Lewis B Sheiner Memorial Symposium

Monday December 4, 2006

7:15-8:00
Continental Breakfast at University of California Washington Center

8:00-8:15
Welcome and Introduction
Leslie Z. Benet

8:15-10:10
Session A: Therapeutic Optimization and PK Prediction in Individual Patients. How Do We Affect Health and Patient Care?

8:15-8:45
"The Need to Understand Within Subject Variability" (PDF)
Mats Karlsson (Uppsala University)

8:45-9:10
"Should We Expect to Be Able to Predict PK in Individual Patients?" (PDF)
Leslie Z. Benet (UCSF)

9:10-9:40
"Pharmacogenomics and PK Prediction in Individual Patients"
Kathleen M. Giacomini (UCSF)

9:40-10:10
"Systems Pharmacokinetics, the Basis for Prediction"
Malcolm Rowland (University of Manchester)

10:10-10:35
Coffee Break

10:35-12:35
Session B: Individual and Population PK/PD Modeling and Estimation. What Do We Need?

10:35-11:05
"Pharmacodynamics and Disease Systems Analysis" (PDF)
Meindert Danhof (Leiden University)

11:05-11:35
"Optimal Design of Population PK/PD" (PDF)
France Mentre (INSERM)

11:35-12:05
"The Time Course of Drug Action – When PK is Not Needed"
Nicholas H. G. Holford (University of Auckland)

12:05-12:35
"Semi-Parametric Methods Applied to Modeling, Optimal Design and Model Selection" (PDF)
Davide Verotta (UCSF)

12:35-2:00
Lunch at the Beacon Hotel

2:00-5:30
Session C: Quantitative Drug Development Science (Modeling and Simulation). How Do We Make the Connection?

2:00-2:30
"Connecting Models to Real LifeÑA Regulatory Perspective" (PDF)
Robert Powell (FDA)

2:30-3:00
"Creating the Sheiner Vision in the Pharmaceutical Industry: An Opportunity with Obstacles"
Donald Stanski (Novartis)

3:00-3:30
"Pharmacometric Guided Product Design" (PDF)
Suneel Gupta (ALZA)

3:30-3:55
Coffee Break

3:55-4:25
"Leveraging Quantitative Pharmacology in Drug Disposition"
Sandra Allerheiligen (Lilly)

4:25-4:55
"Simulations Using a Physiologic Based Drug-Drug Interaction Model: Individual Risk Assessment"
Roeline Jochemson (IRIS)

4:55-5:25
"Fitting PK/PD Models in the Biotech Landscape" (PDF)
Nancy Sambol (UCSF)

6:00
Banquet at Doubletree Hotel

Tuesday December 5, 2006

7:45-8:30
Continental Breakfast at University of California Washington Center

8:30-11:30
Session D: Epistemology in Drug Development and Drug Regulation. How Should We Think?

8:30-9:00
"Validly Estimating True Dose-Response When Only Treatment vs. Control is Randomized" (PDF)
Donald B. Rubin (Harvard)

9:00-9:30
"Model Based Development of Anti-HIV Drugs" (PDF)
Terrence F. Blaschke (Stanford)

9:30-10:00
"From 'Pharmacokinetics/ Pharmacodynamics' to 'Modeling & Simulation' in Drug Development"
Jean Louis Steimer (Novartis)

10:00-10:30
Coffee Break

10:30-11:00
"Engineering the Transition to Model-Based Development"
Thaddeus Grasela (Cognigen Corporation)

11:00-11:30
"Putting Science into Drug Regulatory Science" (PDF)
Carl C. Peck (UCSF)

11:30-1:00
Lunch at the Beacon Hotel

1:00-3:30
Session E: Development of a Pharmacometrics Curriculum
Moderator: Nicholas H.G. Holford

1:00-1:30
"Creating Communicators: A Paradigm for Teaching Presentation" (PDF)
Tim Sheiner (Pharsight)

1:30-3:30
Panel Discussion and Audience Input. Discussants include: Richard C. Brundage (University of Minnesota), Nicholas H.G. Holford (University of Auckland), Mats Karlsson (Uppsala University), Dennis Fisher (The "P Less Than" Company), Kyungsoo Park (Yonsei University)

3:30-3:40
Closing Remarks
Carl C. Peck

Lewis B Sheiner Memorial Symposium, Special Session for Former Colleagues

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