discussion group 

The Joint DMDG/GMP Open Meeting 2016
19 - 21 October, Espace St Martin, 199bis rue Saint Martin, 75003, Paris, France

Introduction Session Synopsis Programme Hotels Sponsorship    Register   

Offers of posters are welcome -
the email addresses of the Poster Session organisers can be found in the
Session Synopsis.
Posters will be available for viewing throughout the conference.

Wednesday 19th October
11-12:00   Arrival, Registration & Lunch
13:00   Chairs’ Opening Address
Suzanne Iverson Hemberg, Sahlgrenska University Hospital, Sweden
Vassilios Aslanis, Novartis, Switzerland
13:30   Keynote Speaker
Spatially resolved assessment of drug-induced changes in metabolism by mass spectrometric imaging
Prof Zoltan Takats, Ph.D, Imperial College London, UK
14:30   Tea and coffee
15:00   Session 1 – The impact of pre-clinical PKPD modelling on drug discovery and development
Chairs: James Yates and Marc Trellu

Application of model based drug discovery from target idea to early clinical studies – a case study
Rasmus Jansson Löfmark,: AstraZeneca R&D Mölndal, Sweden

Drug profiling in discovery using model based approach to project from in vitro to patients
Caterina Bissantz , Roche, Switzerland

How early ePKPD may help the drug discovery process? Specific examples and case studies will be highlighted to help demonstrate key points for opportunities and benefits
Pierre-Yves Abecassis, Sanofi R&D, France
17:00   Poster Blitz - 5-minute presentations from selected posters to engage audience prior to the poster session
17:30   Poster Session
Wine and food available
Organisers:  Peter Kilford, Florence Gattacceca and
Sunil Mathur
19:00   End of session
Thursday 20th October
09:00   Session 2 – Implementing biodistribution to better understand PK
Chairs: Sherri Dudal; Graeme Clark and Florence Gattacceca

Hunt for off-target binding - biodistribution and in vitro attempts to solve atypical PK
Kevin Brady, F. Hoffman-La Roche, Switzerland

Mass spectrometry imaging applied to investigating drug efficacy and toxicity across pharmaceutical R&D
Richard Goodwin, AstraZeneca, UK

Optimising PK of therapeutics using Veltis®-albumin-based technologies – from rational design to PK/PD and biodistribution
Jenny McLaughlan, Albumedix (formerly Novozymes), UK

Ocular Drug Distribution: Impact of Melanin Binding
Arto Urtti, University of Helsinki, Finland
10:30   Coffee
10:50   Session 3 – Skin Metabolism
Chairs: Vibeke Hougaard Sunesen and André Huss Eriksson

Drug metabolism in the skin: Relevance for development of dermally applied drug products
Clemens Günther, Bayer, Germany

Skin Metabolism: Comparison of In Vitro Methods and Models
Carine Jacques-Jamin, Pierre-Fabre, France

In Vitro Measurements to Determine Cutaneous Bioavailability
Joan Eilstein, L'Oréal, France

Contribution of dermal metabolism to local toxicities
Simon Wilkinson, University of Newcastle, UK

12:20   Lunch
13:50   Session 4 – New Approaches for the Prediction of ADME Parameters
Chairs: Angus Nedderman and Marion Millet

Direct and quantitative evaluation of the human CYP450 contribution (fm) to drug clearance using the in vitro SILENSOMES™ model
Yannick Parmentier, Servier, France

Upcyte® Human Hepatocytes – Application for clearance prediction of metabolically stable compounds
Michelle Schaefer, Boehringer Pharma, Germany

Computational prediction of sites of metabolism
Prof Robert Glen, Imperial College London, UK
15:20   Tea and coffee
15:40   Session 5 – Bioanalysis of Biomarkers: Challenges, pitfalls and new perspectives
Chairs: Karelle Menochet & Tim Sangster

Biomarker strategy and bioanalytical challenges for biologics in preclinical drug discovery and development for use in PKPD
Sherri Dudal, UCB, UK

Biomarker assay validation in practice: EBF Recommendation in practice and feedback from the recent EBF Focus Workshop (June, Lisbon)
Marianne Scheel Fjording, NovoNordisk, Denmark and Philip Timmerman, Janssen R&D, Belgium

Bioanalysis of miRNAs: The Same but Different
Keith Sutton, Charles River Laboratories, UK

17:10   Keynote Speaker
The TeGenero and Bial trials - the importance of pharmacology for taking medicines safely into humans
Michael Eddleston
, University of Edinburgh, UK
18:00   End of session
19:30   Conference Dinner & Entertainment
Friday 21st October
09:00   Session 6 - The impact of Transporters in drug discovery: its not just about small molecules
Chair: Mohammed Ullah

Transporter strategy in drug discovery and development: Understanding the impact of active transport on human pharmacokinetics
Karelle Menochet, UCB, UK

Cross-membrane transport of NBEs: a cell-based approach to study impact of FcRn recycling in vitro and its correlation with in vivo clearance  
Silke Simon, Roche, Switzerland

Assessment of Antisense Oligonucleotide Disposition in cells 
Erich Koller, Roche, Switzerland
10:30   Tea and coffee
10:50   Session 7 – PBPK application in clinical development to support regulatory submission
Chairs: Antoine Deslandes and Sylvaine Cartot-Cotton

A Case of Regulatory Acceptance of a PBPK Modelling Approach to Answer Key Drug-Drug Interaction Questions
Venkatesh Pilla Reddy, AstraZeneca, UK

Physiologically-based pharmacokinetic modeling for prediction of drug-drug interactions: Eliglustat (Cerdelga®) as a case study 
Vanaja Kanamaluru, Sanofi R&D, USA

PBPK, a tool for designing better clinical trials – application to pediatric studies
Marylore Chenel, Servier, France
12:30   Closing Remarks
13:00   Lunch and Delegates Depart

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