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Sunday, November 11

8:30 am – 4:00 pm

• Methods for Pre-Screening Protein Therapeutics for Potential Clinical Immunogenicity

Short Course

8:30 am – 4:00 pm

• Recent Advances in HPLC and Related Chromatographic Procedures ? Application in Small vs. Large Molecules; Cross-fertilization Between Bioanalytical and Pharmaceutical Analysis Disciplines

Short Course

8:30 am – 4:00 pm

• Challenges in Developing Biologics: Industry and Regulatory Expectations

Short Course

Monday, November 12

2:00 pm – 4:30 pm

• Technology Challenges and Risk Analysis of Immunogenicity Assessment on Biologics

symposium

Tuesday, November 13

8:30 am – 11:00 am

• Preclinical Safety Evaluation for High Risk Therapeutic Proteins

symposium

9:00 am – 11:00 am

• Variability of Ligand Binding Assays Used for PK Protein Drug Bioanalysis ? Database Collected as a Follow-up to the 2006 AAPS Crystal City III Workshop

roundtable

2:00 pm – 4:30 pm

• Development of a Clinical Meaningful Immunogenicity Assessment Program

Tuesday Afternoon Symposia are Funded by a Grant from

symposium

Wednesday, November 14

7:00 am – 8:15 am

• Evaluation of Selectivity and Specificity of a Ligand Binding Assay for Macromolecules: An Underestimated Challenge

Sunrise Session

8:30 am – 11:00 am

• Design and Conduct of First-in-Human Studies for “High-risk” Therapeutic Proteins

Wednesday Morning Symposia Funded by a Grant from

Symposium

8:30 am – 11:00 am

• Adaptive Design for Clinical Trials

Wednesday Morning Symposia Funded by a Grant from

Symposium

2:00 pm – 4:00 pm

• Devices Used for Nucleic Acid Delivery

Roundtable

Thursday, November 15

9:00 am – 11:00 am

• Biosimilar/Biogenerics: Review of Regulatory Pathway

Roundtable

9:00 am – 11:00 am

• Emerging Pharmaceutical Markets: Are We Afraid of Outsourcing Yet?

Roundtable

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