The 20th European Congress of Toxicologic Pathology will be held in Basel, Switzerland, and will take place from 26th - 29th of September 2023.
The 2023 Congress will focus on a very interesting and important hot topic for the pharmaceutical industry with regard to the safety of their new/future products, namely the safety assessment of emerging therapeutics. The title of the Congress is “Emerging Therapeutic Modalities: Gene and Cell Therapies, New Generation Biologics and Targeted Protein Degraders.” The program will be of interest to toxicologic pathologists and preclinical safety scientists. Topics on new methods/technologies in view of these new modalities will also be part of the scientific program. There will be plenary lectures, oral presentations of original scientific work, interactive case presentations, a half-day IATP session, a poster session and of course plenty of opportunity for interactions both formally and informally with colleagues and friends.
The European Society of Toxicologic Pathology (ESTP) was established in October 2002 by a transition of the "Gesellschaft für Toxikologische Pathologie" (GTP). The former GTP members felt that it was important to adapt to future challenges and form a strong Europe oriented international society. The modification of the constitution to found the ESTP was accepted by a high majority (about 90%) of the members present at the annual meeting in Giessen.
The goals of our European Society of Toxicologic Pathology (ESTP) are:
• to organize scientifically attractive annual meetings
• to obtain more visibility by authorities/agencies,
• to actively promote toxicologic pathology,
• to contribute to guidelines by comments and proposals,
• to participate in scientific working groups (e.g. historical tumor control data),
• to offer training courses in toxicological pathology and related fields,
• and at last but not least to collaborate intensively with the other Societies of Toxicological Pathology.
For more information visit the ESTP website: www.eurotoxpath.org
IATP Satellite Symposium
Medical Device Safety Assessment: Pathology and Toxicology Perspectives. The IATP Satellite Symposium will take place on 26th September.
The global medical device (MD) industry continues to grow due to significant rise in use of medical devices as an interventional therapy or delivery tool. The preclinical development process of safety assessment of medical devices is unique, ever evolving to meet the regulatory requirements that are often different from that of other modalities. This symposium provides an overview of the current status, recent advances, and future trends on the following topics in Medical Device Safety Assessment.
- Toxicology perspectives on medical device safety assessment
- Fundamentals and challenges associated with microscopic evaluation and biocompatibility
- Artificial Intelligence (AI) and Machine Learning (ML) for image analysis and interpretation of MD-associated pathological findings
- Novel applications of currently existing MD for emerging therapeutic modalities
- Extractables and leachables
- Regulatory requirements and differences with various agencies
- Dr. Antoine Alves, NAMSA, Lyon, France
- Dr. Flora Wegener, Fresenius Kabi, Bad Homburg, Germany
- Dr. Nicole Soucy, Boston Scientific, MN, USA
- Dr. Uta Bussmeyer Merz Aesthetics GmbH, Frankfurt, Germany
10th ESTP International Expert Workshop
Designed to stay yet do no harm: Safety assessment of Long-Acting Injectables and the evaluation of the injection site. The ESTP International Expert Workshop will take place on 29th September PM and 30th September AM.
The main reason for the development of novel “long-acting injectable” (LAI) depot formulations, is to meet the needs of chronic or life-long disease therapy. The long-term treatment of diseases such as psychiatric conditions (e.g., schizophrenia) and infectious diseases (e.g., HIV), is often hampered by the fact that patients do not adhere to their daily (oral) medication. In many instances, the slow drug-release provides steady plasma exposures, eliminating the “peak and trough” kinetics of repeated daily dosing. Evaluation of LAI related injection site reactions in animal studies is a key component for risk assessment.
Currently, some important details of study designs, such as the collection and processing of injection sites, or the terminology and interpretation of injection site observations for these compounds are not well defined. This workshop will contain interactive elements, recommendations, and practical examples for the safety assessment of LAIs at the injection sites. In this workshop we aim to discuss and share our recommendations for the evaluation of LAI injection site reactions in local tolerance studies.
For the study design of in-life portion of the studies we will include species and administration site comparison for subcutaneous (SC) and intramuscular (IM) administration of long acting injectables. Currently the evaluation of clinical observations is often based on the “Draize score”, adopted from ocular/dermal evaluations. Because the current Draize scoring scale might not be suitable for depot formulations, we will also provide recommendations for an adapted scoring system and terminology, including examples.
Many long-acting injectables are formulated in a poorly soluble depot or a device, from which the active agent is slowly released over time. Assessment of these injection sites should include both the acute and chronic response to SC/IM injection of LAIs and their recovery. We will share our recommendations on the collection and trimming of SC/IM injection sites in different species. The available CDISC/SEND and INHAND nomenclature for histological description of these lesions will be reviewed, and proposed updates to the current INHAND nomenclature will be presented with examples.
We aim to provide criteria for pathologists to assess the local tolerance of LAIs, based on clinical observations and injection site histopathological findings. We will present case studies to discuss tolerability of LAIs, their translatability to the clinic and impact on drug label.
Finally we consider that the outcome of this workshop will also be useful to other studies using parenteral routes.