08:40 Pharma IQ Welcome And Chairperson’s Opening Address

Dr Eric Blomme
Director of Investigative Toxicology
Abbott

08:50 Predictive And Integrated Toxicology For The Effective Development Of Topical Drugs

• Available predictive toxicology tools for topical drugs
• Keys for selecting dermatology effective and safe new drugs
• Specific safety assessment for topical treatments
• Are we doing enough for the safety of topical products?
• Cosmetics versus drugs: are they different?

Dr Marc Princivalle
Director of Toxicology, Head of Preclinical Risk Assessment
EMEA Stiefel laboratories

09:35 Application And Impact Of Early Genotoxicity Assessment And Predictive Toxicology At GSK

• Review of the need for reliable and predictive assays that can be used early in drug development
• Approaches: In silico methods and genotoxicity methods including implementation of the GreenScreen in routine screening
• Benefits of employing early Predictive Toxicology – reducing late stage drug attrition and missed opportunities

Dr Paul Hastwell
Senior Scientist
GlaxoSmithKline

10:20 Overview Of Genetic Toxicology: Predictivity And Future Directions

• Use of genetic toxicology assays to predict cancer and heritable mutation
• Mechanistically based genetic toxicology assays
• Promising new approaches and assays

Dr Martha Moore
Director, Division of Genetic and Reproductive Toxicology
FDA

11:30 ProtoTissue™: A New Functional Human 3D Liver Tissue For In Vitro Drug Testing

• Functionality mimics human liver
• Drug testing: from minutes to months, single or multiple dosing
• Highly reproducible stable system
• No apoptotic background to cloud results
• Well suited for drug candidate selection

Mr Stephen Fey
CEO
Drugmode

12:15 Predicting Hepatotoxicity At Early Stages: Tools And Illustrations With Case Studies

• Assays and approaches to predictive hepatotoxicity: implementation, strengths, limitations
• Where, when, and how should the technology and assays be applied using case studies from internal programs
• Developing an optimum strategy to reduce late stage attrition at an affordable cost

Dr Eric Blomme
Director of Investigative Toxicology
Abbott

14:00 Which Technology, Approach And Model To Detect Hepatotoxicity?

• Models: HepG2, HepaRG, THLE, stem cells, hepatocyte cocultures, zebrafish
• Mitochondrial toxicity, gene biomarkers of hepatotoxicity
• Technology: Real time cell electronic sensing, cell imaging/multiplexing

Dr Franck Atienzar
Head of In Vitro Toxicology Unit
UCB pharma

14:45 Computational Tools And Guidance For The Regulatory Assessment Of Chemicals

• Guidance on the regulatory use of computational methods, including QSARs
• QSAR reporting formats for models and predictions
• Computational tools developed by the JRC
• Challenges for the further acceptance and use of computational methods

Dr Andrew Worth
Project Leader Computational Toxicology, Systems Toxicology Unit Institute for Health and Consumer Protection (IHCP)
European Commission, Joint Research Centre

15:55 Fulfilling Information Requirements For Regulatory Hazard Assessment By Taking An Integrated Approach

Dr Maurice Whelan
Head of system toxicology, Institute for Health and Consumer Protection (IHCP)
European Commission Joint Research Centre and member of European Centre for the Validation of Alternative Methods (ECVAM)

16:40 Panel Discussion: The Future Of Predictive Toxicology: What Needs To Be Changed?

• What are the current challenges?
• Improving the reliability of predictive technology to avoid late stage drug attrition
• Building upon established techniques
• Evaluating the new tools
• Certification of new technology with regulatory bodies

17:40 Chairpersons Summary And End Of Day Two