IIVS, Advancing Science & Animal Welfare Together | November 2024 Issue

Holiday Closings at IIVS

IIVS wishes all our sponsors, supporters, and contributors an enjoyable holiday season!

Please note that we will be closed and unable to receive test materials between the following dates:

November 28th-December 1st

December 24^th-January 1^st

Additionally, IIVS will be unable to perform studies requiring human reconstructed epidermal or epithelial tissues during these weeks

(including the week of January 6^th).

Please contact clientservices@iivs.org for further information or with questions

IIVS Respiratory Toxicology:

Advancing the Science and Engaging the Industry

Our Respiratory Toxicology team has had a productive year, staying at the forefront of the latest industry developments while also contributing new insights of our own. We've had the opportunity to attend and present at key conferences, as well as showcase the exciting progress we're making in advancing in vitro toxicology testing.

Key Conference Highlights:

Association of Inhalation Toxicologists (AIT) Annual Conference:

Dr. Vivek Patel (Senior Toxicologist/Study Director) and Joseph Hughes (Client Relationship Manager) attended the event which allowed IIVS to reconnect with existing partners, meet potential collaborators, and explore the latest advancements in smoke and aerosol exposure equipment. Our participation not only reinforced our position in the industry but also provided valuable insights into the cutting-edge tools and techniques shaping respiratory toxicology.

Cooperation Centre for Scientific Research Relative to Tobacco (CORESTA) Congress:

At CORESTA, we engaged with leaders from the tobacco industry and shared our expertise on laboratory quality standards. IIVS President Amanda Ulrey delivered a presentation emphasizing the importance of Good Laboratory Practices (GLP) and Good In Vitro Method Practices (GIVIMP) in ensuring consistent, reliable results. Her talk underscored the need for rigorous standards to support reproducible and trustworthy data in toxicological studies.

Lung In Vitro Event (LIVe 2024):

In June, IIVS Director of Respiratory Toxicology, Dr. Holger Behrsing, presented a poster on Fibrotic Responses in Human Precision-Cut Lung Slices (PCLS) After Cryopreservation (Marimoutou et al, 2024). The research demonstrated that cryopreserved PCLS retain their ability to exhibit fibrotic responses similar to fresh tissue. This work has garnered significant interest, both for its potential to advance our understanding of lung diseases and for its practical application in toxicology studies. Following the presentation, the team published the findings in a peer-reviewed article, The Fibrotic Phenotype of Human Precision-Cut Lung Slices is Maintained after Cryopreservation. This breakthrough has sparked increased interest in using diseased PCLS models for research and has led to a growing demand for IIVS to conduct studies and provide these specialized models for purchase.

Recent Publications:

Precision Cut Lung Slices: Emerging Tools for Preclinical and Translational Lung Research. An Official American Thoracic Society Workshop Report

Lehmann et al. American Journal of Respiratory Cell and Molecular Biology, 2024 Nov 5

The Fibrotic Phenotype of Human Precision-Cut Lung Slices is Maintained after Cryopreservation

Marimoutou et al. Toxics 2024 Aug 30;12(9):637

Understanding the GIVIMP Certification Process

Good In Vitro Method Practices (GIVIMP) is a quality system developed to ensure the quality and reliability of in vitro methods used in scientific research and testing. IIVS has created the business-to-business GIVIMP certification program to help laboratories implement the guidance within their facilities. For new organizations considering joining the GIVIMP program, understanding the certification process can help demystify what it entails and highlight its benefits.

The GIVIMP certification process starts by determining the scope of work that is ready for standardization through quality. The process can be completed for anything from a single method to an entire laboratory facility. Pricing is highly dependent on the scope of the work included. Any existing documentation around test systems, training, method design, building plans, purchasing procedures, standard operating procedures (SOPs) etc., within the scope of the certification are provided to IIVS to begin the quality improvement process.

During the next phase of work, several remote meetings are held to discuss process details and begin making quality improvements. This process of iterative quality improvement moves at a pace agreed on by both parties. It continues until both parties agree that they are ready for the on-site assessment. This groundwork is essential for auditors to understand the practices already in place at the facility prior to arrival and allows the laboratory to begin making quality improvements immediately.

A significant milestone in the certification process is the on-site audit. During this phase, the auditor verifies the documented procedures followed and examines practical work while it is being conducted in the laboratory. Critical elements such as equipment, laboratory notebooks, data storage, and documentation are inspected. This thorough evaluation ensures that the procedures in place are well understood by the auditor and all practices meet the high standards set by GIVIMP.

Since methods progress and procedures change, it is important to periodically reassess procedures to determine if newly implemented technologies meet the GIVIMP recommendations and to verify that there hasn’t been any drift in the quality procedures. This reassessment is recommended every 3 years, unless there is an expansion of the scope.

By understanding and embracing the GIVIMP certification process, organizations can ensure high standards of quality and reliability in their in vitro methods, ultimately benefiting their research and testing outcomes.

Peer Review Poster Presented at ASCCT

In collaboration with colleagues from a number of organizations, Amanda Ulrey (IIVS) and Emily Reinke (Inotiv/NICEATM) presented a poster giving advice on independent peer review, a key aspect of gaining confidence in new methods.

"Peer Review for Validation Studies:

Building Confidence and Transparency Into a New Validation Paradigm" outlines recent experience with conducting a transparent method peer review, with lessons learned on how to avoid conflict of interest, ensure quality assurance of the data, and coordination with interested parties.

View the poster on our web site.

ASCCT 13th Annual Meeting, Oct. 28-30, 2024, Research Triangle Park, NC

Practical Methods Training Workshop Evolves to Meet Growing Needs

Training in non-animal methods is a vital part of the work IIVS does to accomplish our mission to increase the use and acceptance of non-animal testing worldwide.

Flagship Course Offers Foundational

In Vitro Knowledge

Many are familiar with our flagship Practical Methods workshops, intensive multi-day events incorporating lectures from study directors and scientists who use the assays every day with hands-on laboratory demonstrations of several key in vitro assays. Lectures focus on quality techniques, good in vitro practices, data analysis, and regulatory applicability. These trainings are held with small groups to maximize engagement and tailor activities to attendees' needs.

In 2024, we have continued to hold these vital workshops at our headquarters laboratory in Gaithersburg while adapting and expanding our training activities to reach a wide range of toxicologists and regulatory professionals. Three workshops were held in Gaithersburg in January, May, and September, and included a mix of toxicologists from industry, academia, and regulatory agencies from the US and abroad.

International Outreach a Focus

As we aim for global adoption of non-animal methods, reaching a global audience is essential. This past year Practical Methods workshop attendees hailed from Columbia, China, and multiple countries in Europe. As we look ahead to 2025, we will welcome a group of regulators, agrochemical and pharmaceutical industry scientists, and research laboratories from India for one session.

Beyond Practical Methods, we collaborated with a number of organizations to offer training in Argentina, Brazil, Poland, Japan, Korea, China, and Columbia. Each session is slightly different, including demonstrations, activities, and lectures guided by the needs of the audience.

Finally, we increased our use of online platforms to:

Hold a hybrid workshop focused on the ToxTracker assay,
Offer 15 webinars with partner organizations,
Conduct private web trainings for two regulatory agencies, and
Create recorded lectures.

Contributor Support Crucial to Success

In 2025, we will continue to hold our Practical Methods workshop while pursuing additional opportunities around the world. Many of our staff invest extensive time and effort to share their knowledge during these events. We can only continue to do this with the direct financial support of our contributors, and are grateful for that support.