Simulations Plus

StrategiesPlus™ COVID-19 ACT Program to speed consulting assistance to any organization involved in coronavirus research.

Since last month’s newsletter, the world has become Coronavirus conscious.

Throughout the drug discovery process, companies need to eliminate poor drug candidates early to avoid costly studies and dead ends.

It is still winter and cold here in New England; however the workshop and meeting schedule is heating up!

In trying to share the excitement that is building in the SimsPlus development team for the new GPX™ platform… I can only think of the signature Frank Sinatra song “The Best is yet to Come”

Thank you to everyone who joined us for the Simulations Plus, Inc. Annual Forum at American Association of Pharmaceutical Scientists (AAPS) Pharmsci360 in San Antonio, TX.

Taking fit-for-purpose (F4P) models to the next level – Collaboration between scientists and software designers

Walt Woltosz, chairman of Simulations Plus Inc., commented on the passing of world-famous astrophysicist, Professor Sir Stephen Hawking...
"Stephen Hawking was a remarkable man and a global scientific leader. But he was also charming and witty, with a nice sense of humor. He would "dance" in his electric wheelchair at festive events, spinning in circles and dazzling all who watched. He made his place in history, along with Newton, Einstein, Bohr, and so many others. He will be missed."

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.

Prior to 1978, PK data was obtained from drugs that were tested on healthy young volunteers (typically medical students).

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.

Speed and agility is more important than ever as the demand for M&S increases. KIWI 1.5 allows you to easily select and compare parameters estimates and diagnostic plots across multiple candidate models in one view to make decisions quickly and confidently, and delivers high quality graphs to inform team decision making and put in regulatory documents- all formatted, all validated!

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.

Developing a disease drug model is an intensely creative and collaborative effort. It requires the ability to assemble available knowledge and data and to gain a collective appreciation of important relationships. As this collaborative synthesis gets underway, pharmacometricians are charged with translating the ideas and hypotheses about diseases biology and drug pharmacology into mathematical equations. The equations are then coded into the control streams that, along with the data, become the basis for investigating the feasibility of various hypotheses.

Over the years, our relationships with clients have deepened and Cognigen is often asked to begin working on projects at the earliest stages of development and to continue to refine a model as new data arrives from ongoing clinical development programs. Consequently, if a assets continues to show promise, we have the opportunity to provide modeling and simulation results at decision-making milestones over the lifecycle of clinical development. Typically, these activities culminate in a comprehensive synthesis of exposure-response relationships for efficacy and safety endpoints that are included in the regulatory submission.

View our milestones.