Cognigen Launches KIWI Version 4.0
June 11 2019 - 8:30AM
Business Wire
Exciting New Features to its Pharmacometric
Communication and Collaboration Platform
Cognigen Corporation, a Simulations Plus company (Nasdaq: SLP)
and a leading provider of population pharmacokinetic and
pharmacodynamic modeling and simulation services, today announced
that it has released Version 4.0 of its KIWI™ Pharmacometric
Communication and Collaboration Platform.
KIWI is a private cloud-based, validated platform to efficiently
and consistently organize, process, visualize, evaluate, and
communicate modeling and simulation results. Since the introduction
of KIWI 1.0 in 2011, our mission has been to provide
pharmacometricians with the most efficient analysis environment
possible. The release of KIWI version 4.0 continues that mission
with the introduction of the Model Wizard and the Covariate
Analysis toolset.
A pharmacometric analysis is an evolutionary process – one that
often results in the creation of hundreds of new program files and
code changes to hundreds more due to common typographical and
programmatic errors. The Model Wizard and the Covariate Analysis
toolset aim to significantly reduce the time spent creating models,
correcting errors, and replicating program files for performing
stepwise covariate analyses, allowing pharmacometricians to focus
on advancing science. With continued feedback from KIWI license
holders, various visualizations within KIWI 4.0 and the
pharmacometric-specific Data Repository will continue to be updated
with new features and functionality.
KIWI has been specifically designed to recognize the
dynamic nature of the model building effort in an ongoing drug
development program. KIWI provides the functionality to meet the
scientist’s need for extensive documentation of the analysis
pathway and collateral results, management’s need for summaries of
modeling and simulation highlights, and the regulatory agencies’
needs for transparency and reproducibility. KIWI continues to bring
user experience to a new level through efficient and decisive
model building. KIWI demonstrations will be available through
Cognigen personnel attending the PAGE meeting this week in
Stockholm, Sweden.
Dr. Sebastien Bihorel, director of Pharmacometrics and KIWI
Applications, said: “Our team continues to introduce exciting
functionality into KIWI. The new Wizards greatly decrease the time
and effort required to create model codes for 3 different
industry-standard modeling platforms: NONMEM®, mrgsolve, and
Berkeley Madonna. They will significantly lower the learning curve
for modelers who are new to these platforms while providing
consistent coding standards to more experienced users.”
Dr. Ted Grasela, president of Cognigen, added: “Over the course
of a typical drug development program, fit-for-purpose (F4P) models
based on the current facts and available data are used to inform
development decision making and aid in the design of clinical
trials. These F4P models represent an important repository of
knowledge which can be expanded as new knowledge emerges. The
cloud-based KIWI platform serves a key role in this process by
tracking the model refinement process and capturing development
team insights and suggested improvements.”
KIWI was featured at a NONMEM workshop held as part of the
University of Buffalo’s annual PK/PD course held this past May,
with international attendance from both academia and industry.
Another workshop is now planned for September 23-25, 2019, at
Johannes Gutenberg University in Mainz, Germany. Attendance is
limited. Contact Jill Harlach (jharlach@cognigencorp.com) for
further information.
About Cognigen Corporation
Cognigen Corporation is well-recognized as providing insightful
analysis and reports that guide regulatory decision making and
minimize follow-up questions from regulators, saving sponsors
considerable time and money in getting new pharmaceutical products
to market. Cognigen Corporation deployed KIWI in 2011 to provide
pharmacometricians and clinical teams lead access to a dynamic
modeling and simulation platform for population analyses. More
information is available on the Cognigen section of the Simulations
Plus website.
About Simulations Plus, Inc.
Simulations Plus, Inc., is a premier developer of drug discovery
and development software as well as a leading provider of both
preclinical and clinical pharmacometric consulting
services for regulatory submissions and quantitative
systems pharmacology models for drug-induced liver
injury, drug-induced kidney injury, and nonalcoholic
fatty liver disease. Our software is licensed to and used in the
conduct of drug research by major pharmaceutical, biotechnology,
chemical, and consumer goods companies and regulatory agencies
worldwide. Our innovations in integrating new and existing science
in medicinal chemistry, computational chemistry, pharmaceutical
science, biology, and physiology into our software have made us the
leading software provider for physiologically based
pharmacokinetic modeling and simulation. For more information,
visit our website at www.simulations-plus.com.
Safe Harbor Statement Under the Private Securities Litigation
Reform Act of 1995 – With the exception of historical
information, the matters discussed in this press release are
forward-looking statements that involve a number of risks and
uncertainties. Words like “believe,” “expect” and “anticipate” mean
that these are our best estimates as of this writing, but that
there can be no assurances that expected or anticipated results or
events will actually take place, so our actual future results could
differ significantly from those statements. Factors that could
cause or contribute to such differences include, but are not
limited to: our ability to maintain our competitive advantages,
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software by our customers, the general economics of the
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