The New Era of CDx in Oncology: Adapting Clinical Research Strategy to Evolving Regulations

In oncology, companion diagnostics (CDx) are crucial for identifying patients who are most likely to benefit from a particular cancer therapy based on their biomarker status. This personalized approach enhances targeted patient selection, treatment efficacy, minimizes adverse effects, and contributes to more efficient clinical trials by focusing on defined patient populations.

With the increase in the application of CDx in oncology therapeutic development, regulatory scrutiny has intensified. Beginning May of 2025, manufacturers will face more stringent requirements for analytical and clinical validation of laboratory-developed tests (LDTs), including CDx. This shift in regulatory requirements may demand additional resources, lengthen development timelines, and increase operational complexity.

In this webinar, the expert speakers will explore the shifting landscape of CDx in oncology, highlighting key regulatory, assay development and study design considerations for biomarker-guided clinical trials.

Speakers

Meera Belur, Executive Director, Program Strategy, Oncology, Premier Research

Meera Belur, Executive Director, Program Strategy, Oncology, joined Premier Research in 2024 and is an integral member of the oncology leadership team responsible for providing strategic planning, coordination, knowledge and expertise for Oncology & Hematology projects. She brings more than 20 years of industry experience (academia, small biotechs, large pharma and CROs).

Prior to joining Premier Research, Meera served as the Portfolio Group Head for a large pharma company overseeing Radioligand, CAR-T and gene therapy assets within the oncology business unit. Meera has a diverse background in global clinical operations, drug development and project management where she has a proven track record of providing strategic leadership and successfully managing multiple aspects of numerous global phase I-IV clinical trials across various therapeutic areas with a reputation for building and maintaining top-tier project management teams.

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Charlie Chrisawn, Executive Director, Program Strategy, Diagnostics, Premier Research

Charlie Chrisawn has spent his entire career focused on diagnostic development and has amassed over 15 years of experience designing and leading diagnostic trials, including sample collection, validation and utility studies. Mr. Chrisawn’s background consists of both small- and large-scale diagnostics studies, including management of all development stages of diagnostics across a range of study settings. Under Charlie’s leadership, Premier Research celebrated a milestone achievement enrolling 100,000 participants in their diagnostic studies worldwide.

Mr. Chrisawn’s programs have successfully garnered MA and 510(K) approvals, including the only FDA-approved screening test for colorectal cancer and the first FDA-cleared at-home test for COVID-19. Mr. Chrisawn has also enabled dual 510(k)/CLIA study execution and drug/device combination studies in the 505(b)(2) pathway. His expertise includes protocol and study design, domestic and international study startup, site management, sample accountability, staff training and study closure. Mr. Chrisawn earned a Bachelor of Science (BS) in Biology from Davidson College.

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