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Integrated Development

Strategy Overview

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Preparation of Albendazole under strict sterile conditions for the final manufacture before being bottled and packaged for distribution worldwide.

Our Goal:

to strengthen regulatory systems and expedite the development, regulatory approval, and manufacturing of innovative new drugs, vaccines, diagnostics, and devices that advance global health.

The Challenge

The time it takes for a novel idea or discovery to result in a viable global health product can be years, even decades. Numerous obstacles stand in the way, from the time-consuming clinical trial stage to the regulatory approval process and the search for cost-effective manufacturing options. Lack of access to other researchers’ data can also stymie efforts to innovate and can lead to repetitive efforts and inefficiency.

The Opportunity
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At A Glance

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We serve as a “solutions shop” within the foundation to help troubleshoot complex challenges across all stages of the product development process, in areas ranging from regulatory planning and policy to clinical trial design and manufacturing.

We work to reduce the time needed for novel medical products to gain regulatory approval so they can more quickly reach the people who need them most.

We create platforms for knowledge sharing and collaboration so researchers can analyze large amounts of data from widely dispersed sources and get to insights and discoveries faster.

We support the development of technologies that facilitate drug discovery, low-cost drug manufacturing, and drug delivery.

Our Integrated Development strategy is led by Dan Hartman and is part of the foundation’s Global Health Division.

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If product development processes can be made more streamlined, life-saving products can more quickly reach the people who need them most. The Integrated Development team was formed in 2012 to address shortcomings in the product development and regulatory ecosystem in order to better serve the foundation’s global health programs, our partners, and the global health community at large.


Our Strategy

The Integrated Development program serves as a “solutions shop” within the foundation to help troubleshoot complex challenges across all stages of the product development process, in areas ranging from planning and clinical trial design to manufacturing and regulatory approval. This includes providing guidance on evaluating drug and device candidates at predetermined points in the development cycle to inform go/no-go decisions related to efficacy, risk, cost, and other factors. We also create platforms for knowledge sharing and collaboration so researchers can analyze and interpret large amounts of data from widely dispersed sources and get to insights and discoveries faster.

Areas of Focus
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Strengthening Regulatory Systems

The push to improve global health depends on having reliable sources of high-quality medical products—including vaccines, drugs, and diagnostics—at prices that are affordable for people in developing countries. Many of those countries, as well as multilateral organizations such as Gavi, UNICEF, and UNITAID, require that the medical products they buy meet standards set by the World Health Organization (WHO).

We work to reduce the time needed for a novel medical product to achieve WHO prequalification and other regulatory approval, by taking the guesswork out of the process and fostering an ecosystem in which products can more quickly proceed through the regulatory pipeline. We also strive to improve monitoring and surveillance of medical products after they have been licensed for use, in order to identify any adverse reactions.

Data Analytics for Decision Making

We provide data analysis support to other foundation programs and to our partners and grantees to inform their decision making. One key effort is an initiative that integrates massive amounts of existing data—covering 12 million children in 34 countries—about risk factors affecting birth, growth, and neurodevelopment. Researchers can analyze this data set to generate insights and facilitate rapid progress.

We apply this same data-driven approach to our model-informed drug development platform and our dose-selection platform for vaccines and therapeutic drugs. Another key initative is our support for data collection and research on infecting Aedes aegypti mosquitos with Wolbachia bacteria, which renders them less able to transmit dengue, chikungunya, and Zika. Other projects include support for development of long-acting oral and inhaled drugs, including contraceptives.

Chemistry, Manufacturing, and Controls

We provide technical expertise to other foundation programs on manufacturing, delivering, and seeking regulatory approval for drug candidates, with the aim of accelerating timelines and increasing the probability of success. We also work with the foundation’s country offices to facilitate partnerships with low-cost regional manufacturers and invest in promising low-cost manufacturing technologies. In addition, we make grants to support the development of technologies that aid in drug discovery and low-cost drug manufacturing and drug delivery devices.
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