Creating a New Pharma R&D Ecosystem

Celebration

Pioneering Pharma of the Future℠ .

Do you feel that? It’s the industry changing. And no one has a finger on the pulse of drug development like our fearless leader Ted Grasela. So we thought, hey, let’s give him an outlet to share his wisdom. And so the Cognigen blog was born. Check back here often for insightful articles, unique views on industry trends, and a whole lot more on the evolution of this critical field.

April 16, 2016

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.

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March 9, 2016

A historical perspective from Alison Boeckmann

Postscript:

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

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October 3, 2015

Conceptual Schemas

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.

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October 12, 2014

History of Pharma of the Future

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

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November 22, 2013

The inspiration of great architecture.

“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.

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October 31, 2013

Our move to new offices.

Extensive planning, dedicated teamwork, mad skills, and a sense of humor result in a successful move to new digs for Cognigen.

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June 14, 2013

Intelligent wondering – investigative clinical pharmacology.

With the use of modeling, explorations of the determinants of drug efficacy and safety are more thorough, and the analyses provide solid support for dose recommendations and labeling content.

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April 9, 2013

An omission, a recommendation, and a prediction.

A report from the President’s Council of Advisors on Science and Technology gives recommendations that have the audacious goal of doubling, over the next decade, the rate of invention of new medicines for patients, while increasing drug safety.

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February 19, 2013

The drama in drug development.

There is no magic fairy dust that will make a boring, useless, redundant, or merely informative PowerPoint presentation dramatic after it leaves your computer.

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February 5, 2013

Insight. . .Inspiration. . .Innovation

Welcome to 2013. I have much to be grateful for, not the least of which are the relationships we have with one another here at Cognigen and also with our clients.

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