Preclinical Drug Development: Evaluating the Immune System from Discovery to Safety Assessment

Life Sciences, Drug Discovery & Development, Preclinical, Fundamental Research,
  • Wednesday, March 08, 2023

The immune system is extraordinarily dynamic, responsive and powerful. Recent advances have highlighted the potential of the immune system to contribute to and effectively treat disease. Cancer immunotherapies have heralded an age of developing therapies that affect or are designed to target the immune system in complex ways. It is increasingly important and challenging to evaluate and understand the scope of immune system effects that can occur with these and other therapies. In this webinar, the featured speaker will discuss key concepts and considerations for evaluating the immune system across preclinical drug development — from discovery to preclinical safety assessment.

The speaker will discuss the types of immunotoxicology and immunopathology approaches involved in evaluating immune system changes, reporting expectations such as basic report components, interpretation of findings, adversity determination, immunologic correlates and the importance of integrating data sets to the impact (and adversity) of immune system changes.

Register today and learn the importance of evaluating the immune system across preclinical drug development.


Tracey L. Papenfuss, StageBio

Tracey L. Papenfuss, DVM, PhD, MS, DACVP, Senior Pathologist, StageBio

Tracey L. Papenfuss is a veterinary pathologist and immunologist with over 20 years of experience developing and evaluating immunotherapies in academic and industry. Tracey is currently a Senior Pathologist at StageBio where she focuses on the immunosafety space and provides immunopathology expertise. Tracey has worked across multiple sectors in drug and immunotherapy development from discovery to safety assessment and has evaluated translational and animal model systems that evaluate compounds and support the development of new therapies that impact human and animal health.

Prior to her current position, she was a toxicologic pathologist in safety assessment evaluating multiple species and drug/chemical modalities at Charles River Laboratories and was a research faculty member at The Ohio State University (OSU). In her position at OSU, she developed and directed a discovery-focused immunology research laboratory that evaluated novel immunotherapies for the treatment of cancer and both autoimmune and inflammatory diseases. She is currently an active member of the Society of Toxicologic Pathologists (STP), Society of Toxicology (SOT), American College of Veterinary Pathologists (ACVP) and the Health and Environmental Sciences lmmunosafety Technical Committee (HESI-ITC) and maintains an adjunct faculty appointment at OSU.

She has authored or co-authored numerous peer-reviewed publications and book chapters and has been invited to present on topics of immunology, pathology and related topics nationally and internationally.

Message Presenter

Who Should Attend?

  • Discovery/Academic Scientists
  • Nonclinical and Clinical Scientists
  • Study (or Project) Directors working in the immune space
  • Directors, Scientists and Biotech executives working with immunotherapies or other immune-modulating therapies
  • Pathologists

What You Will Learn

Attendees will gain insights into:

  • Considerations in developing immune studies, evaluating immune changes and integrating data sets across the drug development landscape (from discovery to safety assessment)
  • Immunotoxicology and immunopathology assessments
  • Immunopathology evaluation, data correlations and adversity considerations
  • The importance of data integration and weight of evidence approaches

Xtalks Partner


StageBio is a leading provider of GLP-compliant necropsy, histology, pathology, and specimen archiving and biorepository services for the biopharmaceutical, medical device, academic, and contract research industries. The company operates four GLP laboratories as well as three GLP specimen archiving facilities in the U.S., along with one GLP laboratory in Europe. We will continue to make investments in facility and technology infrastructure to meet the growing demand for high-quality histopathology services globally. StageBio has a team of 30+ board-certified veterinary pathologists and more than 100 laboratory technicians on staff supporting our unified commitment to quality, scientific integrity, and client satisfaction. Learn more at

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