Preliminary Program - American Association of Pharmaceutical ...

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66 2009 AAPS Annual Meeting and Exposition AAPS Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) Programming Moderators Yurong Lai, Ph.D. Pfizer, Inc. Marilyn Morris, Ph.D. University at Buffalo, The State University of New York Regulation of Transporters by Nuclear Hormone Receptors: Implications During Inflammation Micheline Piquette-Miller, Ph.D. University of Toronto Impact of Inflammation on Hepatobiliary Transporters Yurong Lai, Ph.D. Pfizer, Inc. Drug Interaction Studies of Therapeutic Protein or Monoclonal Antibodies Iftekhar Mahmood, Ph.D., invited U.S. Food and Drug Administration 8:00 am – 10:00 am Optimization of Systemic Exposure in Preclinical and Clinical Development: “Success Stories” of Proven Methods for Challenging Drug Candidates — What You Did Not Already Know! Roundtable The identification and development of new drug candidates with a desirable systemic exposure that is both efficacious and safe in humans with “developable” formulations based on preclinical data remains a major challenge in the pharmaceutical sciences. One reason is that oral systemic exposure is determined by a variety of physicochemical and metabolic factors including drug solubility, permeability, dissolution, dosage forms, as well as, first-pass, transporter effects, and varying gastrointestinal physiology. Another reason is that multidisciplinary teams often cannot reach consensus which formulation and modeling approaches can be used with confidence to select a dosage form for first in human studies. Thus, science driven strategies to determine the systemic exposure rate limits will be presented based on new compounds and new data. Correct analysis of factors controlling exposure for drugs of all BCS classes. When low exposure is seen, there can be the incorrect perception that formulation improvement works for every compound. In other cases, controlled release formulations should be attempted to optimize the PK profiles. Modeling and simulation are also meaningful tools in designing PK/ formulation/ADME/TK studies, as well as, species scaling to human. Specific formulation strategies, and proven modeling approaches that can be used when facing different BCS classification compounds will be shared. In addition, the role of transporters in drug disposition with a focus on BCS Class II-IV drugs will be discussed, as well as, science-driven optimization of formulation selection studies for clinical trials and final marketing formulations. Moderators Tycho Heimbach, Ph.D., M.S. Novartis Hyo-Kyung Han, Ph.D. Chosun University Successful Methods for Systemic Exposure Optimization: IVIVC and Proven Formulation Strategies to Predict Clinical and Preclinical Outcome for Drugs of All BCS Classes Handan He, Ph.D. Novartis Systemic Exposure and Oral Absorption Assessment of Poorly Water-soluble Drugs in the Fasted and Fed State to Predict Clinical Outcome Makoto Kataoka, Ph.D. Setsunan University BDDCS vs. BCS as an Enabling Tool in Drugs Discovery: Evolving Understandings of Disposition for BCS Class II-IV Drugs Leslie Benet, Ph.D. University of California San Francisco MONDAY AFTERNOON SYMPOSIA Funded by a Grant from 2:00 pm – 4:30 pm AAPS/ACCP Joint Symposium: Strategic Biomarkers for Treating Diseases in Younger Children Safely and Effectively Symposium Recent implementation of removing children (ages 0-4) from the labels of various OTC coldrelief medicines is due to a finding that there have been more adverse events in this age group. Pediatric patients are a vulnerable population that needs special attention to the efficacy and safety of medicines administered. What are the biomarkers for extrapolating adult doses for younger children (age 0-4)? Is the body-weight based approach reasonable? What biomarkers (ontogenic development of phase I and phase III metabolizing enzymes) should we explore? Is systemic exposure of drug a reliable biomarker for selecting pediatric dose and predicting adverse events in younger children? What is known about the difference between adults and younger children of this age group in terms of the pharmacological and pharmacodynamic responses? This symposium will have a panel of clinical experts and regulatory authority to discuss dose selection biomarkers for younger children based on our understanding of drug absorption, ontogenic development of metabolizing enzymes, and pharmacological receptors that affect the efficacy and safety of pediatric medical use. The FDA’s pediatric guidance update and drug-disease interactions in pediatrics will be discussed as well. Our symposium has been aligned with the symposium, entitled “Leveraging Prior Quantitative Knowledge in Guiding Pediatric Drug Development,” which is scheduled for 2:00 pm – 4:30 pm, November 10, 2009. The goal of our alignment is to give the attendees a complete overview of pediatric drug development. Moderators Bernd Meibohm, Ph.D. University of Tennessee Health Science Center Pei Fan (Jane) Bai, Ph.D. U.S. Food and Drug Administration Ontogeny of Drug Metabolizing Enzymes and Transporters: Potential Biomarkers for Drug Disposition in Newborns and Infants Bernd Meibohm, Ph.D. University of Tennessee Health Science Center Predicting Pediatric Doses for Therapeutic Success via Simulation and Modeling Jeffrey Barrett, Ph.D. University of Pennsylvania Experience with Infants and Young Children in Drug Studies Performed Under BPCA and PREA Gilbert Burckart, Pharm.D., invited U.S. Food and Drug Administration Clinical Biomarkers: Nice to Have or a Clinical Imperative? Paul J. Desjardins, D.M.D., Ph.D. Wyeth Consumer Healthcare 2:00 pm – 4:30 pm The Modeling and Simulation Frontier: Multi-level, Multi-scale, Multi-attribute, Adaptable, and Extensible Discrete Event Models Symposium This session will allow attendees to better understand how multi-level, multi-scale, multiattribute, adaptable, and extensible, discrete event models can be used to advance pharmaceutical research. Understand the uses and capabilities of different classes of models and methods. Understand how new classes of models can help bridge the gap between current PK/PD models and the wet-lab, animal, and clinical trial models on which pharmaceutical research depends.
SM 67 2009 AAPS Annual Meeting and Exposition AAPS Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) Programming Pharmaceutical R&D can benefit greatly from adopting important advances in discrete event M&S methods, which have occurred within the past decade. The time is ripe to begin exploring the insights that can be achieved using these methods; they provide capabilities beyond those of traditional analytical, inductive, equation-based PK and PD modeling and simulation (M&S) methods. These new M&S methods make it easier to instantiate increasingly realistic, multi-level, multi-scale, multiattribute, adaptable, and extensible models relevant to pharmaceutical R&D. The models are suitable for use in research and in testing hypotheses about the pharmacological and toxicological mechanisms that are relevant to pharmaceutical R&D. This symposium will provide the audience an overview of these new methods. Presentations will draw on specific, pharmaceutically relevant models. Because the new methods are intended to be synergistic with traditional PK/PD M&S methods, the new and traditional methods will be compared and contrasted. Moderator Steven Chang, M.S. Immunetrics Inc. Dynamic Knowledge Representation Using an Agent-based Modeling Paradigm Gary An, M.D. Northwestern University Measuring, Modeling, and Modulating Inflammation in Mice and Men Yoram Vodovotz, Ph.D. University of Pittsburgh Bridging the Gap Between Mathematical Models and Wet-lab Models C. Anthony Hunt, Ph.D. University of California San Francisco Using Agent-directed Simulation to Accelerate Unraveling the Complexities of Adaptive Biological Systems Levent Yilmaz, Ph.D. Auburn University Tuesday, November 10, 2009 TUESDAY SUNRISE SESSIONS 7:00 am – 8:15 am The Blood Brain Barrier Sunrise Session Pharmacokinetic assessment in early drug discovery is now a commonly accepted approach to increase the chances of identifying candidates with suitable properties for further development. For CNS therapeutics, there is the additional requirement of blood brain barrier (BBB) penetration and brain localization. Several tools, both old and new, are being applied to guide drug design and medicinal chemistry to increase brain penetration. This sunrise session will contain presentations about in silico prediction tools for BBB, discuss in vitro models of the BBB, and present a case study of BBB enhancements in drug discovery. Moderator Nurulain Zaveri, Ph.D. Molecular Medicine Research Institute Key Principles for Optimization of CNStargeted Therapeutics Stephen Hitchcock, Ph.D. Amgen Inc. Presentation Title to be Determined Andrew Coop, Ph.D. University of Maryland School of Pharmacy 7:00 am – 8:15 am The Story of the Three Bears: Too Big, Too Small, Just Right! Size Issues in Drug Development Sunrise Session Determining the most appropriate dose for a new pharmaceutical one must take into account two different perspectives the patient and the drug. Patients come in a variety of sizes and drugs vary in their therapeutic range, and the necessity to customize the dose for individual patients. Healthy volunteers participating in phase 1 studies are usually within 15% of ideal body weight. Subjects participating in phase 2 and 3 trials are also usually within a reasonably narrow range of weight, compared to the people who will eventually be treated including premature neonates (0.5kg) to the very obese (200 kg+). How can adequate information be collected during drug development on the best way to dose patients who are either much smaller than average, or much larger than average to avoid increased incidence of adverse events or inadequate treatment? Some medications are prescribed in ‘flat’ doses expressed in mg for example, while others are dosed on a mg/m2 or mg/kg basis. When is it appropriate to do either? Biologics have conventionally been doses by weight, as have drugs used to treat cancer, yet in some cases, normalizing for size increases variability and potential for dose administration error. What factors should be considered in developing dosing recommendations? At the end of the session participants will be able to describe the different ways that size is described (ideal body weight, actual body weight, lean body weight, fat free mass, dry weight, body surface area, body mass index, growth charts), list the data/ conventions upon which dosing per kg and dosing per m2 is based, become familiar with study design and analysis methods to determine if dosing needs to be adjusted for size, and describe the potential impact of over and underdosing on patient outcome. Moderator Joan M. Korth-Bradley, Pharm.D., Ph.D., R.Ph. Wyeth Research How Big? How Small? Methods and Conventions of Describing Size Joan M. Korth-Bradley, Pharm.D., Ph.D., R.Ph. Wyeth Research Size is Not Everything — Life Beyond Allometry Nick Holford, M.D., M.S. University of Auckland AAPS Graduate Student Symposia and Research Achievement Awards 8:30 am – 11:00 am AAPS Graduate Student Symposium in Pharmacokinetics, Pharmacodynamics and Drug Metabolism and Clinical Pharmacology and Translational Research (PPDM & CPTR) Sponsored by During this Symposium, a presentation from the Research Achievement Award winner will be given. AAPS Research Achievement Award in Clinical Pharmacology and Translational Research Sponsored by
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