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 |
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Session 1: Managing risks in early phase clinical trials |
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| 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 |
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| 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 |
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| 11:40 | Usefulness of physiology-based pharmacokinetics to mitigate risk? An Van Den Bergh, Belgium |
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| 12:05 | Metabolomics and emerging applications in drug discovery and precision medicine. Elaine Holmes, UK |
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| 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 |
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Session 3: Innovative methods and imaging techniques in early medicines development – oral presentations from selection of submitted abstracts |
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| Chairs: Luc Van Bortel, Belgium and Henri Caplain, France | |||
| 14:00 |
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| 14:15 |
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| 14.30 |
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| 14.45 |
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| 15.00 |
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| 15:15 | Break | ||
Session 4: Examples of innovation and risk management |
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| (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 |
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| 16:05 | Toxicity and dose escalation: progression rules in integrated protocols. David Jones, UK |
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| 16:25 | Innovative in-vitro models of toxicology assessments Christopher Goldring, UK |
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| 16:45 | Examples of innovation and risk management: perspective from university and industry. Alan Boyd, UK |
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| 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 |
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| 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 |
10:45 |
Parallel workshops: |
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| 12:15 | Lunch |
Session 6: Assessment and mitigation of risk in trials with biologicals |
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| 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 |