ODD09 – Schedule

March 8-13, 2009 • Garmisch Germany

 

Day	Lecture	Title	Speaker
Sunday	3/8	Opening Day
6:00 - 7:00		Registration
7:00 - 9:00		Reception
Monday	3/9	GI Physiological Variables and Drug Absorption
8:30 - 9:20	1	Oral Drug Delivery: A Mechanistic Approach	Amidon
9:20 - 10:30	2	Gastrointestinal Physiological Variables	Bermejo
10:30 - 10:50		Break
10:50 - 12:00	3	GI Permeability and Transit: Oral Fraction Absorbed	Amidon
12:00 - 1:30		Lunch
1:30 - 2:20	4	Mechanisms of Intestinal Membrane Permeation	Lennernäs
2:20 - 3:10	5	Fraction Dose Absorbed: Soluble and Insoluble Drugs, BCS	Amidon
3:10 - 3:30		Break
3:30 - 4:20	6	Cellular/Molecular Mechanisms of Transport across Epithelium	Lee
4:20 - 5:00	7	Panel Discussions	Amidon Bermejo Lennernäs Lee
Tuesday	3/10	Dissolution and Oral Absorption Evaluation
8:00 - 8:50	8	Overview - Permeability Methods from In Vitro to In Vivo human	Lennernäs
8:50 - 9:40	9	Cell Culture Methods and Permeability	Polli
9:40 - 10:30	10	In Vitro Approaches to Drug Absorption Screening	Yamashita
10:30 - 10:45		Break
10:45 - 11:35	11	Biophysical Predictive Absorption Models & Applications	Bermejo
11:35 - 12:25	12	Development of BCS Class 2 to 4 Compounds – Recommendations and Experiences from a Company Consortium	Yamashita
12:30 - 2:00		Lunch
2:00 - 2:50	13	In Vivo Dissolution and IVIVC	Cook
2:50 - 3:40	14	Analysis of Drug Absorption from PK Studies	Langguth
3:40 - 4:00		Break
4:00 - 4:45	15	Dissolution of Water Insoluble Drugs: Ex Vivo Fluids	Abrahamsson
4:45 - 5:30	16	Panel Discussion	Lee Abrahamsson Langguth Yamashita Bermejo Cook Lennernäs
Wednesday	3/11	Intestinal and Hepatic Transport and Metabolism
8:30 - 9:20	17	Role of Transporters in Drug Absorption	Tamai
9:20 - 10:10	18	Liver Transport: Uptake and Excretion	Lennernäs
10:10 - 10:30		Break
10:30 - 11:15	19	Access path to the site of Action: Predictability and Relevance of Apparent Transporter Affinities	Spahn-Langguth
11:15 - 12:00	20	Simulation of the Non-linear Dose Dependence for Substrates of Influx and Efflux Transporters in the Human Small Intestine	Bolger
12:00		Lunch (Box Lunch)
		Wednesday Afternoon Free
7:00 - 10:00		Computational Approaches In Silico Predictions of Drug Absorption and Bioavailability Computer Demonstrations – software provided (please bring laptops)
	21	The “Bottom-Up” Approach to Predicting Population PK - Simcyp	Tucker
	22	Computer Simulations: GastroPlus®	Woltosz
	23	Computer Simulations: PK-Sim	TBA
Thursday	3/12	Oral Delivery Systems: Formulation & Regulatory Standards
8:30 - 9:20	24	Nanoparticles of Poorly Soluble Drugs	Lindfors
9:20 - 10:10	25	Formulation Approaches for Water Insoluble Drugs	Langguth
10:10 - 10:30		Break
10:30 - 11:20	26	Regulatory Assessment of Pharmaceutical Quality	Yu
11:20 - 12:10	27	The 100 mg Approach – Maximizing Information in Early Development	Balbach
12:10 - 1:30		Lunch
1:30 - 2:20	28	Dissolution Absorption and IVIVC	Polli
2:20 - 3:10	29	Prodrug Approaches to Enhancing Absorption	Tamai
3:10 - 3:25		Break
		Oral Delivery Challenges
3:25 - 4:05	30	Enhancement of Oral Absorption of Polar Drugs	Hilfinger
4:05 - 4:45	31	Mucosal Immune Systems and Vaccine Delivery	Lee
4:45 - 5:30	32	Panel Discussions	Polli Lindfors Langguth Lee Hilfinger Yu Tamai Balbach
6:30 - 10:00		Dinner and Social Event
Friday	3/13	Biopharmaceutics: From Discovery to Regulation
8:30 - 9:40	33	Formulations Development – BA/BE: An Industrial Perspective	Cook
9:40 - 10:30	34	BE Requirements: Regulatory Assessment	Yu
10:30-11:00	35	Biopharmaceutics: Discovery, Development, Regulation	Amidon