| Monday, November 12, 2007 | ||
| 07:00:00 | Registration and Morning Coffee (07:00-08:00) | |
| 08:00:00 | Chairperson's Opening Remarks (08:00-08:15) | Ned Mozier |
| 08:15:00 | Assessing Structure/Function Relationships (08:15-10:45) | Xu-Rong Jiang, Aparna Deora, Tatjana Matejic, Michael W. Washabaugh |
| 08:15:00 | Assessing Structure/Function Relationships :Development and Validation of Rapid Homogeneous Quantitative Potency Assays for Biotech Products (08:15-08:45) case study | Xu-Rong Jiang |
| 08:45:00 | Assessing Structure/Function Relationships :Developing Functional Bioassays to Monitor Quality of Protein Therapeutics (08:45-09:15) | Tatjana Matejic |
| 09:15:00 | Assessing Structure/Function Relationships :Protein Changes that Make a Difference: Measuring the Impact on Biopotency with Various Bioanalytical Methods (09:15-09:45) | Aparna Deora |
| 09:45:00 | Assessing Structure/Function Relationships :Assessing Product Potency & Related Characteristics of Gardasil,® a Recombinant HPV Vaccine (09:45-10:15) case study | Michael W. Washabaugh |
| 10:15:00 | Assessing Structure/Function Relationships :Networking Refreshment Break and Poster/Exhibit Viewing (10:15-10:45) | |
| 10:45:00 | Analysis of Protein Glycosylation (10:45-13:25) | Parastoo Azadi, An Song, Tina S. Morris |
| 10:45:00 | Analysis of Protein Glycosylation:Anticipating Effects of Glycosylation on Effector Functions (10:45-11:15) | An Song |
| 11:15:00 | Analysis of Protein Glycosylation:Glycosylation of Biologically Important Glycoproteins and Determining Their Glycan Structure (11:15-11:45) | Parastoo Azadi |
| 11:45:00 | Analysis of Protein Glycosylation:Developing Standards and Compendial Assays for Glycoprotein and Glycan Analysis (11:45-12:15) | Tina S. Morris |
| 12:15:00 | Analysis of Protein Glycosylation:Networking Luncheon and Poster/Exhibit Viewing (12:15-13:25) | |
| 13:25:00 | Causes and Assessment of Product and Process-Related Impurities:Chairperson's Remarks (13:25-13:30) | Michael G. Mulkerrin |
| 13:25:00 | Causes and Assessment of Product and Process-Related Impurities (13:25-18:30) | Michael G. Mulkerrin, Peter J. Nicastro, Patrick H. Brown, Fred Jacobson, Allen Minton, Louise E. Duffy |
| 13:30:00 | Causes and Assessment of Product and Process-Related Impurities:Protein Aggregation and Bioprocessing (13:30-14:00) | Fred Jacobson |
| 14:00:00 | Causes and Assessment of Product and Process-Related Impurities:Comparison of Techniques for Aggregate Measurement (14:00-14:30) case study | Peter J. Nicastro |
| 14:30:00 | Causes and Assessment of Product and Process-Related Impurities:Concentration-Dependant Aggregation of Proteins (14:30-15:00) | Allen Minton |
| 15:00:00 | Causes and Assessment of Product and Process-Related Impurities:Networking Refreshment Break and Poster/Exhibit Viewing (15:00-15:30) | |
| 15:30:00 | Causes and Assessment of Product and Process-Related Impurities:Detection of Antibody Trace Aggregates by Sedimentation Velocity Analytical Ultracentrifugation (15:30-16:00) | Peter Schuck, Patrick H. Brown |
| 16:00:00 | Causes and Assessment of Product and Process-Related Impurities:Development of Standards for the Quantification of Protein A and DNA Impurities in Human Therapeutics (16:00-16:30) | Michael G. Mulkerrin |
| 16:30:00 | Causes and Assessment of Product and Process-Related Impurities:Keynote Address,Current and Future Challenges of Bringing Biopharmaceuticals to Market (16:30-17:10) | Louise E. Duffy |
| 17:10:00 | Causes and Assessment of Product and Process-Related Impurities: Exhibit Hall Networking (17:10-18:30) | |
| 18:30:00 | End of Day 1 | |
| Tuesday, November 13, 2007 | ||
| 07:30:00 | Morning Coffee (07:30-08:00) | |
| 08:00:00 | Chairperson's Opening Remarks (08:00-08:15) | Carol Hasselbacher |
| 08:15:00 | Analytical Techniques to Determine Relationship of Immunogenicity and Post-Translational Modifications to Protein Structure: Development of Immunogenicity Assays for Topically Applied Thrombins (08:15-08:45) case study | Linda Zuckermann |
| 08:15:00 | Analytical Techniques to Determine Relationship of Immunogenicity and Post-Translational Modifications to Protein Structure (08:15-09:15) | Matthew M. Champion, Linda Zuckermann |
| 08:45:00 | Analytical Techniques to Determine Relationship of Immunogenicity and Post-Translational Modifications to Protein Structure: Targeted LC/MS/MS Techniques Characterize Recombinant Therapeutics, Including Sequence Heterogeneity, and Low-Frequency Post Translational Modifications (08:45-09:15) | Matthew M. Champion |
| 09:15:00 | Stability Indicating Methods and Interpretation of Stability Data for Biotech Products: Stability Guidances and Regulations: Gaps, Lapses, and Missing Links (09:15-09:45) | Joseph Kutza |
| 09:15:00 | Stability Indicating Methods and Interpretation of Stability Data for Biotech Products (09:15-12:15) | Carol Hasselbacher, Brian D. Schmidt, Matthias Kretschmer, Joseph Kutza, Martin D. Sterman |
| 09:45:00 | Stability Indicating Methods and Interpretation of Stability Data for Biotech Products: Networking Refreshment Break and Poster/Exhibit Viewing (09:45-10:15) | |
| 10:15:00 | Stability Indicating Methods and Interpretation of Stability Data for Biotech Products: Multivariate Analysis Applied to Protein Stability Studies (10:15-10:45) | Martin D. Sterman |
| 10:45:00 | Stability Indicating Methods and Interpretation of Stability Data for Biotech Products: Use of Forced Degradation Studies in Development of Product Stability Programs (10:45-11:15) case study | Carol Hasselbacher |
| 11:15:00 | Stability Indicating Methods and Interpretation of Stability Data for Biotech Products: Transitioning to Platform Capillary Electrophoresis Technology to Support Accelerated IND Programs (11:15-11:45) | Brian D. Schmidt |
| 11:45:00 | Stability Indicating Methods and Interpretation of Stability Data for Biotech Products: Interpretation of Stability Data (11:45-12:15) | Matthias Kretschmer |
| 12:15:00 | Stability Indicating Methods and Interpretation of Stability Data for Biotech Products: Networking Luncheon and Poster/Exhibit Viewing (12:15-13:25) | |
| 13:25:00 | Regulatory Perspectives: Chairperson's Remarks (13:25-13:30) | Nadine M. Ritter |
| 13:25:00 | Regulatory Perspectives (13:25-17:00) | Nadine M. Ritter, Malcolm Moos, Duu-Gong Wu, Emily Shacter, Kathleen A. Clouse, Hannelore Willkommen |
| 13:30:00 | Regulatory Perspectives: Regulatory and Scientific Perspectives on Follow-On Biologics (13:30-14:00) | Duu-Gong Wu |
| 14:00:00 | Regulatory Perspectives: Current Regulatory Expectations for Pre and Post Approval Stability Studies (14:00-14:30) | Nadine M. Ritter |
| 14:30:00 | Regulatory Perspectives: Potency Issues - Cell-Based Functional Assays vs. Binding Assays (14:30-15:00) | Emily Shacter |
| 15:00:00 | Regulatory Perspectives: Networking Refreshment Break and Last Chance to View Posters/Exhibits (15:00-15:30) | |
| 15:30:00 | Regulatory Perspectives: Problems and Limitations with Analytical Methods - A Regulator's Perspective (15:30-16:00) | Malcolm Moos |
| 16:00:00 | Regulatory Perspectives: Assessing Impurities in Biotherapeutics (16:00-16:30) | Kathleen A. Clouse |
| 16:30:00 | Regulatory Perspectives: Virus Safety Evaluation of Clinical material - A New European Guideline (16:30-17:00) | Hannelore Willkommen |
| 17:00:00 | End of Day2 | |
| Wednesday, November 14, 2007 | ||
| 07:30:00 | Morning Coffee (07:30-08:00) | |
| 08:00:00 | Chairperson's Opening Remarks (08:00-08:15) | Alan Klotz |
| 08:15:00 | Early Formulation Development: Early Development Screening of Monoclonal Antibody Formulations (08:15-08:45) | Jim Andya |
| 08:15:00 | Early Formulation Development (08:15-09:15) | Jim Andya, Rohn Millican |
| 08:45:00 | Early Formulation Development: Pre-Formulation Assessment of Monoclonal Antibodies in Discovery (08:45-09:15) | Rohn Millican |
| 09:15:00 | CMC Approaches to Specific and Emerging Biotech Products: Characterization of Synthetic Peptides for Biotechnology - Unique Challenges (09:15-09:45) | Michael R Schlittler, |
| 09:15:00 | CMC Approaches to Specific and Emerging Biotech Products (09:15-10:45) | David Wohlpart, Michael R Schlittler, |
| 09:45:00 | CMC Approaches to Specific and Emerging Biotech Products: Characterization of Synthetic Peptides for Biotechnology - Unique Challenges (09:45-10:15) | David Wohlpart |
| 10:15:00 | CMC Approaches to Specific and Emerging Biotech Products: Networking Refreshment Break (10:15-10:45) | |
| 10:45:00 | Impact of Extractables and Leachables on Well Characterized Protein Products: Regulatory Considerations for Evaluating the Impact of Extractables and Leachables - A Risk-Based Approach (10:45-11:15) | Ingrid Markovic |
| 10:45:00 | Impact of Extractables and Leachables on Well Characterized Protein Products (10:45-13:25) | Richard Strong, Jerold Martin, John P. Hennessey, Ingrid Markovic, Raymond Colton, Thomas J. Murphy |
| 11:15:00 | Impact of Extractables and Leachables on Well Characterized Protein Products: Extractable and Leachable Issues and Concerns for Biopharmaceuticals - A Manufacturer's Perspective (11:15-11:30) | Richard Strong |
| 11:30:00 | Impact of Extractables and Leachables on Well CExtharacterized Protein Products: Extractables and Leachables Panel Discussion - Perspectives from the Suppliers,Topics to be discussed include: (11:30-12:10) | Raymond Colton, Thomas J. Murphy, Richard Strong, Jerold Martin |
| 12:10:00 | Impact of Extractables and Leachables on Well CExtharacterized Protein Products: Lunch on Your Own (12:10-13:25) | |
| 13:25:00 | Emerging Analytical Technologies (13:25-15:30) | James L. Wilbur, Huawei Qiu, John P. Hennessey, John R. Engen |
| 13:25:00 | Emerging Analytical Technologies: Chairperson's Remarks (13:25-13:30) | John P. Hennessey |
| 13:30:00 | Emerging Analytical Technologies: Use of Electrochemiluminescence for Immunogenicity, Production Release and Potency Assays (13:30-14:00) | James L. Wilbur |
| 14:00:00 | Emerging Analytical Technologies: Hydrogen/Deuterium Exchange Mass Spectrometry for the Analysis of Protein Conformation and Dynamics (14:00-14:30) | John R. Engen |
| 14:30:00 | Emerging Analytical Technologies: Comparison of Surface Plasmon Resonance and Bio-Layer Interferometry Technologies (14:30-15:00) | Huawei Qiu |
| 15:00:00 | Emerging Analytical Technologies: Networking Refreshment Break (15:00-15:30) | |
| 15:30:00 | Process and Analytical Related Issues (15:30-17:00) | William M. Egan, Amit Banerjee, Ron Taticek, Timothy Schofield |
| 15:30:00 | Process and Analytical Related Issues: Quality by Design in the Development of Post-Approval Changes for Cell Culture Processes (15:30-16:00) | Ron Taticek |
| 16:00:00 | Process and Analytical Related Issues: Specifications - The Interface between Clinical, Analytical, and Process (16:00-16:30) | William M. Egan, Timothy Schofield |
| 16:30:00 | Process and Analytical Related Issues: A Risk-Based Approach to Process Characterization and Mapping of Design Space (16:30-17:00) | Amit Banerjee |
| 17:00:00 | End of Day3 | |
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