AAPS 2012 PPDM Open Forum, Thursday Oct 18th: Systems Therapeutics: Attaining Intimate Understanding by Unraveling Complexity

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Please join us on Thursday, October 18th for the 2012 AAPS PPDM Open Forum, McCormick Place, Chicago: Systems Therapeutics: Attaining Intimate Understanding by Unraveling Complexity. Register for this open forum at http://www.aaps.org/AMRegister/ Objectives: 1. To provide an overview of quantitative systems pharmacology approaches 2. To identify and discuss key issues regarding methodology and utility of QSP 3. To identify and discuss major barriers to implementing this holistic approach The majority of drugs are developed to combat disease by focusing on a single intercession point (single-pathway targeted approaches). However, often the results achieved are suboptimal and therapeutic failures are not realized until the conduct of clinical proof of concept (POC) studies. Arguably, the largest hurdle to improving POC outcomes is the quantitative bridging of target modulation to clinical manifestations. Such links would fill the void of incomplete understanding and provide early, model-informed support of therapeutic targets. Quantitative links would bring meaning to the multiplicity and complexity of genetic and epigenetic changes during disease, and elucidate redundancies and cross-talk found in key signaling pathways. Thus, quantitative systems pharmacology (QSP) approaches aimed at understanding the global physiologic environment of the targets and the whole-body effects of modulation by therapeutic candidates would improve the probability of drug development success. QSP models provide an approach to quantitatively analyze biological and physiological complexity and generate understanding of how multi-scale biological systems function, by viewing the organism as an integrated, and interacting, network of genes, proteins, biochemical reactions, and endocrine feedbacks. Instead of analyzing individual components or aspects of the organism, QSP models aim to holistically examine all the components and the interactions among them, to understand the orchestrated outcome of the entire system in response to disease and therapeutic intervention. By integrating across disciplines and available quantitative approaches (e.g., systems biology, genetic modeling, agent-based, PK/PD), QSP can provide mechanistic understanding of a target, potential therapeutic, the potential adverse effects, and knowledge gaps. Models may include components for increasing understanding of how a drug acts in various tissues and cell types, as well as potential issues arising from multiple actions within a single cell type due to the presence of several interacting pathways. Thus, QSP models can be important translationally to help identify new drug targets, predict adverse events and improve the safety and efficacy of existing drugs prior to entering humans. This implied goal of identifying high probability candidates early is especially important in complex diseases such as cancers, psychiatric disorders and metabolic syndrome. Through QSP paradigm and actual applied models presentations attendees will receive an introduction to the developing field of QSP modeling and obtain an appreciation for how these concepts and models are being applied to drug discovery and development. Discussion will center on issues regarding methodology, utility, effectiveness, and barriers to implementation. Topics and speakers: 1. "Why do applied mathematics and systems biology matter and do these approaches yield valuable targets for drug development?" Speaker: Dr. Piet van der Graaf, Department of Pharmacometrics, Global Clinical Pharmacology, Pfizer 2. "Do models of organ-level physiology and target drug action aid the understanding or design of drug induced organ injury?" Speaker: Dr. Amin Rostami, Professor of Systems Pharmacology, University of Manchester 3. "Is it feasible to attempt a more holistic understanding of drug effects by consideration of coherence of multipathway networks of signaling, metabolism, and gene expression?" Speaker: Dr. Matt Riggs, Principal Scientist II/Group Leader, Systems Biology M&S, Metrum Research Group LLC 4. "Can the collaboration between pharmacologists, clinicians, and systems biologists be promoted/enhanced?" Speaker: Dr. Mark Peterson, Director Pharmacometrics, Global Clinical Pharmacology, Pfizer For more information: http://www.aaps.org/Meetings_and_Professional_Development/Conference_Mini_Sites/2012_AAPS_Annual_Meeting_and_Exposition/content/Open_Forum%E2%80%94Systems_Therapeutics__Attaining_Intimate_Understanding_by_Unraveling_Complexity/ Steering Committee: Douglas H. Sweet, Chair - Virginia Commonwealth University, USA Jenny Chien - Eli Lilly and Company, USA Liesbeth de Lange - LACDR/Pharmacology, NL Bernd Meibohm, University of Tennessee Health Sciences Center Di Wu (Chair Systems Biology FG) - The Children's Hospital of Philadelphia/University of Pennsylvania