Discover how innovative data mining approaches are transforming drug safety applications in our upcoming webinar. The presentation will focus on Target Safety Assessments (TSAs) and Weight of Evidence (WoE) assessments, aligning with the addendum to the International Council for Harmonisation (ICH) S1B (R1) guideline on testing for carcinogenicity of pharmaceuticals.
In this webinar, the expert speakers will discuss methods for rapidly generating TSAs to identify potential adverse effects of target modulation. They will also explain how extending this strategy in the WoE assessment can potentially avoid the need for the two-year rat carcinogenicity study. This approach not only enhances ethical standards but also offers considerable financial savings by minimizing reliance on long-term animal testing.
They will show how an ‘augmented intelligence’ approach is applied to thoroughly understand target biology and its safety implications. This includes an extensive literature review, bioinformatics profiling, pharmacological analysis and expert synopsis. Translational informatics integrates data, information and knowledge from research, development and clinical practice, supporting translational science and medicine.
The goal in producing TSAs is to leverage relevant information from across the research and development (R&D) continuum and combine data from clinical practice and molecular-focused laboratory research. The speakers will also present the latest TSA workflow developments, featuring significant improvements in speed and scale and greater adoption of findability, accessibility, interoperability, and reusability (FAIR) data principles.
Conventionally, TSAs are conducted during early-stage development. However, later in development, the content of the TSA can serve as a foundation for WoE documentation, in accordance with the Addendum to the ICH S1B (R1) guideline, to determine whether a two-year rat study would add value to the assessment of human carcinogenic risk.
Register for this webinar today to understand what is required to make robust, evidence-based documentation for drug safety evaluations.
Speakers
Frances Hall, PhD, Scientific Application Director, In Silico and Translational Science Solutions, Instem
Frances Hall is involved with the KnowledgeScan™ Target Safety Assessment and Advance™ Weight of Evidence services, together with the Centrus™ translational solution suite. She completed a PhD in Molecular Microbiology from the University of East Anglia in 2011 and immediately joined Perceptive Instruments working with a suite of image analysis and data collection tools specifically for genetic toxicology.
After this company was acquired by Instem, Frances moved into the In Silico and Translational Sciences team, working on customer liaison, satisfaction and engagement projects. Frances is a frequent presenter at scientific and industry conferences. She has a collection of peer-reviewed publications and sits on several consortia and working groups with a specific interest in aligning working solutions to regulatory guidance.
Message Presenter
Arianna Bassan, PhD, Principal Consultant and Co-Founder, Innovatune
Arianna Bassan has a broad expertise covering computational toxicology, computational chemistry, data collection and curation to support the evaluation of toxicity for human health hazard assessment. She graduated in Chemistry at the University of Padova (Italy) with first-class honours and earned a PhD in Chemical Physics at Stockholm University (Sweden).
She worked in international environments, including Stockholm University, MSD/Merck & Co and the European Commission. She is part of international networks of experts aimed at promoting the use of alternative methods for industrial and regulatory applications, where she has led a cross-organization working group to establish a consensus approach for the ICH S1B (R1) integrated assessment.
She is part of the EFSA experts supporting the authority in different fields and engages with the Italian health authority in collecting genotoxicity data for pesticides. Arianna has authored several toxicity reports and toxicity-related peer-reviewed publications.
Message Presenter
Paul Bradley, MSc, Vice President, Data Science Solutions, Instem
Paul Bradley has played a pivotal role in the creation and leadership of the KnowledgeScan™ Target Safety Assessment and Advance™ Weight of Evidence solution lines. Paul started his career in drug development, specializing in protein characterization, and worked on one of the first recombinant biopharmaceutical products to be approved in Europe.
After completing a Master of Science degree in Bioinformatics at the University of Manchester in 2000, he spent four years with the European Bioinformatics Institute, applying protein sequence analysis techniques to elucidate protein function and disease mechanisms for novel gene families.
Paul joined BioWisdom (later acquired by Instem) in 2004, where he collaborated with leading pharmaceutical companies in text and data mining to assess potential safety liabilities associated with target modulation. Paul has a wide range of experience, including late-stage drug development, bioinformatics, data analytics and developing and commercializing scientific software.
Message PresenterWho Should Attend?
This webinar will appeal to professionals in the following areas or those with the following job titles:
- Toxicologist/Toxicology services/Investigational toxicology
- Director/Manager/Head of Preclinical Services
- Reproductive Toxicologist/Toxicologic Pathologist
- Safety assessment studies/Drug safety evaluation
- Head of Safety/R&D
- Clinical pharmacology
- Drug discovery services
- Informatics/Bioinformatics
- Chief Scientific Officer/Principal Scientist
- Data Analyst/Information Analyst/Data mining
What You Will Learn
Attendees will learn about:
- How the KnowledgeScan™ solution is advancing drug safety applications, including target safety assessments (TSAs) and weight of evidence (WoE) assessments
- How translational informatics integrates data, information and knowledge from research, development and clinical practice
- How augmented intelligence and translational informatics are enhancing the efficiency and ethical standards of drug development, aligning with the latest ICH guidelines
Xtalks Partner
Instem
A global provider of leading software solutions and scientific services, Instem is helping clients bring their life enhancing products to market faster.
We enable organizations in the life sciences to more efficiently collect, report and submit high quality regulatory data, while offering them the unique ability to generate new knowledge through the extraction and harmonization of actionable scientific information.
Across the entire drug development value chain, every day Instem solutions are meeting the rapidly expanding needs of life science organizations for data-driven decision making, leading to safer, more effective products. Instem supports its global roster of clients through offices in the United States, United Kingdom, Europe, Japan, China, and India.
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