Institute for Scientific Exchange, Inc. Presents:

DDI – 2007 10th International Conference on Drug-Drug Interactions: Scientific and Regulatory Updates and DDI Technologies in Depth: Enzyme Inhibition, Enzyme Induction and Drug-Transporter Interactions June 24-26, 2007 Pre-Conference Workshop: In Vitro Evaluations of ADMET Drug Properties in Drug Development June 24, 2007 Bellevue, WA, USA

Featuring experts from the following institutions: Amgen Inc.; APSciences; Boehringer-Ingelheim Pharmaceuticals, Inc.; BRI Biopharmaceutical Research Inc.; BRIVAL, LLC.; CellzDirect, Inc.; IVAL; Millennium Pharmaceuticals, Inc.; .; Novartis; NCI-NIH; Novartis; Pfizer, Inc.; Pfizer Global R&D; Promega; SimCyp; Sonus Pharmaceuticals Inc.; Tufts University; University of Sheffield; University of Washington

 

REGISTER NOW

 

 

June 24-26, 2007

DDI – 2007

10^th International Conference and Preconference Workshop on Drug-Drug Interactions:

Scientific and Regulatory Updates and DDI Technologies in Depth: Enzyme Inhibition, Enzyme Induction and Drug-Transporter Interactions

 

Sunday, June 24, 2007

 

 

The workshop is designed to provide novice and veteran practitioners with practical information on the application of in vitro ADMET experimental systems in drug development.  The following will be emphasized

1.       Scientific principles of the in vitro approaches

2.       Advantages and limitations of each approach

3.       Experimental procedures, with emphasis on critical steps

4.       Data evaluation and presentation

5.       Application of data to advance drug development projects

 

7:00 AM – 8:00 AM – Registration

 

8:05 AM – 8:10 AM Exhibitor Presentation – BRIVAL Inc.

 

8:05 AM – 9:05 PM

Role of In Vitro Experimental Systems in Drug Development (Albert P. Li, APSciences Inc. and IVAL/BRIVAL, Columbia MD and Vancouver, BC, CANADA)

·          Properties of in vitro experimental systems

·          Advantages and limitations

·          Choice of systems for specific applications

 

9:05 AM – 10:05 AM

Metabolic Stability and Drug-Drug Interactions (Chuang Lu, Millennium Pharmaceuticals Inc.; Cambridge, MA)

·          Advantages and limitations of using microsomes, S9, and hepatocytes

·          Buffer versus whole human plasma as medium

·          Calculations of T1/2 and intrinsic hepatic clearance

·          Reversible inhibition and mechanism-based inhibition

·          Ki and Kinact calculations

·          high-throughput automated system using commercially available hardware and software for incubation and LC/MS/MS analysis

 

10:05 AM - 10:35 AM - COFFEE BREAK

 

10:35 AM – 11:35 AM

Enzyme Induction (Nicky Hewitt, CellzDirect; Pittsboro, NC)

·          General protocol for enzyme induction studies

·          Freshly isolated hepatocytes versus cryopreserved hepatocytes

·          Inducible P450 isoforms and P450 isoforms to be included in routine P450 induction studies

·          Activity versus protein, mRNA as endpoints

·          Criteria for positive response

 

11:35 AM – 12:35 PM

Transporters (Cindy Xia, Millennium Pharmaceuticals Inc.; Cambridge, MA)

·          Key transporters for drug development

·          Procedures for assaying transporter activities

·          Data evaluation procedures

·          Application of data to advance drug development

 

12:35 PM – 2:00 PM - LUNCH BREAK

 

2:00 PM – 3:00 PM

Toxicity Screening (Albert P. Li, APSciences Inc. and IVAL/BRIVAL, Columbia MD and Vancouver, BC, CANADA)

Cytotoxicity endpoints

·          Intrinsic cytotoxicity screening (cell lines)

·          Organ-specific toxicity screening (primary cultures)

·          Reactive metabolite cytotoxicity assay

·          IdMOC assay for multiple organ cytotoxicity

 

3:00 PM – 4:00 PM

In Vitro ADME Screening Assays for Early Drug Discovery (Lilly Xu, Amgen; Thousand Oaks, CA)

·          Metabolic stability screening

·          P450 inhibition screening

·          P450 induction screening

 

4:00 PM - 4:30 PM - COFFEE BREAK

 

4:30 PM – 5:30 PM

LC/MS and LC/MS/MS Applications in ADME Studies (David Kwok, BRI Biopharmaceutical Research Inc.; Vancouver, BC CANADA)

·          Development and validation of LC/MS assays

·          Assays for simultaneous measurement of drug and metabolites

·          FDA/ICH’s guidance on validation of assay methods for GLP studies

·          Novel LC/MS/MS assay applications

 

5:30 PM – 6:30 PM

Bioluminescent Approaches For In Vitro ADME/Tox (Jim Cali, Promega; Madison, WI)

·          Bioluminescent assays that utilize firefly luciferase for sensitive, homogenous ADME/Tox applications

·          Cytotoxicity assays

·          Assays for individual P450 isoforms

·          Multiplexed cell-based assays for cytotoxicity and P450 induction at the transcriptional level and at the level of P450 enzyme activity

 

6:30 PM - 7:00 PM– PANEL DISCUSSION

REGISTER NOW

REGISTRATION FORM: DDI-2007

Event(s) (check all events registered)	Individual Course/Conference - $ DDI-2007
Preconference Workshop   06/24/2007	US $450.00 ______ (until May 15th, 2007)   US $550.00 ______
DDI-2007 06/25-06/26/2007	US $1200.00 ______ (until May 15th, 2007)   US $1500.00 ______
Both Workshop and DDI-2007	US $1550.00 ______ (until May 15th, 2007)   US $1750.00_______