Clinically-Relevant Biomarker Strategies in Drug Development and the Potential of Machine-Learning for Biomarker Assessment

Life Sciences, Clinical Trials, Drug Discovery & Development, Biomarkers,
  • Friday, November 18, 2022

Biomarker quantification plays an integral role in the drug development process, providing guidance for downstream decision-making that has shown to correlate positively with clinical trial success. Biomarker-based stratification enriches clinical populations, reducing cost and trial duration. However, the real value of biomarker insights have not been fully realized due the limitations in the development and implementation of effective biomarker strategies in many clinical programmes across therapeutic areas, resulting in the absence of predictive biomarkers in the latest drug approvals.

It is also worth considering the prospect of applying machine-learning to biomarker assessment, which promises improved patient stratification of treatment response to drive drug development.

Register to learn about the importance of utilising biomarkers within clinical trials and how to go about developing effective biomarker strategies.


Justin Devine

Justin Devine, CMO & Interim CSO, Synexa Life Sciences

Justin is a medical doctor, immunologist and pharmacologist, Co-Founder of Synexa Life Sciences and is currently the CMO and interim CSO at Synexa. His primary focus is to understand the company’s clients’ objectives in new drug development and to implement biomarker strategies that bring real insight to the challenges of clinical development and the immunological underpinning of health and disease.

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Nicholas Woudberg

Nicholas Woudberg, Scientific Engagement and Proposals Manager, Synexa Life Sciences

Nick is a medical scientist with experience in soluble biomarkers and lipidology. He completed his PhD in medicine at the University of Cape Town, which focused on exploring new novel lipid-based biomarkers of cardiovascular disease. Nick joined Synexa as a Scientist in the Soluble Biomarkers lab where he was involved in developing and validating methods for unique client compounds. He is now part of the client services unit, assisting with outreach to clients, developing bespoke biomarker and analytical strategies and proposal generation.

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Who Should Attend?

  • Senior Medical Directors
  • Medical Directors
  • Clinical Biomarker Leads
  • Biomarker Leads
  • Translational Biomarker Leads
  • Clinical Development Directors
  • Clinical Research
  • Clinical Operations
  • Clinical Trial Managers
  • Clinical Outsourcing
  • Purchasing Managers
  • Project Directors
  • Project Managers

What You Will Learn

  • Learn about the important role of biomarkers in clinical development
  • How to implement an effective structure for developing clinically relevant biomarker strategies and enhance the success rate of clinical trials
  • Understand the value of machine-learning for disease stratification and how it can significantly improve the prediction of treatment response and drug efficacy

Xtalks Partner


Synexa is an industry leading biomarker and large molecule bioanalytical research service provider.  Our core expertise is in the understanding of immune system mediated diseases and therapeutic modulation of the immune system.

For nearly 20 years we have supported our partners across the globe to achieve their clinical milestones. As a science driven organization, we deliver bespoke bioanalytical solutions to meet each of our client’s specific needs. Our purpose-built laboratories located in London, Berlin, Cape Town and Rockville, Maryland (USA) have been designed to meet the rapidly evolving complexity of drug development pipelines.

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