Product Development Partnerships: The cutting edge of Global Health innovation

Eoghan Walsh Global Health, HIV & AIDS, Poverty-Related and Neglected Diseases

Credit: Kate Holt/AusAID

Global Health Series: Support for global health is at the core of DSW’s advocacy work. One of the four focus areas for the organisation is to have global health policies and financing include and support SRHR. We recognise at DSW recognises the urgent need to improve the global health situation, and we continue to advocate for health improvements in low- and middle-income countries. As part of this work, we have launched a series of policy briefs on the issue of global health research and development, outlining why we need to increase financial and political support (in Europe) for efforts aimed at creating new ways to tackle diseases such as HIV and AIDS, TB and malaria.

Last week, we posted on why we need to invest in global health R&D, and how this could benefit everyone – in Europe and in the countries most affected.

This week, we want to look at what kind of innovative mechanisms that could be the source of the next R&D breakthrough – product development partnerships (PDPs).

Download the factsheet now!

Global Health: What are PDPs and why do we need them?

PDPs are:

– Nonprofit organisations that develop appropriate and affordable innovative tools for populations affected by poverty-related and neglected tropical diseases (PRNDs).

 

– Public health-driven and focused on patients’ needs in designing product for use in low- and middle-income countries with a high disease burden.

 

– Are working along the product development continuum from early discovery to product implementation, covering specific research gaps or the full innovation cycle.

 

– Employing a portfolio approach to R&D to accelerate product development by pursuing multiple strategies for a disease area and allowing only the most promising products to move forward.

Engaged as partners with academic and public research institutions, the private sector, governments, and civil society organisations—including partners in developing countries, stimulating medical research in developing countries and linking scientists across the North-South divide.

Global Health: Bridging the 10/90 Gap

PDPs2The absence of an effective market and resulting lack of financial incentives to private sector investment has contributed to limited private sector engagement and restricted innovation in the field of global health R&D technologies. This is particularly the case for diseases such as HIV and AIDS, TB and malaria, as well as a host of other diseases collectively known as neglected tropical diseases. As a consequence, only 10 percent of global health research is devoted to conditions that account for 90 percent of the global disease burden—a “fatal imbalance” often referred to as the “10/90 gap”.

This damning imbalance triggered the creation of what are known as product development partnerships (PDPs); the goal of these new partnerships is to fill these R&D gaps. PDPs research, develop, and facilitate access to new health technologies that target diseases disproportionately affecting populations in low- and middle-income countries. PDPs drive R&D with patients’ needs in mind and facilitate access to appropriate and affordable medical interventions in the worst-affected countries. PDPs aim to advance global health goals by accelerating the development of products that may not otherwise have been created. Today there are 16 major PDPs operating globally, each with a specialised focus on vaccines and other preventive tools, microbicides, treatments, or diagnostics. They have been central to the development of new treatments and interventions need to reach the health-related targets of the MDGs.PDPs, global health, innovation

PDP achievements – products in the pipeline

PDPs have helped to create the largest product development pipeline ever for drugs, vaccines, and diagnostic tools for global health. Prior to the creation of PDPs, the neglected disease R&D pipeline was noticeably empty. A 2001 study estimated that only 1.1 percent of new drugs approved between 1975 and 1999 were for PRNDs, though they represented 12 percent of the global disease burden.

With a focus on diseases that disproportionally affect developing countries, PDPs are committed to conducting research with and in these countries, and as they integrate partners from the North and South, they have made important contributions to building and sustaining capacity for health research. The organisations currently support research centers and scientists across Africa, Asia, and Latin America.

Vaccines, Microbicides and more  

Download the factsheet for a full rundown of some of the most successful PDPs working to advance global health right now. Some of the (non-exhaustive) concrete examples of the great work being done by these partnerships in recent years include:

Drugs for Neglected Diseases initiative (DNDi) is working to deliver new treatments for neglected diseases, in particular leishmaniasis, human African trypanosomiasis (sleeping sickness), Chagas disease, malaria, specific filarial infections, and paediatric HIV. Since its inception, DNDi has delivered six treatments: two fixed-dose anti-malarials, combination therapy (NECT) for late-stage sleeping sickness, combination therapy for visceral leishmaniasis in Africa, a set of combination therapies for visceral leishmaniasis in Asia, and a pediatric treatment for Chagas disease.

The International AIDS Vaccine Initiative (IAVI) has as its mission to ensure the development of safe, effective, accessible, preventive AIDS vaccines. It has a strong focus on the countries where HIV/AIDS has greatest impact, coordinating a network of research laboratories in five African countries and in India, building clinical research capacity, engaging with local communities and providing services such as free HIV testing and counselling. IAVI is dedicated to ensuring that a future AIDS vaccine will be available and accessible to all who need it, including those vulnerable groups (such as women and girls) who are often poorly served by existing HIV prevention tools.

The International Partnership for Microbicides has been working since 2002 to prevent HIV transmission by accelerating the development and availability of safe and effective microbicides for use by women in developing countries. IPM’s most advanced product is a monthly vaginal ring that slowly releases the antiretroviral drug dapivirine. The dapivirine ring is now in two parallel Phase III studies—the first efficacy studies of a microbicide ring for HIV prevention. These studies are expected to provide the evidence needed to secure regulatory approvals and licensure when results become available in 2016.

PATH, an international non-profit organisation focused on transforming health through innovation. One of PATH’s flagship product development programmes is the PATH Malaria Vaccine Initiative (MVI). MVI was established in 1999 to accelerate the development of malaria vaccines and catalyze timely access in endemic countries, toward realizing its vision of a world free from malaria. MVI identifies potentially promising malaria vaccine approaches and systematically moves them through the development process. Since its founding, MVI has moved dozens of projects through its pipeline, with half a dozen in clinical development in 2014—including the RTS,S malaria vaccine candidate, under development with GlaxoSmithKline, which is currently in late-stage development.

Read more in the Factsheet

As I have said, this is a very non-exhaustive list. Check out the factsheet for the full rundown on the PDPs working today to improve global health, including Aeras, the European Vaccine Initiative (EVI), FIND, Medicines for Malaria Venture, Sabin PDP and the TB Alliance.

Next week: Global Health R&D supporting the fight for improved reproductive, maternal, newborn and child health. Stay tuned!