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Online Seminar (Audio & Video)
Online Seminar (Audio & Video)
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Symposium II - Model-Based Drug Development: Status 2007 - Cosponsored by The American Society for Clinical Pharmacology and Therapeutics (ASCPT)
ACCP 36th Annual Meeting
Price: FREE
Duration: 7 Hours 10 Minutes
Original Program Date: Monday, September 24, 2007
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  Item Description | Faculty | Course Materials
Item Description Back to top
American College of Clinical Pharmacology:
Symposium II
September 10, 2007
 Model-Based Drug Development: Status 2007
 
Cosponsored by The American Society for Clinical Pharmacology and Therapeutics (ASCPT)
 
8:00 AM - 9:00 AM
Keynote Presentation: Transformation of the Pharmaceutical Industry: The Role of Critical Path
Andrew M. Dahlem, Ph.D., Lilly Research Laboratories, Indianapolis, IN

 

9:00 AM - 9:45 AM
Drug Target Validation/Molecular and Genetic Pathway Approaches
Lise Lund Kjems, M.D., Ph.D., Novartis Institutes for BioMedical Res., Inc., Cambridge, MA

                        

10:00 AM - 10:45 AM 
Translational PK-PD, From Animals to Man
 Kathleen M. Giacomini, Ph.D., University of California, San Francisco, San Francisco, CA
 
10:45 AM - 11:30 AM
Experience with Novel INDs and Biomarkers in Early Clinical  Development
Rebecca Boyd, Ph.D., Pfizer, Inc., Ann Arbor, MI                        

 

11:30 AM - 12:15 PM
Panel Discussion (including all speakers)   
 
1:45 PM - 2:20 PM
Applications of Adaptive Designs, including Seamless Phase 2b/3 Trials
Donald A. Berry, Ph.D., M.D. Anderson Cancer Center, Houston, TX

           

2:20 PM - 3:20 PM
Application of Model-Based Methods to Improve Drug Development Strategy in Phase 2&3
Thomas G. Tensfeldt, M.S., Pfizer Global R&D, Groton, CT

                                                                      

3:30 PM - 4:10 PM
Application of Modeling and Simulation for the Preclinical-Clinical Interface with
Oncology Drug Development
Dinesh De Alwis, Ph.D., Eli Lilly & Company Ltd., Windlesham, Surrey, United Kingdom
                                                                                                             
4:10 PM - 4:40 PM
Next Steps:  Sharing of Data to Build Disease Progression Models
J. Robert Powell, Pharm.D., FCP, Food and Drug Administration, Silver Spring, MD        

           

4:40 PM - 5:30 PM
Panel Discussion (including all speakers)

Faculty Back to top
Sandra Allerheiligen, Director, Drug Disposition - ADME and Global PK/PD, Eli Lilly, Indianapolis, IN
Richard L. Lalonde, Pharm.D., FCP, VIce President & Global Head of Clinical Pharmacology, Pfizer Global R & D, New London, CT
Andrew M. Dahlem, Ph.D., Vice President, Operations, Lilly Research Laboratories, Indianapolis, IN
Lise Lund Kjems, M.D., Ph.D., Senior Director Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, MA
Kathleen Giacomini, Ph.D., Professor and Chair, Dept. of Pharmaceutical Sciences, University of California, San Francisco, San Francisco, CA
Rebecca Boyd, Ph.D., Senior Director in Cardiovascular/Metabolic Disease , Pfizer Global Research and Development, Groton, CT
Donald A. Berry, Ph.D., Head and Chair, Division of Quantitative Sciences, MD Anderson Cancer Center, Houston, TX
Thomas G. Tensfeldt, M.S., Director, Global Pharmacometrics Department, Pfizer Global Research & Development, Groton, CT
Dinesh De Alwis, Ph.D., Head, PK/PD and Trial Simulation Group, Eli Lilly & Co., Windlesham, Surrey, UK
J. Robert  Powell, Pharm.D., FCP, Associate Director for Science, Office of Translational Sc., Food and Drug Administration, Silver Spring, MD

Course Materials Back to top

icon_acrobatPowerPoint Slides (in note-taking format) (81 Pages, 1.83 MB)
htmHelp

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