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Sunday, November 11

8:30 am – 4:00 pm

• Challenges in Developing Biologics: Industry and Regulatory Expectations

Short Course

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

Monday, November 12

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8:00 am – 10:00 am

• AAPS Graduate Student Symposium in Biotechnology and the Biotechnology Research Achievement Award Winner Lecture

2:00 pm – 4:30 pm

• Technology Challenges and Risk Analysis of Immunogenicity Assessment on Biologics
  

Symposium

5:00 pm – 6:15 pm

• AAPS Biotechnology (BIOTEC) Section Membership Meeting

6:30 pm – 7:30 pm

• AAPS Biotechnology (BIOTEC) Section Reception

Tuesday, November 13

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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

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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

• Adaptive Design for Clinical Trials
  Wednesday Morning Symposia are Funded by a Grant from
  

symposium

8:30 am – 11:00 am

• Design and Conduct of First-in-Human Studies for "High-risk" Therapeutic Proteins
  Wednesday Morning Symposia are Funded by a Grant from
  

Symposium

2:00 pm – 4:00 pm

• Devices Used for Nucleic Acid Delivery

Roundtable

Thursday, November 15

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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

1:30 pm – 5:00 pm

• BIOTEC Open Forum
  Practical Biomarker Assay Development, Validation and Sample Results for Drug-Exposure-Effect Assessments
  Co-sponsored with Ligand-binding Assays Bioanalytical Focus Group
  

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