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

Dr Franck Atienzar
Head of In Vitro Toxicology Unit
UCB pharma

08:50 In Vitro Methods: Optimising Cell Models For Detecting Drug Induced Mitochondrial Dysfunction

• Many drugs have ‘off-target’ deleterious effects on mitochondrial function
• These effects have been underappreciated because many cell and animals models fail to report them
• New assays and animal models have been developed that do detect drug- induced mitochondrial dysfunction
• These data support a new model of idiosyncratic drug toxicity

Dr James Dykens
Associate Research Fellow, Drug Safety R&D
Pfizer

09:35 An In Vivo Gene Mutation Assay For Hazard Identification And Risk Assessment: The Pig-A Story

Mutation is involved in cancer onset and progression. Regulatory authorities require thorough characterization of all new drugs for mutagenicity. Cost efficient high throughput approaches are needed for better predicting genotoxic hazards that may impact on human health. A new model for detection of in vivo mutation in the endogenous Pig-A gene of cells in peripheral blood is a sensitive tool for use in screening and identification of potential mutagens during preclinical safety evaluations and in early clinical trials. The following topics will be covered:

• Limitations of the current ICH battery of genotoxic tests for safety assessment
• Design of a novel high throughput model for detection of in vivo gene mutation
• Laboratory animals - background and induced Pig-A mutation in rats and monkeys
• Human PIG-A model - results from healthy and exposed populations

Dr Vasily N. Dobrovolsky Division of Genetic and Reproductive Toxicology
National Center for Toxicological Research
US FDA (DGRT/NCTR/FDA)

10:45 The Future Of Predictive Toxicology: In Silico Technologies

• Current challenges in the development of In silico Predictive
• Toxicology technologies
• Future directions of In silico Predictive Toxicology
• Integration and evaluation of In silico toxicology to enable regulatory acceptance
• On-going research projects addressing In silico toxicology

Dr Mark Cronin
Professor of Predictive Toxicology, School of Pharmacy and Chemistry
Liverpool John Moores University

11:30 Methods And Models For The Prediction Of Genotoxicity, Carcinogenicity And Acute Toxicity

• Is off-the shelf good enough? What makes a model useful beyond its statistics?
• How to understand the models you are using, an end-users' guide
• Specific examples of models developed using the state of the art tools
• The challenges of managing the in silico safety assessment information avalanche

Dr Constantine Kreatsoulas
Senior Research Chemist
Chemical Modelling and Informatics Group Merck & Co.

13:15 Introduction to Stem Cells and UK Research

Dr Ben Sykes
Senior Programme Manager
National Stem Cell Network (UKNSCN)

14:15 UK Regulatory Overview Of Predictive Toxicology

• The role of MHRA
• Guidelines provided by the MHRA
• Scientific Advice
• Future Perspectives

Dr David Jones
Principle Scientific Officer
MHRA

15:25 AstraZeneca’s Experience In Using Computational Biology To Improve Prediction And Problem-Solving In Safety Assessment

• What is Computational Biology and how can it contribute to predictive toxicology?
• Understanding and exploiting toxicology data more effectively: learning from the past to predict the future
• Examples of project support: de-risking and problem-solving
• Looking to the future: use of dynamic computational simulations in toxicology

Dr David Cook
Associate Director for Global Safety Assessment
AstraZeneca

16:10 Predictive Toxicology: Transformative Paradigm Shift In The Evaluation Of Changes In Biological Processes For Assessing Health Effects Of Environmental Agents

Dr William Suk
Director of the Centre For Risk and Integrated Science
US National Institute of Environmental Health Sciences (NIEHS), an institute of the NIH

17:20 Predicting Success/Failure: Common Mistakes In Discovery And Development

• Mistakes to avoid in choosing compounds from discovery
• Mistakes to avoid in early development
• Case studies that illustrate pharmaceutical folly
• Dealing with toxic assets

Dr Mitchell Friedman
Director of Toxicology
Takeda Pharmaceuticals

18:05 Human-Centric Systems Biology: Translation To Clinical Management: A Top-Down Approach

• Building in variability in responses - why animal models fail
• The mechanisms of acquiring human cells and tissues
• Building a holistic view into in vitro model systems
• Data interpretation tools
• Toxicogenomics - from regulatory toxicity testing to clinical management

Dr Nirmala Bhogal
Scientific Director
Fund for the Replacement of Animals in Medical Experiments (FRAME)

18:50 Chairpersons Summary And End Of Day One