Integrated Development

Our goal

To accelerate the development, regulatory approval, and manufacturing of innovative products and enabling platforms that advance global health.

Preparation of Albendazole under strict sterile conditions for the final manufacture before being bottled and packaged for distribution worldwide. — A sterile manufacturing facility that produces albendazole, an anti-parasitic drug.

At a glance

We synergize our collective expertise in quantitative sciences / pharmacology, manufacturing, and regulatory affairs to advance impactful products.
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 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 support the development of technologies that facilitate drug discovery, low-cost drug manufacturing, and drug delivery.

Our strategy

The Integrated Development program serves as a “solutions shop” within the foundation to address complex challenges across all stages of the medical products development process, in areas ranging from cross disciplinary planning to 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 and adjust if indicated 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.

We focus on decision quality utilizing the totality of data to guide investments.

Participants meet and brainstorm innovative healthcare solutions at the second day of the Global Health Product Development Challenge Workshop in Seattle, WA on April 27, 2016. — Brainstorming innovative health care solutions at the Global Health Product Development Challenge Workshop in Seattle, Washington.

Areas of focus

Regulatory systems strengthening and programmatic support

Quality health care systems require access to quality medical products (vaccines, therapeutics, diagnostics, and vector control products) and this access can be assured only through quality regulatory systems.

We work to optimize the low-income country regulatory and pharmacovigilance systems through which products go to be developed, marketed, procured, and used safely. Technical standards harmonization and regulatory process optimization (including reliance and regionalization) foster an efficient ecosystem where products with the requisite data achieve World Health Organization (WHO) prequalification and regulatory approvals in the shortest time without sacrificing rigor. We also strive to improve monitoring of products post-approval to ensure continued patient safety.

We work with other foundation teams and product development partners to develop regulatory strategies that accelerate the introduction of innovative, high-quality products. This work begins with the development of target product profiles and continues through the entire product development cycle, resulting in strategies for obtaining clinical trial authorizations, marketing authorizations, and policy recommendations from regulatory agencies, WHO, and others.

Quantitative sciences

We provide data analysis support to other foundation teams to help guide their decision-making.

We also work in collaboration with external partners and grantees to learn from the data generated by our investments and inform the direction of our subsequent work. This decision-centric data-driven approach guides our efforts in model-informed drug development (MiDD), improved clinical trial designs through our Design, Analyze, Communicate (DAC) initiative, the integration of real-world evidence (RWE) to explore new hypotheses, and Knowledge Integration (Ki) of the resulting data from our investments. These efforts support foundation teams as they assess the progress of their investments against their strategic goals and explore insight gained from integrated data analyses.

Chemistry, manufacturing, and controls

We provide technical expertise to other foundation programs on product and process development as well as manufacturing, quality, and related issues 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 to lower the cost of goods and increase supply. In addition, we make grants to support the development of promising technologies for low-cost manufacturing, long-acting drug delivery, and other innovations to increase access for patients in low-income countries.

Contraceptive technology research and development

Women who have access to a range of safe, effective, user-responsive contraceptive methods are better able to plan the number and timing of their children, leading to better health outcomes for mothers, babies, and families.

We support the foundation’s Family Planning team by investing across the contraceptive R&D value chain to develop transformational new methods that better meet the needs of the most vulnerable women and adolescents and the delivery constraints of low-resource settings, including methods that decrease reliance on the formal health care system. The foundation is the largest funder of R&D in this field, and we bring the Global Health Division core product development skills and resources to ensure that our grant portfolio is designed and managed effectively.

Why focus on integrated development?

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.

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 improve 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.

Production facilities at the Serum Institute of India.

Strategy leadership

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