Toxicological histopathological assessments are more than mere technical necessities. They are critical for evaluating drug safety and part of the gateway for securing pharmaceutical approval for First-In-Human studies. Understanding this, choosing a histopathology partner becomes a pivotal decision for any drug developer. This blog explores the essential qualities of a reliable histology partner and how Scantox’s strategic approach aligns with the highest data quality standards.
Choosing the Right Histopathology Partner
Finding the right partner with the right expertise and flexibility to handle your study’s specific needs is crucial but challenging. As you consider your options, you should ask:
- What range of services are available?
- Are pathologists board-certified with proven experience?
- Can they deliver on time and within budget?
- Do pathologists effectively listen and discuss study needs?
- What do other customers say about the lab’s quality?
- Is the lab GLP compliant with in-house SOPs and a QA department?
At Scantox, we focus on all these criteria. Our on-site senior-level pathologists – led by board-certified pathologist Gitte Jeppesen, a fellow of the Royal College of Pathologists in the UK – specialize in delivering comprehensive toxicological histopathological evaluations for a diverse range of species except non-human primates.
Scantox’s Strategic Approach to Histopathology
The histopathology laboratory is built on three pillars to meet the diverse needs of preclinical drug development:
1. Expert Team: Our first and most important focus is the team. It’s about scientific experience, technical expertise, and engagement. Gitte and her team leverage over a decade of experience interpreting complex data. They ensure top-tier expertise in every study. The team commits to rapid and transparent communication, tailoring our services to meet specific client’s needs.
2. Comprehensive Service Solutions: Beyond standard Hematoxylin and Eosin staining – essential for evaluating toxicity across various animal species – we can integrate advanced techniques to identify specific cellular responses to new drug compounds. Our capabilities extend to detailed wound-healing assessments critical for evaluating the safety and efficacy of topical formulations and other dermal applications.
3. Regulatory Compliance and Quality Assurance: We maintain rigorous SOPs and an in-house quality assurance team to produce reliable data. These practices are designed to meet strict GLP standards, essential for studies intended for FDA submission.
Implementation of Histopathology Excellence
Scantox implements its strategy through critical investments in several core areas:
High-Quality Scientific and Technical Training
- Through regular training, our team remains at the forefront of pathological techniques and technologies. For instance, our strategic collaboration with Dr. Maurice Cary of Pathology Expertsenhances our capabilities and supports the team during specialized challenges.
- We also actively engage in international toxicologic pathology societies, contributing to expert working groups and publications on terminology and harmonization.
Operational Flexibility and Collaborative Reviews
- “We allow our pathologists adequate time for thorough slide assessments without compromising report timelines,” states Gitte Jeppesen. This operational flexibility ensures precise and detailed evaluations.
- An advanced digital pathology system (Provantis) speeds up evaluations and workflow and improves data integrity. This system enables pathologists to scrutinize slides with detail and share their findings instantly with sponsor pathologists, enhancing the collaborative nature of our peer reviews.
- Using a Hamamatsu Nanozoomer slide scanner, we can provide our sponsors with whole slide scanned images upon request.
High Reliability
- Our experts deliver reliable and defendable results across all projects. A notable initiative is our development of the world’s largest historical control database for minipigs, which plays a crucial role in identifying treatment-related issues in studies.
Invitation to Connect With Our Histopathology Experts
If you value high-level expertise combined with an open and agile client-centered approach, we invite you to discover how our pathologists can advance your drug development projects. Our proven processes accelerate development timelines and align closely with regulatory expectations and industry best practices. If you want more information, please schedule a consultation with our experts to discuss your project.
