Preliminary Program - American Association of Pharmaceutical ...

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SM 42 2009 AAPS Annual Meeting and Exposition Clinical Pharmacology and Translational Research (CPTR) Programming Track 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 JOINT MEMBERSHIP MEETING AND RECEPTION 5:30 pm – 7:00 pm Clinical Pharmacology and Translational Research (CPTR) Section Joint Membership Meeting and Reception Tuesday, November 10, 2009 TUESDAY SUNRISE SESSIONS 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 TUESDAY AFTERNOON ROUNDTABLES Funded by a Grant from 2:00 pm – 4:00 pm Inclusion of Women in Clinical Trials and Drug Development — How Far Have We Gone Roundtable Women were initially excluded from clinical research due to liability concerns and historical precedence. The result was the “male norm” of research. Research subjects were predominately men since most researchers thought men and women were biologically the same except for their reproductive organs. By the 1980’s, it was clear that the exclusion of women from clinical studies compromised the health care they received. This created a scientific knowledge gap that has resulted in health care disparity for women over the past many years. Sex affects health and health care; the following examples illustrate why it is imperative that diseases and treatments be studied for the different effects they can have on women and men. A 2001 report from the General Accounting Office (GAO) on the U.S. Food and Drug Administration (FDA) revealed that eight of 10 drugs recently withdrawn from the market caused more adverse events in women than men. Heart disease kills 500,000 American women each year, over 50,000 more women than men, and strikes women, on average, 10 years later than men. Women are 2.7 times more likely to acquire an autoimmune disease, such as multiple sclerosis, lupus or rheumatoid arthritis. Women wake up from anesthesia an average four minutes before men do. Moderator Emmanuel O. Fadiran, R.Ph., M.S., Ph.D. U.S. Food and Drug Administration Inclusion of Women in Clinical Trials & Drug Development — Regulatory Perspectives Ameeta Parekh, Ph.D. U.S. Food and Drug Administration Inclusion of Women in Clinical Trials & Drug Development — Clinical Perspectives C. Noel Bairey Merz, M.D. Cedars-Sinai Medical Center, UCLA Inclusion of Women in Clinical Trials and Drug Development — Industry Perspectives Poornima Sood, M.D. Abbott Laboratories
43 2009 AAPS Annual Meeting and Exposition Clinical Pharmacology and Translational Research (CPTR) Programming Track TUESDAY AFTERNOON SYMPOSIA 2:00 pm – 4:30 pm Leveraging Prior Quantitative Knowledge in Guiding Pediatric Drug Development Symposium The U.S. Food and Drug Administration and European Medicines Agency have recently renewed their call for innovative model-based approaches to pediatric drug development. It is evident in the requirements for sponsors to include a modeling and simulation plan, where applicable, in their pediatric investigational plans (PIP) and use of clinical trial simulations to support pediatric written request. The key issues facing us today are high pediatric trial failure rate due to lack of powerful and innovative clinical trial designs, failure to establish informative pediatric dosing recommendations due to lack of appreciation for differences in exposureresponse relationship between pediatric and adult population. Traditionally, studies have focused on PK differences only. Inappropriate or lack of use of prior quantitative knowledge to better design pediatric development programs. The objectives of this session are to demonstrate through case studies the value of designing pediatric developing programs using model-based approaches, and demonstrate through case studies the impact of prior quantitative knowledge on pediatric development/dosing decisions. This symposium has been aligned with the symposium, entitled “Strategic Biomarkers for Treating Diseases in Younger Children Safely and Effectively” scheduled for Monday, November 9, 2009 at 2:00 pm. The goal of this alignment is to give the attendees a complete overview of pediatric drug development. Moderator Pravin Jadhav, Ph.D. U.S. Food and Drug Administration Transforming Pediatric Drug Development by Informed Decision Making Pravin Jadhav, Ph.D., invited U.S. Food and Drug Administration Role of Modeling and Simulation in Developing PIP and Regulatory Decision Making Anja Henningsson, Ph.D. Medical Products Agency (MPA Swedish Agency) Efficient Decision Making for Clinical Trials Using a Model Based Approach Steven Kern, Ph.D. University of Utah Bayesian Model-based Approaches to Pediatric Trial Design and Dosing Rule Determination: Case Studies Marc Gastonguay, Ph.D. Metrum Research Group LLC OPEN FORUM 7:00 pm – 9:30 pm Adequacy of PK/PD Model Validation and Simulation Funded by Grants from AAPS Clinical Pharmacology and Translational Research (CPTR) Section Open Forum An additional fee is required to attend this open forum As PK/PD modeling (M) and clinical trial simulation (S) are becoming routine in drug development, success ultimately depends on the robustness of the chosen model. Yet Brendel, et. al. recently concluded that only 26% to 28% of PK and PD models were adequately evaluated following a review of 324 articles published from 2002 to 2004 (Clin. Pharmacokinet. 2007; 46(3):221-34). While this article’s conclusion may be subject to dispute, it does raise a legitimate question on how much model validation should be practiced in the M&S community. For example, the following questions may be considered: what are the minimum validation requirements for internal data? Among the more advanced internal validation methodologies, e.g. bootstrapping, jackknifing, Monte Carlo simulation, and etc., which approach is preferred? What is the rationale of choosing that approach? When and how should external validation be considered? What are the limitations to external validation and how might these limitations be overcome? What lessons can we learn from other industries with regard to validation, e.g. the aerospace and defense industries? Taking the PK/ PD model validation question one step further, one might want to consider what type of quality requirements are needed before attempting clinical trial simulation (CTS)? What types of assumption are considered acceptable? While the successful examples of CTS have been well documented within the past few years, what lessons can we learn from them? If you would like to share your opinion with us, come join us at the 2009 CPTR Open Forum. We will survey the standards and practices to probe the questions stated above in greater depth. The results will be shared with the participants during the meeting. Similar to last year’s event, no speakers are planned as the goal is to have an open discussion among participants about their experiences and opinions on these topics. It promises to be a lively evening of food, drink, and exchange of scientific ideas. Our intent is to publish the proceedings in a refereed journal. Come join us! We look forward to having you in an enlightening open forum. Moderators Dale K. Yu, Ph.D., R.Ph. Allergan, Inc. Peter Lockwood, Ph.D. Pfizer, Inc. Wednesday, November 11, 2009 WEDNESDAY SUNRISE SESSIONS 7:00 am – 8:15 am Pharmacogenetics: Methods and Clinical Applications Sunrise Sessions 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
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