Managing Biomarker/Companion Diagnostic (CDx) Programs with Pharma: A Diagnostic Company’s Perspective

Life Sciences, Medical Device, Biomarkers, Medical Device Diagnostics,
  • Tuesday, May 21, 2024

The partnership between a diagnostic provider and a pharmaceutical/biotechnology company is crucial when developing a companion diagnostic (CDx). It is important to ensure that the strategic approach for the therapy and diagnostic is aligned to achieve the same clinical, regulatory and commercial goals, as well as aligned with the program risk profile.

When developing a CDx, it is critical to define a clear and aligned goal and vision from the outset. Then, to determine the CDx strategy, the important technical, regulatory and commercial considerations that need to be examined. In fact, the clinical trial design can affect diagnostic development; therefore, there are many challenges associated with a diagnostic-pharma partnership.

In this webinar, the expert speakers will share recommendations on how to optimize the diagnostic-pharma partnership and build synergy. They will also explore some of the realities of managing CDx development programs with pharma and biotech partners from a diagnostic providers’ perspective.

Register for this webinar today to gain insights into the realities of managing CDx development programs with pharma and biotech partners from a diagnostic providers’ perspective.


Laura Nelson, Almac Diagnostic Services

Dr. Laura Nelson, PhD, Associate Director, Project Management, Almac Diagnostic Services

Dr. Laura Nelson has been a Senior Project Manager within Almac Diagnostic Services for many years. In this role, she leads a team of Project Managers with responsibility for the delivery of Almac Diagnostics’ clients’ biomarker discovery and CDx development and validation programs. Laura has a breadth of experience in the biomarker field with a strong interest in the development of diagnostics for chronic diseases. Prior to joining Almac, Laura received a first-class Honours degree in Pharmacology before completing her PhD in Pharmacy at Queen’s University Belfast.

Message Presenter

Who Should Attend?

This webinar will appeal to professionals in pharma and biotech companies and is relevant to both oncology and chronic disease fields. This webinar will benefit decision-makers with responsibilities including, but not limited to:

  • Biomarker program/project management
  • Clinical development
  • CDx development

What You Will Learn

Attendees will learn about:

  • The importance of defining a clear and aligned goal/vision from the outset
  • Key technical, regulatory and commercial considerations when defining a CDx strategy
  • How the clinical trial design can affect diagnostic development
  • Challenges associated with working within a diagnostic-pharma partnership
  • How to optimize the partnership and build synergy

Xtalks Partner

Almac Diagnostic Services

Your global partner for biomarker discovery, development & commercialisation.

Almac Diagnostic Services supports global pharma and biotech companies with their biomarker strategies from discovery through to companion diagnostic partnerships.

We have clinical and research laboratories in Europe and the USA, alongside strategic partnerships in China, enabling us to support global studies.

The core services we offer fall into three main categories:

  • Genomic Services
  • Clinical Trial Assays
  • Companion Diagnostics

Click here to find out more.

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