Conference Day Two: Thursday 16th February 2012

08.00 Morning coffee

08.45 Chairman’s Opening Remarks

Outsourcing Decisions in Predictive Screening

09.00 Opening Keynote: Scientific Advances in Non-Animal Approaches to Assuring Safety: Perspective from a Consumer Goods Company

  • Looking at successes to date for acceptance of non-animal approaches for assuring consumer safety (e.g. skin penetration, skin irritation)
  • Evaluating the current status of 'alternatives' for areas where animal tests are still needed for assuring consumer safety (i.e. recent reports from European Commission etc)
  • 'Toxicity Testing in the 21st Century': Bringing the US NAS vision to life (a case study example of chemically-induced DNA damage)

Carl Westmoreland
Director, Science & Technology
Unilever

09.40 Practical Stem Cells 1: Application and Benefit to Predictive Toxicology

  • Assessing the current state of stem cell models: what works, and what does not?
  • Applying stem cell models for predictive toxicology analysis
  • Running efficacy screening with stem cell models
  • Highlighting recent success stories and what lessons can be taken from them

Julie Holder
Preclinical Director
GlaxoSmithKline

10.30 Morning coffee

Hepregen 10.50 A Novel Micropatterned Hepatocyte Co-culture System for Drug Metabolism and Toxicity Studies

  • Need for clinically-relevant and higher through put liver models for drug screening
  • Overview of a microscale hepatocyte co-culture system
  • Advantages of the co-culture system: Relevant examples of how the microscale hepatocyte co-culture system could aid in prediction of human in vivo metabolites and toxicity prediction

Okey Ukairo
Sr Principal Scientist for ADME/Tox Services
Hepregen Corporation

STREAM A: Incorporating the Latest Predictive Technologies to Enhance Your Drug Screening Strategies

STREAM B: Advancing the Practical Application of Stem Cells in Therapies and Regenerative Medicine

11.30 Comparing the Uses and Limitations of Different Models for Predicting Drug Induced Cardiac Arrhythmias

  • Discussing how to overcome key challenges with different models
  • Evaluating the latest developments in proarrhythmic models; in vitro, ex vivo and in vivo
  • Understanding and navigating the current regulatory hurdles

Tomas Mow
Head of Exploratory Toxicology
Lundbeck

11.30 3D Tissue Models: Development of More Advanced Tissue Models for In Vitro Toxicity Testing

  • Developing and using 3D tissue culture technology
  • Discussing the Importance of perfusion
  • Ensuring controlled differentiation of stem cells in 3D
  • Monitoring and assay methods for 3D tissue culture

ZhanFang Cui
Professor
Oxford University

12.00 Overcoming Safety Challenges In CNS Drug Projects

  • Giving an overview of the key reasons why the CNS area is at high risk of safety-related attrition
  • Using an integrated safety assessment approach from target selection to regulatory studies
  • Instigating a wider implementation of predictive toxicology methods
  • Discussing non-traditional methods in early safety studies

Gvido Cebers
Principal Scientist, Global Safety Assessment
AstraZeneca

12.00 Safety Concerns Related to Pluripotent Stem Cell Therapies: Understanding and Overcoming Them

  • Pluripotency - a risk factor for safe stem cell therapies?
  • Discussing the risk of tumourigenicity and how to control it
  • Assessing some of the risks related to reprogramming
  • Practicalities and regulators: discussing the challenges in the clinical use of iPS cells

Tiina Palomäki
SWP and CPWP
EMA, and Finnish Medicines Agency

12.40 Networking Lunch Break

14.00 Case Study: Early Toxicity Assessment Strategy at Ferrer: Cardiotoxicity, Hepatotoxicity, Renal Toxicity and Genotoxicity

  • Discussing the strategy for early toxicity assessment
  • Predictive toxicology set up early in the drug development procedure
  • Analysis of the alternative testing for safety prediction
  • Improving drug candidates selection

Jorge Borr oto
Head of In Vivo Toxicology
Ferrer Pharmaceuticals

14.00 The Importance of being Organotypic: Stem Cell-Derived Cardiomyocytes for Prediction and Resolution of Drug-Induced Structural Cardiotoxicity

  • Addressing the incidence of structural cardiotoxicity in candidate and marketed drugs
  • Developing predictive screens for structural cardiotoxicity in cell lines and human stem cell derived cardiomyocytes
  • Using stem cell-derived cardiomyocytes to identify mechanisms of cardiotoxicity in candidate drugs

James Sidaway
Principal Scientist, Molecular Toxicology
AstraZeneca

14.40 Translation of Off-Target Effects to Clinical Adverse Reactions

  • Successfully mapping off-target effects to clinical adverse reactions
  • Utilising these to make early-stage decisions during drug discovery
  • Reducing late-stage attrition through effective translation of predicted toxicological effects

Laszlo Urban
Executive Director
Novartis

14.40 Regenerative Medicine: Cells vs Drugs – Highlighting the Advantages and Limitations

  • Challenges and advantages of cell vs drug therapy
  • What are Regenerative Drugs?
  • Discovery of new Regenerative Drugs

Yen Choo
CEO
Progenitor Labs

15.20 Networking Afternoon Coffee

15.40 Polypharmacology: Friend or Foe?

  • How to recognize compounds / series with unintended, safety-relevant polypharmacology issues early in a drug discovery project
  • How to mitigate unintended activities at “frequently hit off- targets” by drug design
  • Is exclusive selectivity for a single target really desirable?
  • How could we approach multi-targeted / polypharmacological drug discovery?

Jens-Uwe Peters
Principle Scientist
Roche

Manfred Kansy
Associate Director
Roche

15.40 hIPSCs Challenges and Opportunities for In Vitro Clinical Applications and Cell Based Therapy

  • Addressing the challenge and technical development of the generation of hIPSC lines fully compatible with clinical applications
  • Discussing the myth and reality of disease modelling in vitro using hIPSCs.
  • Large scale derivation of hIPSCs for stratified medicine
  • Commercial development of hIPSCs and their applications.

Tamir Rashid
Laboratory for Regenerative Medicine
University of Cambridge

16.20 Closing Interactive Debate:

New Directions in Drug Discovery: the Application of Embryonic Stem Cells

This session will see the pro’s and con’s of the practical application of embryonic stem cells in drug discovery debated, as well as the ethical and regulatory challenges, including the recent ECJ decision. Be prepared to ask questions and get involved with the debate!

Chaired by

Laszlo Urban
Executive Director
Novartis

17.00 Chairman's Closing Remarks, and Close of Conference Day Two

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