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STP Virtual Continuing Education Course 💻
These programs have been approved for 3.00 and 2.00 hours of continuing education credits in jurisdictions that recognize RACE approval.
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Cardiovascular Medical Devices: From Bench to Bedside
(3.00 CE Credits)
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, Device Pathology Consultant, Think Pathology LLC
Regulatory Considerations for the Development, Submission, and Approval of Medical Devices for Cardiovascular Indications: General Considerations for Nonclinical and Clinical Development of Medical Devices
Annabelle Crusan, DVM, MS, US FDA
Regulatory Considerations for the Development, Submission, and Approval of Medical Devices for Cardiovascular Indications: Specific Considerations and Examples of Regulatory Guidance on Medical Devices for Cardiovascular Disease
Natalie Miller, VMD, PhD, US FDA
Application of Medical Devices for Cardiovascular Indications in the Clinic
Aloke Finn, MD, CVPath Institute
Spatial Profiling in Toxicologic Pathology and Drug Discovery
(2.00 CE Credits)
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
Society of Toxicologic Pathology | 11190 Sunrise Valley Drive, Suite 300 | Reston, VA 20191
(703) 438-7508 | Fax: (703) 438-3113 | www.toxpath.org | STP Headquarters
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