Instem at SOT 2024
Empowering Collaboration and Life Enhancing Science
Stop by Island Booth #1401
Visit us to learn more about our leading Preclinical Study Management, SEND, In Silico Toxicology and Translational software and services.
Provantis®
the #1 solution for managing preclinical studies. Provantis streamlines processes and workflows with straightforward, intuitive functionality for simple and complex studies within both GLP and non-GLP environments.
SEND Solutions
The most comprehensive and widely deployed set of software (Submit™) and services (SEND Advantage™) supporting the creation and management of SEND datasets.
Genetic Toxicology
Image analysis and data management solutions helping users better collect, manage, review and extract data while transitioning information into insight, utilizing our Comet Assay IV and Cyto Study Manager tools.
KnowledgeScan™ Target Safety Assessment (TSA) Service
Delivering comprehensive TSAs for clients around the world, enabling them to make faster, better-informed decisions on their drug targets.
Watch the KnowledgeScan Explainer video
Leadscope Model Applier™ In Silico Toxicology Software
Advanced informatics and prediction technology, together with comprehensive database solutions that are helping organizations effectively unlock valuable knowledge contained in both public and proprietary sources of research data.
Predict™ In Silico Toxicology Service
A leading edge, technology-enabled service that delivers a combination of powerful computation models with expert scientific review, to help clients predict chemical safety more quickly, efficiently and comprehensively.
Advance™ – Weight of Evidence Assessments
A technology-enabled approach for assessing carcinogenicity based on the recently published ICH S1B Weight of Evidence (WoE) Addendum.
If you would like to schedule a discussion with us during SOT contact us at info@instem.com indicating your area of interest.
Instem Event Schedule
Monday March 11
Exhibitor Hosted Event: Does SEND Pave the Way for Creating Virtual Control Groups?
Monday, March 11, 3:00 PM - 4:00 PM (Mountain), Room 155 E
SEND-format data is a required submission standard, but practically, what else can we do with highly formatted and controlled datasets? The industry's universal adoption of standardization and quest for improvement opens the door to exciting, innovative data-reworking applications. This session will discuss the opportunities for data use beyond submissions, specifically in the area of constructing virtual control groups.
Presented by Marc Ellison, Director of SEND Solutions, Instem & Brenda Finney, PhD, Instem’s VP of Translational Science
Tuesday March 12
Exhibitor Hosted Event: Future Proofing Drug Safety: Target Carcinogenicity Risk Assessment Meets ICH S1B(R1) Standards
Tuesday, March 12, 3:00 PM - 4:00 PM (Mountain), Room 155 E
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 a collaboration to standardize a procedural framework supporting the ICH S1B(R1) integrated assessment. Specifically, target biology (WoE #1) will be presented.
Presented by Frances Hall, PhD, Scientific Application Director, In Silico and Translational Science Solutions, Instem
Symposium Session 1208: Nitrosamines: Mechanistic Evidence to Support Subclasses with Varying Mutagenic Potency
Tuesday, March 12, 4:45 PM - 6:15 PM (Mountain), Grand Ballroom A
This Symposium will present the findings of the EMA-funded MUTAMIND project and US Food and Drug Administration (US FDA) experimental investigations, as well as discuss the latest regulatory guidelines for SAR-based potency assessment.
Presenter & Chair- Kevin Cross, PhD, VP, Regulatory Science, Instem
Symposium Session Panel Discussion: Carcinogenic Potency Assessment and Other Hot Topics for Regulation of N-Nitrosamines
Tuesday, March 12, 5:50 PM - 6:15 PM (Mountain), Grand Ballroom A
This panel discussion will present the latest issues regarding the regulatory risk assessment of N-nitrosamines for carcinogenic potency and provide a forum for discussion of issues with the audience.
Chair: Kevin Cross, PhD, VP, Regulatory Science, Instem
Co-Chair: Timothy McGovern, US FDA
Proud Sponsors of the Computational Toxicology Specialty Section (CTSS)
Instem are proud to be Gold Sponsors of the Computational Toxicology Speciality Section (CTSS) who will be hosting a Reception on Tuesday 12th March at 6:00 PM - 7:30 PM in the Salt Lake Ballroom B at the Hyatt Regency. The event is open to all interested Annual Meeting Attendees
Wednesday March 13
Exhibitor Hosted Event: Using the Carcinogenicity Potency Categorization Algorithm to Predict N-Nitrosamine Carcinogenicity
Wednesday, March 13, 12:00 PM - 1:00 PM (Mountain), Room 155 E
This session will describe the Carcinogenicity Potency Categorization Algorithm (CPCA) that is used by regulators for quickly predicting carcinogenicity potency of N-nitrosamines under ICH M7. It will also present a Health and Environmental Sciences Institute (HESI) nitrosamine QSAR workgroup where Instem is co-leading a collaboration with health authorities, academics, and industry to address current and future nitrosamine regulatory issues.
Presented by Kevin Cross, PhD, VP, Regulatory Science, Instem & Connie Chen, PhD, Senior Scientific Program Manager, Health and Environmental Sciences Institute
We are also pleased to be involved in the following posters:
Posters in order of session time:
Abstract Number/Poster Board number: 3106/P210
Abstract Title: Mutamind: Benchmark Dose Modelling of N-Nitrosamines based on comet and enhanced Ames assay data
Presenting Author: Anke Londenberg, Fraunhofer Institute for Toxicology and Experimental Medicine, Co-Author, Kevin Cross, Instem
Session Title: Genotoxicity/DNA Repair
Session Time: 11th March 2024 11:45 AM to 1:45 PM
Abstract Number/Poster Board number: 3036/P137
Abstract Title: Reviewing carcinogenicity potency of N-nitrosamides and N-nitrosoureas in terms of structure-activity-relationship considerations
Presenting Author: Arianna Bassan (Innovatune), Co-Author, Kevin Cross, Instem
Session Title: Safety Assessment: Pharmaceutical-Drug Development II
Session Date and Time: 11th March 2024 2:15 PM to 4:15 PM
Abstract Number/Poster Board number: 3042/P143
Abstract Title: Emerging applications of computational methods in the reactivity assessment of extractables and leachables
Presenting Author: Candice Johnson, Instem, Co-Author, Kevin Cross, Instem
Session Title: Safety Assessment: Pharmaceutical-Drug Development II
Session Date and Time: 11th March 2024 2:15 PM to 4:15 PM
Abstract Number/Poster Board number: 4671/P558
Abstract Title: Use of Implantable Wireless Data Loggers to Enhance Cardiovascular Safety Assessment
Presenting Author: Bob Brockway, TSE Systems, Co-Author, Logan Laszczyk, Instem
Session Title: Cardiovascular Toxicology/Hemodynamics
Session Time: 13th March 2024 9:15AM – 11:15AM
Abstract Number/Poster Board number: 4393/P180
Abstract Title: Application of (Q)SARs for the genotoxicity assessment of flavorings
Presenting Author: Manuela Pavan, Innovatune SRL, Co-Author, Kevin Cross, Instem
Session Title: Computational Toxicology II
Session Time: 13th March 2024 2:15 PM to 4:15 PM
Abstract Number/Poster Board number: 4409/P196
Abstract Title: Exploring the Carcinogenicity Potency Categorization Algorithm for N-Nitroso Carcinogenicity Predictions - limitations and the future
Presenting Author: Kevin Cross, Instem
Session Title: Computational Toxicology II
Session Date and Time: 13th March 2024 2:15 PM to 4:15 PM
Abstract Number/Poster Board number: 4573/P408
Abstract Title: Advancement of New Drug Evaluation Process and Required Manufacturer & CRO Responses
Presenting Author: Takayuki Anzai, Instem
Session Title: Regulation/Policy
Session Date and Time: 13th March 2024 2:15 PM to 4:15 PM
Abstract Number/Poster Board number: 5025/P126
Abstract Title: The Application of Skin Sensitization In Silico Models for the Assessment of Pharmaceuticals and Their Related Compounds
Presenting Author: Mingzhu Fang, Bristol-Myers Squibb, Co-Author: Candice Johnson, Instem
Session Title: Late-Breaking 1
Session Date and Time: 14th March 2024 8:30 AM to 11:30 AM