08.45 Chairman’s Opening Remarks

Understanding the Current Regulatory Thinking & Focus

09.00 FDA Perspective: New Developments in Safety Assessment – the View from the Bench of an FDA Genotox Research Lab

• Highlighting the current regulatory guidelines
• Assessing the need for the creation and use of new approaches
• The Pig-a assay: developing a new tool for detection of gene mutation
• Bridging rodent and human data: effective translation of toxicological observations

Vasily Dobrovolsky
Research Microbiologist
FDA

09.40 European Regulatory Perspective for Advanced Therapy Medicinal Products (ATMPs)

• Outlining the European regulatory framework
• Highlighting some of the initiatives and tools available from the EMA
• Using the work programme to foster development of advanced therapies
• Hospital exemption – specific provision at the EU member state level

Janis Ancans
Committee for Advanced Therapies (CAT)
European Medicines Agency (EMA)

10.20 Speed Networking

Like Speed Dating, But Without the Pressure to Commit!

You’ve seen each other across the room…now meet face-to-face. Bring plenty of business cards to exchange in a series of 2-5 minute meetings with your fellow speakers, attendees and vendors. Get to know your peers and make the most of your networking for the rest of the event!

10.50 Technology Spotlight Session

For more information on our technology spotlights and to enquire about presenting in this spot please contact sponsorship@iqpc.co.uk or call us on +44 (0) 207 368 9300

11.00 High Content Analysis with Cytiva™ Cardiomyocytes for Investigative Toxicology

• Functional characterisation and validation of cardiomyocytes produced from human embryonic stem cells on an industrial scale
• Multi-parameter phenotypic profiling of an anticancer drug panel to identify cardiotoxic drug effects and gain insights into mechanisms of cell injury
• Phenotypic cluster analysis and alignment with reported clinical cardiotoxicity

Nick Thomas
Principal Scientist, Cell Technologies
GE Healthcare

15.00 Human Stem Cell Derived Neuronal Cultures for Assessment of Target - and Chemistry - Driven Toxicity

Gvido Cebers
Senior Project Director, Global Safety Assessment
AstraZeneca

15.40 TRAILBLAZER SESSIONS

Hear short presentations on the latest scientific discoveries from two trailblazing biotechnology companies

Presenting: Biobide and Biostatus

Ensuring Accurate Safety Assessment

16.10 New Models for Predictive Toxicology and the devTOX Stem Cell Based Assay for Human Developmental Toxicity

16.50 MetaMap® Tox: Development and Qualification as a Tool for Prediction of Preclinical Toxicity

• BASF SE and metanomics have developed an in vivo metabolomics data base (MetaMap® Tox) using more than 500 data rich chemicals, agrochemicals and pharmaceuticals on the basis of 28-day repeated dose rat studies.
• Metabolomics effects can be correlated to target organs and toxicological modes of action. More than 110 patterns of metabolome changes specific for certain toxicities have been developed.
• MetaMap® Tox is sucessfully used on a routine basis for prediction of toxicity and decision making at BASF SE.
• DSEC (Drug Safety Executive Council) evaluated and successfully qualified the applicability of MetaMap® Tox for preclinical research under the participation of 13 leading pharmaceutical companies.

Hennicke Kamp
Toxicologist, Head of Services Experimental Toxicology and Ecology
BASF SE

17.30 Interactive Panel Discussion with the Drug Safety Executive Council:

Predictive Toxicology Tools: Evaluation and Qualification of New Technology in Safety Assessment

18.00 Chairperson’s Closing Remarks and Close of Day One