The Joint Conference of European Human Pharmacological Societies was held on 11th and 12th April, in Nice, France. The AHPPI were proud to work with European colleagues from France (Club Phase 1), Germany (AGAH), and Belgium (BAPU) human pharmacological societies to bring delegates a series of workshops and lectures for this year’s title theme ‘Early Clinical Utility Assessment of New Medicines in Development’. Please find below the presentations and workshops from the conference.
Day 1: Thursday, April 11th
Session 1: Lessons learned from late phase failures and successes, chaired by Y. Donazzolo, Grenoble (France) and M. Raghoebar, Antwerp (Belgium)
Introduction – Y. Donazzolo, Grenoble (France) and M. Raghoebar, Antwerp (Belgium)
Lessons learned from Rimonabant and other CB1 blockers: did we try to crack a nut with a
sledgehammer? – R. F. Witkamp, Wageningen (The Netherlands)
Clinical Pharmacology and Clinical Utility of Abiraterone Acetate – E. Mannaert, Beerse (Belgium)
The role of Phase I in the quest for “good” cholesterol – failure of the CETP modulator Dalcetrapib – M. Derks, Basel (Switzerland)
Session 2: New translational tools and methodologies, chaired by A. Patat, Rennes (France) and M. Hammond, Slough, Berkshire (UK)
Usefulness of modeling and simulations in drug development – E. Pigeolet, Basel (Switzerland)
Pharmacometrics: a new tool for optimizing early drug development in oncology – R. Gomeni, La Fouillade (France)
New biomarkers for drug-induced liver injury: first insights from clinical quantification – M. Merz, Basel (Switzerland)
Quantification of EEG: pre-competitive consortium on the use of EEG as a CNS biomarker – Ph. Danjou, Paris (France)
Session 3: Training and education in early clinical drug development, chaired by K. Breithaupt-Grögler and J. de Hoon
European post-graduate training in pharmaceutical medicine and drug development – I. Klingmann, Brussels (Belgium)
Human Pharmacology courses: the UK experience – J. Posner, London (UK)
Day 2: Friday, April 12th
Session 4: Innovative approaches to Proof-of-Concept, chaired by J. Taubel, London (UK) and O. van Schoor, Antwerp (Belgium)
Rapid transition from bench to bedside: An overview; what is new, what has proven its value, what are the latest trends in translational medicine – J. Theis, Bergisch-Gladbach (Germany)
Network-based drug discovery – rationale and successful application to epilepsy – M. Johnson, London (UK)
Cutting edge developments: biomarker qualification as an indicator for clinical endpoints and their role in setting an optimal biologic dose – S. Jurcevic, London (UK)
Session 5: Strengthening European Human Pharmacology for the Early Development of New Medicines, chaired by P. Dewland, Cardiff (UK) and H. Sourgens, Munich (Germany)
A critical review of the proposed EU Clinical Trial regulation – W. Janssens, Brussel (Belgium)
Need for a uniform European registration system for volunteer participation? – A. Peremans, Aalst (Belgium)
Risk adapted approaches and clinical trial notification scheme – M. O’Kane, London (UK)
Workshops
WS1 Cardiac safety, QT assessment – B. Mendzelevski, London (UK) and J. Taubel, London (UK)
WS2 PK/PD modelling – R. Gomeni, La Fouillade (France)
WS3 Application of Bayesian Statistics in early development studies – P. Sanwald Ducray, Basel (Switzerland) and F. Vandenhende, Genappe (Belgium)
WS4 Adaptive Study Design in Early Phase Clinical Research – U. Lorch, London (UK)
WS4 Adaptive Study Design in Early Phase Clinical Research – M. O’Kane, London (UK)
WS5(Day1) Draft Suicidal Ideation and Behavior Guidance
WS5(Day 2) Pain Models – Ph. Danjou, Paris (France)