Advance™
Six Modules. One WoE Solution.
The Advance service offers researchers a comprehensive solution aligned with the ICH S1B Weight of Evidence (WoE) Addendum for assessing carcinogenicity risk. By utilizing six specialized modules corresponding to the six guideline-defined factors, Advance helps streamline early-stage safety evaluations, reducing costs, saving valuable time, and minimizing the need for animal testing.
Request a demo today to see how Advance can accelerate safety assessments, reduce reliance on animal testing, and support confident, evidence-based decisions.
What is Advance?
Advance service uses six integrated modules to assemble evidence regarding the added value of conducting a two-year rat carcinogenicity study, in line with the ICH S1B Weight of Evidence Addendum. With Advance, researchers can rapidly produce industry-standard carcinogenicity assessments, potentially enabling them to avoid time-consuming and costly animal-based testing. This is made possible through the analysis of comprehensive, up-to-date toxicological data, including in silico datasets.
Drug discovery is naturally time-consuming and costly, with expenses rising as development timelines lengthen. Two-year rat carcinogenicity studies are especially resource-intensive in terms of both time and money. While the ICH S1B WoE Addendum provides a pathway to avoid these burdens, assembling a regulator-ready WoE dossier is often complex and time-consuming.
Advance empowers researchers to mitigate these challenges, potentially saving millions in costs, accelerating development, enhancing safety assessments, and reducing reliance on animal testing.
Key Benefits of Advance
Saves Time
Advance means researchers can avoid years of carcinogenicity testing, potentially reducing time to market by 3-5 years. The service fits seamlessly into in-house workflows, further minimizing delays.
Reduces Reliance on Animal Testing
Expert-led
Advance was designed by experts with hands-on ICH S1B framework experience, ensuring the delivered service is scientifically robust, regulator-aligned, and grounded in real-world drug development needs.
Lowers Costs
Scalable
Core Modules
Advance offers a robust suite of modules designed to assess the safety and efficacy of drug candidates throughout the development process. With solutions for target biology, secondary pharmacology, histopathology, and more, Advance provides several tools that deliver comprehensive insights into potential risks such as tumor development, toxicity, and immune modulation, ensuring a thorough evaluation of both therapeutic and safety profiles.
Target Biology
This module evaluates whether the drug target has a known role in tumor development. It integrates expression profiles, pathway analysis, and translational evidence from human and animal data to assess oncogenic potential.
Secondary Pharmacology
Evaluates off-target interactions using in vitro binding assays and computational predictions. The module identifies unintended pharmacological effects potentially linked to tumor development, supporting comprehensive risk assessments.
Histopathology
Hormonal Perturbation
Genotoxicity
Integrates genetic toxicology data from in vivo assays, including micronucleus and comet assays. Such testing helps determine a substance’s potential to cause DNA damage, a key factor in evaluating carcinogenic risk.
Immune Modulation
Why Choose Advance?
Advance can be strategically integrated throughout the various stages of research and development, providing researchers with dynamic tools to collect data for WoE summary submissions. The six Advance modules, developed by experts, are each tailored to specific aspects of the WoE process. This enables our team of experts to collaborate with researchers to create comprehensive, regulator-ready documents, significantly increasing the chances of successfully demonstrating product safety.
With the potential to save years of effort and millions of dollars, Advance is a compelling choice for researchers aiming for strong ROI and accelerated development timelines. The service automates data mining and streamlines the review and interpretation of information, allowing essential safety insights to be generated much faster and more efficiently than traditional methods like manual data collection and organization.
Customer Success Stories
In March 2022, a pharmaceutical company developing a late-stage compound engaged Instem to assess carcinogenicity risks linked to its drug’s primary target. Instem collaborated closely with the client, defining the scope and delivering review drafts by the summer of 2022.
By October, Instem’s Drug Target Carcinogenicity Risk Assessment, combined with client insights, supported a WoE summary submitted to the FDA. The FDA accepted the supplemental NDA in January 2023.
By May 2023, the drug had successfully reached the market. Instem’s expertise in biological data mining and risk cataloging played a pivotal role in expediting regulatory approval and ensuring patient access to the new treatment.
How It Works
Advance can be implemented at any stage of the development process. Its flexible design allows clients to assess a single guideline-defined factor or all six, with the ability to combine data as needed. Automated data mining integrates seamlessly with in-house data, delivering instant insights from complex inputs. As new studies are conducted and data is generated, it can be continuously added to a growing, regulator-ready dossier, streamlining preparation for WoE summary submissions.
Featured Resources
Discover a range of expert resources designed to enhance your understanding of carcinogenicity assessments and the ICH S1B Weight of Evidence Addendum. Our featured blog articles, white papers, and additional materials provide valuable insights, practical tips, and in-depth knowledge to help you leverage the full potential of Advance service and streamline your drug development process.
Technology-enabled Approval Acceleration: Spotlighting the ICH S1B Weight of Evidence
The ICH S1B WoE directive is a real game-changer for the pharma industry In this White Paper you will learn the importance and significance of the recent ICH S1B Guideline, and how technology-enabled approaches, such...
Future Proofing Drug Safety: Target Carcinogenicity Risk Assessment Meets ICH S1B(R1) Standards
Let’s re-imagine the carcinogenicity assessment In the fast-paced and cost-conscious ‘drug to market’ race, momentum can be gained by implementing a Weight of Evidence (WoE) to negate unnecessary preclinical testing. We will present results from...
Instem Enables Clients to Leverage ICH S1B Weight of Evidence Guideline
Advance™ technology-enabled solution enables R&D organizations to cut study timelines, deliver cost savings and reduce animal experimentation.
Frequently Asked Questions
The Instem team is here to provide you with clear answers about the service’s features, scope, and how it can support your drug development process. Below you can find the responses to common questions on exactly how our service can enhance your safety assessments and decision-making.
Can Advance be integrated into our existing R&D workflows?
Is Advance compatible with regulatory submission requirements?
How is Advance delivered?
Advance assessments can be performaed at any point of the drug discovery and drug development process by a team of experts who are up to date on the regulations and science.
What support does Instem offer with Advance?
Instem provides expert-led support throughout the assessment process. Our scientific team works closely with you to ensure your evidence dossier is complete, accurate, and submission-ready.
Get a Free Demo Today
Accelerate your drug development while reducing costs and reliance on animal testing. Advance delivers regulator-ready carcinogenicity assessments using six expert-built modules aligned with ICH S1B WoE. Streamline safety evaluations and make confident, evidence-based decisions—faster.
Request your demo today and see Advance in action.