Senior Staff Fellow (Pharmacologist) US Food and Drug Administration Silver Spring, Maryland
Complex drug substances and formulations present unique development and regulatory challenges for progression from the bench to bedside. Identifying suitable biomarkers, assessing bioavailability for locally acting products, or establishing bioequivalence may not be feasible by the conventional approaches. New and innovative characterization and in-silico modeling approaches may overcome these hurdles, thereby reducing product development time and cost, while providing strong evidence to support regulatory decision-making. For example, novel characterization methods and advanced in-silico models (especially when utilized in tandem) can provide a comprehensive understanding of the complex physicochemical, structural, and metamorphic properties of products, and can provide a compelling demonstration of product sameness when needed, either to establish the equivalence of generic topical, ophthalmic, and other locally acting complex drug products. Overcoming potential challenges related to innovative in vitro characterization methods with the in-silico modeling-based approaches can help to identify the critical quality attributes of these complex products. These alternative approaches may be used to assess bioavailability, in lieu of in vivo studies, depending, among other factors, on the sensitivity, robustness and/or correlation of these in vitro tests with the resulting product performance. These presentations, and the interactive panel discussion, will focus on the development of innovative analytical and statistical characterization and modeling approaches that can, together, accelerate the progression of complex products into the clinic, and to market. Included in the discussions will be the specific areas in which these approaches can contribute significantly, how and when these approaches may be employed and evaluated to overcome scientific challenges often encountered. Active engagement of the audience in the panel discussion is expected and is anticipated to improve the current understanding of present and future characterization methods and their potential impact to modern drug development paradigms.
Learning Objectives:
Upon completion, the attendees will identify the areas in which new in vitro analytical and statistical methods can contribute to the preclinical development of complex products and support regulatory assessments of equivalence
Upon completion, the attendees will describe how in vitro testing for demonstrating complex product equivalence should be conducted and evaluated
Upon completion, the attendees will solve scientific challenges with assessing critical quality attributes of complex products and with developing new analytical methods to elucidate the physicochemical, structural, and performance characteristics of complex products, to improve their advancement to the clinic
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