Join us for an insightful webinar exploring key technological capabilities driving innovation in drug safety and regulatory science.
We’ll discuss how these technologies integrate seamlessly into workflows aligned with evolving regulatory guidelines, including ICH S1B (which may replace the traditional two-year rat carcinogenicity study), ICH M7, and the emerging concepts outlined in Step 2 of the ICH Q3E guideline, currently under public consultation.
Beyond regulatory applications, the session will also highlight non-regulatory use cases – such as toxicity profiling for drug candidates and assessing the predictivity of preclinical studies for clinical outcomes.
What you will learn:
- How the value of preclinical data lies in how it is curated, interpreted and applied in decision-making
- Why transparency, interpretability and reproducibility are essential for predictive technologies to be accepted and trusted
- Ways data-driven technologies can effectively integrate with regulatory workflows such as ICH S1B, ICH M7 and emerging frameworks such as ICH Q3E
- How these data-driven technologies support toxicity profiling, lead compound selection and evaluation of preclinical predictivity for clinical outcomes
Key Speakers:
- Frances Hall, PhD, Scientific Application Director, Instem (Presenter)
- Candice Johnson, PhD, Product Manager, Instem (Presenter)
- Brenda Finney, PhD, Director of Product – In Silico & Data Insights, Instem (Q&A Panelist)
- Kevin Cross, PhD, Director of In Silico Science, Instem (Q&A Panelist)
Register for this webinar to learn how data-driven strategies can enhance preclinical drug discovery and improve downstream decision-making.
