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STP Virtual Continuing Education Courses

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The Society of Toxicologic Pathology is offering three continuing education courses virtually in 2024. All course registrants will also be able to download the course book a week before each webinar.

 

STP Virtual Continuing Education Courses

This program (20-1159230) has been approved for 3.50 hours of continuing education credits in jurisdictions that recognize RACE approval.

AAVSB RACE Approved for CE Credits logo seal

Identifying and Understanding Seizure Liability in Pharmaceutical Development

(Sponsored by the American College of Toxicology)

Friday, April 12, 2024, 12:00 Noon–3:45 PM EDT

Co-Chairs: Katie B. Sokolowski, PhD, DABT, Denali Therapeutics; and Brad Bolon, DVM, MS, PhD, DACVP, DABT, FATS, FIATP, FRCPath, GEMpath, Inc

Drug-induced seizures are a major concern for central nervous system neuroactive pharmaceuticals during development. Currently, there are no guidelines for interrogating and mitigating seizure liability associated with new pharmaceuticals. Because of the risks to patient safety during clinical trials, the understanding of nonclinical characterization that informs the translation of risks to humans is an area of intense interest among drug developers and regulators. The goals of this session are to (1) understand the diverse mechanisms of seizures; (2) examine typical findings in nonclinical studies indicating seizure liability; (3) understand objectives and the elements of a screening and a pivotal nonclinical electroencephalographic (EEG) study; and (4) implement the principles of risk mitigation to de-risk seizure liability in clinical trials. To achieve these goals, we will bring together a practicing clinical neurologist with primary knowledge of patients experiencing seizures, a pharmaceutical consultant with expertise in identifying seizure liability in nonclinical studies, a director of a contract research organization with experience in designing nonclinical EEG studies, and a US FDA regulator to discuss mitigation strategies. After the session, attendees will have a better understanding of how to mitigate risks of pharmaceutical products that carry a seizures liability and understand the limitations of the current state of the art to inform research in this area.

Clinical Description and Mechanisms of Seizures
Judy S. Liu, MD, PhD, Brown University

Identifying Seizure Liability in Nonclinical Studies
Marcus Delatte, PhD, Allucent

General Design Elements of a Nonclinical EEG Study
Simon Authier, DVM, MSc, MBA, PhD, DSP, Charles River Laboratories

Risk Assessment: Management and Mitigation of Drug Products with Seizure Liability
Owen McMaster, PhD, US FDA

Active Practice 1: Identify Seizure Liability in Nonclinical Studies
Moderator: Marcus Delatte, PhD, Allucent

Active Practice 2: General Design Elements of a Nonclinical EEG Study
Moderator: Simon Authier, DVM, MSc, MBA, PhD, DSP, Charles River Laboratories

Active Practice 3: Risk Management and Mitigation of Drug Products with Seizure Liability
Moderator: Owen McMaster, PhD, US FDA

You may register for the course separately or include it with your 2024 meeting registration.

   

Registration    

Registration required to access course.

Course Registration

*A letter of verification from a department chair must accompany student registration.


STP Virtual Registration Fees
(per CE course)
STP Member $ 210
Nonmember $ 260
STP Student Member $ 50
Nonmember (Student)* $ 90

*A letter of verification from a department chair must accompany student registration.

SAVE THE DATES!
Registration will open in July.

   
STP Virtual Continuing Education Courses

Cardiovascular Medical Devices: From Bench to Bedside

Friday, September 13, 2024, 12:00 Noon–3:45 PM EDT

Co-Chairs: Rebecca A. Kohnken, DVM, PhD, DACVP, AbbVie; and Jaime Paulin, DVM, MSc, DACVP, StageBio

The discovery, development, approval, and application of medical devices for cardiovascular indications presents a unique niche within the medical device industry. General toxicologic pathologists have little exposure to this field which is a segment of medical therapies with more rapid innovation and regulatory submission compared to pharmacological therapies. This course will provide information, insight, and perspectives from different points of view by scientists that contribute to each life stage of a cardiovascular medical device.

This CE course will cover the topic from bench to bedside, beginning with the biomedical research behind the discovery of medical devices for the treatment of cardiovascular disease, and ending with their use in the interventional cardiology setting. In between, of course, are the dedicated scientists that design nonclinical animal studies, as well as non-animal-based investigations, into assessing the efficacy and safety of these devices, those that review the toxicology and pathology data from these studies, and those that provide regulatory guidance and approval for the devices. This course will therefore provide the general audience of the STP membership with a one-stop-shop overview of the field of cardiovascular medical devices and provide attendees with an opportunity to ask questions of experts in this area.

Design and Discovery of Medical Devices for Cardiovascular Indications: Use of Animal Models in the Discovery of Medical Devices for Pediatric Cardiovascular Disease
Christopher K. Breuer, MD, Nationwide Children’s Hospital

Nonclinical Development of Medical Devices for Cardiovascular Indications: Medical Device Toxicological Risk Assessment
Kelly P. Coleman, PhD, Medtronic

Nonclinical Development of Medical Devices for Cardiovascular Indications: Study Design Considerations for Nonclinical Development of Medical Devices for Cardiovascular Indications
Allison Ostdiek, DVM, PhD, DACLAM, University of Chicago

Nonclinical Development of Medical Devices for Cardiovascular Indications: Pathologic Assessment of Medical Devices for Cardiovascular Indications
Nicole Kirchhof, DVM, DACVP, Medtronic

Regulatory Considerations for the Development, Submission, and Approval of Medical Devices for Cardiovascular Indications: General Considerations for Nonclinical and Clinical Development of Medical Devices
Natalie Miller, VMD, PhD, US FDA

Application of Medical Devices for Cardiovascular Indications in the Clinic
Aloke Finn, MD, CVPath Institute



 

 

STP Virtual Continuing Education Courses

Spatial Profiling in Toxicologic Pathology and Drug Discovery

Friday, October 4, 2024, 12:00 Noon–3:45 PM EDT

Co-Chairs: Chandra Saravanan, DVM, MS, PhD, DACVP, Novartis Institutes for Biomedical Research; and Elijah F. Edmondson, DVM, PhD, DACVP, DABT, Frederick National Laboratory for Cancer Research

Spatial biology is a rapidly developing frontier, driven by rapidly advancing technologies including multiplexing methods, transcriptomics, proteomics, and MALDI mass spectrometry. These techniques allow a holistic and unbiased assessment of molecular changes as informed by histologic features. Spatially resolved cellular phenotypes, interactions, and neighborhoods offer mechanistic insights into physiological and pathological processes and hold promise to revolutionize the practice of pathology. The technological advancements occurring in the field of spatial biology rely on the expertise that well-trained pathologists and toxicologists can provide. In this CE course, experts in this field will highlight available technologies and their applications, including data analysis and integration to other data sets.

Overview of Spatial Profiling Technologies
Kerstin Hahn, DVM, PhD, DECVP, Roche

Spatial Transcriptomics Applications in Animal Models
Elijah F. Edmondson, DVM, PhD, DACVP, DABT, Frederick National Laboratory for Cancer Research

Spatially Resolved Proteomics in Investigative Pathology
Milind Pore, PhD, Frederick National Laboratory for Cancer Research

Applications and Challenges of Spatial Transcriptomic Technologies in FFPE Sections of Toxicology Species
Byunghak Kang, DVM, PhD, DACVP, Novartis Institutes for Biomedical Research



Continuing Education Chair:
Melanie Greeley, DVM, PhD, DACVP, Charles River Laboratories

Continuing Education Co-Chair:
Debra A. Tokarz, DVM, PhD, DACVP, EPL, Inc.

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    Suite 300, Reston, VA 20191