Preliminary Program - American Association of Pharmaceutical ...

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70 2009 AAPS Annual Meeting and Exposition AAPS Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) Programming Moderators Tycho Heimbach, Ph.D., M.S. Novartis Jennifer J. Sheng, Ph.D. AstraZeneca Minimizing the Guesswork of Early Human Dose Predictions: Application of PK Prediction Methodologies Including PBPK (Part 1) Steven C. Sutton, Ph.D., R.Ph. Simulation Consultation Services Minimizing the Guesswork of Early Human Dose Predictions: Application of PK Prediction Methodologies Including PBPK (Part 2) Natilie Hosea, Ph.D. Pfizer, Inc. 7:00 am – 8:15 am Today, Tomorrow, and Beyond: Approaches and Challenges in Modeling Pharmacodynamic Effects with Long Time Delays Sunrise Session This session will provide a comprehensive summary of empirical, semi-mechanistic, and mechanistic approaches for modeling long time delays in exposure-response relationships and discuss their advantages and limitations. Modeling & simulation activities are widely applied in various stages of drug development, and quantitative model-based drug development is strongly promoted by U.S. Food and Drug Administration (FDA) and many pharmaceutical companies. Establishment of exposure-response relationships and their prospective application in drug development is oftentimes hampered by long time delays between drug concentration-time profiles and effect-time profiles in the order of days, weeks or even months. The development of small molecule NCEs as well as biologics may be complicated by these time delays between exposure and response. Examples of safety as well as efficacy endpoints include myelosuppression and/or the antiproliferative effect of cancer chemotherapy, the interaction with processes such as erythropoiesis and granulocytopoiesis, and the inhibition of cytokine signaling leading to clinical disease improvement. Different approaches to model this kind of delayed effects have emerged in recent years, for example transit compartment and cell lifespan models. This sunrise session intends to provide a comprehensive overview on the available modeling approaches for delayed PD responses and will discuss their advantages, disadvantages and limitations. Moderators Nageshwar Budha, Ph.D. Genentech, Inc. Bernd Meibohm, Ph.D. University of Tennessee Health Science Center Empirical and Semi-mechanistic Modeling Approaches for Long Time Delays in Concentration Response Profiles Lena Friberg, Ph.D. Uppsala University Mechanistic Approaches for Modeling Long Time Delays in Drug Response Juan Jose Perez Ruixo, Ph.D. Amgen Inc. 7:00 am – 8:15 am Pharmacogenetics: Methods and Clinical Applications Sunrise Session This session will introduce the building tools and technologies that are currently used in pharmacogenomics (PGx) testing in laboratory diagnostics, drug therapy, and drug and biomarkers discovery. The clinical application of molecular diagnostics and relevant SNPs and gene expression technology used in PGx will be discussed to illustrate that patient outcome can be optimized and adverse drug reactions can be minimized through a combination of genetic testing and serum drug therapeutic level monitoring. Moderator Lawrence Fleckenstein, Pharm.D. University of Iowa Building Tools of Pharmacogenetics Majid Moridani, Pharm.D., Ph.D. Texas Tech Health Sciences Center The Application of Pharmacogenetics in Clinical Medicine and Drug Discovery Gilbert Burckart, Pharm.D., invited U.S. Food and Drug Administration WEDNESDAY MORNING SYMPOSIA Funded by a Grant from 8:30 am – 11:00 am Pharmacoproteomics: Targeted Absolute Quantitative Proteomics in ADME Symposium Proteins are intimately responsible for modulating drug disposition, as binding proteins, enzymes of metabolism and uptake/efflux transporters. Novel protein therapeutics are also an increasing fraction of new drugs and endogenous proteins are being identified as biomarkers of disease. Proteins are often measured in drug development and discovery though most quantitative measurements of specific proteins are done using semi-quantitative western blotting or with ELISA assays. Western blots are tedious, not very reproducible between or within labs, are relative quantification, and have a limited dynamic range. ELISA assays require significant validation and are often non-specific. Most limiting is the requirement of a specific antibody that often precludes successful quantitation, since many proteins have resisted extensive efforts to develop specific antibodies. Moreover, often a specific antibody developed for one species will not be applicable to another, thus necessitating the laborious development of additional antibodies. Clearly, improved methods to quantify specific targeted proteins are desirable, and if available, would benefit drug discovery and development. Recent reports have demonstrated the ability of LC-MS/MS to quantify proteins in complex biological matrixes. Targeted absolute quantitative proteomics (TAQP) is the use of LC-MS to quantify unique peptides characteristic of a specific protein. TAQP is a novel technology to quantify proteins and should create a new research field, i.e., “Pharmacoproteomics” defined as targeted absolute quantitative proteomics based pharmacokinetics, pharmacodynamics, toxicokinetics and toxocodynamics. This symposium will introduce TAQP and contrast it to other methods for absolute and relative protein quantitation and global protein quantification, provide rationale and examples for the use of the method in understanding drug metabolism, provide rationale, application, and examples for the use of the method in studying drug transport, and describe how TAQP may be employed for following protein therapeutics and biomarkers relevant to disease and drug effects. The speakers will integrate the use and applicability of TAQP to drug development and pharmacoproteomics. Moderators Tetsuya Terasaki, Ph.D. Tohoku University Philip C. Smith, Ph.D. University of North Carolina at Chapel Hill Emerging Techniques in Quantitative Proteomics for Biomedical Research Christie Hunter, Ph.D. Applied Biosystems Prediction of In Vivo ADME Based on the Transporter Protein Quantification Tetsuya Terasaki, Ph.D. Tohoku University Improved Extrapolation of Hepatobiliary Secretion via Transporter Quantification Yurong Lai, Ph.D. Pfizer, Inc. Quantitative Proteomics of Glucuronidation Philip C. Smith, Ph.D. University of North Carolina at Chapel Hill
71 2009 AAPS Annual Meeting and Exposition AAPS Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) Programming 8:30 am – 11:00 am Pharmacokinetic-pharmacodynamic Aspects of Inhaled Lung-targeted Agents Symposium Discovery and development of inhaled lung-targeted therapeutic agents such as bronchodilators and corticosteroids present substantial PKPD challenges; lung PK is not easily measurable in preclinical models and may not be measurable in clinical studies. Systemic PK is relevant for systemic effects but may not be so for airway effects such as bronchodilation. Sufficient understanding of the lung as an absorption barrier for small molecules is not currently available to allow for inference of lung PK from systemic observations. Quantitative dose-exposure-response analysis is rarely possible because of lack of relevant exposure data. Therefore, basic research is needed in order to characterize the ADME profile of lung-targeted inhaled agents. This symposium will provide specific information on the gaps that exist in our understanding of the lung as an ADME barrier, and in the absence of requisite clinical information, what quantitative tools exist to help develop PKPD understanding of lungtargeted agents. Moderators Dennis K. O’Connor, B.S. Boehringer Ingelheim Pharmaceuticals, Inc. Balaji M. Agoram, Ph.D. Pfizer Global Research & Development Lung ADME Ann Tronde, Ph.D. AstraZeneca Inhalation by Design Rhys Jones, M.S. Pfizer Global Research & Development PK-PD Considerations of Inhaled Agents — Corticosteroids as an Example Gunther Hochhaus, Ph.D. University of Florida Bioequivalence Testing for Inhaled Lungtargeted Agents Wallace Adams, Ph.D. U.S. Food and Drug Administration WEDNESDAY MORNING ROUNDTABLES 9:00 am – 11:00 am Facilitating the Transition to Modelbased Drug Development Roundtable The goal of this roundtable session is to elicit discussion regarding the issues surrounding the implementation of quantitative modeling and simulation strategies and their integration into drug development project timelines. Use of these strategies in a model-based development paradigm has been proposed as a mechanism to improve both the efficiency and productivity of drug development. However, recognition of common obstacles to the seamless integration of these methods as a critical component of decision-making may facilitate systematic changes to achieve the optimal benefit. Brief presentations addressing the role of integrated project teams in supporting this paradigm, the essential infrastructure elements required for successful implementation, and the team communication and integration issues to be addressed for optimal management buy-in and efficient and informed decision-making will come before an open discussion of lessons learned and strategies for success. The presentation, the Other Critical Path: The Role of Integrated Project Teams in Drug Discovery and Development, will explore the following areas: how do we structure integrated project teams for maximum efficiency and effectiveness; what are the roles and responsibilities of the members of a drug development integrated project team; how can an integrated project team assist a pharmacometrician and facilitate modelbased drug development; how can integrated project teams be used to meet aggressive timelines and facilitate informed decision-making. The presentation, the Engineering the Pharmacometrics Enterprise: Science in Support of Science, will discuss the following areas: what are the key components of the pharmacometrics enterprise; how do we move from model-supported drug development to model-based drug development; and what can be done to improve the efficiency and effectiveness of pharmacometrics. Moderator Jill B. Fiedler-Kelly, M.S. Cognigen Corporation The Other Critical Path: The Role of Integrated Project Teams in Drug Discovery and Development David Y. Mitchell, Ph.D. Mitchell Pharmaceutical Consulting, LLC Engineering the Pharmacometrics Enterprise: Science in Support of Science Thaddeus H. Grasela, Pharm.D., Ph.D. Cognigen Corporation 9:00 am – 11:00 am Impact of Pharmacogenomics on Drug Development: An Industrial Perspective Roundtable Pharmacogenomics has emerged as an important tool for discovering new therapeutic agents as well as re-evaluating existing drugs for improving their efficacy and/or applications. The pharmaceutical industry continues to contribute significantly to development of high-throughput technologies applied to pharmacogenomic research. Efficient translation of the scientific data into clinical applications requires careful analyses, prioritization and streamlining of the information at various levels even as the regulatory approvals are sought. While pharmaceutical organizations follow their own set of internal standard operating protocols and process guidelines, it would be useful to provide a common platform to researchers from the industry to share their experiences and perspectives on what strategies worked, how challenges were overcome, what do they foresee as emerging issues in the near future, and what is the impact of the pharmacogenomic approach on the overall economics of the drug development/ approval process. Moderators Lawrence Fleckenstein, Pharm.D. University of Iowa Pramod Mahajan, Ph.D. Drake University Impact of Pharmacogenomics on Drug Development: An Industrial Perspective Allen Roses, M.D. Cabernet Pharmaceuticals Inc. Impact of Pharmacogenomics on Drug Development: A Medco Perspective Felix Frueh, Ph.D. Medco Health Solutions, Inc. Impact of Pharmacogenomics on Drug Development: A GSK Perspective Ann Saunders, Ph.D. GlaxoSmithKline plc
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