BSTP & IATP Educational Webinar: Translational Considerations of NonClincial Findings in AAV-vector Gene Therapy

This webinar will provide a detailed look at the nonclinical studies employed to characterize the emergent nonclinical, nonhuman primate microscopic finding of dorsal root ganglia toxicity in a preclinical program and how these findings influenced clinical monitoring and product label for the AAV9 gene therapy product onasemnogene abeparvovec indicated for spinal muscular atrophy. The natural of history of spinal muscular atrophy will be briefly reviewed along with the components of the AAV9 gene therapy construct and the nonclinical program developed to support its development. Finally, we will review, from a translational medicine and toxicology perspective,  the potential for and considerations of potential clinical translation of nonclinical nonhuman primate microscopic DRG findings.

Speakers: Emily Meseck and Tukov, Francis Fonyuy

Monday, May 13, 2024

6:00 – 7:30 AM US PDT
9:00 – 10:30 AM US EDT
2:00 – 3:30 PM UK
3:00 – 4:30 PM Europe
6:30 – 8:00 PM India
9:00 – 10:30 PM China
10:00 – 11:30 PM Japan/Korea



Digital Toxicologic Pathology - Part 3
November 7,2023
9:00 AM - 10:30 AM US EDT
This webinar was the third in a series of three webinars.  This webinar dealt with the technical aspects of the GLP validation: the validation process from planning to execution; what to monitor during/after the validation and integration of CRO validation efforts into the process to validate peer reviews by the sponsor.  Data integrity, file transfer, temporary storage, warm storage and archiving workflows as well as the system life cycle were also discussed. 

Speakers: Brian Knight, Senior Research Fellow, Boehringer Ingelheim Pharmaceuticals, Inc; Charles (Chuck) Halsey, Associate Research Fellow, Global Pathology, Pfizer, Inc. and Pierre Maliver, Digital Regulatory Pathology Scientific Area Lead, F. Hoffmann-La Roche Ltd.

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Password: DigitalPart3

Digital Toxicologic Pathology – Part 2
October 24, 2023
9:00 AM - 10:30 AM US EDT

This is the second webinar in a series of three webinars on digital toxicologic pathology. This webinar focused on the GLP considerations when companies are working toward a digital pathology platform. Covered topics were from instruments, image quality, software systems to metadata integration, as well as the purpose of validation from a pathology a perspective and the utilization of equivalency versus concordance studies in this regard.

Speakers: Jonathan Carter, Head of Pathology, Labcorp Early Development Labs Ltd. and Moritz Radbruch, Head of Digital Pathology, Bayer Pharmaceuticals

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Password: DigitalPart2

Digital Toxicologic Pathology – Part 1
October 10, 2023

This webinar was the first in a series of three webinars on digital toxicologic pathology. This webinar defined what digital pathology is and outlined the digital pathology workflow. The webinar also provided information about the BigPicture project under the Innovative Medicines Initiative in Europe. It covered perspectives of AI-assisted toxicologic pathology and addressed the regulatory landscape as well as direct interactions with regulatory authorities. 

Jonathan Carter, Head of Pathology, Labcorp Early Development Labs Ltd.
Julie Boisclair, Head, Digital and Computational Pathology, Novartis Institutes for BioMedical Research
Xavier Palazzi, Head of Global Pathology, Pfizer Drug Safety Research & Development

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Password: PqHHvYJ5

Introducing Toxicologic Pathologists to the Concept of Virtual Control Groups
August 16, 2023

Toxicologic Pathologists are well familiar with the use and value of Historical Control Data. Historical Control Data can be used to support the interpretation of study results. It can also be used to generate what has recently been introduced as  Virtual Control Groups (VCG). A VCG is a data set that can be used to replace or reduce in size the concurrent control group in a new experiment. This concept has the potential to reduce animal usage by up to 25%, since the conventional setting of a regulatory toxicology study uses 25% of the animals as controls (see OECD TG 407 Repeated Dose 28-Day Oral Toxicity Study in Rodents” as an example). This webinar will introduce the concept of VCGs, the current efforts, which are undertaken to qualify the concept as well as the challenges that are associated with it.

Speakers: Thomas Steger-Hartmann, Head of Investigational Toxicology, Bayer AG & Matthew Clark, VP of Data Science, Stealth Startup

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Password: August17@2023


Spatial Biology: Applications in Toxicologic Pathology
June 8, 2022

Modern pathology has imbrication with many disciplines such as microbiology, biochemistry and immunology. These disciplines have flourished from molecular technologies that allow the simultaneous analysis of hundreds or even thousands of molecules. Yet, maintaining the spatial context of the biology is key to a fundamental understanding of pathology on the scale of whole tissues and organs. In recent years, novel technologies emerged that provide spatial resolution for the expression of small molecules, genes and proteins in a single tissue sample. Such spatial biology tools preserve critical data in situ, offering cellular or even subcellular resolution. For the first time, pathologists can obtain a far more comprehensive picture of gene or protein interaction. This webinar provides an insight into spatial biology and how it can contribute to toxicologic pathology.

Arun Kumar R. Pandiri, US National Institute of Environmental Health Sciences, Durham, NC, USA  
Shawn O’Neil, Pfizer Drug Safety Research & Development, Cambridge, MA, USA
Chandra Saravanan, Novartis Institutes for BioMedical Research, Inc, Cambridge, MA, USA

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Password: IATPJune@22

Nomenclature in Toxicologic Pathology: Past, Present and the Future

October 6, 2021

Achieving and maintaining globally harmonized nomenclature remains the cornerstone in the practice of toxicologic pathology. This webinar is focused towards an understanding on current efforts of how diagnostic terminology is linked to technology, future applications within regulatory settings, as well as a background on the historical initiatives that provide perspective on where we are today. Join us for a comprehensive, lively and informative webinar and platform discussion session on nomenclature with our speakers and panelists.

Speakers:Wolfgang Kaufmann, Charlotte Keenan and Kevin Snyder
Panelists: Erin Muhlbradt and Emily Meseck

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Password: October06

Stage-Aware Evaluation of the Testis: A Practical Approach for Toxicologic Pathologists Webinar
February 23, 2021
10:00 AM - 11:30 AM US EST 

Justin D. Vidal, DVM, PhD, DACVP - Senior Scientific Director of Pathology, Charles River
Prof. Dr. Gerhard F. Weinbauer - VP DART, Covance Preclinical Services GmbH

Testicular toxicity is a common finding in nonclinical toxicity testing.  Histopathology is the most sensitive method for detection of effects on spermatogenesis as many testicular changes require an extended dosing period before changes in sperm or mating indices can be detected.  This requires a detailed microscopic approach as many of the early testicular changes can be subtle (e.g., missing cell layers, spermatid retention, degeneration of specific cell types).  Since these changes are often present in a cell or stage specific manner this is often termed “stage-aware evaluation” or “staging.”  While this detailed evaluation is a critical component of assessing the male reproductive system in nonclinical toxicity testing, there is confusion on what stage-aware evaluation entails and how to approach it.  This webinar will provide the toxicologic pathologist with a review of stage-aware evaluation of the testis using a simplified approach based on evaluation of routinely processed study materials (H&E) in both rodents and non-rodents.

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Password to Access the Recording: 3E8ArAeEM2u

What Toxicologic Pathologists Need to Know About Digital Pathology: The Basics to Get Started
Speaker: Aleksandra Zuraw, Charles River Laboratories, Frederick, MD, USA
August 3, 2020

Digital pathology has been gaining momentum in toxicologic pathology and it seems this technology is here to stay and thrive. Toxicologic pathologists are getting more and more involved in different digital pathology initiatives and projects and are expected to be familiar with this technology. This presentation introduced and explained the basic concepts necessary to understand the discipline. Upon completion, participants were able to understand and actively use the digital pathology terminology, including such concepts as artificial intelligence, machine learning, deep learning and image analysis as well as understand the dependencies between them.

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Password to Access the Recording: IATPWebinar2020

Telepathology for the Toxicologic Pathologist
Speakers: Matthew Jacobsen, Elizabeth Neyens, Daniel G Rudmann
June 2, 2020

This webinar presentation discussed the improvements in digital pathology, data sharing and virtual meeting technology advancements in the last deciade and the telepathology opportunities and workflow for the toxicologic pathologist.  The audience was introduced to an updated view of the field and its tools and technology.  Specific workflows were highlighted including consultation, primary digital slide evaluation, and digital peer review.

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Password to Access the Recording: IATPWebinar2020

Click Here to Read the Additional Post Question & Answers from the Webinar 

Preclinical Safety Assessment of Topical Drugs and Associated Pathology
Jointly Sponsored by IATP and STP-I
Speaker: Thierry Flandre, Novartis Pharma 
January 24, 2020

This webinar presentation reviewed the preclinical safety package requested for topical/dermal drugs. Topical drugs are used in numerous skin disease indication which include psoriasis, dermatitis, wound healing or even skin cancer. A brief review of safety package for topical drug development and the different step from pharmacology/efficacy to toxicity studies was introducted. If rodents are the preferred models to assess efficacy, minipig is the species of choice to assess the toxicology associated with topical drugs due to the close similarity of minipig skin to human skin. The webinar focused on the microscopic findings associated with some efficacy model like wound healing and then discussed the background vs toxicological related microscopic findings observed in topical toxicology studies.

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Password to Access the Recording: IATPWebinar2020

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Bridging the Gap Between Toxicologic Pathologists and the Medical Device Industry
Speaker: JoAnn Schuh, JCL Schuh PLLC., Bainbridge, Washington 
December 4, 2019

This webinar 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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Password to Access Recording: IATPWebinar@2019

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IATP/STP-I Webinar: Translational Aspects of NAFLD/NASH Models: A Pathologist’s Perspective
Speaker: Chandra Saravanan, DVM, MS, PhD, DACVP
April 16, 2019

The presentation emphasized the critical roles played by comparative pathologists in NAFLD/NASH model development/characterization. Few case examples were discussed, including development and utility of a model-specific histopathologic scoring system, tissue-based quantitation of NASH features in the context of changing liver volume, comparative target localization/validation in animal models and diseased human tissues and evaluation of translation of proof of mechanisms from animal models to humans.  

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**Password to Access Recording: April162019 

Update on Reproductive Toxicologic Pathology Webinar
January 21, 2016
Speakers: Karen Regan and Justin Vidal
Moderator: Kevin Keane
Co-sponsored by IATP and IFSTP

Pathology of the Posterior Segment in Ocular Toxicity Studies Webinar 
December 8, 2015
Speaker: Steve Sorden
Moderator: Satish Panchal

Regulatory Views on Pathology Results Webinar
November 5, 2015
Speaker: Jan Willem van der Laan
Moderator: Joost Lensen
Hosted by NLSTP. Co-sponsored by IFSTP & IATP

Investigaciones en disrupcion hormonal. Su cara cambiante Webinar
July 1, 2015
Speakers: Ricardo Ochoa & Jeff Wolf
Moderator: Maria Dagli
Hosted by LASTEP. Co-sponsored by IFSTP & IATP

Pathology Techniques in Rat Neurotoxicity Studies Webinar
May 11, 2015
Speaker: Alok Sharma
Moderators: Bhanu Singh & Satish Panchal
Hosted by STP-I. Co-sponsored by IFSTP & IATP

Tissue Section-Based Investigative Technologies Webinar
April 28, 2015
Presented by: ESTP 2015 Pathology 2.0 group
Speaker: Famke Aeffner
Moderator: Helen Angell
Hosted by ESTP. Co-sponsored by ESTP, IFSTP & IATP