Topics Covered

• GI Physiological Variables and Drug Absorption
• Dissolution and Oral Absorption Evaluation
• Intestinal and Hepatic Transport and Metabolism
• Oral Delivery Systems: Formulation and Regulatory Standards
• Biopharmaceutics: From Discovery to Regulation

Organizers

• Gordon L. Amidon, USA
• Hans Lennernas, Sweden
• Peter Langguth, Germany
• James Polli, USA
• Shinji Yamashita, Japan

Agenda

Sunday, March 7th - Opening Day

• 5:30 - 7:00 PM: Registration – 3rd Floor – Promenade 2 – right off escalator
• 7:00 - 9:00 PM: Cocktail Reception – 3rd Floor – Emerald Bay 4 & 5

Monday, March 8th - Day 2

GI Physiological Variables & Drug Absorption (3rd Floor – Emerald Bay 4 & 5)

• 7:30–8:30 AM: Breakfast – (Tallac Room – 12th Floor)
• 8:30-9:20 AM: 1 - Oral Drug Delivery: A Mechanistic Approach (Amidon)
• 9:20-10:30 AM: 2 - Gastrointestinal Physiological Variables (Bermejo)
• 10:30-10:50 AM: Break     
• 10:50-12:00 AM: 3 - Cell Culture Methods & Permeability (Polli)
• 12:00-1:30 PM: Lunch – (Tallac Room – 12th Floor)     
• 1:30-2:20 PM: 4 - Mechanisms of Intestinal Membrane Permeation (Lennernas)
• 2:20-3:10 PM: 5 - Cell/Molecular Biology of Epithelial Cells in GI, Liver & Kidney (KD Lee)
• 3:10-3:30 PM: Break 
• 3:30-4:20 PM: 6 - GI Permeability & Transit:  Oral Absorption (Swaan)
• 4:30-6:00 PM: 7 - Poster/Abstract Session:  Wine & Cheese – Pre-function area    

Tuesday, March 9th - Day 3

Methods for Evaluation of Oral Drug Absorption and Drug Formulation (3rd Floor – Emerald Bay 4 & 5)

• 7:00-8:00 AM: Breakfast – (Emerald Bay 1 & 2 – 3rd Floor)
• 8:00-8:50 AM: 8 - In Vivo & In Situ Permeability Methods (Lennernas)
• 8:50-9:40 AM: 9 - Biophysical Predictive Absorption Models & Applications (Bermejo)
• 9:40-10:30 AM: 10 - In Vitro and In Vivo Approaches to Drug Absorption Screening: Permeability Assessment (Yamashita)
• 10:30-10:45 AM: Break 
• 10:45-11:35 AM: 11 - Analysis of Drug Absorption From PK Studies (Langguth)
• 11:35-12:25 PM: 12 - In Vivo Dissolution and IVIVC (Cook)
• 12:30-2:00 PM: Lunch – (Tallac Room – 12th Floor)
• 2:00-2:50 PM: 13 - Unit Operations in Solid Dosage Forms (Gupta)
• 2:50-3:40 PM: 14 - Dissolution Methodologies & Issues (Abrahamsson)
• 3:40-4:00 PM: Break 
• 4:00-4:45 PM: 15 - Case Studies & Discussion – Groups 1 & 2    
• 4:45-5:30 PM: 16 - Extended Release Technology (Gupta)
• 6:30-10:00 PM: Dinner and Social Event – (3rd Floor – Emerald Bay A 1, 2 & 3)

Wednesday, March 10th - Day 4  

Intestinal and Hepatic Transport and Metabolism (3rd Floor – Emerald Bay 4 & 5)

• 7:30-8:30 AM: Breakfast – (Emerald Bay 1 & 2)
• 8:30-9:20 AM: 17 - Role of Transporters in Drug Absorption (Tamai)
• 9:20-10:10 AM: 18 - Liver Transport: Uptake and Excretion (Lennernas)
• 10:10-11:00 AM: 19 - Intestinal Metabolism: Mechanisms & Effect on Fsys (Langguth)
• 11:00–11:30 AM: Lunch (Box Lunches Available)    

**Wednesday Afternoon Free** 

• 7:00-10:00 PM: Hands On – (Emerald Bay A); In Silico Predictions of Drug Absorption &  Bioavailability (Computer Demonstrations – software provided – please bring laptops) (Bolger)

Thursday, March 11th - Day 5

Poorly Soluble Drugs (3rd Floor – Emerald Bay 4 & 5)

• 7:30-8:30 AM: Breakfast – (Emerald Bay 1 & 2)
• 8:30-9:20 AM: 20 - Selected Formulation Approaches for Water Insoluble Drugs (Langguth)
• 9:20-10:15 AM: 21 - Dissolution of Insoluble Drugs: Ex Vivo Fluid Studies (Abrahamsson)
• 10:15-10:30 AM: Break     
• 10:30-11:20 AM: 22 - Regulatory Evaluation of Pharmaceutical Quality (Yu)
• 11:20-12:10 PM: 23 - Development of BCS Class 2 to 4 Compounds: Recommendations and Experiences from a Company Consortium (Yamashita)
• 12:10-1:30 PM: Lunch – (Emerald Bay 1 & 2)
• 1:30-2:20 PM: 24 - Dissolution Absorption and IVIVC (Polli)
• 2:20-3:10 PM: 25 - Case Studies & Discussion – Groups 3, 4 & 5    
• 3:10-3:25 PM: Break

Oral Delivery Challenges

• 3:25-4:05 PM: 26 - Prodrug Approaches to Enhancing Absorption (Tamai)
• 4:05-4:45 PM: 27 - Enhancement of Oral Absorption of Polar Drugs (Hilfinger)
• 4:45-5:30 PM: 28 - Mucosal Immune Systems and Vaccine Delivery (KD Lee)

Friday, March 12th - Day 5

Biopharmaceutics: From Discovery to Regulation (3rd Floor – Emerald Bay 4 & 5)

• 7:30-8:30 AM: Breakfast – (Emerald Bay 1 & 2)
• 8:30-9:40 AM: 29 - The Science of BE Requirements: Perspective from a Pharmaceutical Company (Cook)
• 9:40-10:30 AM: 30 - Evolving Bioequivalence Standards    Yu
• 10:30–11:00 AM: 31 - Biopharmaceutics & BCS: Future Role in Discovery, Development, Regulation (Amidon)

Full program is available here.