The 2017 conference took place….
…from the 18th to 19th May 2017 at the Kensington Conference and Events Centre in London and was preceded by a pre-conference workshop on the 17th May.
Feedback
For feedback on the meeting – click here.
Conference summary
The first formal conference of the EUropean Federation for Exploratory MEdicines
Development (EUFEMED) held in London was the result of a collaborative effort of
its founding associations: the Association for Applied Human Pharmacology (AGAH;
Germany), the Association for Human Pharmacology in the Pharmaceutical Industry
(AHPPI; UK), the Belgian Association of Phase-I Units (BAPU; Belgium), and Club
Phase-I (France). The conference focused on innovation and risk management
in early clinical drug development. Among other innovations, immunotherapy in
oncology and inflammatory diseases were discussed as well as the importance of
adaptive trial designs in early clinical drug development. Consideration was given
to assessing and mitigating risk in early clinical drug development, and included a
preconference workshop. Different measures to minimize risks in healthy volunteers
and patients in first-in-human trials were discussed in addition to the importance
of non-clinical data, the need for reliable biomarkers, improved communication on
adverse events (AEs) and well-trained study sites with ready access to intensive care
units and clinical specialists. The need for a European-wide system for prevention of
over-volunteering was also discussed. The conference provided opportunity to discuss
these developments and concerns and the changing regulatory environment with
stakeholders from academia, industry, and regulatory agencies including the European
Medicines Agency (EMA). Presentations given by invited speakers are published on
https://www.eufemed.eu/london-conference-2017/ (below).
A more extensive report has been published in Frontiers in Pharmacology 2018; 8: article 901 (click the logo below).
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): Dr Tim Hardman, Dr Ulrike Lorch, Mr Steffan Stringer
Conference Faculty
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
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
Dr An Van Den Bergh, Johnson & Johnson, Belgium
Dr Kirsty Wydenbach, Medicines & Healthcare products Regulatory Agency (MHRA), UK
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