This year’s conference will take place
from the 18th to 19th May 2017
in the Kensington Conference and Events Centre in London
preceded by a pre-conference workshop on the 17th May
AGAH, Germany: Dr Kerstin Breithaupt, Dr Ingrid Klingmann, Professor Hildegard Sourgens
AHPPI, United Kingdom: Dr Michael Hammond, Dr Ulrike Lorch, Dr Jorg Taubel
BAPU, Belgium: Professor Jan de Hoon, Professor Luc Van Bortel
CLUB PHASE I, France: Dr Henri Caplain, Dr Yves Donazzolo
Local organising committee (AHPPI): Mr Tim Hardman, Dr Ulrike Lorch, Mr Steffan Stringer
Dr Elizabeth Allen, Quintiles, UK
Dr Claire Ambery, GSK, UK
Professor Dr Christian Blank, Netherlands Cancer Institute, The Netherlands
Dr Milton Bonelli, European Medicines Agency (EMA) Dr Bruno Boutouyrie, Novartis, Switzerland
Dr Malcolm Boyce, Hammersmith Medicines Research Ltd, UK
Professor Alan Boyd, Faculty of Pharmaceutical Medicine, UK
Dr Kerstin Breithaupt-Groegler, kbr – clinical pharmacology services, Germany
Dr Henri Caplain, Club Phase I, France
Professor François Chapuis, Lyon University Hospital, France
Dr Philippe Danjou, Biotrial, France
Professor Dr Jan de Hoon, UZ Leuven, Belgium
Professor Saskia de Wildt, Radboud University Medical Centre, The Netherlands
Dr Yves Donazzolo, EUROFINS OPTIMED, France
Dr Katharina Erb-Zohar, Clinphase, Germany
Professor Ann Gils, University of Leuven (KULeuven), Belgium
Dr Christopher Goldring, University of Liverpool, UK
Professor Roberto Gomeni, PharmacoMetrica, France
Mr Philippe Grosjean, Sanofi, France
Professor Geoff Hale, Freelance Scientist, UK
Dr Mike Hammond, Clinical Quality Management Solutions Limited, UK
Dr Tim Hardman, Niche Science and Technology, UK
Professor Elaine Holmes, Imperial College, UK
Dr Walter Janssens, Federal Agency for Medicines and Health Products, Belgium Dr David Jones, Medicines & Healthcare products Regulatory Agency (MHRA), UK
Dr Ioannis Karydis, Southampton General Hospital, UK
Dr Ingrid Klingmann, Pharmaplex, Belgium Dr Eric Legangneux, Novartis, Switzerland
Mr Peter Liedl, Boehringer Ingelheim, Germany
Dr Ulrike Lorch, Richmond Pharmacology, UK
Dr Stuart Mair, Quotient Clinical, UK
Professor Christoph Male, Medical University of Vienna, Austria
Dr Heike Oberwittler, Ipsen Innovation, France
Professor Marc Pallardy, Paris-Sud University, France
Ms Annick Peremans, Research Centre Aalst, Belgium
Dr Jean-Louis Pinquier, DECISIONS R&D consulting, France
Dr Stephanie Plassmann, PCS Consultants, Switzerland
Professor Dr Sylvie Rottey, Ghent University, Belgium
Dr Friedemann Schmidt, Sanofi, Germany
Dr Barbara Schug, SocraTec R&D, Germany
Professor Hildegard Sourgens, Sourgens Consulting, Germany
Professor Thomas Sudhop, Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Germany
Dr Jorg Taubel, Richmond Pharmacology, UK
Professor Dr Luc Van Bortel, Ghent University, Belgium
Professor Johannes Van den Anker, Children’s National Health System, USA
Dr An Van Den Bergh, Johnson & Johnson, Belgium
Dr Kirsty Wydenbach, Medicines & Healthcare products Regulatory Agency (MHRA), UK
Exploratory medicines development: innovation and risk management
PROGRAMME (download programme here)
|Day 1 – Thursday 18 May 2017|
|08:30||Welcome and Introduction to the 1st EUFEMED conference (Jan de Hoon, Belgium)|
|08:45||Keynote: Incidences 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)|
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||Innovative in-vitro models of toxicology assessments.
Christopher Goldring, UK
|13:30||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
Session 4: Examples of innovation and risk management
|(Session organized by the AHPPI)
Chairs: Elizabeth Allen, UK and Stuart Mair, UK
|16:15||Integrated protocols: from First-in-Human to Proof of Concept.
Jorg Taubel, UK
|16:35||Toxicity and dose escalation: progression rules in integrated protocols.
David Jones, UK
|16:55||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 and John van den Anker, USA / Switzerland|
|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
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
|15:55||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||Toxicological risk assessment for early medicines development: case studies & discussion.
Stephanie Plassmann, Switzerland
|11:05||Other preclinical risk assessment strategies: PK/PD modeling 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
|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
|15:15||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|
Scientific committee / Faculty: (in alphabetic order)
AGAH, Germany: Kerstin Breithaupt, Ingrid Klingmann, Hildegard Sourgens, Jorg Taubel
AHPPI, United Kingdom: Michael Hammond, Ulrike Lorch
BAPU, Belgium: Jan de Hoon, Luc Van Bortel
Club Phase I, France: Henri Caplain, Yves Donazzolo
Local organizing committee (AHPPI): (in alphabetic order)
Tim Hardman, Ulrike Lorch, Steffan Stringer
The conference will be held in the historic estate of Kensington. The Kensington Conference and Events Centre is one of the largest event spaces in London. To the north of the venue the large Royal Park of Kensington Gardens (contiguous with its eastern neighbour, Hyde Park) is a wonderful expanse of green.
The venue is well serviced with excellent public transport links and is within walking distance of major hotels to suit all tastes and budgets and a wide variety of restaurants minutes away.
The centre boasts contemporary architecture combining a range of halls and breakout rooms including the Great Hall, which offers unrivalled conference, exhibition and banqueting facilities.
The hall provides an easy-to-use and endlessly adaptable space. Complimentary Wi-Fi is available throughout.