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Oct 24
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08:30 - 09:00 30 mins
09:00 - 09:10 10 mins
Chairperson's Opening Remarks
09:10 - 09:45 35 mins
Genotoxic Impurities
Industry case study: In silico assessment for the control of genotoxic impurities
  • Strategies for using predictive tools to reduce the risk of genotoxicity
  • Exploration of how to improve in silico prediction
09:45 - 10:20 35 mins
Genotoxic Impurities
Presentation title to be finalised
  • Catrin Hasselgren - Computational Toxicologist - Senior Scientist, Genentech, USA
10:20 - 10:55 35 mins
Genotoxic Impurities
Big Data Based Machine Learning Approach for Improving Analog Search for Mutagenicity Prediction
  • Suman Chakravarti - Vice President, Chief Scientific Officer, Multicase
  • This presentation describes a set of computational methods to identify better analogs for evaluating alerting chemicals during mutagenicity prediction. A novel distributed representation of chemicals fragments was learned from millions of unlabeled chemicals structures and subsequently used for computing chemical fingerprints from structural environments of mutagenicity alerts. The methodology demonstrates the value of transfer machine learning in chemistry. The fingerprints also facilitate automatic mining of mitigating and activating features of mutagenic alerts. Excellent prediction performance was achieved using the distributed fingerprints when compared to traditional binary fingerprints. Additional factors that are relevant in analog based mutagenicity evaluation will also be discussed e.g. how to determine optimal similarity thresholds, number of analogs etc.
10:55 - 11:25 30 mins
Morning Coffee
11:25 - 12:00 35 mins
Genotoxic Impurities
Novel methodologies for trace level analysis of potentially genotoxic impurities
  • Exploring current and new analytical techniques for GTI identification and qualification
  • Overcoming key challenges experienced when developing low level detection methods for GTI analysis
  • Ensuring analytical methods control GTIs to below the threshold of toxicological concern (TTC) level
  • Case examples of sensitive and selective methods used
12:00 - 12:35 35 mins
Genotoxic Impurities
Analytical control strategies for mutagenic impurities: Current challenges and future opportunities
  • Dave Elder - Principal Consultant, David P Elder Consultancy, UK
12:35 - 13:10 35 mins
Genotoxic Impurities
Round-table session: Experience share of analytical method development and transfer for genotoxic impurities
  • What issues are people having with genotoxic impurities?
  • How to control difficult impurities?
  • What new analytical strategies are being developed?
  • How to develop transferable analytical methods for genotoxic impurities?
13:10 - 14:30 80 mins
14:30 - 15:05 35 mins
Genotoxic Impurities
Spotlight session
15:05 - 15:40 35 mins
Genotoxic Impurities
Presentation title to be confirmed
  • Raphael Nudelman - Head of Chemical & Computational Toxicology, Teva Pharmaceutical Industries Ltd., Israel
15:40 - 16:10 30 mins
Afternoon Tea
16:10 - 16:45 35 mins
Genotoxic Impurities
ICH Q3D: Elemental Impurities and our approach on how to calculate limits for topical products
  • Carla Landolfi - Head of Toxicology - Preclinical Development, Angelini, Italy
16:45 - 17:20 35 mins
Genotoxic Impurities
Control and analysis of elemental and genotoxic impurities in extractables and leachables
  • How to use ICH M7 limits to control for extractables and leachables
  • Understanding the complexities in control and regulation of extractables and leachables
  • Case studies
17:20 - 17:25 5 mins
End of Conference Day Two