Instem at SOT 2023
Instem, Island Booth #615
Visit our Preclinical Solutions Center & In Silico Center of Excellence
Stop by the Preclinical Solutions Center to learn how Instem’s powerful preclinical solutions enable organizations to collect, manage, review and submit research data that streamline processes, increase quality and enhance development programs.
Provantis®
As the #1 preclinical software suite for organizations engaged in non-clinical evaluation studies, Provantis streamlines processes and workflows with straightforward, intuitive functionality for simple and complex studies within both GLP and non-GLP environments.
Learn more about our new standalone modules within our Pathology suite, including modules for Tissues Processing, Image Management, and SpotlighterTM, our historical data solution that helps you find the hidden value in your reference data.
SEND Solutions
The most comprehensive and widely deployed set of software (Submit™) and services (SEND Advantage™) supporting the creation and management of SEND datasets. Stop by our booth to learn more about our two NEW software solutions, DefineNow™ for the creation and editing of define.xml files and GuidePro™, Instem’s Study Data Reviewer’s Guide generator.
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. Also, don’t miss the opportunity to learn more about our new Transgenic Rodent Assay module!
Visit Instem’s In Silico Center of Excellence and find out how our software and outsourced services enable researchers to generate new scientific insights through the identification, extraction and analysis of data to create actionable information.
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: 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.
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 20
Exhibitor Hosted Event: The life of a SEND Dataset
Monday, March 20, 12:00 PM - 1:00 PM (CT), Room 101C
The past few years have seen the proliferation of standardized nonclinical data through the implementation of the SEND standard. This session looks at the full lifespan of the study data as they relate to the SEND dataset and address some of the challenges and explore the opportunities they bring.
Presented by Marc Ellison, Director of SEND Solutions, Instem & Brenda Finney, PhD, Instem’s Director of Translational Solutions
Tuesday March 21
Exhibitor Hosted Event: Implementation of a Weight of Evidence Carcinogenicity Assessment Aligned with ICH S1B
Tuesday, March 21, 4:30 PM - 5:30 PM (CT), Room 101B
This presentation will review the state-of-the-art in assessing carcinogenicity based on the ICH S1B weight of evidence (WoE) addendum, including progress towards developing a transparent and defendable protocol based on the 6 WoE factors.
Presented by Glenn Myatt, PhD, SVP of In Silico & Translational Science Solutions, Instem, Arianna Bassan, Principal Consultant, Innovatune and Frances Hall, PhD, Senior Director, In Silico Solutions, Instem
Wednesday March 22
Workshop: Assessing and communicating the developing safety profile of a new product
What do we need and how do we find it?
Wednesday, March 22, 12:00 PM - 1:00 PM (CT)
Join Brenda Finney, PhD, Instem’s Director of Translational Solutions, for an interactive workshop to discuss best practices and challenges facing project toxicologists in gathering and reviewing study data across a development programme.
During the workshop, we will discuss the current practices and tools used when working with the data associated with a new therapeutic. These discussions will allow attendees to explore and assess the processes and information needs of toxicologists charged with monitoring and submitting safety assessments throughout the development lifecycle of a new therapeutic.
Exhibitor Hosted Event: Assessing N-nitrosamine Potency Classes
Wednesday, March 22, 12:00 PM - 1:00 PM (CT), Room 101D
This session will review recent regulatory and industry updates in the assessment of N-nitrosamine potency classes based on various collaborations. It will outline new defendable methods, including SAR and read-across approaches, based on a mechanistic understanding of N-nitrosamine carcinogenicity.
Presented by Kevin Cross, PhD, VP of Product Development, Instem & Arianna Bassan, Principal Consultant, Innovatune
We are also pleased to be involved in the following posters:
Posters in order of session time:
Abstract Number/Poster Board number: 3172/P287
Abstract Title: Challenges in SEND Conversion of Embryo Fetal Development (EFD) Studies in Compliance with the SENDIG DART v1.1 and Practical Examples Addressing the CDISC SEND Conformance Rules v4.0
Presenting Author: Takayuki Anzai
Session Title: Regulation/Policy
Session Time: 20th March 2023 9:00 AM to 10:45 AM (CT)
Abstract Number/Poster Board number: 3176/ P291
Abstract Title: Application of in Silico Methods for the Definition of Occupational Exposure Banding
Presenting Author: Manuela Pavan (Innovatune), Co-Author Kevin Cross, Instem
Session Title: Regulation/Policy
Session Date and Time: 20th March 2023 9:00 AM to 10:45 AM (CT)
Abstract Number/Poster Board number: 3233/ P350
Abstract Title: Mechanisms of Nitrosamine Mutagenicity and Their Relationship to Carcinogenicity
Presenting Author: Graham Smith, Co-Author Kevin Cross, Instem
Session Title: DNA Damage and Repair
Session Date and Time: 20th March 2023 10:45 AM to 12:30 PM (CT)
Abstract Number/Poster Board number: 3096/ P202
Abstract Title: Polo-Like Kinase 4 (PLK4) Safety Review: Distilling the Risks with a Rapid Augmented Intelligence Approach
Presenting Author: Frances Hall
Session Title: Safety Assessment: Pharmaceutical - Drug Discovery
Session Time: 20th March 2023 2:30 PM to 4:15 PM (CT)
Abstract Number/Poster Board number: 3058/ P163
Abstract Title: In Silico Approaches in Carcinogenicity Hazard Assessment: Case Study of Pregabalin, a Nongenotoxic Mouse Carcinogen
Presenting Author: Kevin Cross
Session Title: Computational Toxicology I
Session Date and Time: 20th March 2023 2:30 PM to 4:15 PM (CT)
Abstract Number/Poster Board number: 3692/ P177
Abstract Title: EMA Mutamind: Data Gap Analysis of N-Nitrosamines for Structure-Activity Relationship
Presenting Author: Anke Londenberg, (Fraunhofer Institute), Co-Author, Kevin Cross, (Instem)
Session Title: Computational Toxicology II
Session Date and Time: 21st March 2023 9:00 AM to 10:45 AM (CT)
Abstract Number/Poster Board number: 3671/ P156
Abstract Title: Predicting the Acute Toxicity 6-Pack to Support Health, Safety, and Environmental Product Stewardship
Presenting Author: Glenn Myatt
Session Title: Computational Toxicology II
Session Date and Time: 21st March 2023 9:00 AM to 10:45 AM (CT)
Abstract Number/Poster Board number: 4477/ P351
Abstract Title: Risk (Re)Assessment of N-Methyl-N-Nitrosophenethylamine for Use in Computing Acceptable Intake Levels of N-Nitrosamine Drug Substance-Related Impurities
Presenting Author: David Woolley (ForthTox Ltd) Co-Author, Kevin Cross, (Instem)
Session Title: Risk Assessment III
Session Date and Time: 22nd March 2023 2:30 PM to 4:15 PM (CT)
Abstract Number/Poster Board number: 5152/P253
Abstract Title: A protocol to support weight-of-evidence assessments in the ICH S1B guideline
Presenting Author: Arianna Bassan, Co-Authors, Paul Bradley, Jon Chambers, Kevin P. Cross, Brenda Finney, Francis Hall, Candice Johnson, and Glenn J. Myatt
Session Title: Late-Breaking 5
Session Date and Time: 23rd March 2023 8:30 AM to 11:30 AM (CT)