April 16, 2016

Global Health Initiative

Pharma of the FutureSM - Global Health Initiative

Background

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.

Global Health Initiative

Sponsored by The Bill and Melinda Gates Foundation, the Global Health initiative has its origins in the PoF program and is designed to provide strategic, operational, and technical support for development programs focused on delivering innovative new medicines for neglected diseases, such as malaria. The initiative is intended to meet the needs of not-for-profit organizations such as The Medicines for Malaria Venture and the for-profit pharmaceutical and biotechnology companies who are partnering in the effort to eradicate malaria.

The goal of the Global Health initiative is to reduce the risks and cost of antimalarial drug development and speed the delivery of new life-saving medicines. This goal will be pursued via two interrelated activities. The first is to deploy a technology infrastructure, incorporated into the KIWI platform, that will remove the barriers to communication amongst team members and provide the processing power and organizational tools required to support complex modeling and simulation activities. The second is to harness the extensive knowledge of team scientists to create a comprehensive model of the lifecycle of the malaria parasite and the pharmacology of potential new drugs. This disease-drug model will be used to guide the design, analysis, and interpretation of clinical trials; enhance the regulatory review process; and, eventually, optimize the clinical use of new medicines for malaria.

Why this initiative?

Scientists relish the challenge of puzzling over difficult problems, but effectively dealing with some of the world’s most intractable problems, such as the eradication of malaria, will require the ideas and insights that emerge when scientists from different disciplines collaborate as a team. Ultimately, by fostering interdisciplinary collaboration and effective decision-making, the Global Health initiative opens up new frontiers in the effort to meet societal needs for innovative, cost-effective therapies.

Building a comprehensive disease-drug model for malaria

A comprehensive disease-drug model for malaria will be developed by knitting together existing pharmacokinetic and pharmacodynamic models with an understanding of the biology of the disease and the mechanism of action of potential new medicines. The team will develop a conceptual schema to serve as a blueprint for establishing a systems pharmacology model which can be challenged with data arising from a variety of sources, including in vitro experiments, in vivo preclinical experiments utilizing the SCID mouse, and human challenge studies. The model will be used to perform simulations exploring the likely outcomes of alternative study designs and dosing regimens, either with single- or multiple-drug regimens. In this way, we will support model-based decision-making to improve the cost-effectiveness of R&D programs for life-saving therapies.

The Global Health Initiative is a program in support of the Foundation mission that “everyone deserves a chance to live a healthy life.”

 

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Global Health Initiative

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