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

Life Sciences, Clinical Trials, Drug Discovery & Development, Biomarkers,
  • Monday, October 24, 2022

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.

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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.


Dr. Frank Lynch, Executive VP, Global Head of Sales, Scientific Services, Discovery Life Sciences

For more than 30 years Frank Lynch has been a pioneer in immunohistochemistry (IHC) applications in research and clinical studies. Frank co-founded QualTek Molecular Laboratories in 1997 and developed an IHC services platform built around this powerful tool that allows for the expression and localization of specific proteins with cell and subcellular specific resolution. Frank has worked with hundreds of biopharma companies and oncology groups. He has overseen over 1,500 studies and hundreds of oncology clinical studies using IHC biomarkers, including the development of a crucial, high profile, PD-L1 prototype companion diagnostic test. QualTek recently merged with Discovery Life Sciences where Frank now serves as Executive Vice President, Global Head of Sales Services.

Prior to QualTek, Frank helped grow start-up company BioTek Solutions (later merging with Ventana) where he assisted in automating clinical IHC assays in hundreds of hospitals and anatomic pathology labs around the world. At BioTek, he developed the first widely accepted automated IHC test for estrogen receptor (H222 clone) in FFPE breast cancer using the TechMate immunostainer. Frank received his PhD from Rutgers University/UMDNJ, where he researched dUTPase and its role in patient response to 5FU in colorectal cancer.

Message Presenter

Who Should Attend?

Biopharma/Biotech R&D scientists and professionals who are interested in the following areas:

  • Oncology
  • Precision Oncology
  • Precision Medicine
  • Companion Diagnostics
  • Immuno-oncology
  • Biomarkers
  • Translational
  • Exploratory Biology
  • Assay Development

What You Will Learn

Attendees will gain insights into:

  • Validated target expression using immunohistochemistry (IHC) assays is a critical step in cancer drug development
  • Sound, strategic decisions around target expression can quickly be made based on reliable IHC biomarker data, from performing translational studies through to prospectively screening patients into clinical studies designed to increase the chance of patient response
  • Working with an experienced biomarker service provider at all stages of drug development can accelerate the rate of success with reliable and actionable IHC data to help inform development

Xtalks Partner

Discovery Life Sciences

Discovery Life Sciences is the company of Biospecimen and Biomarker Specialists, combining the world’s largest commercial biospecimen inventory and procurement network with preeminent multi-omic biomarker service laboratories, including genomic, tissue biomarker, proteomic, and cell-based services to accelerate new therapies supported by biomarker and companion diagnostic programs for cancer, infectious disease, and other rare and complex conditions.

Through AllCells, our cell and gene therapy division, we offer one of the largest recallable donor pools, Research Use Only (RUO) and clinical-grade (GMP) fresh and cryopreserved human cellular materials to support cell and gene therapy programs at any scale from start to finish.

Driven by leading scientific expertise and innovative use of current technologies, the Discovery team engages and consults with customers to overcome obstacles more rapidly and obtain results to make critical research and development decisions at market-leading speed. We are Science at your Service™!  For more information, visit dls.com.

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