- Development and Evaluation of Controlled Release Products with Emerging Technologies
Patrick Marroum, Ph.D. FDA
- Optical Imaging: Exploring Noninvasive Molecular Imaging Biomarkers for Drug Discovery and Development
Jeremy W. Wellen, Ph.D., Xinkang Wang, Ph.D., & Hong I. Wan, Ph.D. Wyeth Research
- Toxicology Issues in Extractables and Leachables
William P. Beierschmitt, Ph.D, D.A.B.T. Pfizer, Inc.
- Convergence of Auto-Injectors with Prefilled Syringes: Inspection Capabilities and Challenges
Richard Law, Ph.D. Amgen
- Incorporation of a Pharmaceutical QC as Part of Dissolution Testing System Suitability
Lee Allen, Ph.D. Procter and Gamble Pharmaceuticals
- Adventitious Virus Testing:Contribution to the Safety of Biopharmaceuticals
Dr Michael Ruffing Boehringer Ingelheim Pharma GmbH & Co. KG
- Risk Assessment for a Rapid Mycoplasma Test Optimized for Cell Therapy Products
John Duguid, Grace Kielpinski, Barbara Seymour & Gary du Moulin, Ph.D. Cell Therapy Manufacturing Technical Services Genzyme
- The Path Forward for Supercritical Fluid Chromatography in the Drug Development Environment - An Industrial Perspective
Zhenyu Wang, Ph.D., Oscar Liu, Ph.D. & Brent Donovan, Ph.D. Oral and Specialty Product Development, Schering-Plough Research Institute
- Transforming Drug Development with a Fully Outsourced Model: Lessons Learned for Biopharmaceuticals
Terri A. Roberson, Neil V Smith & Joel Scherer Eli Lilly & Co., Inc.
- Complying with the USP Residual Solvents Requirements: Industry Perspectives
Susan Schniepp Schniepp and Associates, LLC
- Quality by Design for Pharmaceutical Microbiology
Stephen Langille. Ph.D., Lynne Ensor, Ph.D., & David Hussong, Ph.D. FDA
- A Comprehensive Strategy to Develop and Implement a Multi-Site NIR Method for Identification of Raw Materials
Guoxiang Chen, Ph.D. & Fred Kamal, Ph.D. Bayer HealthCare Joseph Phillips, Ph.D. Amgen
- Applying Raman Spectroscopy to Design of Lyophilization Cycles for Protein Formulation Development
Sampath Krishnan, Ph.D., Wenjin Cao, Ph.D., & Joseph Phillips, Ph.D. Amgen
- Clinical Pharmacology and Biopharmaceutic Considerations in Pediatric Global Drug Development
Gilbert J. Burckart, Ph.D. Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, U.S. FDA
- Single-Use Technology and the Carbon and Water Footprints of Biopharm Manufacturing
Lindsay Leveen Genentech
