15 - 17 May 2019
Lyon, France
Programme committee members
Yves Donazzolo (CPI)
Henri Caplain (CPI)
Hildegard Sourgens (AGAH)
Ingrid Klingmann (AGAH)
Jan de Hoon (BAPU)
Sylvie Rottey (BAPU)
Steffan Stringer (AHPPI)
Jörg Täubel (AHPPI)
Mike Hammond (AHPPI)
Izaak den Daas (Associate Member)
Organisational committee members
Yves Donazzolo (CPI)
Henri Caplain (CPI)
Steffan Stringer (AHPPI)
Hildegard Sourgens (AGAH)
Download programme
| Day 1: 16 May 2019 | |
| 08:00 | Registration |
| 08:45 | Welcome and Introduction (Hildegard Sourgens, Germany) |
Session 1: Current and future options for virtual trials in early medicines development | |
| Chairs: Eric Legangneux, France and Georg Wensing, Germany | |
| 09:00 | Keynote lecture: The potential role of virtual trials in early medicines development: Beyond pharmacology to mechanisms Adriano Henney, UK |
| 09:20 | The in silico paradigm: understanding the potential of mechanistic models and their limitations, adapting organizations and building the necessary expertise François-Henri Boissel, France |
| 09:40 | The virtual physiological human – impact on early medicines development Stig Omholt, Norway |
| 10:00 | Open forum discussion With session chairs, speakers, and Ingrid Klingmann, Belgium |
| 10:45 | Break |
Session 2: Trends and innovation | |
| Chairs: Henri Caplain, France and Yves Donazzolo, France | |
| 11:15 | #WeAreNotWaiting for better diabetes care Andrew Warrington, Switzerland |
| 11:45 | Engineering Allogeneic Immune Cells to Generate Off-The-Shelf CAR T-cell Immunotherapies Roman Galetto, France |
| 12:15 | Translation of Gene Therapeutics in Neurological and Neuromuscular Diseases Brian K. Kaspar, Switzerland |
| 12:45 | Lunch |
Session 3: Guided poster tours and selected oral presentations | |
| Chairs: Sylvie Rottey, Belgium and Tim Hardman, UK | |
| Selection of posters: Sylvie Rottey (chair), Jan de Hoon, Tim Hardman, Henri Caplain, George Wensig, Bob Wilffert | |
| 13:45 | Guided poster tours |
| 14:15 | Oral presentations (five presentations selected from submitted posters)
3.1: Diurnal and racial variance of white blood cell parameters in early phase clinical trials: a retrospective analysis of pooled data from multiple phase I trials 3.2: Do we need pharmacokinetic data during each data review meeting in adaptive first-in-human trial? From guideline to practice 3.3: Impact of cholinergic tone on the binding of PET tracer [11C]MK-6884, a positive allosteric modulator of M4 acetylcholine receptor in monkeys and healthy elderly volunteers 3.4: Outcome of patients participating in early phase oncology trials at the Drug Research Unit Ghent (D.R.U.G.), Belgium 3.5: Volumetric Absorptive Microsampling (VAMS) for Blood Collection in Clinical Studies of Padsevonil |
| 15:30 | Break |
Parallel Break-out Sessions: | |
| 16:00–17:30 |
|
| 17:30 | End of Day 1 |
| 19:30 | Conference Dinner – Hèrmes River Boat |
| Day 2: 17 May 2019 | |
Session 4: Update on regulatory considerations for early clinical development (including Brexit) | |
| Chairs: Mike Hammond, UK and Ingrid Klingmann, Belgium | |
| 09:00 | MHRA perspective Ian Rees, UK |
| 09:20 | EMA perspective Fergus Sweeney, The Netherlands |
| 09:40 | Industry perspective Nick Sykes, Pfizer, UK |
| 10:00 | Round-table discussion |
| 10:30 | Break |
| 10:45– 12:15 | Parallel break-out sessions: The same workshops as those presented on the first day will be repeated |
| 12:15 | Lunch |
Session 5: How to be prepared | |
| Chairs: Jörg Täubel, UK and Jan de Hoon, Belgium | |
| 13:15 | Phase I trials in patients: new approaches and designs in Oncology Nuria Kotecki, Belgium |
| 13:45 | Challenges in exploratory clinical research Maarten Van den Boer, Belgium |
| 14:15 | Current perspectives on digital biomarker development in early clinical research Virginia Parks, USA |
| 14:45 | Closing remarks – How to be prepared? Yves Donazzolo, France |
| 15:00 | End of Conference |
| Workshop 1: Modeling and simulations, including PBPK to improve the clinical development | |
| Chairs: Andreas Kovar, Germany and François Bouzom, Belgium | |
| 11:00 | Welcome and introduction by the chairs Henri Caplain, France |
| 11:15 | Principles of modeling and simulation including physiology-based pharmacokinetic (PBPK) François Bouzom, Belgium |
| 11:45 | A general in-silico framework for maximizing the benefit-risk ratio of a treatment Roberto Gomeni, France |
| 12:30 | Lunch |
| 13:15 | Simulation of first-in-human using an allometrically scaled population mechanistic TMDD model Géraldine Ayral, France |
| 13:45 | From phase I data to phase II trial design: simulation and extension of a population pharmacokinetic model Pauline Traynard, France |
| 14:15 | How PBPK modelling together with Bayesian statistics and targeted clinical data can be used to predict drug pharmacokinetics across patient populations? Lars Kuepfer, Germany |
| 14:45 | Various examples for the integration of cellular effect models from computational systems biology into whole-body PBPK models Lars Kuepfer, Germany |
| 15:15 | Break |
| 15:45 | Population-based and physiology-based PK models for drug-drug interaction trials and trials waiver Kenichi Umehara, Switzerland |
| 16:30 | Advance current PBPK model applications to support internal development and regulatory decisions Maxime Le Merdy, Switzerland |
| 17:00 | How to obtain biowaivers for clinical trials using PBPK, two case studies Maxime Le Merdy, Switzerland |
| 18:00 | What did we learn? / Open forum discussion with all speakers and participants |
| 18:15 | End of Workshop |
| Capacity: 50 – 60 participants | |
| 18:15 | Welcome Reception – Exhibition Area, Centre de Congrès de Lyon |
| Workshop 2: Early clinical development of biologics – what is so different about it? | |
| Chairs: Hildegard Sourgens, Germany and Jan de Hoon, Belgium | |
| 11:00 | Welcome and Introduction by the Chairs |
| 11:10 | New therapeutic concepts Philip Barrington, UK |
| 12:45 | Lunch |
| 13:30 | What is different in PK of biologicals Stefan Glund, Germany |
| 15:00 | Break |
| 15:15 | How to approach PD and safety Meagan O’Brien, US |
| 16:45 | ADAs / Immunogenicity Ann Gils, Belgium |
| 17:45 | What did we learn? / Open forum discussion with all speakers and participants |
| 18:15 | End of Workshop |
| Capacity: 50 – 60 participants | |
| 18:15 | Welcome Reception – Exhibition Area, Centre de Congrès de Lyon |
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