Preliminary Program - American Association of Pharmaceutical ...

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72 2009 AAPS Annual Meeting and Exposition AAPS Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) Programming 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. 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 ROUNDTABLES 2:00 pm – 4:00 pm In Vivo Animal Models for Prediction of Drug-drug Interactions Roundtable With the advent of polytherapy it has become prudent to minimize, as much as possible, the potential for drug-drug interactions. Conducting drug-drug interaction studies is expensive and there is great emphasis to proactively minimize potential for drug-drug interactions. Towards this end, the metabolic and transporter pathways involved in the disposition of a drug candidate (phenotyping) are evaluated in vitro employing available human tissue and specific reagents. Likewise, in vitro screening for inhibition and induction of drug-metabolizing enzymes and transporters is conducted also. Such in vitro human data can be made available prior to human dosing and enable in vitro to in vivo-based predictions of clinical outcomes. Despite some success, however, in vitro systems are not dynamic and sometimes fail to predict drug-drug interactions for a variety of reasons. In comparison, relatively less effort has been made to evaluate predictions based on data derived from in vivo animal models. The focus of this roundtable is to provide examples where animal models can be used to predict cytochrome P450-and transporter-based drug-drug interactions. Following brief presentations, there will be discussion surrounding caveats in employing these animal models and their utility in conjunction with in vitro-in vivo extrapolation methods. Such an integrated data set can be used to select drug candidates with a reduced drug interaction potential. Moderator Punit H. Marathe, Ph.D. Bristol-Myers Squibb In Vivo Animal Models for Prediction of CYP Inhibition-mediated Drug-drug Interactions Cuyue Tang, Ph.D. Merck and Co., Inc. In Vivo Animal Models for Prediction of CYP Induction-mediated Drug-drug Interactions Michael Sinz, Ph.D. Bristol-Myers Squibb In Vivo Animal Models for Prediction of Transporter-mediated Drug-drug Interactions Gary Bowers, Ph.D. GlaxoSmithKline plc WEDNESDAY AFTERNOON SYMPOSIA funded by a grant from 2:00 pm – 4:30 pm Mechanism-based PKPD Modeling: Its Role in Discovery and Early Development of Biologics Symposium Pharmacokinetic-Pharmacodynamic (PKPD) modeling is being increasingly applied early on in the discovery and development of all therapeutics. This technology has even higher relevance for biologics such as antibodies, because of their unique PKPD properties. The increase in computing power and higher resolution in analytical techniques for measuring cellular reactions has prompted increased confidence in in silico approaches such as computational systems biology in the design of therapeutics with optimal PKPD properties. The regulatory environment has also changed in recent years and PKPD modeling using preclinical data may be required to support first-in-human trial designs for “high-risk” biologics such as some antibodies. This symposium will discuss the importance of early investment in a PKPD modeling and simulation platform, discovery through preclinical development, and support the optimal progress of biologic programs. Moderators Ellen Q. Wang, Ph.D. Pfizer Global Research & Development Joseph P. Balthasar, Ph.D. University at Buffalo, The State University of New York Integration Not Isolation: The Role of Computational Systems Biology on the Discovery of Antibody Therapeutics John Burke, Ph.D. Boehringer Ingelheim Pharmaceuticals, Inc. PKPD Modeling of Preclinical Data Using a Surrogate Antibody to Underwrite Reprotoxicology Safety Saileta Prabhu, Ph.D. Genentech, Inc. PKPD vs. Toxicology-based Approach to Starting Dose Selection in First-in-Human Trials Balaji M. Agoram, Ph.D. Pfizer Global Research & Development Application of Mechanistic PKPD Modeling for Predicting Human PKPD Response Philip Lowe, Ph.D. Novartis Pharma AG 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
73 2009 AAPS Annual Meeting and Exposition AAPS Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) Programming 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 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. Thursday, November 12, 2009 THURSDAY SUNRISE SESSIONS 7:00 am – 8:15 am Humanized Transgenic Transporter Models — Update on State-of-the-Art Sunrise Session This sunrise session will provide up-to-date information on the state of the art with the various humanized transporter models. The human relevance of transporter based DDI’s can benefit via development of such humanized transporter models that expresses human transporters in animal models. The session will provide insights into all aspects of these project’s background, rationale, challenges, strategies, models, validations, implementation, future direction, etc. Leading scientists from academia and industry will be presenting the overview, as well as, the practical relevance of the humanized transporter models in drug discovery and development. Emphasis will be on the practical, and bottom line relevance of these models in facilitating clinical relevance of transporter based DDI’s. Moderator Praveen Balimane, Ph.D. Bristol-Myers Squibb Humanization Approaches: Technology and Strategic Approaches Kader Thiam, Ph.D. Gelita AG, Eberbach, Germany Use of Humanized Transporter Mice Models: ADME Applications Nico Scheer, Ph.D. Galderma 7:00 am – 8:15 am Physiologically Based Pharmacokinetic Modeling: Concepts and Applications in Drug Discovery and Development Sunrise Session This session will discuss the generic framework of Physiologically Based Pharmacokinetic (PBPK) models, and their applicability in drug discovery and development. In comparison to non-compartmental and compartmental approaches used routinely in drug discovery and development Physiologically Based Pharmacokinetic modeling (PBPK) provides a more mechanistic and physiological approach for integrating data and generating knowledge. Although, PBPK modeling has long been proposed as a modeling option, its application has only increased recently, in part, due to availability of in silico/in vitro prediction tools and generic easy-touse PBPK software. Over the past decade, multiple publications in both academia and industry have demonstrated the applicability of PBPK modeling in drug discovery and development. These applications range from use of PBPK models for candidate nomination in drug discovery, prediction of human pharmacokinetics from preclinical species, to clinical study design and efficacy predictions in drug development. This sunrise session intends to present the basic framework of generic PBPK models commonly used in literature and discuss selected case studies of their applicability in preclinical and clinical studies. Moderator Anjaneya P. Chimalakonda, Ph.D. Bristol-Myers Squibb Generic Physiologically Based Pharmacokinetic Models: Conceptual Framework Peter F. Thiel, Ph.D. Genentech, Inc. Selected Case Studies on Application of PBPK Modeling in Preclinical and Clinical Studies Thierry Lave, Ph.D. F. Hoffmann-La Roche Ltd.
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