within reach thanks to polio vaccines
What is R&D?
Research and development (R&D) is the translation of an idea or discovery into a product that addresses a health need. The result should be a safe and effective product that is appropriate, affordable, acceptable, and accessible to those who need it most.
Why do we need R&D?
Despite tremendous progress in global health, millions of people still suffer or die each year because we don’t have the right technologies to combat many long-standing health challenges. And new health threats are emerging at a rapid pace. To overcome these challenges, new drugs, vaccines, diagnostics, and other tools are needed.
What does the R&D process look like?
The path from promising discovery to lifesaving technology involves multiple steps:
Identify Need
Understanding needs and challenges of end-users to inform research
Basic Research / Discovery
Uncovering insights into the biology of a disease and methods to address it
Preclinical Research
Translating discoveries into potential products and conducting lab testing
Clinical Research
Testing products for safety and efficacy in humans
Regulatory Review and Approval
Confirming the safety, efficacy, and quality of new products
Introduction & Scale
Launching and distributing products to meet global needs
Post-Approval Surveillance
Monitoring the ongoing safety, use, and effectiveness of products
Impact Achieved
Lives saved or improved / Health care costs reduced / Economic growth accelerated
Who are the players?
Many different sectors and stakeholders contribute to the development of global health technologies.
Conduct research to build foundational knowledge of diseases and conditions; advance product development, particularly at the early stage; and build an evidence base to inform R&D.
Engage in education or advocacy efforts to influence and advance R&D. Impacted communities help inform product design, development, and regulation and serve as critical partners in conducting clinical trials.
Directly fund R&D across all stages, particularly for diseases and conditions neglected by the private sector and those with epidemic potential; enact policies to incentivize private-sector R&D; support R&D infrastructure and capacity-building; and oversee regulatory standards and processes.
Convene and coordinate nations around shared health R&D objectives; build an evidence base and provide technical assistance to other stakeholders engaged in health R&D; produce guidelines for product use; and set product efficacy and safety standards for global procurement bodies that purchase and distribute products.
Conducts R&D directly in cases where a profitable market exists for a product or contributes as part of product development partnerships.
Bring together resources and talent from the public, private, and philanthropic sectors to develop critically needed health technologies for neglected diseases and conditions and emerging infectious diseases focusing on public health impact rather than profit.
Fund R&D for diseases and conditions neglected by the private sector, as well as other supportive efforts, including education, advocacy, and research to build an evidence base.
What are the challenges?
There are many obstacles throughout the process of developing new global health technologies.
Financing
Most challenging is the lack of traditional market incentive. Emerging infectious diseases and diseases and conditions that disproportionately impact the world’s poorest places offer limited profit incentives to spur private-sector investments in R&D for new tools. Thus, sustained public-sector investment and philanthropic funding is critical to jump-start research and successfully move products through the R&D process.
Funding for neglected disease R&D
Designing for access
To reach people in need in every corner of the globe, products must be designed from the start to be fit-for-purpose for resource-limited settings. That means technologies should be affordable, easy to administer, and adapted for use in places without reliable electricity or infrastructure, and that early groundwork is laid to advance manufacturing and distribution approaches that will promote widespread availability.
4 “A”s to innovate for global access
Affordability
Will the product be available at a price low- and middle-income countries can afford?
Administration
How challenging is it to administer and what training is required of health workers?
Adaptability
Is it usable in settings without basic infrastructure, electricity, and equipment?
Availability
Can manufacturing and distribution mechanisms meet global need?
Capacity gaps
Under-resourced health systems in low- and middle-income countries (LMICs) can also increase the difficulty of conducting clinical trials. Additionally, limited staff and capacity at regulatory authorities, particularly in LMICs, can delay product review and approval, while different regulatory requirements across multiple countries can delay widespread product introduction. It can also be a challenge to secure local manufacturers that can produce products while meeting pricing, supply, and quality standards.
What is GHTC's role?
The challenges for global health R&D are large, but not insurmountable. GHTC works with academia, advocates, civil society, governments, multilateral organizations, the private sector, product development partnerships, and philanthropic donors to catalyze new investment and advance policy solutions to dismantle these obstacles and accelerate the development of critically needed health technologies.
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