Wednesday, January 23rd, 2008
| 8:15 | Morning Coffee |
| 8:45 |
Chair's Recap of Day One David Lechuga-Ballesteros, PhD, Senior Director R&D, ARIDIS PHARMACEUTICALS Dr. Ian C. Boulton, Former Development Scientist, Formulation & Stability, SANOFI-PASTEUR, |
| 9:00 |
Case Study: Formulation and Forced Degradation Considerations in Vial and Dual Chamber Cartridge and/or Syringe Susan W.H. Martin, PhD, Prinicipal Scientist, PFIZER, PHARMACEUTICAL, R&D-GLOBAL BIOLOGICS |
| 9:30 |
Case Study:When Correlations Fail-Understand the Differences between Differential Scanning Calorimetry and Real-Time Stability David Sek, Scientist II, WYETH BIOPHARMA |
| 10:00 |
Case Study: Structure and Stability Changes of Human IgG1 Fc as a Consequence of Methionine Oxidation Dingjiang Liu, PhD, Principal Scientist, Department of Protein Formulation, Amgen |
| 10:30 | 30 Minute Networking & Refreshment Break |
| 11:00 |
Case Study: Use of Biophysical Characterization Techniques for Forced Degradation Studies to Support Formulation Development Tim Kelly, PhD, Vice President, Biopharmaceutical Development, KBI BIOPHARMA, INC. |
| 11:30 |
Implementation of a flexible yet cGMP complaint Stability Program for Phase I, II and III Studies Nanda K. Subbarao, PhD, Senior Consultant, BIOLOGICS CONSULTING GROUP |
| 12:30 | Luncheon |
| 1:45 |
Therapy Time for Biomolecular Development Challenges! Bring your own case study! Faciliated by the conference co-chairs, attendees are encouraged to bring forth their own formulation and forced degradation challenge(s) and the audience will help with the sharing of suggested solutions. This session promises to be highly interactive and one of the highlights for getting the best real tips!
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| 2:45 | Afternoon Tracks Begin |
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Track A: Formulation Track |
Track B: Forced Degradation/Analytical Track |
Track C: New Generation Application of Innovative Drug Delivery Technology |
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| 2:45 |
Case Study: Leverage Novel Excipients in the Design of Stable Formulations for Inhalable Biopharmaceuticals David Lechuga-Ballesteros, PhD, Senior Director R&D, ARIDIS PHARMACEUTICALS | Case Study: Isomerization of Aspartic Acid and Its Potential Impact on Other Quality Attributes
Christopher J. Roberts, PhD, Assistant Professor, Department of Chemical Engineering, UNIVERSITY OF DELAWARE |
Controlled Drug Delivery Systems that Overcome the Mucus Barrier Justin Hanes, PhD, Oncology Director of Therapeutics, THE INSTITUTE FOR NANOBIOTECHNOLOGY, JOHNS HOPKINS UNIVERSITY |
| 3:15 |
Case Study: Scale-Up of Formulations for the Big Picture for Better Process Design Victor Lee, Associate Director, Manufacturing and Equipment Engineering, TEVA PARENTERAL MEDICINES |
Modeling and Predicting Aggregation Kinetics for Biopharmaceuticals Christopher J. Roberts, PhD, Assistant Professor, Department of Chemical Engineering, UNIVERSITY OF DELAWARE | Advances in Ophthalmic Drug Delivery: Topical Treatment Options – Are We There Yet?
Hovhannes J. Gukasyan, PhD, Worldwide Pharmaceutical Sciences, Research Science & Technology Formulations, PFIZER GLOBAL R&D |
| 3:45 |
Panel Discussion: Orthogonal Methods and Characterization Technologies To Characterize Degradants and Aggregates Panelists: Dingjiang Liu, PhD, Principal Scientist, Department of Protein Formulation, Amgen Elizabeth M. Topp, PhD, Professor of Pharmaceutical Chemistry, UNIVERSITY OF KANSAS Qin Chin Zou, PhD, Research Scientist, ELI LILLY AND COMPANY |
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| 4:15 | Conference Concludes | ||
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