Download presentations of the Brussels conference 2015

Download presentations

Below is the entire pre-conference and conference programme with the possibility to download the presentations of those speakers who authorized it. The presentations are in PDF-format only. Please note that the copyright on these presentations remain with their authors and that anybody who would want to use some of the content, should explicitly refer to its author and the context of the conference.

Click on the titles of the presentations to start the download.


Wednesday 20 May: Pre-Conference workshops

WORKSHOP 1: Implementation of the EU Clinical Trial Regulation – Opportunities and Threats to Early Medicines Development

Session 1: Single Portal: opportunity or burden for early medicines development?

Concept, compromises and implementation plan for the Single Portal
Fergus Sweeney, EMA, United Kingdom

Hopes and fears for the single portal from a Pharma company conducting Phase I trials in Europe
Maria-Gabriela Di Matteo, Belgium

How will the Single Portal work for a Phase I CRO?
Elizabeth Allen, United Kingdom

Needs for IT support in our National Competent Authority due to the Clinical Trial Regulation and the Single Portal
Karina Markersen, Danish Health and Medicines Authority, Denmark


Session 2: Single Dossier: Will national early stage trials suffer or benefit?

Sponsor / CRO view
Bruno Speder, Belgium

Regulatory Authority view
Maria Antonia Serrano Castro, AEMPS, Spain

Ethics Committee view
Saskia de Weerd, NVMETC, The Netherlands


Session 3: National implementation of the Clinical Trial Regulation – how can we ensure improved conditions for early phase studies?

Implementation in France
Cécile Delval, ANSM, France

Implementation in Belgium
Greet Musch and Kristof Bonnarens, FAMHP, Belgium

Implementation in United Kingdom
Martyn Ward, MHRA, United Kingdom

Implementation in Germany
Thomas Sudhop, BfArM, Germany


WORKSHOP 2: An Introduction to PK/PD Modelling

General strategic approaches towards PK/PD modelling in clinical development [author has not authorized on-line publication]
F. Hourcade-Potelleret, Switzerland

Scientific background of PK/PD modelling
Bernd Meibohm, USA

Examples of PK/PD Modelling: Interactive Session I

PK/PD approach in a first-in human clinical trial for a BACE inhibitor in Alzheimer’s disease [author has not authorized on-line publication]
Vassilios Aslanis, Florence Hourcade-Potelleret, Switzerland

Assessment of concentration-QT relationships in pooled Phase I trials using a real example
Philippe Grosjean, Jérôme Msihid and Silvain Nicolas, France


Examples of PK/PD Modelling: Interactive Session II

PopPK and PBPK modeling in paediatric development programs [author has not authorized on-line publication]
Akash Khandelwal, Germany

PK/PD modeling and simulation for efficacy and safety of corticosteroids in asthma and inflammation
Hartmut Derendorf, USA

Population PK/PD modelling of methylphenidate accounting for placebo response and tachyphylaxis [author has not authorized on-line publication]
Roberto Gomeni, France


Thursday 21 May 2015

Session 1: What does the future of phase I research look like in Europe?

New transparency rules in early phase non-therapeutic trials. Open forum discussion introduced by Ulrike Lorch, United Kingdom

The new EU regulation: an asset for early drug development in Europe? Open forum discussion introduced by Clara Heering, Belgium
[pending authorization by the speaker]


Session 2: Global challenges in early development of medicines

Overcoming challenges in early drug development: optimizing CNS Drug discovery using neuroimaging [author has not authorized on-line publication]
Richard Hargreaves, USA

Overcoming challenges in early drug development: focus on biologicals [author has not authorized on-line publication]
Martin Wright, Switzerland

RNA interference (RNAi) as a therapeutic modality: From worms, to flies and now humans [pending authorization by the speaker]
Akshay Vaishnaw, USA

Drug-drug interactions between biologicals and small molecules
Bernd Meibohm, USA


Parallel workshops repeated on Friday 22 May

1. Neuroimaging versus CSF sampling as a scientific tool in human pharmacology:
Mark Schmidt (PPT 1, PPT 2, PPT 3), Belgium and Ilan Rabiner (PPT 4), United Kingdom

2. GCP and GMP inspections in phase I: what can be learned?
Barbara Schug (PPT 1), Germany and Jean-Luc Golnez (PPT 2) and Dominique Delforge (PPT 3) , Belgium

3. How statistical tools can help your proof of concept studies.
Nicolas Bonnet, France

4. Outlook on the upcoming medical device and in vitro diagnostics regulations in the EU
Eric Klasen, Switzerland and Ingrid Klingmann, Belgium


Session 3: European setting for early drug development in special populations

Pediatric drug development – do we need a PIP so early in development? American versus European approach
Angelica Joos, Belgium

Specifics of early orphan drug development in Europe [author has not authorized on-line publication]
Khazal Paradis, The Netherlands

Revisiting the pharmacokinetics in patients with impaired renal function in the light of the latest FDA and EMA guidelines
Eric Legangneux, France and Kasra Shakeri-Nejad, Germany


Day 2 – Friday 22 May 2015

Session 4: Clever approaches to navigating research challenges

To what extent are “challenge agents” acceptable?
Jan de Hoon, Belgium

Non-clinical and early clinical development of nanobodies
Erik Depla, Belgium

Parallel workshops (see Thursday programme)

Session 5: Development of biosimilars: why is Europe the place to be?

Biosimilar development: advantages of the European environment: scientific challenges and implications
Paul Declerck, Belgium

Establishing biosimilarity: the primary contribution of analytical comparability data to the totality of evidence
Paul Chamberlain, Germany

Clinical strategies for global biosimilar development: a European perspective with a focus on monoclonal antibodies
Diane Seimetz, Germany

Safety concerns with early clinical development of biologicals and biosimilars: clinical relevance of anti-drug antibodies
Huub Schellekens, The Netherlands