Managing Biomarker/Companion Diagnostic (CDx) Programs with Pharma: A Diagnostic Company’s Perspective
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.
Access this webinar today to gain insights into the realities of managing CDx development programs with pharma and biotech partners from a diagnostic providers’ perspective.
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
Presenter:
Dr. Laura Nelson, PhD, Associate Director, Project Management, Almac Diagnostic Services
