In this free webinar, learn how innovative data mining approaches are transforming drug safety applications, including target safety assessments (TSAs) and weight of evidence (WoE) assessments. Attendees will learn how translational informatics integrates data, information and knowledge from research, development and clinical practice. The featured speakers will discuss how augmented intelligence and translational informatics are enhancing the efficiency and ethical standards of drug development, aligning with the latest International Council for Harmonisation (ICH) guidelines.
TORONTO, Oct. 3, 2024 /PRNewswire-PRWeb/ -- 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 Harmonization (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 create robust, evidence-based documentation for drug safety evaluations.
Join Frances Hall, PhD, Scientific Application Director, In Silico and Translational Science Solutions, Instem; Arianna Bassan, PhD, Principal Consultant and Co-Founder, Innovatune; and Paul Bradley, MSc, Vice President, Data Science Solutions, Instem, for the live webinar on Wednesday, October 23, 2024, at 10am EDT (4pm CEST/EU-Central).
For more information, or to register for this event, visit Safety-focused from Start to Submission: A Story of Target Safety Assessment and ICH S1B (R1) Guidelines.
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