
Thierry Lavé, Switzerland
16:30 Advance current PBPK model applications to support internal development and regulatory decisions
Maxime Le Merdy, Switzerland
17:00 How to obtain biowaivers for clinical trials using PBPK, two case studies
Maxime Le Merdy, Switzerland
18:00 What did we learn? / Open forum discussion with all speakers and participants
18:15 End of Workshop
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
(speaker to be confirmed)
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!