April 16, 2016
Envisioned by Cognigen Corporation, a Simulations Plus (Nasdaq:SLP) company, in 2003, the Pharma of the FutureSM (PoF) program was conceived as a research and training initiative to design and implement the workflows and computer systems required to support modeling and simulation (M&S) activities. The numerous M&S projects performed by Cognigen scientists became a source of raw material for research initiatives designed to improve the quality, timeliness, and impact of M&S results. These research initiatives have yielded numerous benefits, including:
- Formalized data definitions and data programming requirements that enable the timely delivery of quality data for analysis
- A robust informatic infrastructure and computer system which became the foundation for the KIWITM platform
- A variety of internally and externally focused training programs to advance the science and technology required for planning, executing, and reporting M&S efforts
- Click here for more information about the PoF program.
March 9, 2016
All of us in the pharmacometrics community owe a debt of gratitude to Lewis, Stuart, Alison, and the many others who were involved in the development of NONMEM. The program has proven to be of tremendous value in dealing with the challenges we encounter in pharmaceutical research and development. NONMEM has truly changed the landscape and – really – we are only at the beginning of a new era of model-driven R&D.
A historical perspective from Alison Boeckmann – One of the developers and programmers of NONMEM
Reprinted here with Alison’s permission
October 3, 2015
New Features in KIWI 1.5:
KIWI 1.5 continues to bring user experience to a new level through efficient, decisive model building and co-worker collaboration.
Visualize - Visualize diagnostic plots and parameters for all candidate models in one view
Formats / Labels - Fully customized formatting and labeling within KIWI
Cross Project and Co-Worker Graphical Profiles - Share your share suite of customized diagnostic plots with your co-worker or use them on your next project
October 3, 2015
The central focus of MBR&D is not the mathematical equations but rather the conceptual synthesis process that integrates all available information and rational extrapolations to better understand drug pharmacology in the context of the disease process. The outcome of this synthesis process is a conceptual schema, a term borrowed from database design. The schema represents a series of assertions about the nature of the disease process and drug pharmacology. It describes the entities of significance to a research program, their characteristics or attributes, and the relationships between pairs of entities thought to be significant.
April 25, 2015
The EMA and FDA recommend including a run record in your technical report to describe any major decisions and should include an overview of the steps taken during model development. KIWI 1.3, available in May 2015, will reduce the time taken to perform this task to just minutes.
January 18, 2015
While we now have access to adequate computing power for most applications, we lack the tools required to properly manage the investigative process. We need the tools to organize the results of the numerous model configurations, sort through the results and compare alternative formations of the model in order to determine reasonable next steps and decide that a particular model or group of models is adequate for the task at hand. And this is where the idea of “workflow” comes to the forefront.
January 16, 2015
KIWI has been specifically designed to recognize the dynamic nature of the model building effort in an ongoing drug development program. KIWI provides functionality to meet the scientists’ need for extensive documentation of the analysis pathway and collateral results, management’s need for summaries of modeling and simulation highlights, and regulatory agencies need for transparency and reproducibility.
October 12, 2014
Pharmacometric modeling and simulation has moved from its infancy as a novel way of approaching the analysis of clinical pharmacokinetic data to become an invaluable tool in pharmaceutical and biotechnology research and development. Early, tentative applications of modeling have given way to robust model-based drug development activities in which pharmacokinetic and pharmacodynamic modeling and simulation results are widely utilized to improve the probability of successful clinical trials. Pharma of the Future Historical Time Line
December 12, 2013
A worthwhile podcast highlighting the value of a conceptual schema.
November 22, 2013
“Get the habit of analysis - analysis will in time enable synthesis to become your habit of mind.”
-Frank Lloyd Wright, In Barnes & Noble Book of Quotations, by Robert I. Fitzhenry, 1987.