London conference 2017


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

Register online here!

Programme Committee

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

Conference Faculty

Dr Elizabeth Allen, Quintiles, UK
Professor Dr Christian Blank, Netherlands Cancer Institute, The Netherlands
Dr Milton Bonelli, European Medicines Agency (EMA)
Dr Bruno Boutouyrie, Novartis, Switzerland
Professor Alan Boyd, Faculty of Pharmaceutical Medicine, UK
Dr Kerstin Breithaupt-Groegler, kbr – clinical pharmacology services, Germany
Dr Henri Caplain, Club Phase I, France
Dr Philippe Danjou, Biotrial, France
Dr David Jones, Medicines & Healthcare products Regulatory Agency (MHRA), UK
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
Mr Tim Hardman, Niche Science and Technology, UK
Professor Elaine Holmes, Imperial College, 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 Greet Musch, Federal Agency for Medicines and Health Products, Belgium
Dr Heike Oberwittler, Ipsen Innovation, France
Professor Marc Pallardy, Paris-Sud University, France
Ms Annick Peremans, Research Centre Aalst, Belgium
Dr Jean-Louis Pinquier, International Society of Pharmacometrics, 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

Conference programme

Exploratory medicines development: innovation and risk management

We are pleased to invite companies and organisations associated with human pharmacology and other early phase clinical trials to support EUFEMED 2017 as sponsors and exhibitors. Full details here…

PROGRAMME (download programme here)

Day 1 – Thursday 18 May 2017
08:00 Registration
08:30 Welcome and Introduction to the 1st EUFEMED conference
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, United Kingdom
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, United Kingdom
Panel with representatives from EMA and Competent Authorities: Thomas Sudhop, Greet Musch, Milton Bonelli, David Jones, Kirsty Wydenbach
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: Barbara Schug, Annick Peremans, Peter Liedl
10:45 Break

Session 2: Scientific tools in early development of medicines to mitigate risk
Chairs: Mike Hammond, United Kingdom 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, United Kingdom
12:30 Innovative in-vitro models of toxicology assessments.
Christopher Goldring, United Kingdom
13:00 Lunch and guided poster tour

Session 3: Innovative methods and imaging techniques in early medicines development – presentations from selection of submitted abstracts
14:30 Chairs: Luc Van Bortel, Belgium and Henri Caplain, France
15:45 Break

Session 4: Examples of innovation and risk management
(Session organized by the AHPPI)
Chairs: Elizabeth Allen, United Kingdom and Stuart Mair, United Kingdom
16:15 Integrated protocols: from First-in-Human to Proof of Concept.
Jorg Taubel, United Kingdom
16:35 Toxicity and dose escalation: progression rules in integrated protocols.
David Jones, United Kingdom
16:55 Examples of innovation and risk management: perspective from university and industry.
Alan Boyd, United Kingdom
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 short presentation and best poster.

Day 2 – Friday 19 May 2017

Session 5: Assessment and mitigation of risk in modern development strategies for paediatrics
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: “Too many PIPs and no adequate trials”
Introduced and moderated by Ingrid Klingmann, Belgium
Statement: “Paediatric medicines development should be limited to pharmacokinetic bridging trials”
Pro: NN (to be confirmed)
Contra: 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?
    Roberto Gomeni, France and 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
13:30 Keynote lecture on immuno-oncology – “How it all got started…”
Christian Blank, The Netherlands
14:00 How to monitor and mitigate immunotoxicity during early phase clinical trials in oncology?
Ioannis Karydis, United Kingdom
14:25 How to monitor and mitigate immunotoxicity during early phase clinical trials in inflammatory disease?
Ann Gils, Belgium
14:50 How to monitor and mitigate immunogenicity during early phase clinical trials?
Geoff Hale, United Kingdom
15:15 Panel discussion
15:45 Closing remarks
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, Belgium & David Jones, United Kingdom (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.
Roberto Gomeni, France and 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, Germany and Kirsty Wydenbach, United Kingdom (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 (United Kingdom, MHRA), Greet Musch (Belgium, FAMHP), Thomas Sudhop (Germany, BfArM)
16:15 Open forum discussion with speakers and EU representatives
17:15 End of Workshop
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 venue

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.

Modern equipment

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.