Preliminary Program - American Association of Pharmaceutical ...

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68 2009 AAPS Annual Meeting and Exposition AAPS Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) Programming TUESDAY MORNING ROUNDTABLES 9:00 am – 11:00 am To Test or Not to Test? Risk Assessment Approaches for Human Metabolites Roundtable This session is intended to take the U.S. Food and Drug Administration Guidance on Safety Testing of Drug Metabolites to the next logical step by focusing on strategic approaches for risk assessment of major and unique human metabolites. Currently, many companies have accepted the guidance, but are at a loss for how to implement its recommendations in the real world of drug development. Industry speakers will present case studies that did and did not result in stand-alone nonclinical safety assessment of a human metabolite. The presenters will also address inherent issues with conducting risk assessment on metabolites that are administered directly to an animal instead of formed in situ by normal metabolic processes. Finally, a U.S. Food and Drug Administration representative familiar with this area will address situations where actual metabolite safety testing can be instrumental in deconvoluting toxicity observed in the clinic. The roundtable should be very interactive as audience members are likely to provide their own perspectives and experiences on this hot topic. Moderators Debra Luffer-Atlas, Ph.D. Eli Lilly and Company K. Sandy Pang, Ph.D. University of Toronto Addressing Metabolite-related Safety Concerns in Early Development William G. Humphreys, Ph.D. Bristol-Myers Squibb Complicating Factors in Risk Assessment of Drug Metabolites Shelby Anderson, Ph.D. Eli Lilly and Company A Regulatory Perspective on Characterizing Human Metabolites Aisar Atrakchi, Ph.D. U.S. Food and Drug Administration 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 TUESDAY AFTERNOON SYMPOSIA 2:00 pm – 4:30 pm Reactive Metabolites in Drug Discovery and Development: How Can We Handle the Risk? Symposium Safety-related issues continue to significantly contribute to the overall attrition statistics in the pharmaceutical industry. The metabolic formation of reactive metabolite intermediates in vivo represent a risk in the drug discovery and development process which can manifest itself as drug-induced toxicity later on in patients as unforeseen idiosyncrasies. Significant advances in our knowledge of biotransformation pathways over the last 20 years have resulted in a better understanding of the underlying chemical mechanisms, which drive the formation of reactive intermediates. An increasingly integrative approach of medicinal chemistry, computational chemistry, biology and toxicology holds the promise that academic and industry research has become more capable of designing out unwanted toxicity risks from drug candidates, which will ultimately lead to safer drugs for patients. The present symposium will discuss the current state of the art in reactive metabolite (RM) research regarding compound design, RM detection, RM toxicological implications and RM risk assessment in drug development. Moderators Raimund M. Peter, Ph.D. AstraZeneca Dhiren Thakker, Ph.D. University of North Carolina at Chapel Hill Chemically-induced Toxicity: Concepts Frederick P. Guengerich, Ph.D. Vanderbilt University Reactive Metabolites: Biological and Pharmacological Consequences B. Kevin Park, M.D., Ph.D. University of Liverpool Chemical Toxicophores: Potential for Trouble Amit Kalgutkar, Ph.D. Pfizer Global Research & Development Structure/Toxicity Relationships in Reactive Metabolite-mediated Drug Toxicities Sidney D. Nelson, Ph.D. University of Washington Reactive Metabolites: Risk Management in Discovery & Development David C. Evans, Ph.D. Johnson & Johnson Pharmaceutical Research & Development, L.L.C
69 2009 AAPS Annual Meeting and Exposition AAPS Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) Programming 2:00 pm – 4:30 pm Pros and Cons of Emerging Methods in Population PK and Exposure/Response Analysis Symposium This session will discuss the advantages and limitations of emerging and established algorithms and software implementations of population PKPD analysis methods. The following algorithms (software) will be discussed, with a focus on the versatility of the methods to specify and estimate complex PKPD models (such as mechanistic disease progression models, and models with categorical or time-to-event endpoints): SAEM (MONOLIX), MCMC (BUGS), and MCPEM (S-ADAPT), NLME (MATLAB and NONMEM). Moderator Amit Roy, Ph.D. Bristol-Myers Squibb Likelihood Estimation in Population PKPD Analyses Using the SAEM Algorithm Implemented in MONOLIX Radojka Savic, Ph.D. INSERM Modeling and Nonlinear Mixed-effects Methods in MATLAB and SimBiology Ricardo Paxson, M.S. The MathWorks, Inc. Pros and Cons of Bayesian PKPD Modeling Using BUGS William R. Gillespie, Ph.D. Metrum Research Group LLC Comparison of Population Estimation Methods for Complex PKPD Systems Chee Ng, Ph.D., Pharm.D. Bristol-Myers Squibb 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., invited 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 JOINT MEMBERSHIP MEETING AND RECEPTION 5:45 pm – 7:30 pm AAPS Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) Section Joint Membership Meeting and Reception Wednesday, November 11, 2009 WEDNESDAY SUNRISE SESSIONS 7:00 am – 8:15 am Minimizing the Guesswork of Early Human Dose Predictions: Application of PK Prediction Methodologies Including PBPK Sunrise Session The accurate prediction of pharmacokinetic parameters in humans and anticipation of human dose (AHD) for early human studies based on preclinical and/or physicochemical data remains a major challenge, in spite of coverage of this topic in the literature and at AAPS meetings (e.g. P. Lowe et. al., Xenobiotica, 2007). While many methods are known, such as allometry, or physiology based pharmacokinetic modeling (PBPK) and IVIVC, many questions remain for pharmaceutical scientists on how to predict human dosing regimen for “difficult” compounds with confidence, such as those with species dependent or formulation dependent PK, i.e. BCS class II and IV compounds with solubility/ dissolution limited exposure. Some companies have developed their own strategies, and others have published their methods, but often specifics are not covered in detail. In this sunrise session recent case examples for human PK and dose projections of compounds with new data will be covered. The session will focus on current compounds and will not be a review of text book examples. The session will cover latest AHD applications using practical and tested methods, including; human PK parameter projections including for clearance, (CL) distribution (Vd), and bioavailability (F). How to use multiple approaches to verify human PK parameters, and how to establish and judge confidence in predictions methods with tools such as metabolic IVIVC and reverse pharmacology approaches — thus minimizing “Guesswork”. How to integrate Human PK projections with PK/PD modeling results for predicting human plasma concentration-time profiles and a suitable dosing regimen using a PBPK modeling approach. How to integrate formulation parameters into human PK profile predictions for BCS class II and IV drugs using GastroPlus, assess human PK profiles with new modified release formulations with dissolution data and establish IVIVC for all BCS classes, and establish and use IVIVC for new formulations of marketed drugs or drugs in clinical trials. This event will benefit all pharmaceutical scientists who are involved with first-in-human (FIH) dose projections, or are in early to late development, where human PK and dose projections are sought. This event will cover latest trouble-shooting, modeling, and IVIVC strategies that have been successfully used. The speakers will include speakers from DMPK and biopharmaceutical development departments.
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Preliminary Program 2009 AAPS Annua
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