9th Annual Biomarkers Congress
Well Characterized Biologicals - Continuous Evolution of Chemo- and Bioanalytical Approaches Nov(12 - 14)
Hyatt Regency Reston
1800 Presidents Street
Reston, Virginia 20190
http://www.ibclifesciences.com/wcb/7430.xml
Continuous Evolution of Chemo- and Bioanalytical Approaches - Advancing the State of Understanding for Protein Characterization 
Hyatt Regency Reston
IBC Lifesciences

Schedule of Presentations:

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 :Development and Validation of Rapid Homogeneous Quantitative Potency Assays for Biotech Products (08:15-08:45) case study Xu-Rong Jiang
08:15:00 Assessing Structure/Function Relationships (08:15-10:45) Michael W. Washabaugh, Tatjana Matejic, Aparna Deora, 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) Tina S. Morris, An Song, Parastoo Azadi
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 (13:25-18:30) Louise E. Duffy, Allen Minton, Fred Jacobson, Patrick H. Brown, Peter J. Nicastro, Michael G. Mulkerrin
13:25:00 Causes and Assessment of Product and Process-Related Impurities:Chairperson's Remarks (13:25-13:30) Michael G. Mulkerrin
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) Patrick H. Brown, Peter Schuck
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) Linda Zuckermann, Matthew M. Champion
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) Martin D. Sterman, Joseph Kutza, Matthias Kretschmer, Brian D. Schmidt, Carol Hasselbacher
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) Kathleen A. Clouse, Emily Shacter, Duu-Gong Wu, Malcolm Moos, Nadine M. Ritter, 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 (08:15-09:15) Rohn Millican, Jim Andya
08:15:00 Early Formulation Development: Early Development Screening of Monoclonal Antibody Formulations (08:15-08:45) Jim Andya
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) Michael R Schlittler,, David Wohlpart
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 (10:45-13:25) Thomas J. Murphy, Raymond Colton, Ingrid Markovic, John P. Hennessey, Jerold Martin, Richard Strong
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
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) Jerold Martin, Richard Strong, Thomas J. Murphy, Raymond Colton
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) John R. Engen, John P. Hennessey, Huawei Qiu, James L. Wilbur
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) Ron Taticek, Amit Banerjee, William M. Egan, 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
4th Annual Pharma R&D Asia Congress
About Us | Privacy Policy | Site Map | FAQs | Advertise With Us | Community
BiotechScienceNews.com promotes research and ranks life scientists working in the life science spectrum involving biotechnology,
drug discovery, genomics, microbiology, neuroscience, medicine, pharmacology, cell biology, and molecular biology.