Animal testing has long been a standard component of drug development, but advances in science and regulations are reshaping that paradigm. Recent milestones, including the 2022 FDA Modernization Act 2.0, the Agency’s 2025 Road to Reducing Animal Testing in Preclinical Safety Studies and the 2026 draft guidance on the use of New Approach Methodologies (NAMs) in drug development, among others, signal a significant shift toward modern, human-relevant methods1.
This webinar will explore how these changes may affect biotech and pharmaceutical companies developing innovative therapies. The featured speakers will review the relevant regulatory guidances, examine the key benefits and challenges of replacing animal testing and discuss near- and long-term implications for drug development programs. The session will conclude with examples of reduced animal testing paradigms and the integration of NAMs and Model-Informed Drug Development (MIDD) approaches into sponsor drug development programs.
For organizations planning their pipelines, understanding these emerging expectations is critical to designing efficient development strategies and preparing for a more modern regulatory environment. Attendees will leave with a clearer view of where the FDA is heading and what steps sponsors can take now to adapt.
Register for this webinar to learn how NAMs are reshaping animal testing strategies in drug development.
- Høeg TB, Kozlowski S, Saber H, Makary MA. Eliminating Unnecessary Animal Testing. JAMA. 2026;335(23):2011–2014. doi:10.1001/jama.2026.7074
Speakers
William Salminen, PhD, DABT, RAC, Vice President, Toxicology and Clinical Pharmacology, Premier Research
Dr. William Salminen has over 20 years of drug development experience for an array of drug products and indications. He is board-certified in Toxicology (DABT) and Project Management (PMP) and a subject matter expert in nonclinical safety and toxicology support for drug product development. His experience includes regulatory strategy and advice, nonclinical safety and toxicology strategy and advice, US FDA pre-Investigational New Drug (pre-IND) meetings, IND applications and maintenance, and New Drug Application (NDA) and Biologics License Application (BLA) submissions. He also has FDA-applied research experience with developing new biomarkers of drug-induced liver injury.
Message Presenter
Angelean Hendrix, PhD, Vice President, Pharmacometrics and MIDD, Premier Research
Angelean Hendrix, PhD, is an executive leader and Mathematician specializing in Quantitative Modeling and Clinical Pharmacology Strategy. With expertise spanning pharmacometrics, quantitative systems pharmacology (QSP) and AI/ML, she develops mechanistic models that drive model-informed drug development (MIDD), translational toxicology and efficacy prediction. Dr. Hendrix has led pharmacometric strategies for multiple rare disease programs, guiding initiatives from discovery through post-marketing and supporting regulatory, clinical and translational decisions across the drug development continuum.
At the intersection of science and leadership, Dr. Hendrix has directed cross-functional teams in product development, marketing and business development for AI/ML-based pharmacometrics platforms. She has advanced R&D roadmaps, built strategic partnerships and represented her organization at global conferences, strengthening both innovation and industry collaboration. Passionate about translating complex science into meaningful therapeutic impact, she continues to mentor emerging scientists and foster a culture of creativity, rigor and excellence in model-informed drug development.
Message PresenterWho Should Attend?
This webinar will benefit Managers and above at biotech and specialty pharma companies with job functions including, but not limited to:
- Drug Development
- Clinical Operations
- Medical Affairs
- Regulatory Affairs
- Project Management
What You Will Learn
Attendees will gain insights into:
- Recent FDA guidance attributing to the shift away from animal testing
- Implications for ongoing and planned drug development programs
- New Approach Methodologies (NAMs) replacing animal testing
- Strategic integration of Model-Informed Drug Development (MIDD) approaches
Xtalks Partner
Premier Research
Premier Research International LLC (Premier) is a global leader in clinical research and consulting services with expertise in driving an efficient and effective path to market for the life sciences industry.
Premier is built with the needs of biotech in mind, turning breakthrough science into life-changing drugs, devices, and diagnostics by addressing trial complexity, overcoming development hurdles, and demonstrating product value.
Leveraging deep therapeutic expertise, innovative technology, and product development operational proficiency—from preclinical planning to clinical trial execution and commercialization—our integrated approach offers personalized, end-to-end solutions to identify the pertinent data and insight necessary to make informed decisions earlier and deliver accelerated development timelines for a smarter, faster path to approval. To learn more visit premier-research.com.
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