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Membership
Vision
Model-based drug development is a core element in the drug development paradigm of
the future, covering the continuum of drug development from early preclinical to
post-marketing phases.
Mission
The M&S focus group promotes model-based drug development and the development and
application of modeling and simulation in the pharmaceutical sciences though
education and scientific programming, and provides an interdisciplinary forum for
scientists and trainees with interest in M&S in drug development.
Goals & Objectives
- Provide a continuous stream of programming proposals for the AAPS annual
meeting and the NBC meeting, as well as other educational events, related to
the application of M&S.
- Facilitate an interdisciplinary exchange of M&S related topics and
discussions with members from CPTR, PPDM, RT, PDD, Biotec as well as others
from within and outside AAPS, including academia, industry and regulatory
agencies.
- Provide a scientific platform for cutting-edge, applied pharmacometric
research related to model-based drug development.
- Support the development and implementation of the AAPS Quantitative
X-ology/Pharmacology initiative and translational medicine.
- Increase awareness of the utility of model-based approaches in quantitative
decision making at all stages of drug development, including early discovery as
well as preclinical, product formulation, and clinical development.
- Provide M&S scientists up-to-date information on relevant
meetings/conferences/workshops.
If you are interested in this focus group, please contact
Dr. Bernd W Meibohm
Modeling and Simulation Courses, Meetings, and Workshops
If you have any additions or corrections to the following list, please send an email to
Stacey J. Tannenbaum, Ph.D.
The list will be updated regularly, so check back periodically for changes.
Modeling and Simulation Courses, Meetings, and Workshops List (PDF)
Upcoming Events
For information on upcoming events (suggestions are always welcome), email
Dr. Bernd W Meibohm.
AAPS Modeling and Simulation Focus Group Posters and Presentations
From the 2006 AAPS Annual Meeting and Exposition. San Antonio, Texas, October 29 - November 2, 2006: Sunrise School, "Modeling and Simulation: Learn to Speak the Language"
Peter Bonate, Genzyme Corporation, San Antonio, TX
On becoming a Modeler (PDF)
Brenda Cirincione , Cognigen Corporation, Buffalo, NY
Modeling (PDF)
Rucha Sane, Boehringer-Ingelheim, Ridgefield, CT
References (PDF)
Stacey Tannenbaum, Novartis Pharmaceuticals Corp., East Hanover, NJ
Simulation (PDF)
From the 2006 AAPS Annual Meeting and Exposition. San Antonio, Texas, October 29 - November 2, 2006: Sunrise School, "A Picture is
Worth a Thousand Tables: The Graphical Display of PKPD Data"
Andreas Krause, Pharsight Corporation, Mountain View, CA
Michael O'Connell, Insightful Corporation, Seattle, WA
Joint presentation (PDF)
From the 2005 AAPS Annual Meeting and Exposition. Nashville, Tennessee, November 6-10, 2005: Symposium, "Now You See It, Now You Don't: A Multidisciplinary Look at the Placebo Response"
Oscar Della Pasqua, GlaxoSmithKline, United Kingdom
Placebo: What Pleases Nature, Researchers and Regulators (PDF)
Tor Wager, Columbia University, NY
The Neural Bases of Placebo Effects in Pain (PDF)
Maurizio Fava, Massachusetts General Hospital, Boston, MA
The Problem of the Placebo Response in Psychiatry: Are There Any Remedies That Actually Work? (PDF)
Nicholas H.G. Holford, University of Auckland, Auckland, NZ
The Time Course of Placebo Response in Clinical Trials: Do Antidepressants Really Take Two Weeks To Work? (PDF)
From the 2005 AAPS Annual Meeting and Exposition. Nashville, Tennessee, November 6-10, 2005: Sunrise School, "Missing Data in Longitudinal Studies: A Review"
Joseph Schafer, Pennsylvania State University, State College, PA
Presentation (PDF)
From the 2005 AAPS Annual Meeting and Exposition. Nashville, Tennessee, November 6-10, 2005:
Lisa Olson, SEC Associates, Inc.
PK Software and 21 CFR Part 11 (PDF)
From the 2004 AAPS Annual Meeting and Exposition. Baltimore, Maryland, November 7-11, 2004:
Symposium "Bridging Drug Discovery and Clinical Pharmacokinetics/Pharmacodynamics With Modeling and Simulation"
Stacey Tannenbaum, Novartis Pharmaceuticals Corp., East Hanover, NJ and Robert Bies, University of Pittsburgh, Pittsburgh, PA
Introduction (PDF)
Lu Xu, Genentech, Inc., South San Francisco, CA
Physiologically-Based Pharmacokinetics and Mechanistically-Based Pharmacodynamics of Anticancer Agents and Their Applications in Clinical Studies (PDF)
Jenny Chien, Eli Lilly and Co., Indianapolis
Predicting Clinical Doses from In Vitro Methods (PDF)
Mark Peterson, Amgen Inc., Thousand Oaks, CA
A PK/PD Model Developed in Cynomolgus Monkeys Predicts Concentrations and Effects of AMG 162 in Healthy Postmenopausal Women (PDF)
From the 2004 AAPS Annual Meeting and Exposition. Baltimore, Maryland, November 7-11, 2004:
Symposium, "Meeting the Challenge of Improving Efficiency in Drug Development: Drug/Disease Modeling Symposium"
Raymond Miller, Pfizer, Inc., Ann Arbor, MI
How Modeling and Simulation Has Impacted Decision-Making in New Drug Development (PDF)
Robert Powell, Food and Drug Administration, Rockville, MD
Organizational Strategies to Integrate Newer Approaches in Quantitative Methodology (PDF)
Ted Grasela, Cognigen Corporation, Buffalo, NY
Reaction and Key Strategic Considerations in Improving the Efficiency in Drug Development (PDF)
For more presentations on Model Based Drug Development, please visit the webpage for "Model-based drug development - A cornerstone of the FDA's Critical Path Initiative" sponsored by the Basel Biometrics Section
From the 2004 AAPS Annual Meeting and Exposition. Baltimore, Maryland, November 7-11, 2004: Roundtable, "Practical Utility of Clinical Trials Simulation." Sponsored by the Clinical Pharmacology and Translational Research Section
Bing Wang, Abgenix, Inc., Fremont, CA
The Utility of Trial Simulation to Investigate Dosing Strategy (PDF)
From the 2003 AAPS Annual Meeting and Exposition, Salt Palace Convention Centre. Salt Lake City, Utah, October 26-30, 2003: Symposium, "What Is the Right Model? Issues surrounding the evaluation of pharmacostatistical models in drug development."
Paolo Vicini, University of Washington, Seattle, WA
Introduction (PDF)
Mark E. Sale, GlaxoSmithKline, Raleigh, NC
Model Fitness Measures and Automated Model Selection Algorithms (PDF)
James V. Burke, University of Washington, Seattle, WA
Mathematical, Statistical and Algorithmic Issues in the Evaluation of PK, PD and Disease Progression Models (PDF)
Stephen Duffull, University of Queensland, Brisbane, Australia
Selecting the Best Model Using Monte Carlo Markov Chain Methods (PDF)
Jogarao V. Gobburu, Food and Drug Administration, Rockville, MD
Posterior Predictive Check - What, When and How? (PDF)
Michael Heathman, Eli Lilly and Co., Indianapolis, IN
Covariate Screening For Population Analysis Using A Back-Propagation Neural Network (PDF)
From the 2003 AAPS Annual Meeting and Exposition, Salt Palace Convention Centre. Salt Lake City, Utah, October 26-30, 2003: Roundtable, "Pharmacokinetics of Monoclonal Antibodies"
Diane R. Mould, Ph.D., Projections Research, Phoenixville, PA
Modeling the Pharmacokinetics and Pharmacodynamics of Therapeutic Monoclonal Antibodies (PDF)
From the 2003 AAPS Annual Meeting and Exposition, Salt Palace Convention Centre. Salt Lake City, Utah, October 26-30, 2003: Symposium, "Clinical Trials Simulation in Drug Development"
Sponsored by the Clinical Pharmacology and Translational Research Section
Mark E. Sale, GlaxoSmithKline, Raleigh, NC
Theoretical Overview of Clinical Trials Simulation (PDF)
Michael J. Fossler, GlaxoSmithKline, King of Prussia, PA
Optimizing Dosing Strategies With Clinical Trials Simulation (PDF)
Lorin K. Roskos, Abgenix., Fremont, CA
Modeling and Simulation to Facilitate Translational Research (PDF)
Sandy R.B. Allerheiligen, Eli Lilly, Indianapolis, IN
Leveraging Pharmacokinetic/Pharmacodynamic Modeling and Trial Simulation in Drug Discovery and Clinical Development (PDF)
Peter L. Bonate, ILEX Oncology, San Antonio, TX
Overcoming Impediments to Implementing Clinical Trial Simulation in Industry (PDF)
From the 2002 AAPS Annual Meeting and Exposition, Metro Toronto Convention Centre. Toronto, Ontario (Canada), November 10-14, 2002: Sunrise Pharmacy School, "Clinical Trial Simulation: A Primer"
Paolo Vicini, University of Washington, Seattle, WA
Simulation Essentials (PDF)
Robert R. Bies, University of Pittsburgh, Pittsburgh, PA
Prospective Simulation to Evaluate Clinical Trial Design (PDF)
Ivan Nestorov, Amgen, Inc.
Modeling Categorical Trial Outcomes (PDF)
PL Bonate and the NONMEM Testing Consortium: "Consistency of NONMEM parameter estimates across platforms and compilers" (PDF), poster presentation R6240, 2002 AAPS Annual Meeting and Exposition, November 10-14, 2002, Toronto, ON, Canada.
Call for Volunteers
The M & S Focus Group is in need of volunteers to plan future events. Please e-mail
Dr. Bernd W Meibohm
if you are interested.
JOIN THE MODELING AND SIMULATION FOCUS GROUP
To join the Modeling and Simulation Focus Group, click here.
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