In this free webinar, gain insights into understanding approaches to assess anatomical and functional neurotoxicity in animal species. The featured speakers will discuss integrating various types of data to create a toxicity profile and manage risk. Attendees will explore case studies to understand the intricacies of assessing and managing CNS risks.
TORONTO, Nov. 28, 2023 /PRNewswire-PRWeb/ -- Risk assessment is a complex process intended to protect human health. In drug development, this process includes identifying drug candidate-related hazards in relationship to dose and exposure via traditional in vitro and in vivo frameworks. Nonclinical studies in pharmacology, pharmacokinetics and toxicology are designed and conducted under conditions that closely mimic the clinical setting to facilitate proper risk assessment. The introduction of novel model-informed approaches can further translate this information to predict clinical pharmacokinetic and pharmacodynamic (PK/PD) outcomes for supporting clinical development. A well-designed risk assessment strategy, plan and analysis ultimately ensures patient safety relative to potential therapeutic benefit.
In risk assessment for drugs designed to treat neurological diseases, there are additional challenges. These include overcoming the barriers of drug delivery to the central nervous system (CNS), verification of CNS drug exposure and mitigation of safety concerns unique to the CNS such as seizure risk or off-target adverse effects on neurotransmitter pathways. Therefore, novel and intelligent designs for a risk management strategy for CNS drug development are essential. This strategy may be informed by various types of data that include in vitro and in vivo findings, as well as data from multiple types of modeling: e.g., physiologically-based pharmacokinetic (PBPK) modeling, in vitro in vivo extrapolation (IVIVE) and more.
Join this webinar on CNS risks in the context of drugs intended for neurological use and explore case studies and perspectives on their current and future challenges.
Join experts from Allucent, Marcus S. Delatte, Ph.D. Vice President, Regulatory Strategy; Devin Welty, Ph.D. Vice President, Clinical Pharmacology; and Alison Wakeford, Ph.D. Scientist, for the live webinar on Tuesday, December 12, 2023, at 10 am EST (4 pm CET/EU-Central).
For more information, or to register for this event, visit Risk Assessment of Novel Neurotherapeutics: Mechanistic Translation of Preclinical Safety and PK/PD Data to a Clinical Setting.
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