IATP Satelllite Symposium: Medical Device Safety Assessment: Pathology and Toxicology Perspectives
Held at the ESTP Congress. September 2023

This symposium provided an overview of the status, recent advances, and future trends in medical device safety assessment.


Toxicology Perspectives on MD Safety Assessment Requirements and Biocompatibility
Dr. Nicole Soucy
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Focus on bone implant pathology: a workup, shortfalls and forecasts
Dr. Antoine Alves

Extractables and leachable testing of medical devices
Dr. Flora Wegener
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Regulatory requirements and differences with various agencies and Regulatory differences in USA, Canada, Europe Including non-animal testing assays/approaches
Dr. Uta Bussmeyer 
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IATP Maronpot Guest Lecture: “Digital pathology and AI: real world applications in toxicologic pathology"
Society of Hungarian Toxicologists (Toxicology Pathology Branch) Annual Meeting, October 2023
Speaker: Lise Bertrand
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IATP Maronpot Guest Lecture: “Biologic Associated Immune-mediated Renal Disorders in nonclinical toxicity studies and their relationship to the clinical syndrome of BAIRD”
ESTP Congress. September 2023
Speaker: Ken Frazier

IATP Satellite Symposium: Alzheimer’s Disease: New Insights into the Pathogenesis, Treatment Modalities, and Translational Models
Held at the ESTP Congress, September 2022

This Satellite Symposium gave an overview of the many aspects of Alzheimer’s Disease (AD) from understanding the manifestation of clinical disease to current therapies, translational models, and gene-environment interactions. The Symposium gave an overview of clinical disease and its pathogenesis, which included risk factors for AD and maintenance of cognitive health. The session furthered explore novel therapies and approaches, and mechanisms of action of effective treatments.  Appropriate and relevant models that have comparative aspects representative and translatable to AD in human were also discussed and the pros and cons of the proposed models were reviewed. The concept of how environmental factors interact with genetic factors, and AD and the exposome were explored. 

Overview of Alzheimer's Disease
Pieter Jelle Visser, Maastricht University
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Novel Alzheimer’s Disease therapies and approaches to cross the Blood Brain Barrier
Kerstin Hahn & Vanessa Schumacher, Roche Innovation, Basel
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Translational Models for Alzheimer’s Disease
Donna Wilcock, University of Kentucky, USA
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Gene-Environment Interactions and Alzheimer’s Disease
Caleb Finch, USC, USA
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IATP Maronpot Guest Lecture: Modeling Cancer Immunotherapy in Tumor-Bearing Nonhuman Primates
ESTP Congress, September 2022
Speaker: Mark Cline


IATP Maronpot Guest Lecture: The Scientific Value of Histopathological Evaluation During the Nonclinical Safety Assessment of Medical Devices
Society of French Toxicologic Pathology Annual Meeting, May 19, 2022
Speaker: Serge Rousselle 

IATP Maronpot Guest Lecture: Digital pathology and tissue image analysis – how did we start and where are we now?
39th Annual Meeting of the Japanese Society of Toxicologic Pathology
January 27, 2022
Speaker: Aleksandra Zuraw
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Special Lecture: IATP Accreditation for Trainees 
38th Annual JSTP Annual Meeting, January 2022
Speaker: Kevin Keane 
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IATP Satellite Symposium: Biomarkers for the 21st Century: The Critical Role of the Microbiome in Toxicology, Health and Disease
September 14, 2021 (Held during the ESTP Cutting Edge Meeting)

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  • Diet, Microbiome and Health - Past, Present and Future. Speaker: Cindy Davis
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  • Modulation of Host-Microbiome Interactions by Xenobiotics: Implications for Disease Outcomes. Speaker: Gary Perdew
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  • Microbiota and the Gut-Brain Axis. Speaker: Niall Hyland 
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  • The Human Gut: Remote Manifestations Regulated by the Microbome. Speakers: Davide G. Ribaldone and Giovanni C. Actis
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IATP Special Lecture: Choosing the Most Appropriate Rodent Model of Chronic Kidney Disease
Speaker: Ken Frazier 
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IATP Maronpot Guest Lecture:  INHAND Terminology in the SEND Era:  How is it working to date?
37th Annual Meeting of the Japanese Society of Toxicologic Pathology
January 28, 2021
Speaker: Charlotte Keenan
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IATP Maronpot Guest Lecture: Confounders for Kidney Carcinogenesis in Cancer Bioassays
36th Annual Meeting of the Japanese Society of Toxicologic Pathology, Tokyo, Japan
February 13, 2020
Speaker: Gordon C. Hard

L to R: Gordon Hard, Dai Nakae, Robert Maronpot and Shim-mo Hayashi


IATP Satellite Symposium: New Approaches and Practices in Reproductive and Developmental Toxicology – Role of the Toxicologic Pathologist
Tuesday, September 17, 2019
9:00 AM - 12:30 PM
Held during the 17th European Congress of Toxicologic Pathology, Cologne, Germany

This half-day workshop was oriented for toxicologists and pathologists who are engaged in the nonclinical assessment of reproductive and developmental toxicology studies. The speakers covered usage of micro CT in reproductive and developmental toxicology studies, current approaches for sampling and evaluation of female and male reproductive tract including juvenile studies, emerging mechanistic in vitro models of embryonic implantation and organ-on-a-chip technologies in reproductive toxicology. 

Micro-CT for Evaluating Drug Toxicity in Developmental and Reproductive Toxicology (DART) - Howard Solomon, GSK, USA - View Presentation 

Current Approaches to Evaluating and Sampling the Male Reproductive Tract- Eveline de Rijk, Charles River Laboratory,Netherlands - View Presentation 

Current Approaches to Evaluating and Sampling the Female Reproductive Tract = Claudine Tremblay, Charles River, Canada - View Presentation 

Organs on a Chip for Female Reproductive System Predictive Toxicologic Pathology - Daniel Rudmann, Charles River, Colorado, USA - View Presentation 

Emerging In Vitro Models of Human Embryonic Implantation - Yaakov Nahmias, Hebrew University of Jerusalem, Israel = View Presentation 

Name, Name, Name
L to R: Eveline de Rijk, Dan Rudmann, Claudine Tremblay, Yakov Nahmias, Howard Solomon


IATP/STP Maronpot Guest Lecture Series: Bridging the Gap Between Toxicologic Pathologists and the Medical Device Industry
Speaker: JoAnn Schuh, JCL Schuh PLLC
Wednesday, June 26, 2019
12:30 PM - 1:30 PM 
Held during the STP Annual Meeting, Raleigh, NC  

This presentation discussed the existing gap between the fields of toxicologic pathology and the medical device industry and the need for toxicologic pathologists to improve this relationship. Biomaterials and medical devices have a long history in the therapeutic intervention for multiple diseases, but safety and efficacy testing of these products has been largely overlooked by toxicologic pathologists. Toxicologic pathologists have the core skills and are ideally suited to provide high-level safety and efficacy assessment of medical device products; however, toxicologic pathologists face limitations due to the lack of formal training or continuing education programs, and a lack of familiarity with types and appearance of biomaterials. Most of the relevant publications/references for the medical device industry are in the bioengineering field and differences exist in terminology, testing standards, and endpoints compared to testing of drugs and biologics. Additionally, the medical device industry has resisted robust safety and efficacy testing, but recent device failures and the increasing complexity of medical devices and combination products is driving a need for improved risk management. The current atmosphere provides an opportunity for toxicologic pathologists to bridge the gap with the medical device industry. Toxicologic pathologists need to become more active as the leaders in establishing nomenclature, best practices, testing standards, and regulations for biomaterials and finished medical devices.

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L to R: Darlene Dixon, Bob Maronpot, JoAnn Schuh, Thomas Rao, John Foster


IATP Satellite Symposium: ToxicoPathology Assessment of Stem Cells and Regenerative Medicine. 
September 11, 2018 
Held during the ESTP Annual Meeting, Copenhagen, Denmark 

This half-day workshop was oriented for toxicologists and pathologists who are engaged in the nonclinical safety assessment of stem cell-based therapeutics intended for implantation in humans. The speakers covered the biological knowledge and regulatory framework necessary to develop a nonclinical development strategy for stem cells. Additionally, examples of specific stem cell products and nonclinical development challenges were presented. 

Overview of Stem Cell Biology - Poul Hyttel, University of Copenhagen, Denmark (View Presentation)

Translating Stem-Cell Based Therapies in the Clinic - We’re Talking   Regulatory Not Science, or Are We? - Joy Cavagnaro, Access BIO, Boyce, Virginia, USA (View Presentation)

Nonclinical Assessment of Islet Beta Stem Cells - Kevin Keane, Novo Nordisk, Måløv, Denmark (View Presentation)

Nonclinical Studies with Hematopoietic Stem Cells to Support Gene Therapy in an Academic GLP Test Facility - Patrizia Cristofori, GlaxoSmithKline, United Kingdom and Francesca Sanvito, San Raffaele Scientific Institute, Italy (View Presentation)

Nonclinical Immunological Assessment of Stem Cells - Richard Haworth, GlaxoSmithKline, United Kingdom (View Presentation) 

IATP Workshop: Evaluation of stem cell-derived cellular therapy products. 
Speaker: Alys Bradley, Charles River Laboratories 
June 20, 2018 
Held during the STP Annual Meeting, Indianapolis, IN 

The lunchtime lecture discussed stem cells and stem cell-derived cellular therapy products and the role of pathologists in evaluating such products. Due to a rapid and expanding interest in stem cell-derived cellular therapeutics, along with medical devices and tissue engineering in the burgeoning field of regenerative medicine, toxicologic pathologists are confronted with evaluating these types of preclinical studies with few guidelines available to help in the design and assessment of such studies. Therefore, we thought it would be timely and of interest to the STP community to have a presentation on stem cell-derived cellular therapy products and approaches to doing toxicologic pathology evaluations of such products. The importance of input from the pathologist on initial study design and addressing issues of appropriate tissue collection, and optimal species and cell marker selection will be addressed. Regulatory issues to be considered in designing and evaluating preclinical studies on stem cell-derived cellular therapy products were also covered.

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IATP-Path 2.0 Satellite Symposium: ToxPath21
August 30, 2017
Held at the ESTP Annual Meeting, Lyon, France

This 4-hour session discussed toxicologic pathology in the 21st century and the role of the pathologist in the era of "omics", high throughput screening, and alternative in vitro testing. The session covered molecular tools and technologies available to pathologists and toxicologists, in vitro models and approaches used in modern pathology, adverse outcome pathways, and the challenges pathologists face in correlating molecular outcomes with histopathology findings in toxicity testing. A panel discussion convened at the end of the speaker presentations to engage the audience on how these new approaches may be implemented in toxicologic pathology.

Speaker: Darlene Dixon, NIEHS, NTP
The Tool Box for the Molecular Pathologist.
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Speaker: Bridgette Landesmann, ECVAM
In vitro Approaches to Modern Toxicology: Where Are We Going?
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Speaker: Arun Pandiri, NIEHS, NTP
Adverse Outcome Pathways: A Pathologist's Perspective.
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Speaker: Alessandro Piaia, Novartis and Frieke Kuper, TNO
When Morphology Meets Omics-Are Gene Expression Profiling and Histopathology Truly Complimentary in Toxicity Assessments?
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IATP Workshop: Nanotechnology Reflections: Understanding the Toxicologic Pathology of Nanoscale Interactions
June 28, 2017
Speaker: Ann Hubbs
This lunchtime lecture discussed nanotechnology from its development to contemporary applications and the challenges for toxicologic pathologists.

IATP Workshop: Application of In Vivo and Ex Vivo Multimodality Imaging in Toxicology and Toxicologic Pathology
November 7, 2016
Held at the ACT Annual Meeting, Baltimore, MD 
View the Published Manuscript

Imaging methods are established tools in biomedical basic science research with applications in drug discovery, pathology, and toxicology research. Contemporary imaging tools extend the ability of the toxicologist, and toxicologic pathologist, to comprehensively study whole animal, and tissue structure and function, in tandem with metabolism and distribution of molecules, biomarkers, metabolites, peptides, drugs, etc. and to correlate these chemical events with conventional histology at high resolution. These imaging tools provide for noninvasively conducting longitudinal studies in the same experimental animals, for monitoring gene expression, signal transduction, and tumor growth and therapy, and give us the ability to quantitate multiple tissue lesions in three dimensions. This workshop is offered by the International Academy of Toxicologic Pathology and will provide practical applications of multimodality imaging for toxicologists and toxicologic pathologists. Speakers: Robert Maronpot (Moderator), Kathy Gabrielson, Vyacheslav (Slava) Kalchenko, Yael Schiffenbauer, Abraham Nyska, David Bonnel.

IATP Satellite Symposium: Juvenile Toxicity
September 20, 2016
Held at the ESTP Annual Meeting, Barcelona, Spain

The session provided an overview of study design and testing methods in juvenile toxicity followed by presentations of toxicity and pathology responses in rodents, minipigs, and non-human primates. The focus was on the relevance and challenges of responses in these studies to toxicologists and pathologists with a presentation of tissue pathology and identification of adverse responses in these animal models

Speaker: Robert Parker - View Presentation

Speaker: Catherine Picut -  View Presentation

Speaker: George Parker - View Presentation

Speaker: Darlene Dixon  - View Presentation

Speaker: Paul Howroyd - View Presentation 

Speaker: Alys Bradley - View Presentation

IATP Course: Postnatal Organ Development as a Complicating Factor in Juvenile Toxicity Studies
June 29, 2016

Speakers: George Parker and Catherine Picut
Held at the STP Annual Meeting, San Diego, CA
View the Published Manuscript

This session presented a practical approach to evaluating juvenile toxicity studies in rodent models, speakers will present a spectrum of histological changes not commonly seen in conventional toxicity studies.

IATP Lecture "Adverse, Non-adverse, and Adaptive Responses in Toxicologic Pathology"
January 28, 2016
Held at the JSTP Annual Meeting
Speaker: Robert Maronpot

Applications of In Vivo and Ex Vivo Multimodality Imaging in Toxicologic Pathology (IATP Satellite Symposium at ESTP/BSTP Congress)
September 22, 2015
University of Guildford, Surrey, UK
Speakers: Kathy Gabrielson, Johns Hopkins University; Vyacheslav Kalchenko, Weizmann Institute of Science; David Bonnel, Imabiotech; Yael Schiffenbauer, Aspect Imaging and Abraham Nyska, Sacklar School of Medicine
Session Overview: This course addressed small animal imaging including MRI (in vivo and ex vivo), micro-CT, ultrasound, and optical imaging. The emphasis was on toxicologic pathology and the use of imaging in toxicology animal models.

Responsible Authorship and Publication Practices
Held at the JSTP Annual Meeting, January 2015
Session Overview: This presentation covered recommendations for conducting, reporting, editing, and publication of manuscripts in medical journals according to the International Committee of Medical Journal Editors. Topics presented included data presentation, criteria for authorship and acknowledgments, identification of abuses of publication practices, dealing with Conflict of Interest, use of correct English syntax and grammar, and discussed the ethics of publication and ethics of image adjustment for figures and photomicrographs. Concluding remarks dealt with the responsibility of journal editors and reviewers and a former editor's perspective on how to get your paper published.

Practical Application of MRI Histology in Toxicologic Pathology
Held at the JSTP Annual Meeting, January 2014
Session Overview: This session provided examples of major organ system pathologies encountered in rodent toxicity and carcinogenicity studies with emphasis on how MRI imaging technology can serve as an important adjunct to conventional pathology evaluation. The objective was to use rodent animal models and show how live animal images followed by images of the fixed specimens from the same animal model and compare with conventional H&E stained sections.

IATP/IFSTP Pathology Peer Review
Held at the 2014 STP-I Meeting, November 2, 2014
Session Overview: Pathology peer review verifies and improves the accuracy and quality of pathology data and interpretations. Pathology peer review is a critical phase when important risk assessment or business decisions are based on nonclinical studies. A recent OECD advisory document entitle Draft OECD Guidance on the GLP Requirements for Peer Review of Histopathology, is under discussion with various Tox Path societies worldwide. The following topics were covered and discussed in the seminar: roles of the study pathologist, peer review pathologists, pathology working groups; peer review of clinical pathology data; regulatory perspective on pathology peer review and perspective of a pathologist on peer review in Indian CRO.

View Meeting Summary
View Peter Mann's Talk
View Jerry Hardisty's Talk
View Sabine Francke's Talk
View Lila Ramaiah's Talk
View Kalai Selvan's Talk

IATP/STP Excel Tips and Tricks: Easy Ways to Quickly Visualize Your Pathology Data
Held at the 2014 STP Annual Meeting, June 25, 2014, Washington, DC
Session Overview: This interactive presentation demonstrated ways to quickly visualize numeric pathology data primarily using Microsoft Excel. Although Excel's built-in graphing capabilities are limited compared to dedicated graphing programs, some of its functions are ideally suited to evaluating pathology data from toxicity studies. The session began by demonstrating methods to get data into Excel from Word and PDF documents and how to best format different types of data. Next, several methods of graphing were demonstrated, including scatterplots and pivot charts. At the end of the session, attendees had new tools to evaluate data for interpretation and presentations.

Cell Death and New Sampling Procedures for the Brain
Held at the JSTP Annual Meeting, January 2013
Session Overview: This presentation was aimed at toxicologic pathology trainees. The first talk introduced and defined the concept of apoptosis, showed examples of how to recognize apoptosis, and provided an explanation of how it differs from single-cell necrosis and other forms of necrosis. The second talk addressed the new sampling procedure for toxicologic pathology evaluation of the rodent brain and showed how the sampling differs from the previous three standard sections to the present 7 standard sections. Visual examples of the 7 sections were provided for the audience

Current Standard for CNS Evaluation in Rodent Toxicity Studies
Sponsored by IATP, IFSTP, Charles River, EPL, ILS, NIH, and NTP
Held at the 2013 ESTP Congress in Ghent, Belgium - September 2013
Session Overview: Based on concerns of regulatory scientists and growing recognition that the rodent brain was being insufficiently evaluated, a new sampling procedure for evaluation of the rodent central nervous system (CNS) has been adopted by the National Toxicology Program (NTP) and Contract Research Organizations (CROs). The new sampling procedure includes seven transverse sections of the brain compared to the traditional three-section approach and is designed to include major brain structures with functional significance.

Robert Sills, NIEHS/NTP, Research Triangle Park, NC, USA
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Use of NTP Revised Rodent Brain Trimming Procedures for Routine Studies in CROs
Alys Bradley, Charles River, Edinburg, Scotland
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Substitute Awareness in the NTP CNS Protocol
Deep Rao, NIEHS/NTP, Research Triangle Park, NC, USA
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Brain Microanatomy: Cytology, Artifacts, Neoplastic Lesions and Utilization of Special Stains
Robert Garman, Consultants in Veterinary Pathology, Inc., Monroeville, PA USA
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Overview of Non-Neoplastic Lesions of the Nervous System
Robert Garman, Consultants in Veterinary Pathology, Inc., Monroeville, PA USA
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IATP/STP Practical Application of MRI Histology in Toxicologic Pathology
Held at the 2013 STP Annual Meeting, Portland, OR
Session Overview: This session provided examples of major organ system pathologies encountered in rodent toxicity and carcinogenicity studies with emphasis on how MRI imaging technology can serve as an important adjunct to conventional pathology evaluation. The objective was to use rodent animal models and show how live animal images followed by images of the fixed specimens from the same animal model and compare with conventional H&E stained sections.

Robert Maronpot, Maronpot Consulting, Research Triangle Park, NC, USA
Yael Schiffenabuer, Aspect Imaging, Shoham, Israel
Abraham Nyska, Consultant in Toxicologic Pathology, Tel Aviv, Israel
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Ethical Figure Adjustments for Publication (Part 2 of Responsible Authorship & Publication Practices
Held at the STP Annual Meeting, June 27, 2012. Boston, MA
View Presentation

Session Overview: Electronic images of graphs, charts, blots, photomicrographs, etc. are typically provided as part of manuscript submissions to journals. With the currently available image adjustment programs, it is relatively easy to modify any of the various figures submitted along with manuscript text for publication in scientific journals. Photomicrographs captured with electronic cameras often need adjustment for white balance and require some sharpening. While global image adjustment changes are generally accepted, other electronic image adjustments are considered unethical. The purpose of this workshop is to present practical approaches and techniques for image adjustment, with emphasis on photomicrographs. Following the 90-minutes presentation, individuals may bring specific questions and problem images for one-on-one interaction with imaging experts.

Review of Rodent Pulmonary Lesions: Morphology and Risk Assessment
Held at the JSTP Annual Meeting, February 1, 2012, Tokyo, Japan
Session Overview: This one-hour lecture was aimed at toxicologic pathology trainees and consisted of a presentation of a series of non-neoplastic and neoplastic lung lesions. The focus was on lung lesions that would be encountered in typical preclinical toxicology studies. The significance of each lesion was discussed in terms of whether it was relevant for human health risk or was simply a rodent-specific lung change.

IATP Educational Seminar: Pathology of the Rodent Immune System and Its Challenges
Held at the ESTP Meeting, September 7, 2011. Uppsala, Sweden
Session Overview: The immune system is an increasingly important organ system for therapeutic product development and safety assessment of chemicals. It is also one of the more difficult body systems for pathology interpretation and evaluation. Over the past several years, an expanded pathology protocol for the examination of the thymus, spleen, lymph nodes, epithelial-associated lymphoid tissue and bone marrow has been suggested. A half-day session on the pathology of the rodent immune system will review the anatomy and histology of the lymphoid system, by tissue compartments to be also used in lesion diagnosis, lesions in aging mice, interpretation and diagnoses of reactive and neoplastic lesions and aspects of immune system pathology for the development and safety assessment of therapeutic products. Presentations will include immunohistochemistry and other laboratory diagnostic aids. Attendees can bring glass slides or Aperio digital slides to the meeting for consultation by session lecturers.

Differentiation of Hematopoietic and Immune System Reactive Lesions (Hyperplasia) from Neoplasia Using Anatomical and Immuno-histochemical Considerations
Jerrold M. Ward, Global Vet Pathology, Montgomery Village, Maryland, USA
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CD1 Mouse Immune System Pathology
Alys E. Bradley, Charles River Laboratories, Tranent, Edinburgh, Scotland
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Challenges for development and safety assessment of therapeutic products for immune-mediated disorders triggered by dietary gluten, with focus on Celiac Disease
Olga M. Pulido, Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch, Health Canada, Ottawa, Ontario, Canada, K1A 0L2

Responsible Authorship and Publication Practices
An IATP And STP Sponsored Workshop
Held at the STP Annual Meeting, June 22, 2011
Denver, CO
Session Overview: The course addressed issues related to authorship, order of authorship, what constitutes plagiarism and self-plagiarism, ethical issues, and conflict of interest related to manuscript preparation and submission. The session included pointers on how to get your manuscript published, how to deal with reviewers' comments, what constitutes a least publishable unit, and the responsibilities of editors and associate editors. Practical and realistic case presentations were discussed including when it is appropriate to include the pathologist as an author and how best to determine the order of authorship for publications produced by a committee or working group, such as INHAND documents.
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