Skip navigation

Understanding the CDx Development Process – From Biomarker Discovery to Marketed Diagnostic Product

08:00 – 14:00

Location:
Chesterford Resarch Park, Little Chesterford, Saffron Walden CB10 1XL
Date:
14 March 2017
 
This event is now at full capacity, please email aline@onenucleus.com if you would like to be added to the waiting list.




With the prospect of a more personalised approach to new therapeutics, biomarkers research is really vibrant in academia and industry.   
Although their identification and characterisation processes are well established, their route to clinic and market doesn’t come without pitfalls.

This event will provide a comprehensive understanding of the CDx development process from biomarker discovery to approved and marketed CDx product including:

  • In depth insight into the needs of both pharmaceutical and diagnostic companies as well as global regulatory agencies and reimbursement
  • Pharma – Diagnostic interactions and partnering
  • Identify pitfalls and solutions in biomarker and CDx strategy
  • CDx development – the difference between Dx and Rx
  • The impact of early decisions on the whole CDx development process
  • The importance of product requirements
  • Choices and decisions on regulatory routes and interacting with regulatory agencies
  • Overcoming the issues with reimbursement

This should appeal to anyone involved in CDx research interested in knowing more about clinical validation and application or simply looking for a development partner. 

Programme:

08.30 – Registration over Tea and Coffee

09.00 – Welcome Introduction  
Please click here to view the presentation

09.15
– Diagnostic Development from the Drug Development Perspective 
Martin Armstrong, UCB Pharma  
Please click here to view the presentation

09.55 – Diagnostic Development from the Diagnostic Perspective 
Bob Holt, Hologic  
Please click here to view the presentation

10.30 – Discussion on Rx – Dx Partnership to Enable Success
Bob Holt, Hologic 
Martin Armstrong, UCB Pharma 

11.00 – Coffee Break

11.30 – Interactive Session

11.45 – Market Landscape, Commercial Development and Market Access for CDx
Iain Miller, Healthcare Strategies Group 
Please click here to view the presentation

12.30 – Closing Remarks
Paul Docherty, Hologic 
Please click here to view the presentation

12.45 – Lunch and Networking

14.00 – End 
Title: Understanding the CDx Development Process – From Biomarker Discovery to Marketed Diagnostic Product
Start: 2017-03-14 08:00:00Z
End: 2017-03-14 14:00:00Z