Download THE 32nd ANNUAL MIDWEST BIOPHARMACEUTICAL

THE 32nd ANNUAL MIDWEST BIOPHARMACEUTICAL STATISTICS WORKSHOP
MAY 18 – 20, 2009 • BALL STATE UNIVERSITY ALUMNI CENTER, MUNCIE, INDIANA
Final Program
MONDAY , MAY 18
8:30 AM – 4:30 PM
WORKSHOP REGISTRATION
FEE: $150 until May 1 ($60 for students), $180 after May 1
9:00 AM – 1:00 PM
SHORT COURSE (Separate Registration Fee: $60)
Presenter: MICHAEL O’CONNELL, TIBCO
Topic: Statistical Graphics for Clinical Data Analysis
2:15 PM – 2:30 PM
INTRODUCTION AND WELCOME
ALAN MENIUS, GlaxoSmithKline
SHERYL STUMP, Chair, Department of Mathematical Sciences, Ball State University
2:30 PM – 3:30 PM
PLENARY SESSION
Speaker: SCOTT EVANS, Harvard University
Topic: Benefit/Risk Considerations
3:30 PM – 4:30 PM
PLENARY SESSION
Speaker: PAUL STANG, Johnson & Johnson
Topic: The Observational Medical Outcomes Partnership
MONDAY NIGH T MI XER
Alumni Center
5:00 PM – 7:00 PM
TUESDA Y MO RN ING, MA Y 19
CONCURRENT SESSIONS
8:30 AM – 11:30 AM
B. Advances in Animal Models and Statistical Modeling for Toxicology
Organizer/Chair: Kjell Johnson, Pfizer
1.
“The Relationship Between Biochemical and Morphological Findings in Rat Liver
Injury”, Kay Tatsuoka, GSK
2.
“The use of Hybrid Chemical/Biological Descriptors in QSAR Modeling Improves the
Accuracy of In Vivo Chemical Toxicity Prediction”, Hao Zhu, UNC
3.
“An Alternative to the Peto Analysis for 2-year Carcinogenicity Studies and to Tarone’s
Test for Trend in Censored Survival Data”, Art Roth
C. Propensity Scoring and Beyond: When and How?
Organizer/Chair: Robert Obenchain, Risk Benefit Statistics
1.
“Why go Beyond Propensity Scoring”, Gerhardt Pohl, Lilly
2.
“Confounding Adjustment: Concepts and Heuristic Ideas”, Lingling Li, Harvard
University
3.
“Confounding Adjustment: Ideas in Action – A Case Study”, Xiaochun Li, Indiana
University
4.
“The ‘Local Control’ Approach”, Robert Obenchain, Risk Benefit Statistics
5.
“Discussant”, Gerhardt Pohl, Lilly
D. Stability Analysis
Organizer/Chair: Jyh-Ming Shoung, Johnson & Johnson
1.
“Some Statistical Considerations and Challenges in Open Dish Studies”, Tim Kramer,
Suntara Cahya, Jeff Hofer, Lilly
2.
“A Bayesian Approach to Estimation of Shelf Life”, Oscar Go, Johnson & Johnson
3.
”Analysis of Stability Data with Equivalence Testing for Comparing New and Historical
Processes Under Various Treatment Conditions”, Ben Ahlstrom, Rick Burdick, Laura
Pack, Leslie Sidor, Amgen
4.
“Stability for Dissolution for a Modified Release Product”, David LeBlond, Abbott
5.
“Discussant, Stan Altan, Johnson and Johnson
TUESDA Y EV ENI NG BAN QUET
Robert Morris, Dean of the Graduate School
Ball State University
Announcement of Student Winner of Charlie Sampson Poster Award
Speaker: STAN YOUNG, NISS
Topic: Everything is Dangerous
A. Quantitative Safety Assessment
Organizer/Chair: Jonathan Schildcrout, Vanderbilt University
1.
“Type-1 Error Control in Cumulative Meta-Analysis”, Mingxiu Hu, Millenium/Takeda
2.
“Graphical Displays of Safety Data”, Richard Heiberger, Temple University
3.
“A Flexible Bayesian Method to Model Adverse Event Hazards”, Quan Hong, Lilly
4.
“The Role of Pharmacogenetics in Safety Assessment”, Michael Mosteller, Arlene R.
Hughes, Sara H. Hughes, Mathew R. Nelson, GSK
B. Nonlinear and Mixed Effect Models
Organizer/Chair: David Stock, Bristol Myers Squibb
1.
“The Impact of Observations Below the Limit of Quantification on Pharmacodynamic
Predictions: A Preclinical Example Using New Features of NONMEM VI”, Celine
Dartois, Novartis
2.
“Sigmoid Curves and a Case for Close-to-Linear Nonlinear Models”, Charles Tan, Merck
3.
“Power and Sample Size Considerations for Mixed Models with Non-normal Data”,
Walter Stroup, Univ. of Nebraska
C. Post-Approval Data Mining Opportunities
Organizer/Chair: Patrick Ryan, GlaxoSmithKline
1.
“Large-Scale Observational Studies: Are We in a Post-Statistical Era”, Stephanie
Reisinger, ProSanos
2.
“Comparison of Data Mining Algorithms for Measuring-Drug Event Associations in
Longitudinal Healthcare Data ”, Bill DuMouchel, David Fram, PhaseForward
3.
“Machine Learning for Predicting Adverse Events”, David Page, Univ. of Wisconsin
4.
“The Role of Data Mining in Evidence Based Medicine”, Pamela Bradt, Abbott
D. Analytical Chemistry
Organizer/Chair: Gregory Steeno, Pfizer
1.
“Uncertain Standards With Standard Uncertainties”, Bill Porter, Abbott
2.
“Propagation of Uncertainty in Process Models and Product Performance Models Using
Monte Carlo Methods”, John Kauffman, FDA
3.
“Quality Risk Assessment: A Lifecycle Approach in Evaluating Quality Attributes for
Bioproducts”, Suntara Cahya, Lilly
4.
“Discussant”, Abbie Gentry, J&J Consumer Co.
11:30 AM – 1:00 PM
LUNCH BUFFET
TUESDA Y AFT E RNOON, MAY 1 9
POSTER SESSION
12:00 PM – 1:30 PM
Chair: Krishna Padmanabhan, Wyeth
Posters will be considered on any biopharmaceutical statistical topic.
Abstracts must be received by April 20, 2009. Students may qualify for the Charlie Sampson poster
award if abstract, poster panels, and a paper briefly describing the poster are received by April 20.
For more information contact
Krishna Padmanabhan at [email protected]
Phone: (484)-865-2084
TUESDA Y AFT E RNOON, MAY 1 9
CONCURRENT SESSIONS
WEDNE SDAY M ORNING, MAY 2 0
CONCURRENT SESSIONS
8:30 AM – 11:30 AM
A. Bayesian Methods in Drug Development
Organizers/Chairs: Karen Price, Haoda Fu, Lilly
1.
“An Overview of Bayesian Methods in Clinical Trials”, Scott Berry, Berry Consultants
2.
“Bayesian Adaptive Designs for Dose Escalation Studies”, Anna McGlothlin, Lilly
3.
“Bayesian Hierarchical Models for Detecting Safety Signals in Clinical Trials”, Haijun
Ma, Amy Xia, Amgen
4.
“Power Priors for Adaptive Incorporation of Historical Information in Clinical Trials”,
Brad Carlin, Brian Hobbs, University of Minnesota
B. Statistical Methods in Drug Discovery
Organizer/Chair: Jun Cao, Bristol, Myers Squibb
1.
“High Throughput Screening”, Antara Majumdar, Bristol Myers Squibb
2.
“A Pre-Processing Step for High Content Screening Data”, Stan Young, NISS
3.
4.
“In-Vitro Screening for Combination Drug Discovery”, John Peterson, GSK
“Response Optimization in Oncology In-Vivo Studies Using a Multi-Objective Modeling
Approach”, Max Pashkevich, Phil Iverson, Lilly
C.
Issues for Observational Studies
Organizer/Chair: J. Marc Overhage, Regenstrief Institute
1.
“What Does it Take to Normalize Data in a Health Information Exchange?”, Marc
Overhage, Regenstrief Institute
2.
“Using the Clinical Data Repository for Pharmacovigilance”, Shawn Murphy, Partners
Healthcare
3.
“Multi-Institutional Studies Using Observational Data: Opportunities and Challenges”,
Jeff Brown, Harvard Pilgrim Heath Care/Harvard Medical School
4.
“Challenges in Transforming Observational Data for Analysis”, Don Griffin, CSC
D. QBD: Challenges in the Clinical/Non-Clinical Link
Organizer/Chair: Jeff Hofer, Lilly
1.
“Using PK/PD Modeling to Simulate Impact of Manufacturing Process Variability”,
Alan Hartford, Agensys, Tim Schofield, Biologics Consulting Group
2.
“Connecting the Dots: Accelerating Clinical Development by Integrating Non-Clinical
Aspects in the Plan”, Bruno Boulanger, UCB-Group
3.
“QbD and Applied Biopharmaceutics for Patient Benefit”, Arzu Selen, FDA
4.
“Linking CMC and Toxicology: The Use of Cumulative Carcinogenic Risk for Multiple
Genotoxic Impurities Criteria”, Wherly Hoffman, Daniel Ness, Elan Pharmaceuticals
Inc., Cindy Lee, Joel Bercu, Lilly
11:30 AM – 1:00 PM
Closing Remarks
Alan Menius, GlaxoSmithKline
LUNCH BUFFET
1:30 PM – 4:30 PM A.
Pharmacometrics/Modeling and Simulation
Organizer/Chair: Melvin Munsaka, Takeda
1.
“Quantitative Clinical Pharmacology Applications for Efficient Drug Development”,
Pravin Jadhav, FDA
2.
“A Meta-Analytic Model for Alzheimer's Disease Incorporating Both Summary-Level
and Patient-Level Data”, James Rogers, Metrum Research Group
3.
“Is the Confirmatory Approach in PK/PD Modeling Possible? ”, Chuanpu Hu, Centocor
4.
“A Clinical Trial Simulation System, Its Applications, and Future Challenges”, Kuenhi
Tsai, Merck, Peter Westfall, Texas Tech University
5.
“Discussant”, Kenneth Kowalski, The Ann Arbor Pharmacometrics Group
FOR MORE INFORMATION ON THE WORKSHOP, please contact DALE UMBACH, Ball State University, (765) 285-8657, Email: [email protected] or MELVIN MUNSAKA,
Takeda Global Research & Development, (847) 582-3533, Email: [email protected].