Preliminary Program - American Association of Pharmaceutical ...

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62 2009 AAPS Annual Meeting and Exposition Physical Pharmacy and Biopharmaceutics (PPB) Programming formulation scientists and analytical scientists for exploration of high energy solids and facilitating technical breakthroughs in this field. Moderators Ping Gao, Ph.D. Abbott Laboratories Jun Huang, Ph.D. Bristol-Myers Squibb Crystallization of Amorphous Drug in Solid Dispersions Lynne Taylor, Ph.D. Purdue University Development of Amorphous Solid Dispersions: Formulation Selection and Risk Management Feng Qian, Ph.D. Bristol-Myers Squibb Assessing the Commercialization Potential of Solid Dispersions Marshall D. Crew, Ph.D. Agere Pharmaceuticals, Inc. Wednesday, November 11, 2009 WEDNESDAY MORNING SYMPOSIA Funded by a Grant from 8:30 am – 11:00 am Extrapolation Preclinical Data to Predict Human Pharmacokinetics: Understanding and Practice Symposium Screening, understanding, and optimizing the in vivo performance of drug products is required to achieve desirable clinical efficacy target and safety profiles in patients. Even though the drug products are ultimately investigated in human, the use of human subjects is clearly limited by ethical concerns and restrictions of cost. As the use of animal models in drug research and development is evident, careful and educated utilization of this preclinical approach is required. In this symposium, understanding of physiologies of animal species relevant to PK assessment will be highlighted. Attempts of using animal models to increase the precision and accuracy of PK predictions and to enable a better understanding of complex ADME behavior in humans will be discussed. Moderators Lillian (Hua) Zhang, Ph.D. U.S. Food and Drug Administration Jennifer J. Sheng, Ph.D. AstraZeneca Integrated Approaches in Utilizing Preclinical Models for Human Predictive Absorption Bertil Abrahamsson, Ph.D. AstraZeneca Volume of Distribution Prediction: Physiologically Based Methodologies Patrick Poulin, Ph.D. Consultant in Pharmaceutical Research Prediction of Human Hepatic Metabolism and Clearance from In Vivo Animal Experiments Duxin Sun, Ph.D. University of Michigan Scaling Pharmacokinetics/Pharmacodynamics from Animal Studies to Humans William J. Jusko, Ph.D. University at Buffalo, The State University of New York WEDNESDAY AFTERNOON ROUNDTABLES 2:00 pm – 4:00 pm Salts, Co-crystals, Polymorphs/Solvates, Nanoparticles, or Amorphous: How to Pick the Winner Roundtable In the past the most common approach was to choose the most stable crystalline form to go forward into development. However, many of the new drug candidates have extremely poor solubility, which can result in poor bioavailability. There are multiple methods to increasing the bioavailability of a compound, including generating a salt form, a metastable crystalline form, a co-crystal, a nanoparticle formulation, an amorphous form, or an amorphous dispersion. Choosing which form is often a balance between the benefits of enhanced solubility/bioavailability and the detriment of form interconversion to a different form and correspondingly reduced bioavailability. In this roundtable the speakers will discuss the advantages and disadvantages of choosing each of the different forms, including the issues of producing a less stable form that does not interconvert and the scaleup and manufacturing of metastable forms. Moderator Brian Padden, Ph.D. Abbott Laboratories Introduction to Methods to Increase Solubility: Salts, Co-crystals, and Amorphous Solids Geoff Zhang, Ph.D. Abbott Laboratories Co-crystals: The Future of Improving Solubility? Nair Rodriguez-Hornedo, Ph.D. University of Michigan Which to Choose? A Contract Lab Perspective Rolf Hilfiker, Ph.D. Solvias AG 2:00 pm – 4:00 pm Tumor Targeting Using Nanotechnologybased Drug Delivery Systems Roundtable The method of delivery plays an important role in ensuring that the drug reaches its target site for therapeutic effect. Novel modes of delivery methods using nanosphere technology are receiving wide attention as these have shown superior delivery compared to conventional dosage forms. Recently, nanotechnology has galvanized practically every sector of research, engineering and the business community. From a pharmaceutical standpoint, new functions arising from nanosizing such as improved solubility, targetability and adhesion to tissues allow the design of new drug delivery systems. In the therapeutic arena, nanotechnologybased systems with drug targeting properties promises to expand the repertoire of innovative systems, thereby revolutionizing health care delivery especially in cancer therapy. This roundtable will provide attendees with an overview of the current progress and opportunities as well as challenges in the design of nanotechnology-based drug delivery systems bearing tumor-targeting properties. Moderators Jeffrey Wang, Ph.D. Western University of Health Sciences Duxin Sun, Ph.D. University of Michigan Targeted Delivery of siRNA: Concept to Clinic Mark Davis, Ph.D. California Institute of Technology Nanotechnology-based Drug Delivery Systems Targeting to Glioma Xinguo Jiang, Ph.D. Fudan University Targeted Multifunctional Nanocarriers for Tumor Treatment and Imaging Tamara Minko, Ph.D. Rutgers University
63 2009 AAPS Annual Meeting and Exposition Physical Pharmacy and Biopharmaceutics (PPB) Programming WEDNESDAY AFTERNOON SYMPOSIA funded by a grant from 2:00 pm – 4:30 pm Microdialysis Role in the Development and Optimization of Drug Topical Delivery Symposium The rapid and efficient development and evaluation of topical delivery systems is still a challenge, particularly when new approaches or devices like iontophoresis are tested. In vivo cutaneous microdialysis allows studying drug delivery and pharmacokinetics as close as possible to the site of action and provides a tremendous tool for a better understanding of how the formulation affects drug PK into the skin. The proposed symposium will start with an overview of the microdialysis technique as applied to skin issues and will compare it with the other methods used to study PK in skin or skin layers. Then some of the available studies that utilized MD in skin will be presented and discussed. An expert from the U.S. Food and Drug Administration (FDA) will also be invited to provide insights into the regulatory aspects of the technique. The symposium will provide the attendee with the opportunity to evaluate the contribution of MD to improve our understanding of skin delivery. Moderators Carryn Purdon, Ph.D. Nycomed Chinmay Shukla, Ph.D. U.S. Food and Drug Administration Microdialysis in Skin: Overview and Comparison with Other Techniques Chris D. Anderson, M.D. Linköping University Microdialysis in the Selection of Optimal Formulations for Iontophoretic Drug Delivery Grazia Stagni, Ph.D., M.S. Long Island University Determination of Drug Penetration in Diseased Skin Speaker to be Determined The Regulatory View Point Edward Bashaw, Pharm.D., invited U.S. Food and Drug Administration Thursday, November 12, 2009 THURSDAY SYMPOSIA 8:30 am – 11:00 am Excipient Variability: Why Some Lots Pass and Others Fail Symposium Many common macromolecular excipients such as celluloses are derived from natural products. Changes in harvest time, location, species, and climate can significantly change the properties of the excipients. This can result in significant lot-to-lot variations in the structural and functional properties of the excipients. When developing a pharmaceutical dosage form, it is important to ensure that the same form of an excipient is consistently used during formulation, that the function of the excipient does not become compromised during processing, and that the excipient does not undergo a form change over time. This is particularly important in the production of amorphous dispersions of API in macromolecular excipients, as this product has significant drug-excipient interactions. Despite this need for reliable and accurate characterization methods of excipients, many macromolecular excipients used by the pharmaceutical industry are amorphous and can be difficult to characterize and understand in the solid state. The focus of this symposium is on the characterization of macromolecular excipients. Specific topics include impact of lot-to-lot variations of excipients on final product quality, characterization of structurefunction relationships in macromolecular excipients, role of impurities in excipient properties, and influence of drug-excipient interactions upon stable amorphous formulations. Moderator Joseph Lubach, Ph.D. Genentech, Inc. Advanced Characterization of Macromolecular Excipients Eric Munson, Ph.D. University of Kansas Amorphous Dispersions and Drug-excipient Interactions Lynne Taylor, Ph.D. Purdue University Excipient Variability — Why One Lot is Different than Another Bruno Hancock, Ph.D. Pfizer Global Research & Development Excipient Impurities — Small Amounts Mean Big Problems Venkatramana Rao, Ph.D. Bristol-Myers Squibb THURSDAY ROUNDTABLES 9:00 am – 11:00 am Predicting Oral Drug Absorption: Fiction and Facts Roundtable Finding a safe and effective compound amongst the hoards of available chemical moieties is challenging and costly. To bring a single drug to market may take years, cost hundreds of millions of dollars, and generally require testing in thousands of human subjects. Most drug candidates never make it as far as human testing and many that do are rejected for various reasons. In an effort to minimize time and costs of drug discovery and creation, pharmaceutical manufacturers have produced numerous screening techniques to identify the drug candidates most likely to take them to market. Some of these tests are aimed at drug absorption, distribution, metabolism, and elimination (ADME). Others are aimed at the effectiveness of drugs. In silico methods (i.e. computer models) are the fastest and one of the most efficient means for screening large numbers of drugs for oral absorption. For drugs that have survived the screening process, in silico methods continue to play an important role. This session will review models for predicting oral drug absorption. Moderators Lawrence X. Yu, Ph.D. U.S. Food and Drug Administration Tycho Heimbach, Ph.D., M.S. Novartis Mechanistic Approaches to Predicting Oral Drug Absorption Gordon Amidon, Ph.D. University of Michigan Roles of Oral Drug Absorption and Exposure Prediction in Drug Development Tycho Heimbach, Ph.D., M.S. Novartis Roles of Oral Drug Absorption Prediction in Regulatory Review Robert Lionberger, Ph.D. U.S. Food and Drug Administration
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