Join us for the second installment of our enlightening webinar series with Precision for Medicine, focusing on optimizing immunohistochemistry (IHC) validation and regulatory strategies.

This session will explore in-depth the essential validation and regulatory strategies for IHC, providing crucial insights into the regulatory landscape and validation processes necessary for successful clinical trials.

Our expert speakers, Kennon Daniels, PhD, a scientific and regulatory in vitro diagnostic authority from Precision for Medicine, and Christie Bongel, MS, CT(ASCP), an experienced site director specializing in cytology and molecular diagnostics at Precision for Medicine, will guide you through the complexities of regulatory requirements, ensuring your IHC assays are compliant and optimized for clinical use. Topics include foundational laws and standards, aligning your validation and regulatory strategies with US clinical trial goals, and understanding regulatory differences between the US and Europe.

Key Takeaways:

  • Foundational Overview of Applicable Laws and Standards: Understand key regulations, including CLIA, CLSI, GCLP, and ISO, and their relevance to IHC.
  • Mapping Your US Regulatory Path: Learn how to align your validation and regulatory strategy with your clinical trial goals in the US.
  • Navigating Regulatory Differences: Gain a high-level overview of the regulatory differences between the US and Europe, focusing on IHC in clinical trials.
  • Utilizing Assays in Clinical Trials: Explore how assays are used in clinical trials, including exploratory biomarkers and patient enrollment.

Don’t miss this opportunity to enhance your knowledge and ensure your IHC assays are fully compliant and optimized for clinical success. Register now!

To watch the first installment of the webinar series, click here.

Click to watch the webinar recording. To view the presentation full screen simply click the square icon located in the bottom-right corner of the video-viewer.

Presenters

Kennon Daniels, ;PhD

Kennon Daniels, PhD

Vice President
IVD Regulatory Consulting
Precision for Medicine

Kennon Daniels is a scientific and regulatory in vitro diagnostic authority, specializing in the development of US regulatory strategies and FDA marketing submissions for IVD assays and instruments. Her expertise spans all aspects of product development, analytical and clinical trial protocol designs, Q-Submissions, IDEs, de novos, 510(k)s, and pre-market approval platforms.
Christie Bongel, ;MS, CT (ASCP)

Christie Bongel, MS, CT (ASCP)

Site Director - Histology
Precision for Medicine

Christie Bongel, MS, CT(ASCP), brings nearly two decades of experience in both research and clinical medicine. As the site director for Precision for Medicine’s IHC Center of Excellence in North Carolina, she excels in managing scientific operations and collaborating with clients. Christie is skilled in cytology, laboratory medicine, and molecular diagnostics. Her role focuses on building an energized team dedicated to delivering life-changing outcomes for patients. Christie earned her MS in Applied Biotechnology and is an ASCP certified cytotechnologist.

Production Partner

Precision for Medicine

Precision for Medicine is an industry-leading global CRO, specifically designed to apply a biomarker-focused, precision medicine approach to therapeutic development. Our novel approach integrates clinical operations excellence, laboratory expertise, and advanced data sciences to inform every step of clinical development and approval.

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Precision for Medicine

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