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MAS-EPSILON Announce Availability of the
First
FDA-Accepted Type 1 Diabetes Metabolic Simulator
The T1DMS provides a safe, interactive modeling and
learning environment for the research/training/education of
study investigators, healthcare providers and patients and
families managing their disease towards improved glucose
control.
June 16, 2011 -
Charlottesville, VA - MAS-Epsilon announce the availability
of the only diabetes simulation technology accepted by the U.S.
Food and Drug Administration (FDA) as a substitute for animal
trials in the pre-clinical testing of control strategies in the
Type 1 Diabetes Metabolic Simulator (T1DMS).
The T1DMS is designed to simulate early-phase clinical studies
on an in-silico population with the glucose dynamics of
individuals or a particular person. In collaboration with Drs.
Claudio Cobelli and Chiara Dalla Man at the University of Padova
(Padova, Italy), Drs. Boris Kovatchev and Marc Breton at the
University of Virginia Diabetes Technology Center developed a
computer simulator of the human metabolic system based on the
previously introduced Meal Model of glucose-insulin dynamics.
This simulator became the first computerized simulation tool
accepted by the FDA as a substitute for animal trials in the
pre-clinical testing of control strategies in Type 1 Diabetes.
In silico testing can produce credible pre-clinical results from
testing interventions and management strategies at a fraction of
the time and cost of current pre-clinical animal testing
methods.
"We are very enthusiastic about the opportunity to build and
provide a robust commercial version of the model technology to
the diabetes research and disease management community," states
Kurt Wassenaar, MAS-Epsilon CEO. "We believe that "in silico"
modeling can be a significant factor in improved and accelerated
development of new products for diabetes care, as well as
central to the development of the artificial pancreas."
The computerized modeling provides a safe, interactive learning
environment for the training/education of study investigators,
healthcare providers involved in diabetes management using CGM
sensors, insulin pumps and controllers and for patients and
families managing their disease towards improved glucose
control; and provides an important means of standardization of
the research and development process of new diabetes management
tools and interventions as well as a blueprint for modeling
other disease processes.
The T1DMS is available to the academic/scientific/medical and
pharmaceutical communities for research on a training
population. As new treatment methods become available, the
current version of the T1DMS will be upgraded accordingly for
simulations that match and keep pace with new treatments and
commercial demand for testing and simulation.
Currently, over 50 academic and 10 industrial sites are using
the test version of the simulator worldwide toward development
of an artificial pancreas. Additionally, over 100 pharmaceutical
and Diabetes device companies are active in developing novel and
more effective medications for diabetes and related conditions.
The cost and time savings of metabolic simulation modeling is
estimated in the millions of dollars and years of development
when compared to current pre-clinical animal testing methods.
In early 2012, MAS-Epsilon plans to have a web-based study, testing and
training services to both academic and industrial investigators
involved in the R&D of control algorithms, pumps, sensors and
novel insulin formulations for the Artificial Pancreas Project
(APP) sponsored by the Juvenile Diabetes Research Foundation (JDRF).
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MAS-Epsilon:
MAS-Epsilon combines contract research organization capabilities
with strategic advisory services to formulate evidence-based
strategy, identify market opportunities through research, and
translate new knowledge into sales and market share. MAS-Epsilon
partners with clients to identify strategic research questions
and design studies that will definitively answer clinical
questions while enhancing the practice of medicine. Experience
with real-world patient care combined with marketing insight
allows MAS-Epsilon to design and implement studies that advance
scientific knowledge and support a client’s long-term strategy.
With appropriate use of the latest technology, this data is
acquired and analyzed quickly then professionally disseminated
through our efficient technical and scientific communication
strategies. The new information acquired is the basis for
evidence-based clinician and consumer education to improve
medical outcomes and increase our client’s market share.
MAS-Epsilon possesses the unique combination of clinical
experience, scientific expertise, and strategic skills needed to
identify your knowledge and data needs, profile your
marketplace, and map a campaign to increase sales and provides
an evidence-based framework to move forward rapidly and
decisively. |
