Policy Innovations

Name
Accelerated Approval Determining the clinical outcome for a new health technology, that is whether a patient’s health improves and in what way, can take significant time, even years. The Accelerated Approval program of the FDA allows companies to reach a clinical surrogate, a physical sign or laboratory measurement, to determine clinical effectiveness. This can reduce valuable review time and allow companies to reap the benefits of their innovation more quickly. The FDA reserves the right to remove the product from the market if confirmatory trials do not align with the original testing.
Advance Market Commitment (AMC) The Advanced Market Commitment (AMC) is a legally binding fund to incentivize R&D through a guaranteed purchase commitment. Funding groups agree to help pay for the purchase of a currently unavailable vaccine at a given price if the product meets agreed technical specifications which are set with the health needs of low income countries in mind. This induces developers to complete the product’s development and scale up production to the funder’s needs. A pilot AMC has been implemented for an improved pneumococcal vaccine appropriate for the developing world.
African Network for Drug and Vaccine Innovation (ANDI) The African Network for Drug and Vaccine Innovation (ANDI) is a partnership initiated by the WHO TDR aiming to build African health R&D capacity drawing from both western expertise and the biologics of traditional medicine. ANDI attempts to unite the fragmented landscape of African R&D to strengthen and sustain product development. The partnership draws upon the existing resources in the private and public sectors in Africa in addition to investing in new research infrastructure.
Bio Ventures for Global Health (BVGH) Business Cases BVGH profiled successful examples of global health R&D in a series of case studies that present opportunities for greater participation of biotechnology companies in global health. The case studies reveal the progress to date for research in specific diseases and also provide market assessments of the market potential of R&D and the potential return on investment.
BIO Ventures for Global Health (BVGH) Milestone-Based Prize BVGH proposes a milestone-based prize to promote the development and launch of a point-of-care (POC) diagnostic test for differential diagnosis of fever. This “Global Health Innovation Quotient Prize” will divide product development into successive parts and reward successful completion of each milestones. Proponents argue that this approach not only incentivizes the private sector, but allows small and medium-sized companies to participate by decreasing the required capital investment while decreasing the risk associated with pursuing global health R&D as well.
Biomedical R&D Treaty In 2005, a group of 162 scientists, public health experts, non-governmental organizations and government officials proposed a medical R&D treaty that would place global obligations on funding medical R&D. The treaty would set minimum levels of support for each participating country to finance medical R&D based upon their national incomes.
Cambia Initiative for Open Innovation The Initiative for Open Innovation is a new grant funded facility aiming to foster "equity in science" by making patent information more accessible and navigable. The Initiative works to centralize the fragmented approach to innovation. It builds upon the Patent Lens, an open source tool that makes full text patent information accessible to the public. Beginning with the life sciences and global health, the Initiative will landscape the patents in a given sector through a web based platform and display the information as an ecosystem of knowledge.
Center for Technological Development in Health In 2002, the U.K. Commission on Intellectual Property Rights suggested the creation of a network of public-private partnerships in the developing world that would mobilize the research resources of public sector institutions while taking advantage of the private sector’s ability to build research capacity. The goal of the Center for Technological Development in Health (CDTS) at the Oswaldo Cruz Foundation (Fiocruz) is to fuse individual research projects with industrial production partners in the private sector.
Chagas Disease Prize Fund for the Development of New Treatments, Diagnostics and Vaccines Bangladesh, Barbados, Bolivia and Suriname proposed a Chagas Disease Prize Fund to the WHO Expert Working Group. The prize would be endowed with $250 million and incentivize product development and information sharing. The fund would reward the development of vaccines, diagnostics and medicines that improve health outcomes for populations at risk for Chagas disease. New medicines and vaccines would be eligible for final product prizes, whereas solutions for technical challenges would receive awards in a “best contributions” category.
Clinical Trial Efficiencies Clinical trials are an expensive component of the drug development process. Streamlining trials to reduce the time needed for testing or allowing companies or allowing better comparison of trial outcomes (like using agreed outcomes, simplifying age de-escalation steps, and coordinating ethical approval for multi-center trials) could lower costs for drug developers and may encourage R&D for global health.

Name

Determining the clinical outcome for a new health technology, that is whether a patient’s health improves and in what way, can take significant time, even years. The Accelerated Approval program of the FDA allows companies to reach a clinical surrogate, a physical sign or laboratory measurement, to determine clinical effectiveness. This can reduce valuable review time and allow companies to reap the benefits of their innovation more quickly. The FDA reserves the right to remove the product from the market if confirmatory trials do not align with the original testing.

Advance Market Commitment (AMC)

The Advanced Market Commitment (AMC) is a legally binding fund to incentivize R&D through a guaranteed purchase commitment. Funding groups agree to help pay for the purchase of a currently unavailable vaccine at a given price if the product meets agreed technical specifications which are set with the health needs of low income countries in mind. This induces developers to complete the product’s development and scale up production to the funder’s needs. A pilot AMC has been implemented for an improved pneumococcal vaccine appropriate for the developing world.

African Network for Drug and Vaccine Innovation (ANDI)

The African Network for Drug and Vaccine Innovation (ANDI) is a partnership initiated by the WHO TDR aiming to build African health R&D capacity drawing from both western expertise and the biologics of traditional medicine. ANDI attempts to unite the fragmented landscape of African R&D to strengthen and sustain product development. The partnership draws upon the existing resources in the private and public sectors in Africa in addition to investing in new research infrastructure.

Bio Ventures for Global Health (BVGH) Business Cases

BVGH profiled successful examples of global health R&D in a series of case studies that present opportunities for greater participation of biotechnology companies in global health. The case studies reveal the progress to date for research in specific diseases and also provide market assessments of the market potential of R&D and the potential return on investment.

BIO Ventures for Global Health (BVGH) Milestone-Based Prize

BVGH proposes a milestone-based prize to promote the development and launch of a point-of-care (POC) diagnostic test for differential diagnosis of fever. This “Global Health Innovation Quotient Prize” will divide product development into successive parts and reward successful completion of each milestones.

Proponents argue that this approach not only incentivizes the private sector, but allows small and medium-sized companies to participate by decreasing the required capital investment while decreasing the risk associated with pursuing global health R&D as well.

Biomedical R&D Treaty

In 2005, a group of 162 scientists, public health experts, non-governmental organizations and government officials proposed a medical R&D treaty that would place global obligations on funding medical R&D. The treaty would set minimum levels of support for each participating country to finance medical R&D based upon their national incomes.

Cambia Initiative for Open Innovation

The Initiative for Open Innovation is a new grant funded facility aiming to foster "equity in science" by making patent information more accessible and navigable. The Initiative works to centralize the fragmented approach to innovation. It builds upon the Patent Lens, an open source tool that makes full text patent information accessible to the public. Beginning with the life sciences and global health, the Initiative will landscape the patents in a given sector through a web based platform and display the information as an ecosystem of knowledge.

Center for Technological Development in Health

In 2002, the U.K. Commission on Intellectual Property Rights suggested the creation of a network of public-private partnerships in the developing world that would mobilize the research resources of public sector institutions while taking advantage of the private sector’s ability to build research capacity. The goal of the Center for Technological Development in Health (CDTS) at the Oswaldo Cruz Foundation (Fiocruz) is to fuse individual research projects with industrial production partners in the private sector.

Chagas Disease Prize Fund for the Development of New Treatments, Diagnostics and Vaccines

Bangladesh, Barbados, Bolivia and Suriname proposed a Chagas Disease Prize Fund to the WHO Expert Working Group. The prize would be endowed with $250 million and incentivize product development and information sharing. The fund would reward the development of vaccines, diagnostics and medicines that improve health outcomes for populations at risk for Chagas disease. New medicines and vaccines would be eligible for final product prizes, whereas solutions for technical challenges would receive awards in a “best contributions” category.

Clinical Trial Efficiencies

Clinical trials are an expensive component of the drug development process. Streamlining trials to reduce the time needed for testing or allowing companies or allowing better comparison of trial outcomes (like using agreed outcomes, simplifying age de-escalation steps, and coordinating ethical approval for multi-center trials) could lower costs for drug developers and may encourage R&D for global health.

Discover Policy Innovations

Our Policy Innovations page allows you to browse the dozens of proposed policies to accelerate product development for global health. You can use the search field to look for specific policies or you can simply browse through the entire list. The Innovations are divided into Push and Pull proposals. In other words, do the innovations help pay or manage R&D costs up front or do they present a reward for the development of the final product? The list is also divided into 8 types of Innovations which correspond to what specific area of R&D the Innovation intends to improve.

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Our Policy Innovations page allows you to browse through the dozens of policy innovations that have been proposed to accelerate global health R&D. You can use the search panel on the right side of the screen to view innovations by type or you can simply browse through the full list. If you click on the "+" button you can expand the list of innovation types.

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