ODD2009: Strategies for Oral Drug Delivery

Presented By

The Drug Delivery Foundation, Ann Arbor, MI

Garmisch-Partenkirchen, Germany

07:30-08:30am: Breakfast
08:30-09:20am: Oral Drug Delivery: A Mechanistic Approach, Amidon
09:20-10:30am: Gastrointestinal Physiological Variables, Bermejo
10:30-10:50am: Break
10:50am-12:00pm: GI Permeability and Transit: Oral Fraction Absorbed, Amidon
12:00-01:30pm: Lunch
01:30-02:20pm: Mechanisms of Intestinal Membrane Permeation, Lennernas
02:20-03:10pm: Fraction Dose Absorbed: Soluble and Insoluble Drugs, BCS, Amidon
03:10-03:30pm: Break
03:30-04:20pm: Cellular/Molecular Mechanisms of Transport Across Epithelium, KD Lee
04:20-05:00pm: Panel Discussions, Amidon, Bermejo, Lennernas, Lee

07:00-08:00am: Breakfast
08:00-08:50am: Overview - Permeability Methods from In Vitro to In Vivo human, Lennernas
08:50-09:40am: Cell Culture Methods and Permeability, Polli
09:40-10:30am: In Vitro Approaches to Drug Absorption Screening, Yamashita
10:30-10:45am: Break
10:45-11:35am: Biophysical Predictive Absorption Models & Applications, Bermejo
11:35-12:25am: Development of BCS Class 2 to 4 Compounds – Recommendations and Experiences from a Company Consortium, Yamashita
12:30-02:00pm: Lunch
02:00-02:50pm: In vivo Dissolution and IVIVC, Cook
02:50-03:40pm: Analysis of Drug Absorption from PK Studies, Langguth
03:40-04:00pm: Break
04:00-04:45pm: Dissolution of Water Insoluble Drugs: Ex Vivo Fluids, Abrahamsson
04:45-05:30pm: Panel Discussion, Abrahamsson, Cook, Langguth, Yamashita, Bermejo, Lennernas

07:30-08:30am: Breakfast
08:30-09:20am: Role of Transporters in Drug Absorption, Tamai
09:20-10:10am: Liver Transport: Uptake and Excretion, Lennernas
10:10–10:30am: Break
10:30-11:15am: Access Path to the Site of Action: Predictability and Relevance Of Apparent Transporter Affinities, Spahn-Langguth
11:15–12:00pm: Simulation of the Non-linear Dose Dependence for Substrates of Influx and Efflux Transporters in the Human Small Intestine, Bolger
12:00pm: Lunch (Box Lunch)
**Wednesday Afternoon Free**
07:00-10:00pm: Computational Approaches: In Silico Predictions of Drug Absorption and Bioavailability & Computer Demonstrations – software provided – please bring laptops
The “Bottom-Up” Approach to Predicting Population PK - Simcyp, Tucker
Computer Simulations: GastroPlus, Woltosz
Computer Simulations: PK-Sim, Willmann

07:30-08:30am: Breakfast
08:30-09:20am: Nanoparticles of Poorly Soluble Drugs, Lindfors
09:20-10:10am: Formulation Approaches for Water Insoluble Drugs, Langguth
10:10-10:30am: Break
10:30–11:20am: Regulatory Assessment of Pharmaceutical Quality, Yu
11:20-12:10pm: The 100 mg Approach – Maximizing Information in Early Development, TBA
12:10-01:30pm: Lunch
01:30-02:20pm: Dissolution Absorption and IVIVC, Polli
02:20-03:10pm: Prodrug Approaches to Enhancing Absorption, Tamai
03:10-03:25pm: Break
Oral Delivery Challenges
03:25-04:05pm: Enhancement of Oral Absorption of Polar Drugs, Hilfinger
04:05-04:45pm: Mucosal Immune Systems and Vaccine Delivery, KD Lee
04:45-05:30pm: Panel Discussions, Polli, Lindfors, Langguth, Lee, Hilfinger, Yu, Tamai
06:30-10:00pm: Dinner and Social Event

07:30-08:30pm: Breakfast
08:30-09:40am: Formulations Development BA/BE: An Industrial Perspective, Cook
09:40-10:30am: BE Requirements: Regulatory Assessment, Yu
10:30-11:00am: Biopharmaceutics: Discovery, Development, Regulation, Amidon