Preclinical Development – Chemical
Priyanka Ghosh, PhD
Pharmacologist
US Food and Drug Adminstration
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. Pharmacokinetic and clinical endpoint-based approaches for the evaluation of bioavailability remains challenging for complex locally acting drug products. An understanding of how physicochemical and structural product attributes impact product performance, using drug product characterization and performance evaluation tools, can accelerate the availability of safe and effective medicines for patients.
The first presentation will outline the challenges and successes with in vitro characterization-based approaches to rapidly advance product development, regulatory approval, and patient access. Complex case studies of topical, ophthalmic, and other locally acting drug products will be discussed with an emphasis on the complexity of drug substance and formulation and successful development of novel in vitro methods for characterization now accepted by global regulatory agencies.
The second presentation will discuss challenges associated with utilizing drug characterization and in-silico (model) based approaches to complement in vitro evidence by mitigating the risk of potential product failure modes, thereby accelerating the progression from the bench to bedside. Case studies successfully utilizing in-silico approaches for complex drug product development will be discussed, with an emphasis on specific approaches utilized to overcome common challenges.
The moderated panel discussion will actively engage the audience in various concepts that may be adopted to overcome the pitfalls and risks when advancing complex locally acting formulations through development and regulatory assessment. The body of evidence from a growing number of drug products will be discussed with a group of panelists from industry, academia, and the FDA. The target audience for this hot topic talks includes scientists within the pharmaceutical industry, academia, as well as regulatory bodies across the globe who can gain insights from the case studies and the discussion relating to preclinical development and characterization of complex drug products.
Government Speaker: Ahmed Zidan, PhD – US Food and Drug Administration
Government Speaker: Eleftheria Tsakalozou, PhD – US Food and Drug Adminstration
Government Speaker: Sam Raney, PhD – US Food and Drug Adminstration
Government Speaker: Andrew Babiskin, PhD – US Food and Drug Administration
Hot Topic Speaker: Stephanie Barrett, PhD – Merck & Co., Inc.
Hot Topic Speaker: Naveen Thakral, PhD – Schrodinger, Inc. USA