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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

Monday, November 12

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8:00 am – 10:00 am

• Clinical Trial Simulations: Many Questions, Few Answers

Roundtable

8:30 am – 11:00 am

• AAPS/ACCP Joint Symposium

2:00 pm – 4:00 pm

• Making a Decision on Drug Metabolism Data – Go or No Go

Roundtable

2:00 pm – 4:00 pm

• Pediatric Drug Development - Identifying the Needs, Meeting the Challenges

Roundtable

2:00 pm – 4:30 pm

• Monocarboxylate Transporters in Drug Disposition: Characterization, Regulation and Significance
  Monday Symposia are Funded by a Grant from
  

symposium

5:00 pm – 6:00 pm

• AAPS Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) Section Membership Meeting

6:15 pm – 7:15 pm

• Pharmacokinetics, Pharmacodynamics Aand Drug Metabolism (PPDM) Section Reception

Tuesday, November 13

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7:00 am – 8:15 am

• Imaging Technology and Clinical Target Site PK and PD Assessments: Emerging Opportunities and Potential Limitations

Sunrise Session

7:00 am – 8:15 am

• Metabolic and Transporter Drug Interactions: Design and Conduct of Preclinical and Clinical Studies

Sunrise Session

8:30 am – 11:00 am

• AAPS Graduate Student Symposium in Pharmacokinetics, Pharmacodynamics, Drug Metabolism and Clinical Pharmacology and Translational Research
  Sponsored by Eli Lilly and Company

9:00 am – 11:00 am

• Clinical and CMC Regulatory Considerations in Pediatric Drug Development

Roundtable

9:00 am – 11:00 am

• Formulation and Stability of Nutraceuticals

Roundtable

9:00 am – 11:00 am

• Translational Research in Neurological Sciences

Roundtable

2:00 pm – 4:00 pm

• Impact of Efflux Transporters in Drug Delivery

Roundtable

2:00 pm – 4:00 pm

• The Value of Domestic and International Outsourcing

Roundtable

2:00 pm – 4:30 pm

• Current Issues and Advances in the Determination of Bioequivalence

symposium

2:00 pm – 4:30 pm

• Role of Enzymes in Toxicity: Reactive Metabolites

symposium

2:00 pm – 4:30 pm

• Translational Research

poster/podium

Wednesday, November 14

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7:00 am – 8:15 am

• Appropriate Selection of Animal Models and their Use in Drug Development

sunrise Session

8:30 am – 11:00 am

WEDNESDAY MORNING SYMPOSIA

• Adaptive Design for Clinical Trials

• Current Advances in Xenobiotic Biotransformation and Transport

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

9:00 am – 11:00 am

• Pathophysiology Meets Modeling: Development of Disease Progression Models

roundtable

9:00 am – 11:00 am

• Toxicity Testing and Qualification of Impurities, How Far is Too Far?

roundtable

2:00 pm – 4:00 pm

• Predicting Metabolism and Toxicity between Species – Consequence for Human and Veterinary Medicine

roundtable

2:00 pm – 4:30 pm

• Advances in Modeling and Simulation of Drug Absorption to Support Oral Formulation Development

Symposium

2:00 pm – 4:30 pm

• Osteoporosis and Bone Disorders: A Showcase for Model-based Drug Development

Symposium

2:00 pm – 4:30 pm

• Transporters in Pathophysiology and Toxicity

Symposium

Thursday, November 15

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7:00 am – 8:15 am

Sunrise Session

• Practical LC-MS/MS Method Development Supporting the Drug Development Process

• What Does Food Have to Do With It? Effects on Enzymes and Transporters
  Thursday Sunrise Sessions are Funded by a Grant from
  

8:30 am – 11:00 am

• BCS Class IV Drugs: Develop or Discard?

symposium

8:30 am – 11:00 am

• Biomarkers and Metabolic Profiles; Microdialysis Sampling and Analytical Frontiers in Tissue Targeted Metabonomics

symposium

8:30 am – 11:00 am

• PK/PD Modeling and Simulation in Drug Discovery

roundtable

9:00 am – 11:00 am

• Prodrug Approaches for Site-Specific Cellular Targets

roundtable

1:30 pm – 5:00 pm

• PPDM Open Forum

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