Companion Diagnostics - Roles and Perspectives of the Therapeutic Product Manufacturer and Diagnostic Partner - Best Practices for Effective Collaboration

A significant proportion of therapeutic products (e.g. small-molecule drugs, biological therapeutics such as antibody-drug candidates and vaccines) are developed a particular biomarker or biological target. Accurate diagnostic tests are critical for effectively identifying patients who can benefit the most from these targeted therapeutic products. Precision medicine co-development projects (where the therapeutic product is developed in parallel with a diagnostic test) have become common in the oncology space and are being actively explored in other therapeutic areas.

Therapeutic products are typically approved by FDA through the NDA or BLA pathway in the US, and by the EMA in the EU. In contrast, diagnostic tests are approved in the US through the medical device 510(k) or PMA pathway, and through a Notified Body under the IVDR regulations in the EU. The quality standards of the products are also different, as diagnostic tests are required to follow the requirements of ISO 13485:2016, including documentation of design, while therapeutic products are required to follow local GMP requirements. These differences in process can lead to a misalignment of incentives, goals, and timelines between the therapeutic partner and the diagnostic partner.

Additionally, financial incentives are different for the therapeutic partner and the diagnostic partner. For example, the therapeutic partner is incentivized to market their drug or vaccine to the broadest possible population, and a companion diagnostic test is typically a means to an end. In this example, from the diagnostic partner perspective, the companion diagnostic test may have an unacceptable return on investment on its own, but the value of the project is in the funding of the company’s R&D by the therapeutic partner.

Therapeutic and diagnostic stakeholders on our panel will discuss examples from their own experience and what best practices they have used to achieve success in working with their partners.