Download presentations of the Lyon conference 2019

Presentations by invited Speakers and Oral Presenters

Our speakers and oral presenters delivered some very compelling and thought provoking presentations at the EUFEMED 2019 conference and we’re pleased to be able to share them with you.

Please click on the links within the conference programme below for the individual presentations.

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: The potential role of virtual trials in early medicines development: Beyond pharmacology to mechanisms
Adriano Henney, UK
09:20 The in silico paradigm: understanding the potential of mechanistic models and their limitations, adapting organizations and building the necessary expertise
François-Henri Boissel, France
09:40 The virtual physiological human – impact on early medicines development
Stig Omholt, Norway
10:00 Open forum discussion
With session chairs, speakers, 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
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 selected from submitted posters)

3.1: Diurnal and racial variance of white blood cell parameters in early phase clinical trials: a retrospective analysis of pooled data from multiple phase I trials
Simon Coates, UK

3.2: Do we need pharmacokinetic data during each data review meeting in adaptive first-in-human trial? From guideline to practice
Nariné Baririan, Belgium 

3.3: Impact of cholinergic tone on the binding of PET tracer [11C]MK-6884, a positive allosteric modulator of M4 acetylcholine receptor in monkeys and healthy elderly volunteers
Inge De Lepeleire, Belgium 

3.4: Outcome of patients participating in early phase oncology trials at the Drug Research Unit Ghent (D.R.U.G.), Belgium
Brant Delafontaine, Belgium 

3.5: Volumetric Absorptive Microsampling (VAMS) for Blood Collection in Clinical Studies of Padsevonil
Hugues Chanteux, Belgium

15:30 Break

Parallel Break-out Sessions:
  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 Leonie Leithold, 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 – Hèrmes River Boat
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 
10:00 Round-table discussion
10:30 Break
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

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 Gomeni, 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
Kenichi Umehara, 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
18:15 Welcome Reception – Exhibition Area, Centre de Congrès de Lyon

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
Stephan Glund, Germany
15:00 Break
15:15 How to approach PD and safety
Meagan O’Brien, 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
Welcome Reception – Exhibition Area, Centre de Congrès de Lyon

EUFEMED would like to thank Niche
for their support with this conference