Advancing the Science and Engineering the Systems of Model-Based Drug Development  

Pharma Of The Future℠

The pharma industry is evolving at a breakneck pace. But luckily, we're here to keep you up to speed on what's happening in drug development.

Latest Topic: Global Health Initiative

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.


Pharma of the Future Historical Time line


A Fresh Approach to "Clouded" Thinking

Latest Topic: Visualize in KIWI 1.5 - Available Now!

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


Pharmacometric Model Development

Using population-based pharmacokinetic models, we can characterize drug disposition using sparse drug concentration data in patients with the condition of interest, whereas characterizing the relationships between drug exposure and patient response is done using exposure-response models. By gaining this understanding, we can support the selection or justification of dosing strategies, determine the maximum tolerated dose or the minimum effective dose, and characterize sub-population differences or drug-drug interaction effects for inclusion in the drug’s labeling information. 

Completing modeling and simulation activities for a development program is an important first step in addressing team questions. The critical next step is to synthesize the modeling results into a compelling story that can inform and guide decision-making. In 2018, Cognigen worked on more than 40 development programs, each with their own story and 50% of the projects resulted in direct regulatory correspondence or interactions. Cognigen’s experience and expertise can help you prepare for the highly visible stress-inducing presentations to senior management or regulatory agencies.

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The best company in the world, pharmacometrically speaking.

Changing the world of drug development.

At Cognigen, you’ll work side-by-side with leading pharmaceutical and biotechnology companies. Each year we evaluate 30 to 40 drugs. In fact, annually 25% of the compounds we work on are submitted to regulatory agencies where our work for dose selection and justification is an integral part. It’s that kind of success that has earned Cognigen a tremendous amount of credibility within the pharma and biotech industries – a reputation we invite you to be a part of.

There’s no “I” in “development.”

On each project, you’ll collaborate with a group of hand-picked individuals, each bringing a specific skill to the table. There’s PK/PD scientists, clinical pharmacologists, statisticians, software developers, data programmers, project managers, technical writers, and administrative staff. Through experience, we’ve found this organization helps create the ideal environment where ideas are generated, problems are solved, and creativity is inspired.

Good times will be had.

Fun is as much a part of our work environment as data analysis and automating our solutions. We have theme lunches, family picnics, holiday parties, ice cream socials, grill days, and baseball game outings.  And we’ve been known to have spontaneous tournaments of trashcan Frisbee (a classic Buffalo tailgating game).

We're always looking for clever people to join us. See the positions we currently have available. If one sounds up your alley, please send us your resume and we’ll be more than happy to get in touch.

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