Preliminary Program - American Association of Pharmaceutical ...

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44 2009 AAPS Annual Meeting and Exposition Clinical Pharmacology and Translational Research (CPTR) Programming WEDNESDAY MORNING ROUNDTABLES 9:00 am – 11:00 am Translational Challenges in PK/PD/TD of Biotechnology-derived Products Roundtable The unique complexities associated with the PK and PK/PD of biotechnology-derived products including immunogenicity, species specificities, and target/immune-mediated clearance pose special challenges in translation of PK/PD/TD from preclinical to clinical domain. In preclinical safety assessment, a loss of exposure of humanized antibody due to neutralizing immune response may prevent appropriate end-organ toxicity or safety margin estimation and may not have human relevance, and translation of safety biomarkers from early to late stage of clinical development. Moderator Anis A. Khan, Ph.D. Merck & Co., Inc. PK/PD Translational Issues with Biologics Anis A. Khan, Ph.D. Merck & Co., Inc. Translation of Safety Biomarkers from Early to Late Stage of Clinical Development Joy A. Cavagnaro, Ph.D., D.A.B.T., R.A.C AccessBio WEDNESDAY AFTERNOON SYMPOSIA funded by a grant from 2:00 pm – 4:30 pm The Graying Globe — Drug Development in the Elderly Symposium The U.S. Food and Drug Administration Guidance for Industry for the study of drugs likely to be used in the elderly was first published in 1989 and was followed by the Guideline for Industry for Studies in Support of Special Populations: Geriatrics in 1994. The corresponding ICH guidance was published the same year. In the 15 years since that time, so many new tools useful in clinical pharmacology have been developed, and so much data on drug use in the elderly have been collected. With the Baby Boom generation entering their senior years, and with the large increase in the number of the individuals in their 80’s and 90’s, as well as the large increase in age-related morbidity associated with cancer and Alzheimer’s disease, it is time to review our understanding of the issues of drug development and the elderly. The topics to be discussed include current and projected demographic statistics including anticipated consumption of medical and pharmaceutical services, physiology of healthy aging as well as disease progression in the elderly, study design issues in phase 1, 2, and 3 associated with the elderly – including appropriate comparisons, and summarization of data to link what is learned in the young healthy volunteers to what is actually happening in the elderly receiving the drug; dosage form considerations for the elderly. At the end of the session, participants will understand the increasing number of elderly, especially those older than 75 years of age, and the magnitude of the demand for clinical and pharmaceutical services in the next 25 years; be able to describe the physiological changes associated with aging as well as those associated with common disease progression and the interaction; and be able to formulate a strategy for study design, analysis, and interpretation to develop the information needed to demonstrate exposure effect relationships in the elderly and other patients likely to receive medications. Moderators Vijay Tammara, Ph.D., M.Pharm. Merck and Co., Inc. Joan M. Korth-Bradley, Pharm.D., Ph.D., R.Ph. Wyeth Research Physiological Changes Associated with Aging and Aging-related Disease James E. Tisdale, Pharm.D. Purdue University Implications of Aging on Clinical Pharmacology: Regulatory Perspective Chandrahas G. Sahajwalla, Ph.D., invited U.S. Food and Drug Administration Implications of Aging on Clinical Pharmacology: Pharmaceutical Industry Perspective Vijay Tammara, Ph.D., M.Pharm. Merck and Co., Inc.
45 2009 AAPS Annual Meeting and Exposition Clinical Pharmacology and Translational Research (CPTR) Programming Thursday, November 12, 2009 THURSDAY SYMPOSIA 8:30 am – 11:00 am Using Modeling and Simulation to Safely Adjust Dose Regimens for Obese Patients Symposium Obesity has reached epidemic proportions worldwide. Obesity presents major health, social, and economic implications. Obese patients are more susceptible to a variety of chronic diseases than individuals with normal body composition. For example, obese patients frequently have hypertension, arterial sclerosis, and other cardiovascular diseases. Diabetes is also common in obese patients. Despite increased pharmacotherapy among obese patients, there is little information about dose adjustments for this population. Particularly for drugs with a narrow therapeutic index. The main factors affecting tissue distribution are body composition, regional blood flow, and the affinity of the drug for plasma proteins and/or tissue components. All these factors are altered in obese patients. The obese have larger absolute lean body masses as well as fat masses than lean patients. However, the percentage of fat per kilogram of total body weight is markedly increased. Drug clearance can also be altered in obese patients. Morbid obesity is strongly associated with non-alcoholic fatty liver disease, and cytochrome P450 isoform expression is altered, but no clear overview of drug hepatic metabolism in obesity is currently available. Pharmacology studies have reported different results on renal function in obese patients as well, making it difficult to forecast the pharmacokinetic behavior of drugs in obese patients. There have been several published reviews of various strategies for dose adjustments in obese patients. These reports suggest that a number of widely used empiric strategies for dose adjustments in obese patients, including a priori dose reduction or dose capping, are inappropriate and should be discouraged. However there have been no suitable size descriptors developed for dose adjustments across a wide range of body compositions. The lack of information on mechanisms for dose adjustment in the obese may be partly attributed to insufficient knowledge about pharmacokinetic parameters as a function of body composition due to the exclusion of obese subjects from clinical trials. Contributing to the problem is the myriad of concomitant health issues associated with obesity. Modeling and simulation during drug development may provide insights about safe dose adjustments in drugs in the obese patient population. Moderator Diane R. Mould, Ph.D. Projections Research Inc Thoughts on a Mechanistic Approach to Build Predictive PK Models for the Overweight and Obese Bruce Green, Ph.D. Projections Research, Inc. Estimating Lean Body Weight in Children Stephen Duffull, Ph.D. University of Otago Anesthetics Drugs and Morbid Obesity Hendrikus J. Lemmens, M.D., Ph.D. Stanford University Considerations for Dose Adjustment in Obesity Rajnikanth Madabushi, Ph.D., invited U.S. Food and Drug Administration THURSDAY ROUNDTABLES 9:00 am – 11:00 am Evaluating Fit-for-Purpose Models: Consensus or Controversy Roundtable Disease/PK/PD/Trial Models are now being increasingly used to aid decisions in industry, hospital, and regulatory settings. It is generally agreed that the adequacy of a model should be judged mainly based on its intended application. While modeling zealots continue to debate on what term best fits the process of evaluating model adequacy (model validation, model evaluation, etc.) the more critical issue is the lack of consensus on what constitutes an adequate model for a specific application. The objective of this roundtable is to debate on the appropriateness of models frequently used in 3 areas of drug development; models derived from in vitro, preclinical and literature (study-level) data on competitors to inform decisions in preclinical and clinical development, models used to select doses for Phase 3 testing, and models used for regulatory decisions, specifically to derive labeling statements. The overarching question is, what are the minimally acceptable statistical, biological, and predictive (S, B, P) properties of such models? To encourage an interactive session on specific items, panel presentations will focus on the following scenarios of model application. First, intended application using exposure-response models for efficacy and safety to design a dose response study to find optimal dose(s) for Phase 3 testing. What are minimally acceptable S/B/P properties for such models? What visual and statistical tools would you use to judge model adequacy? Second, intended application benchmark the magnitude of efficacy of your compound relative to competitors based on literature data to make a go/no-go decision. What are minimally acceptable S/B/P properties for such a model that combines subject level data for your compound with study level data with competitors? What visual and statistical tools would you use to judge model adequacy? Finally, intended application labeling statement to include the estimated magnitude of mean change in PK/ efficacy/safety under conditions of an interacting agent or in a special population. What are minimally acceptable S/B/P properties for such models? What visual and statistical tools would you use to judge model adequacy? Moderator Sriram Krishnaswami, Ph.D. Pfizer Global Research & Development A Pharmacologist’s View Nick Holford, M.D., M.S. University of Auckland A Statistician’s View Kenneth Kowalski, M.S. A2PG A Regulator’s View Yaning Wang, Ph.D., invited U.S. Food and Drug Administration
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