Navigating the Animal Rule in Drug Development with Modeling & Simulation, Upcoming Webinar Hosted by Xtalks

In this free webinar, learn how modeling and simulation can help navigate the Animal Rule in drug development. Attendees will gain insight into when the Animal Rule is appropriate to use for drug approval. The featured speaker will discuss how modeling and simulation are used to navigate the Animal Rule. The speaker will also share how to apply the concepts in a real-world example.

TORONTO, Jan. 7, 2026 /PRNewswire/ — Gaining regulatory approval for drugs targeting conditions that cannot ethically be studied in humans presents a unique challenge for drug developers. Without traditional clinical trial pathways, teams must rely on alternative methods to demonstrate efficacy and support approval.

This webinar will explore how modeling and simulation are used to meet the requirements of the Animal Rule, a regulatory mechanism that enables drug approval based on animal efficacy data. The featured speakers will provide practical insights into navigating this pathway using real-world examples.

The Animal Rule permits approval when human trials are unethical or infeasible. In these cases, preclinical data are quantified using mathematical models, and simulations inform clinical dose selection, trial design and the bridging of efficacy between animal models and human exposure data. These tools also guide broader program development and regulatory decision-making.

Attendees will learn:

• When the Animal Rule is appropriate to use for drug approval
• How modeling and simulation is used to navigate the Animal Rule
• How to apply the concepts in a real-world example

Register for this webinar to learn how modeling and simulation can help navigate the Animal Rule in drug development.

Join Jessica K. Roberts, PhD, Senior Director, Pharmacometrics, Allucent, for the live webinar on Wednesday, January 21, 2026, at 11am EST (5pm CET/EU-Central).

For more information, or to register for this event, visit Navigating the Animal Rule in Drug Development with Modeling & Simulation.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars and digital content to the global life science, food, healthcare and medical device communities. Every year, thousands of industry practitioners (from pharmaceutical, biotechnology, food, healthcare and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps professionals stay current with industry developments, regulations and jobs. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit www.xtalks.com

For information about hosting a webinar visit www.xtalks.com/why-host-a-webinar/

Contact:
Vera Kovacevic
Tel: +1 (416) 977-6555 x371
Email: vkovacevic@xtalks.com

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SOURCE Xtalks