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Digital Event: Leveraging Clinical Trial Ready IHC Assays from Target Validation to Prospective Enrollment and CDx Development

October 24, 2022 @ 10:00 am - 11:00 am

Monday October 24, 2022 | 11.00am-12.00pm EDT


Leveraging Clinical Trial Ready IHC Assays from Target Validation to Prospective Enrollment and CDx Development

Many clinical trials fail due to inadequately distinguishing between disease phenotypes and underlying drivers of disease early on in drug development. This impacts a biomarker target’s ability to accurately predict disease, prognosis and therapeutic response. Researchers must adequately understand expression patterns and base decisions made during early development on data derived from high-quality study cohorts that are diverse, comprehensive, highly characterized and representative of the target population.

Oncology drug target validation is more important than ever, particularly given the major investment into biopharma researchers and companies developing so many new types and classes of oncology therapeutics. A critical aspect of target validation includes developing robust assays to accurately reflect expression intended to treat populations. This important work needs to be performed as early in the drug development process as possible. Discovery scientists can quickly and rigorously develop novel clinical trial ready immunohistochemistry (IHC) biomarker assays to assess sensitivity, specificity and reproducibility that can then confidently be leveraged throughout the drug development continuum.

Accurately measuring and analyzing target biomarker expression using validated IHC assays allows clinical researchers to make informed and strategic decisions, particularly in early proof of concept studies and trial design that can provide required scientific support to promote further investment in a potential therapeutic. Establishing fit-for-purpose high-quality, validated IHC assays and appropriate scoring schemes and cut-off points are critical to understanding the prevalence of target expression within and among tumor indications. This actionable data can be used to design programs to screen patients for enrollment into clinical studies based on IHC biomarker results. Patient response and associated IHC biomarker expression can facilitate the decision to commit to a companion diagnostic (CDx) approach. It is never too early in the clinical drug development process to integrate these far reaching, impactful, validated clinical trial ready IHC biomarker assays into the overall drug development plan.

In this webinar, the featured speaker, Dr. Frank Lynch will discuss the development and utility of IHC biomarker assays from early strategic planning through to prospective patient screening in CAP/CLIA laboratories, and decisions around the need and approach to a CDx. Dr. Lynch will discuss the applications of these IHC biomarker assays at all steps of drug development and how the results relate to the successful outcome of clinical studies.

Register to learn why successful drug development studies often begin and end with high quality IHC biomarker assays.




October 24, 2022
10:00 am - 11:00 am
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