Webinar—Designing IND Enabling Toxicity Studies for Complex Drug Modalities

Navigate the discussion with these timestamps: 00:01—Introduction to the Session 01:21—Navigating Drug Modalities: Pathways for Established and Emerging Therapies 07:00—Classical Approaches to Toxicology Studies 11:09—Case Studies in Large Animal Studies 15:25—Recent Guidelines for New Drug Modalities 24:36—Challenges in Juvenile Non-Human Primate Research 27:52—Development of the Nanopig Model 30:02—Role of Program Management in IND Studies 37:04—Coordination Across Functions in Complex Programs 39:50—Accelerated Method Development Strategies 41:16—Q1 What additional data in NHP infants shows similarity in development? 43:42—Q2 What is the optimal method for processing NHP semen for PCR? 44:42—Q3 In your experience, have you seen a standard approach to toxicology study designs for The presentation provides a comprehensive overview of the unique approaches for the design and conduct of IND-enabling toxicity studies for today’s more complex, drug modalities Altasciences is at the forefront of designing studies for new drug modalities and adapting traditional small-molecule IND-enabling studies to meet the evolving needs of the pharmaceutical industry. This webinar, supported by case studies, will explore recommended study designs that align with regulatory requirements, best practices for species selection, and methods employed by Altasciences to optimize the use of research animals while adhering to the principles of the 3Rs (Replacement, Reduction, and Refinement). What will you learn? 1. Modified study designs to address the needs of today’s new drug modalities for a better chance at regulatory acceptance. 2. Selecting the right species for your program while adhering to the principles of the 3Rs. 3. How your CRO’s Program Management team can facilitate quick decision-making and optimal reporting timelines for your crucial IND-enabling studies. Who may this interest? • Biotechnology companies working on drug products • Pharmaceutical companies • Academic researchers working on drug modalities Presenters: Norbert Makori, BVM, MSc, PhD, DABT, Vice President of Toxicology, Altasciences Jennifer Chown, Director Strategic Programs, Altasciences