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Informa
10:00 - 10:10 10 mins
Main agenda
Chair's opening remarks
  • Maria Burian - Associate Director, Innovation Unit Speciality Therapeutics, Grünenthal Group, Germany
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10:15 - 11:00 45 mins
Main agenda
Challenges of implementing biomarkers to early clinical development
  • Sidath Katugampola - Biomarker Development Specialist, Centre for Drug Development, Cancer Research UK, UK
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  • Why we need biomarkers in early clinical development
  • Case studies where biomarkers have made a significant contribution to early phase studies
  • Challenges; scientific for pharmacodynamics and patient selection
  • Challenges; logistical, operational, sponsor, analysing lab and beyond
11:00 - 11:30 30 mins
Main agenda
Morning coffee
11:30 - 12:15 45 mins
Main agenda
A new tool to translate data from an IB into an overview of potential risks. The connection of collected preclinical data”
  • Adam Cohen - CEO, CHDR
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  • Clinical investigators and regulators involved in early drug and device development projects get exposed to a large collection of preclinical data and have to make an independent assessment of benefits and risks of a new health care intervention for humans by translating these data in some integrated manner
  • Connecting this collection of data is the key and there is no standardized methodology available to evaluate and communicate the data in a concise manner
  • We propose a standardized and generic approach that gives a risk-coded overview of the data
12:15 - 13:15 60 mins
Main agenda
Lunch
13:15 - 13:55 40 mins
Main agenda
Biomarkers and translational research: Using biomarkers for early phase clinical trials to demonstrate the drug is doing what it is supposed to be doing
  • Maria Burian - Associate Director, Innovation Unit Speciality Therapeutics, Grünenthal Group, Germany
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  • Biomarker qualification process and regulatory data submission
  • Biomarker utilization in stratified medicine
14:00 - 14:45 45 mins
Main agenda
Immunoassay validation for a biomarker qualification process
  • Thomas Joos - Deputy Managing Director, NMI, Germany
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  • The IMI SAFE-T consortium approach for drug induced organ injury biomarker qualification in a public-private partnership
  • Immunoassay validation for the quantification of biomarkers in clinical samples
  • A generic scientific qualification strategy for translational safety biomarkers
14:45 - 15:25 40 mins
Main agenda
Closing panel discussion
15:30 - 15:40 10 mins
Main agenda
End of workshop