Webcasts / Podcasts from the 2007 AAPS Annual Meeting and Exposition
Recorded at the San Diego Convention Center
Note: All media content contained herein, including mention of products and services, is the opinion of the original presenters and is not necessarily endorsed by AAPS. Content discussing legal issues is offered as general information only and is not to be construed as specific legal advice.
Formats available:
Video: Synchronized PowerPoint™ slides with audio lecture in Windows Media (wmv) format
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Podcasts: Mp3 files of recorded lecture material
Slides: Presenters’ lecture slides in pdf format
Free-to-Members Webcasts:
The following sessions are free to members. Click on the links below and enter your AAPS member number and password.
The Keynote Address
Combining Biomedical Research within Academia and Industry in the 21st Century, Roger J. Pomerantz, M.D., F.A.C.P., Tibotec Pharmaceuticals, Ltd.
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The Plenary Session: The Economics of Pharmaceutical Development
When R&D is Not Enough: Delivering Essential Medicines, Victoria Hale, Ph.D., Institute for One World Health
Economic Perspectives on the Drug Development Process, Kevin I. Kaitin, Ph.D., Tufts University
Maximizing Efficiency in Clinical Development, Michael Rosenberg, M.D., Ph.D., Health Decisions
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The 2007 Distinguished Scientist Lecture
Retrometabolic Drug Design and Targeting Strategies: Soft Drugs and Chemical Delivery Systems, Nicolas Bodor, Ph.D., D.Sc, University of Florida
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The Presidential Debate
The Impact of Mergers and Acquisitions on Innovation in R&D, Drs. R. Bergstrom, V. Shah, M. Rocci
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2008 AAPS Presidential Goals
Karen Habucky, Ph.D.
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Regulatory Relief from PAT and Quality by Design: Does it Truly Exist?
PAT and QbD: Where Have We Come? Where Do We Go From Here?, G.K. Raju, Ph.D., Light Pharma, Inc.
Regulatory Flexibility through PAT and QbD: An FDA Perspective, Chi-wan Chen, Ph.D., U.S. Food and Drug Administration
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Metabolic and Transporter Drug Interactions: Design and Conduct of Preclinical and Clinical Studies
Transporter Phenotyping: Application of Novel Technologies in Drug Discovery and Development, Praveen V. Balimore, Ph.D., Bristol-Myers Squibb
Preclinical Evaluation of Metabolic Drug-drug Interactions, William G. Humphreys, Ph.D., Bristol-Myers Squibb
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Design and Conduct of First-in-Human Studies for High-risk Therapeutic Proteins
TGN1412 A Regulatory Perspective and Recommendations, Jan Mueller-Berghaus, M.D., Paul-Ehrlich-Institut
Points to Consider in Design and Conduct of FIH Studies for High-Risk Therapeutic Proteins: Industrial Perspective, Jennifer E. Visich, Ph.D., Genentech, Inc.
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Fee-Based Symposia:
The following symposia are fee-based and are available individually. Please click on the “REGISTER” button below each title for payment information and a form to be faxed in to AAPS. Upon receipt of payment, you will receive a special URL, username and password. To view content, enter the URL provided and insert the access codes provided in lieu of your member login.
Attendees, presenters and moderators of the 2007 AAPS Annual Meeting and Exposition in San Diego may view all fee-based symposia listed below at no charge, upon receipt of registration form.
Advances in Modeling and Simulation of Drug Absorption to Support Oral Formulation Development
- General Overview: Delineating Factors Limiting Oral Absorption
Lawrence X. Yu, Ph.D., U.S. Food and Drug Administration
- Can Dissolution/Absorption Models be Used to Set API Particle Size Specifications?
Venkatramana Rao, Ph.D., Bristol-Myers Squibb Company
- Drug Absorption Modeling as a Tool to Define the Strategy in Clinical Formulation Development
Martin Kuentz, Ph.D., University of Applied Science
- Predicting Pharmacokinetics of Drugs Using Physiologically Based Modeling
Neil Parrott, Ph.D., Hoffmann-LaRoche, Inc.
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Biomarkers and Metabolic Profiles: Microdialysis Sampling and Analytical Frontiers In Tissue Targeted Metabonomics
- Studying Rat Brain Neurochemistry Using Nanoprobe NMR Spectroscopy: A Metabonomics Approach
Alvin C. Bach, II, Ph.D., Wyeth Research
- Metabolic Profiling of the Traumatic Human Brain
Jonas Bergquist, Ph.D., Dr. Med. Sci
- Metabolic Profiling of Human Liver Microdialysates: Amino Acids and 3-Nitrotyrosine
Douglas Richards, Ph.D., University of Birmingham Medical School
- Tissue-Targeted Metabonomics and Biomarker Approaches to Studying Oxidative Stress
Craig Lunte, Ph.D., University of Kansas
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Development and Regulatory Challenges for Drug-device Combination Products
- Development/CMC Challenges from the FDA Perspective
Kasturi Srinivasachar, Ph.D., U.S Food & Drug Administration
- Development Challenges in Drug-device Combination Products: Industry Perspective
H. Semih Oktay, Ph.D., CardioMed Device Consultants
- Regulatory/Clinical Challenges in Developing Combination Products: FDA Perspective
Elizabeth Hillebrenner, MSE, U.S Food & Drug Administration
- Quality Regulatory Considerations of Combination Products: Industry Perspective
Steven R. Koepke, Ph.D., SRK Consulting
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Marine Natural Products as Candidates for Clinical Development
- Discovery of Marine Natural Products
William Fenical, Ph.D., University of California, San Diego
- Marine Pharmacology: A Critique of the Preclinical and Clinical Literature
Alejandro M. Mayer, Ph.D., Midwestern University
- Marine Natural Products in Clinical Trials
David J. Newman, Ph.D., National Institutes of Health
- Development of Conotoxins as Clinical Candidates
Baldomero Olivera, University of Utah
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Technology Challenges and Risk Analysis of Immunogenicity Assessment on Biologics
- Emerging Technologies for Immunogenicity Assessment
Steven J. Swanson, Ph.D., Amgen, Inc.
- Risk Analysis of Immunogenicity Assessment on Biologics: a Case Study
Michael L. Fox, Genentech
- Drug Interference in Immunogenicity Assays: Issues and Approaches to Resolve
Daniel Baltrukonis & Deborah Finco-Kent, Pfizer, Inc
- Challenge to Choose the Right Analytical Method in Clinical Immunogenicity Assessment
Dong Geng, Ph.D., Bristol-Meyers Squibb Company
- Challenges of Correlating Immunogenicity with Clinical Safety and Efficacy: Naglazyme Case Study
Erik D. Foehr, Ph.D., BioMarin Pharmaceuticals
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Current Issues and Advances in the Determination of Bioequivalence
- Determination of Bioequivalence of Highly Variable Drugs
Laszlo N. Endrenyi, Ph.D., University of Toronto
- Interim and Sequential Analysis
Charles Bon, M.S., Biostudy Solutions, LLC
- Application of Population Pharmacokinetics
Murray P. Ducharme, Pharm.D., FCCP, FCP, University of Montreal
- Challenges in Demonstrating Bioequivalence for Second-Entry Products
Yu-Chung Tsang, B.Sc., Phm, Pharm.D., APOTEX
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What Does Food Have to Do With It? Effects on Enzymes and Transporters
- Dietary/Herbal Supplements and Nuclear Receptor Activation on Enzymes: Effects on CAR and PXR
Thomas K.H. Chang, Ph.D., University of British Columbia
- Diet/Herbal-Drug Interactions: Transporter-mediated Changes in Drug Disposition
Marilyn Morris, Ph.D., University at Buffalo
- Juices, Enzymes and Transporters
David G. Bailey, Ph.D., University of Western Ontario
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