Download presentations of the London conference 2017

Invited speaker presentations

Our invited speakers were an integral part of the EUFEMED conference and we are delighted to be able to share their presentations with you.

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

PROGRAMME (download programme here)

Exploratory medicines development: innovation and risk management

Day 1 – Thursday 18 May 2017
08:00 Registration
08:30 Welcome and Introduction to the 1st EUFEMED conference (Jan de Hoon, Belgium)
08:45 Keynote: Incidents happen – which lessons can we learn?
Jan de Hoon, Belgium

Session 1: Managing risks in early phase clinical trials
Chairs: Hildegard Sourgens, Germany and Milton Bonelli, UK
Open forum discussions with competent authority representatives and stakeholders from different EU countries
09:15 The updated EMA guideline on strategies to identify and mitigate risks in First-in-Human clinical trials with investigational medicinal products. Introduction by Ulrike Lorch, UK
Panel with representatives from EMA and National Competent Authorities / Ethics Committees: Milton Bonelli (UK), François Chapuis (France), Walter Janssens (Belgium), David Jones (UK), Thomas Sudhop (Germany), Kirsty Wydenbach (UK)
10:00 Prevention of over-volunteering in Europe: “How to get a European-wide acceptable system going?” Introduction by Annick Peremans, Belgium
Panel with stakeholders from different EU countries: Milton Bonelli (UK), Malcolm Boyce (UK), Peter Liedl (Germany), Annick Peremans (Belgium), Barbara Schug (Germany)
10:45 Break

Session 2: Scientific tools in early development of medicines to mitigate risk
Chairs: Mike Hammond, UK and Yves Donazzolo, France
11:15 Can assessment of CNS target engagement in early development help to minimise risk?
Philippe Danjou, France
11:40 Usefulness of physiology-based pharmacokinetics to mitigate risk?
An Van Den Bergh, Belgium
12:05 Metabolomics and emerging applications in drug discovery and precision medicine.
Elaine Holmes, UK
12:30 Lunch
13:15 Three guided poster tours chaired by
Henri Caplain, France and Kerstin Breithaupt, Germany
Tim Hardman, UK and Yves Donazzollo, France
Luc van Bortel, Belgium and Hildegard Sourgens, Germany

Session 3: Innovative methods and imaging techniques in early medicines development – oral presentations from selection of submitted abstracts
Chairs: Luc Van Bortel, Belgium and Henri Caplain, France
3.1 Activation of PAC1 by maxadilan: a new human target engagement biomarker
Linde Buntinx, Belgium
3.2 Human challenge studies in healthy volunteers: Considerations for practical implementation.
Josué K Mfopou, Belgium
3.3 Practical risk management in early phase clinical trials
Simon Coates, UK
3.4 A pilot, phase Ib feasibility study of ARGX-110 in patients with nasopharyngeal carcinoma.
Sylvie Rottey, Belgium
3.5 Presenting a decentralized, centrally governed, secure open source software solution for over-volunteering leveraging blockchain and biometrics.
Stuart Robertson, USA
15:15 Break

Session 4: Examples of innovation and risk management
(Session organized by the AHPPI) Chairs: Elizabeth Allen, UK and Stuart Mair, UK
15:45 Integrated protocols: from First-in-Human to Proof of Concept.
Jorg Taubel, UK
16:05 Toxicity and dose escalation: progression rules in integrated protocols.
David Jones, UK
16:25 Innovative in-vitro models of toxicology assessments
Christopher Goldring, UK
16:45 Examples of innovation and risk management: perspective from university and industry.
Alan Boyd, UK
17:20 Session summary and close
17:30 End of Day 1
19:30 Reception and conference dinner at the Museum of London
Award ceremony for the best oral presentations and best posters.
Day 2 – Friday 19 May 2017

Session 5: Assessment and mitigation of risk in modern development strategies for pediatrics
Chairs: Ingrid Klingmann, Belgium
09:00 Microdosing: an opportunity for safer drug development in children?
Saskia De Wildt, The Netherlands
09:25 Oxford Debate: Optimising PIPs through knowledge integration Introduced and moderated by Ingrid Klingmann, Belgium Motion: “Paediatric medicines development should be limited to pharmacokinetic bridging trials.”
For the motion: Claire Ambery, UK Against the motion: Christoph Male, Austria
10:15 Break


Parallel workshops:
  1. How to use the results from non-clinical studies to better predict the risks in early phase clinical trials?
    Stephanie Plassmann, Switzerland
  2. Modern drug development in oncology – How to successfully design the early phase trials?
    Sylvie Rottey, Belgium and Heike Oberwittler, France
  3. Incident management in Phase I trials: what to do if things go wrong?
    Katharina Erb-Zohar, Germany and Yves Donazzolo, France
12:15 Lunch

Session 6: Assessment and mitigation of risk in trials with biologicals
Chairs: Barbara Schug, Germany and Jean-Louis Pinquier, France
13:50 Keynote lecture on immuno-oncology – “How it all got started…”
Christian Blank, The Netherlands
14:15 How to monitor and mitigate immunotoxicity during early phase clinical trials in oncology?
Ioannis Karydis, UK
14:40 How to monitor and mitigate immunotoxicity during early phase clinical trials in inflammatory disease?
Ann Gils, Belgium
15:05 How to monitor and mitigate immunogenicity during early phase clinical trials?
Geoff Hale, UK
15:30 Panel discussion
15:55 Closing remarks (Hildegard Sourgens, Germany)
16:00 End of conference

Preconference 1-day workshop: 17 May 2017

Practical aspects of assessing and mitigating risk in early phase clinical trials

PROGRAMME (download programme here)

10:00 Welcome (Jan de Hoon)
Chairs: Jan de Hoon & David Jones (MHRA)
10:15 How to use the results from non-clinical studies to better predict the risks in early phase clinical trials? Stephanie-Plassmann
Stephanie Plassmann, Switzerland
11:05 Other preclinical risk assessment strategy: Computational Systems Toxicology and in silico prediction of off-target activities. Case studies & discussion.
Friedemann Schmidt, Germany
11:55 Dose selection based on Minimal Anticipated Biological Effect Level (MABEL) for biologicals and high risk small molecules: case studies & discussion.
Bruno Boutouyrie, France
12:45 Lunch
Chairs: Kerstin Breithaupt and Kirsty Wydenbach (MHRA)
13:45 Determination of the first dose for multispecific monoclonal antibodies: practical examples.
Marc Pallardy, France
14:15 Is the concept of maximum tolerated dose useful for medicines development in humans?
Philippe Grosjean, France and Eric Legangneux, Switzerland
15:00 Break
15:15 A regulatory update on the EU guideline on First-in-Human clinical trials.
Thomas Sudhop, Germany
15:45 Statements from European Competent Authorities:
Milton Bonelli (EMA), David Jones (MHRA, UK), Greet Musch (FAMHP)
16:15 Open forum discussion with all speakers and EU representatives
17:15 End of Workshop
17:15 – 19:00 Welcome reception and registration