Biologics, Biosimilars, and Advanced Therapies

This session focuses on the development, clinical application, and safety evaluation of biologics, biosimilars, and advanced therapeutic modalities, including gene and cell therapies, monoclonal antibodies, and recombinant proteins. Emphasis will be placed on the biological mechanisms underlying these therapies, their pharmacokinetic and pharmacodynamic profiles, and the potential for immunogenicity, adverse reactions, and variability in patient response. The session will explore the regulatory and scientific considerations in the development of biosimilars, including demonstration of similarity to reference products in efficacy, safety, and immunogenicity. Case studies will illustrate the clinical benefits of biologics and advanced therapies in treating complex and chronic diseases, alongside strategies to monitor and manage side effects and optimize dosing. Participants will learn how preclinical and clinical data, along with translational insights, guide therapeutic decision-making and regulatory approval processes. Emerging areas such as cell-based therapies, CRISPR gene editing, RNA therapeutics, and nanomedicine will be discussed, highlighting both opportunities and challenges in clinical implementation. The session will also cover risk–benefit assessment, pharmacovigilance, and strategies for personalized application of these therapies. By integrating biological understanding, clinical pharmacology, and safety considerations, this session aims to equip participants with the knowledge to harness the potential of biologics and advanced therapies while ensuring patient safety and maximizing therapeutic efficacy.

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